NECESSARY, BAND OF SOLID SUPPORT UNITS, SUPPORT FOR HOLDING AND METHOD OF DETECTING AT LEAST TWO ANA

专利摘要:
The present invention relates to a kit for the production of a customized test strip for the detection of at least two analytes, the kit comprising at least one strip of solid support units (USS) (1) and at least one support support (2), the USS strip (1) comprising multiple solid support units (111) arranged in tandem, each solid support unit (111) being the same in the USS strip (1) and each solid support unit (111) being detachable from the USS strip (1), and the holding support (2) comprising a body (250) having a generally longitudinal shape, said body (250) being provided with at at least two receiving regions (220, 220'), each receiving region (220, 220') being adapted to receive a solid support unit (111). The present invention also relates to an USS strip, a holding support, and their use, and a method for producing a custom test strip for the detection of at least two analytes in a biological sample.
公开号:BE1024067B1
申请号:E2014/5072
申请日:2014-11-19
公开日:2017-11-10
发明作者:Alain Georges André Vigneron；Nicolas Bodart；Hans Achille Tony Goossens；François Gabriël Théo Royen；Benoît Valère Jacques Ghislain AUTEM
申请人:Tekinvest Sprl；
IPC主号:

专利说明:

NECESSARY, BAND OF SOLID SUPPORT UNITS, SUPPORT FOR HOLDING AND METHOD OF DETECTING AT LEAST TWO
ANALYTE
FIELD OF THE INVENTION In general, the invention relates to the field of analysis, for example in the field of laboratory diagnostics for medical analyzes. The present invention relates to a kit, a strip of solid support units, a holding support, and their uses, and methods for producing an assay band for the detection of at least two analytes in a sample organic. The invention allows the user to prepare a customized multiparametric analysis band for the detection of at least two analytes in a biological sample.
Background of the invention
Several strategies have been developed for the detection of analytes in a biological sample for routine diagnostics in diagnostic laboratories, for example, by immunoassays.
Essentially, immunoassays can be performed in a liquid-based assay using, for example, a plastic well (e.g. in a 96-well plate) with certain immunological reagents. Another possibility is to perform the detection of an immunoassay on a membrane-based system (e.g., assay strips). The well-based system is generally limited to the detection of a single analyte, while recent membrane-based assays have been developed to allow simultaneous detection and / or quantitative determination of different analytes by assay.
Commercially available assay strips are generally coated with a series of different ligands, each of which can bind independently to a respective specific analyte in a biological sample. However, the combination of ligands available on a particular multiparametric analysis band does not always correspond to the set of analytes to be tested for a patient. Therefore, different assay strips must be used to analyze all the analytes required for the patient. However, the ligands available on the various analysis bands are not all useful for a given patient and some of the ligands available on the different analysis bands are even redundant. As a result, the use of multiparametric test strips in routine medical laboratories often lacks flexibility to match the precise analysis required for each particular patient and generally remains, for economic reasons, very limited.
There remains, therefore, in the art a need for new and / or improved multiparameter systems for the detection of analytes in a biological sample. Summary of the invention
The inventors of the present invention have now discovered a kit comprising a strip of solid support units and a holding support, responding to one or more of the above-mentioned problems of the state of the art.
Accordingly, a first aspect of the invention relates to a kit for producing a custom analysis strip for the detection of at least two analytes, the kit comprising at least one solid support unit (USS) strip. and at least one holding support, the USS band comprising multiple tandem solid support units, each solid support unit being the same in the USS band and each solid support unit being detachable from the band of USS, and the holding support comprising a body having a generally longitudinal shape, said body being provided with at least two receiving regions, each receiving region being adapted to receive a solid support unit.
The kit embodying the principles of the present invention advantageously allows the user or the consumer, such as a medical analysis laboratory, to produce an analysis band adapted to the patient, or in other words to adapt the analyte test strip required, for example as prescribed by the practitioner. Such a kit makes it possible to test only the required analytes, without having to test irrelevant and / or redundant analytes. In addition, the present kit advantageously reduces the number of tests to be performed and the number of results to be analyzed, validated and interpreted, which increases the speed of analysis, reduces the amount of sample needed, reduces the impact on the sample. reducing the required reagents and consumables, and therefore lowering costs.
As mentioned above, the present requirement allows the user or consumer, such as a medical laboratory, to test only those analytes that have been prescribed by a practitioner, which may also be important from a point of view. from a legal point of view. Indeed, the present required allows to test and report only the analytes that are prescribed by the practitioner and / or are reimbursed to the patient.
From the point of view of manufacture, the present needs are also economically advantageous, as they allow the manufacturer to control the quality of each USS strip separately. For example, the present kit allows the manufacturer to control the quality of the application of a ligand on the USS band separately from the quality of the application of the other ligands. In contrast, in existing multiparametric assay bands, multiple ligands are applied on a single assay band and therefore, when the application of one of the ligands does not fall within the range of the required quality specifications, the band complete multiparametric analysis (including applied ligands) should be rejected in its entirety.
A second aspect relates to a solid support unit (USS) band for producing a custom analysis band, for the detection of at least two analytes, the USS band comprising multiple solid support units arranged in tandem, each solid support unit being the same in the USS band and each solid support unit being detachable from the USS band.
Another aspect of the invention relates to a holding support for holding at least two solid support units, the holding support comprising a body having a generally longitudinal shape, said body being provided with at least two receiving regions. each receiving region being adapted to receive a solid support unit.
The USS band representing the present invention and the holding support representing the present invention advantageously allow the creation of a multiparametric analysis band adapted to the needs of the user, for example adapted to the patient. The user or consumer, such as a medical analysis laboratory, can select two or more different USS strips for a patient, to create a personalized patient analysis strip, in complete agreement with the patient. the required analysis. The number of diagnostic parameters to be used in the analysis band is thus rationalized, since the detection of irrelevant and / or redundant analytes is avoided.
Accordingly, another aspect of the invention relates to the use of at least two different USS bands as defined herein and a support as defined herein for the production of an assay strip. customized for detecting at least two analytes.
Another aspect of the invention provides a method for producing a customized assay strip for the detection of at least two analytes in a biological sample, comprising the steps of: (a) providing at least two assay units; and (c) charging at least two receiving regions of the holding support, each with a different solid support unit.
In some embodiments of the kit, as taught herein, the kit includes at least two different USS strips.
In some embodiments of the kit or the strip as taught herein, each solid support unit comprises an immunoassay. In some embodiments of the kit or band, as taught herein, the USS strip comprises at one end a coupling member for coupling to a dispenser adapted to dispense a solid support unit at a time. . In some embodiments of the kit or tape, as taught herein, the USS tape is included in a dispenser adapted to dispense one solid support unit at a time.
In some embodiments of the holder or holder, as taught herein, each receiving region comprises a compartment in the body of the holder, having a receiving opening for inserting reception of the solid support unit, and the compartment being designed to mechanically secure the solid support unit. In some embodiments of the holder or holder, as taught herein, the receiving opening is a slot in a longitudinal side wall of the body, which slot is adapted to slidably receive the solid support unit and communicating the outside of the body with an empty space inside the compartment. In some embodiments of the holder or holder, as taught herein, each receiving region comprises an adhesive attachment surface on the body of the holder, designed for adhesively securing to the solid support unit. In some embodiments of the kit or holder, as taught herein, at least two receiver regions are each provided with a solid support unit.
In some embodiments of the method as taught herein, each solid support unit comprises an immunoassay. In some embodiments of the method as taught herein, the method for the detection of at least two analytes in a biological sample further comprises the steps of: (d) introducing a biological sample into a sample chamber of said sample holding support, (e) inserting the holding support loaded with step (d) into a container comprising at least one fluid, and (f) detecting at least two analytes in the biological sample.
These and other aspects and embodiments of the invention are set forth below in more detail in the following sections and in the claims, and illustrated by non-limiting figures. The reference numbers refer to the figures appended hereto.
Brief description of the drawings
Fig. IA schematically represents a USS band according to one embodiment of the invention.
Fig. IB schematically shows a side view of a USS strip according to one embodiment of the invention.
Fig. IC schematically represents an enlarged side view of an end portion of a USS strip according to one embodiment of the invention.
Fig. 1D schematically represents an enlarged side view of an end portion of a USS strip according to one embodiment of the invention.
Fig. 2 schematically shows a holding support according to one embodiment of the invention.
Fig. 3 schematically shows a holding support according to another embodiment of the invention.
Fig. 4A schematically shows a front view of an enlarged portion of a holding support according to an embodiment of the invention.
Fig. 4B schematically shows a rear view of an enlarged portion of a holding support according to an embodiment of the invention.
Fig. 4C schematically shows a side view of an enlarged portion of a holding support according to an embodiment of the invention.
Fig. 4D schematically shows a side view of an enlarged portion of a holding support according to an embodiment of the invention.
Fig.4E schematically shows a side view of a section along the longitudinal axis A-A 'of an enlarged portion of a holding support according to an embodiment of the invention.
Fig.4F schematically shows a side view of a section along the longitudinal axis A-A 'of an enlarged portion of a holding support according to an embodiment of the invention.
Fig. 5 schematically shows a dispenser according to one embodiment of the invention.
Fig. 6 is a plan view of a transition element engaged in the first and second longitudinal members.
Fig. 7 is a schematic view of a detail of a notch of a first or second longitudinal member.
Fig. 7A indicates the angle cxr of the thrust surface (SP) of a notch of a first or second longitudinal member.
Fig. 7B indicates the angle βΓ of the sliding surface (SC) of a notch of a first or second longitudinal member.
Fig. 8 is a schematic view of a detail of a pawl of a transmission element.
Fig. 8A indicates the angle a1 of the thrust surface (SP) of a pawl of a transmission element.
Fig. 8B indicates the angle β1 of the sliding surface (SC) of a pawl of a transmission element.
Figs. 9 to 12 schematically show a method according to one embodiment of the invention for dispensing a solid support unit by a dispenser according to an embodiment of the invention.
FIG. 13 schematically shows a distributor according to one embodiment of the invention.
FIG. 14A schematically represents an assembly comprising a holding support according to an embodiment of the present invention, a dispenser according to an embodiment of the invention, and a loading device according to an embodiment of the present invention.
FIG. 14B schematically represents a view of the assembly of FIG. 14A along the longitudinal axis of the dispenser.
DETAILED DESCRIPTION OF THE INVENTION Unless otherwise indicated, all scientific and technical terms used herein have the same meanings as those commonly accepted by those skilled in the art. All publications cited herein are incorporated herein by reference.
The articles 'a' and 'an' are used here to designate one or more than one, that is at least one of the grammatical object of the article.
Throughout this application, the term "about" is used to indicate that a value includes the error standard deviation for the device or method that is used to determine the value. The indication of numeric ranges using limit points includes all integers and, where applicable, fractions within such a range (eg 1 to 5 may include 1, 2, 3, 4 when it relates, for example, to a number of elements). The end-point indication also includes the end-point values themselves (eg from 1.0 to 5.0 includes both 1.0 and 5.0).
Throughout the present description the reference to "embodiment" or "embodiment" means that a particular feature, structure or feature described in connection with the embodiment is included in at least one embodiment of the present invention. present invention. The occurrences of phrases "in one embodiment" or "in one embodiment" in various places throughout the present description therefore do not necessarily relate to the same embodiment but may relate to it. In addition, the particular features, structures, or features may be combined in any convenient manner, as the present disclosure would have to be apparent to those skilled in the art from the present description, in one or more embodiments. Further, while some embodiments described herein include certain features but not others included in other embodiments, combinations of features of different embodiments are understood to fall within the scope of the invention, and are different embodiments, as will be understood by those skilled in the art. For example, in the appended claims, any of the claimed embodiments may be used in any combination.
As used herein, the terms "comprising", "includes" and "consisting of" are synonymous with "including", "includes" or "containing", "contains", and are inclusive or open ended. do not exclude additional members, elements or process steps, not mentioned. Note that the terms "comprising", "includes" and "consisting of" as used herein include the terms "consisting of", "consists" and "consisting of".
In the following detailed description of the invention, reference is made to the accompanying drawings which form a part thereof, and on which are presented only by way of illustration of particular embodiments in which the invention can be put into practice. It should be understood that other embodiments can be used and that structural or logical modifications can be made without departing from the scope of the present invention.
The inventors of the present invention have realized that a kit comprising at least one solid support unit (USS) band and at least one holding medium allows the creation of a user-specific or customized analysis band. consumer.
Accordingly, in a first aspect, the present invention provides a kit for producing an assay band for the detection of at least two (different) analytes, the kit comprising at least one solid support unit strip. (USS) and at least one holding support, the USS band comprising multiple solid support units arranged in tandem, each solid support unit being the same in the USS band and each solid support unit being detachable from the USS band, and the holding support comprising a body having a generally longitudinal shape, said body being provided with at least two receiving regions, each receiving region being adapted to receive a solid support unit. The analytes are present in a sample.
In one embodiment, the kit as taught herein may include at least two different USS bands as defined herein. For example, the kit as taught herein may include at least three, at least four, at least five, at least six, at least seven, or at least eight different USS bands as defined herein.
Such a kit comprising at least two USS strips advantageously allows the creation of a user-or consumer-specific multiparameter analysis band for the detection of at least two analytes. The analytes can be different.
In one embodiment, the kit as taught herein may comprise two or more USS strips as defined herein, each USS strip being designed for a different dosage.
In one embodiment, the kit as taught herein may include one or more holding brackets as defined herein, each holding bracket being adapted to maintain at least two solid support units.
In one embodiment, the kit as taught herein may further include at least one dispenser adapted to dispense one solid support unit at a time.
The term "necessary" or "necessary parts", as used herein, refers to any combination of devices that can be used to produce an analysis band as defined herein. The kit of the invention may further include any additional devices, containers, reagents, buffers and / or excipients, as required, described herein or known in the art, for the practice of a method of the invention. Other items of the kit may include boxes for packaging, packaging materials, solutions for use in the assay, and the like.
A series of instructions to assist the user in the use of USS tapes, holding brackets, kits, uses or methods of the invention will also normally be included.
In a second aspect, the present invention provides a solid support unit (USS) band for the preparation of an assay band for the detection of at least two analytes, the USS band comprising multiple units of Solid support arranged in tandem, each solid support unit being the same in the USS band and each solid support unit being detachable from the USS band.
The USS band, and therefore a solid support unit, has an upper face and a lower face. The upper face and the lower face are essentially flat. The upper face and the lower face are essentially parallel. The upper face of the USS provides a surface on which a ligand can be immobilized. The upper face may be formed, for example, from a solid support material or may be a dosage membrane which is attached to a backing layer.
Each solid support unit may include an identification element. The identification element allows the user to visually inspect or control what type of solid support unit (s) has (have) been inserted into the holder. Each solid support unit may comprise an orientation or positioning element. The orientation or positioning element enables an automatic reading or interpreting system to identify a reference position from which the different positions of the separate analysis areas (such as ligands, controls, etc.) can be extrapolated. stallions) to be measured on the solid support unit.
In one embodiment, the underside of the solid support may be provided with an identifier. The identifier is preferably optically readable. The identifier may be a visible marking, such as a barcode or a quick response code (QR).
In some embodiments, the USS band may have an ability to be pushed.
As used herein, the term "pushability" refers to the feature of the USS strip which allows for sliding insertion of a solid support into the holder without buckling.
Advantageously, it is not necessary that the USS be transparent, so that it is possible to use ligands that would normally not attach to a conventional microplate transparent well.
In some embodiments, the USS band and thus the solid support unit may consist essentially of a solid support material to which a ligand may be immobilized. In some embodiments, the solid support material may be any suitable rigid material on which a ligand may be immobilized. In some embodiments, the solid support material may be essentially a non-chemically activated material to which a ligand may be immobilized. In some embodiments, the solid support material may consist essentially of a chemically activated material upon which a ligand may be immobilized. It may not have a dosing membrane.
In some embodiments, the solid support material may be a polymeric material or glass. In some embodiments, the solid support material may be essentially a plastic material, such as, for example, polystyrene, polypropylene or polycarbonate. The solid support material may have a substantially uniform degree of opacity and may be of any uniform color. It is preferably opaque. This is particularly advantageous when the underside of the solid support unit is provided with an identifier, such as a barcode or a QR code, which can then be read while being held in the receiving regions of the support medium. maintenance.
In some embodiments, the USS band and thus a solid support unit may comprise a membrane supported on a backing layer. In some embodiments, the USS strip and thus a solid support unit may comprise a backing layer and a metering membrane, the metering membrane being placed on the backing layer. The backing layer is on the underside of the USS web (and thus the solid support unit), and the metering membrane is on the upper face of the USS web (and thus the web). solid support unit).
The terms "membrane" and "dosing membrane" may be used interchangeably herein. The ligand can be immobilized on the "membrane" or "dosing membrane"
The terms "reinforcement layer" or "solid reinforcement" may be used interchangeably herein.
In some embodiments, the backing layer may consist essentially of a polymeric material or glass. In some embodiments, the backing layer may be essentially made of plastic material, preferably polyester.
In some embodiments, the assay membrane may be essentially cellulose, preferably nitrocellulose. In some embodiments, the dosing membrane may be essentially made of nylon or vinyl, preferably polyvinyl.
In some embodiments, the solid support unit may comprise at least one ligand. In some embodiments, the solid support unit may comprise at least one ligand that is specific for at least one analyte to be detected.
In some embodiments, the solid support unit may comprise at least one ligand that is immobilized on the solid support unit, for example on the upper face of the solid support material. In some embodiments, the USS band and thus the solid support unit may comprise at least one ligand that is immobilized on the assay membrane.
In this context, the terms "fixed", "applied", "immobilized", or "linked" may be used interchangeably here. When the solid support unit is described as comprising a ligand, a positive control or a negative control, it is understood that the ligand, positive control or negative control is "fixed", "applied", "immobilized" or " bonded to or on a surface of the solid support unit, preferably at or on the upper face.
In some embodiments, the at least one ligand may be a protein, a modified protein, a peptide, a nucleic acid (such as a deoxyribonucleic acid or a ribonucleic acid), a hapten, an antigen, an antibody, or a metabolite of any of these substances, as well as any other compound (either natural or synthetic) which may be of diagnostic interest and which has a specific ligand-ligand partner (eg receptor ligand-receptor moiety ). For example, the ligand may be selected from the group consisting of an antibody, a protein, an antigen, a hapten and a nucleic acid.
In some embodiments, the ligand may be selected from: an antibody comprising a monoclonal antibody raised against one or more antigens of the sample, such as human or animal proteins, including antibodies, or a hapten or other molecules organic or inorganic; an antigen capable of specifically interacting with one or more antibodies in the sample; a protein, such as protein A, protein G or protein L, capable of binding to the Fc fragment of certain immunoglobulins, a natural or synthetic amino acid sequence capable of entering into specific interactions with certain organic molecules for example a synthetic peptide, a hapten or other organic or inorganic molecules; a natural or synthetic nucleotide sequence, such as a single-stranded or double-stranded DNA or RNA, capable of entering into specific interactions with a complementary nucleotide sequence, or with certain organic molecules, for example a synthetic peptide, a hapten or other organic or inorganic molecules; or a combination of any two, any three, any four, or any five of the aforesaid ligands.
In some embodiments, the ligand may be selected from the group consisting of an antigen, an antibody, a protein, a hapten, and a nucleic acid. In some embodiments, the ligand may be an antigen. In some preferred embodiments, the ligand may be an autoantigen.
As used herein, the term "ligand" means an agent capable of detecting an analyte, for example in a sample, (such as a biological sample).
As used herein, the term "analyte" refers to an agent capable of binding to a ligand, e.g., attached to a solid support unit (such as a dosage membrane).
As used herein, the terms "analyte" and "ligand" refer to members of any specific binding pair whose ligand is immobilized on a solid support unit (such as a dosage membrane), and the analyte is present in a sample (such as a biological sample) to be contacted with the solid support unit (such as the assay membrane). The ligand therefore refers to any capture or trapping agent immobilized on the solid support (surface) unit and the analyte refers to any specific binding partner thereon. The ligand and the analyte may be the same type of molecule depending on the design of the assay. Immobilization may be by an interaction selected from different types of interactions, such as ionic bond, covalent bond, or hydrophobic interactions. The number of ligands immobilized on a solid support unit (as on a solid support unit dosing membrane) depends on the test. The number of ligands immobilized on a solid support unit (as on a solid support unit dosage membrane) can range from 1 to several hundreds depending on the size of the solid support unit and the area occupied by each ligand. .
In some embodiments, the solid support unit may comprise at least one ligand. For example, the solid support unit may comprise one or more ligands, such as at least two, at least three, at least four, at least five, at least six, at least seven, or at least eight ligands. The solid support unit, in particular the upper face, may comprise at least one analysis zone or dosing zone. Preferably, said solid support unit, in particular the upper face, comprises at least 3 dosing zones, more preferably at least 6 dosing zones, more preferably at least 9 dosing zones. Each assay zone may be designed to specifically detect an analyte in the sample.
The terms "assay area" or "assay area" as used herein refer to a separate area on the solid support unit. An assay zone is preferably provided with ligand, i.e. the ligand is immobilized on the solid support unit in a zone limited to the assay zone. It is preferably coated with the ligand. The analysis zone may be provided with a ligand or with 2 or more different ligands. The analysis area may be a dot or a line, or may be any shape allowing detection such as visual detection.
In some embodiments, the analyte may be any molecule for which the detection and / or measurement of the concentration is possible and for which there is a specific complementary molecule, a ligand. For example, the ligand and analyte may be stereo-complementary, allowing the analyte to be attached to the solid support unit by binding to a ligand that is readily accessible on the surface of the solid support unit. . Without limitation, the analytes that can be analyzed and / or detected include narcotics or their metabolites, analytes indicating the presence of an infectious agent or product of an infectious agent, a pollutant, a toxin, a contaminant, an analyte of medical or diagnostic interest, an antibody against any one of the foregoing, and any combination thereof.
The terms "detect" or "detect" generally mean determining the presence or absence of an analyte in a sample, such as a biological sample. The term "analyte detection" may include the assay of an analyte.
The terms "measure" or "measure" generally mean the determination of the rate, amount or concentration of an analyte in a sample, such as a biological sample. The term "semi-quantitative measurement" generally means the determination of an approximation of the rate, amount, or concentration of an analyte in a sample, such as a biological sample.
In some embodiments, the analyte may be selected from the group consisting of an antibody, an antigen, a protein, a hapten, and a nucleic acid. In some embodiments, the analyte may be an antibody. In certain preferred embodiments, the analyte may be an autoantibody.
In some embodiments, the solid support unit may be used to detect an analyte in a biological sample. The biological sample may be a body fluid such as serum, plasma, blood, cerebrospinal fluid, nasopharyngeal secretions, urine, sperm, or saliva; a food; the water ; supernatants or culture media; or feces. In some preferred embodiments, the biological sample may be selected from the group consisting of serum, plasma, and blood.
In some embodiments, the solid support unit may comprise at least one ligand, wherein the ligand may be present in two or more different assay zones at the same concentration on the solid support unit. For example, the same ligand may be present in duplicate (i.e. twice), triplicate (i.e., three times), four times, five times, or six times, at the same time. concentration on the solid support unit. This advantageously makes it possible to calculate a mean value and / or a standard deviation of the values which is recommended or even required for the execution of certain assays such as diagnostic assays.
In some embodiments, the solid support unit may comprise at least one positive control. For example, the solid support unit may comprise one or more positive controls, such as at least two, at least three, at least four, at least five, at least six, at least seven, or at least eight positive controls present in the control. different areas of analysis. The positive controls may have the same composition at the same concentration, the same composition at different concentrations, or a different composition at the same concentration, or a different composition at different concentrations. In some embodiments, the solid support unit may comprise at least one positive control, wherein the positive control may be present in two or more different assay zones at the same concentration on the solid support unit. For example, the positive control may be present in duplicate (i.e., twice), triplicate (i.e. three times), four times, five times, or six times at the same concentration. on the solid support unit. This advantageously makes it possible to calculate a mean value and / or a standard deviation of the values which is recommended or even required for the execution of certain assays, such as diagnostic assays.
As used herein, the term "positive control" refers to an area of analysis in which a phenomenon is expected (100% effect or 100 units). That is, a positive control ensures that there is an effect when there should be an effect, for example by using a ligand that is already known to produce that effect with the sample being analyzed. A positive control may be used to evaluate the validity of the test, as to control the presence of the sample.
The terms "positive control" or "sample control" may be used interchangeably.
In some embodiments, the solid support unit may comprise at least one negative control. For example, the solid support unit may comprise one or more negative controls, such as at least two, at least three, at least four, at least five, at least six, at least seven, or at least eight negative controls present in different areas of analysis. The negative controls may have the same composition at the same concentration, the same composition at different concentrations, or a different composition at the same concentration, or a different composition at different concentrations. In some embodiments, the solid support unit may comprise at least one negative control, the negative control may be present in two or more different assay zones at the same concentration on the solid support unit. For example, the negative control may be present in duplicate (i.e. twice), in triplicate (i.e., three times), four times, five times, or six times at the same concentration. on the solid support unit. This advantageously makes it possible to calculate a mean value and / or a standard deviation of the values which is recommended or even required for the execution of certain assays, such as diagnostic assays.
As used herein, the term "negative control" refers to an area of analysis in which no phenomenon is expected (zero effect or 0% effect). That is, a negative control ensures that there is no effect when there should be no effect, for example by using a ligand that is already known to cause no effect. A negative control can be used to evaluate the threshold or normalization value.
The terms "negative control" or "threshold control" may be used interchangeably.
In some embodiments, the solid support unit may comprise at least one ligand, at least one positive control, and at least one negative control. Such a solid support unit advantageously allows a semi-quantitative assay of an analyte binding to at least one ligand. Said at least one positive control and said at least one negative control allow semi-quantitative determination of an analyte binding to said at least one ligand. It is therefore understood that said at least one positive control and said at least one negative control may be standards. The negative control may be a zero unit standard. The positive control may be a standard of 100 units.
In some embodiments, the solid support unit comprises at least one ligand, at least one positive control, and at least one negative control, said at least one ligand, said at least one positive control, and said at least one control. each of which are present in two or more different analysis zones at the same concentration on the solid support unit. For example, said at least one ligand, said at least one positive control, and said at least one negative control may be present in duplicate (i.e. twice), in triplicate (i.e. three times), four times, five times, or six times at the same concentration on the solid support unit. This advantageously makes it possible to calculate a mean value and / or a standard deviation of the values which is recommended or even required for the execution of certain assays, such as diagnostic assays.
In some preferred embodiments, the solid support unit comprises a ligand, a positive control, and a negative control. In some preferred embodiments, the solid support unit comprises a ligand, a positive control, and a negative control, the ligand, the positive control, and the negative control being present in two or more different assay zones. the same concentration on the solid support unit. For example, the ligand, the positive control and the negative control are present in duplicate (i.e. twice), in triplicate (i.e., three times), four times, five times, or six times at the same concentration on the solid support unit. In certain preferred embodiments, the solid support unit comprises a ligand, a positive control and a negative control, the ligand, the positive control and the negative control being present in triplicate at the same concentration on the solid support unit. (such as the dosing membrane of a solid support unit). This advantageously makes it possible to calculate a mean value and / or a standard deviation of the values which is recommended or even required for the execution of certain assays, such as diagnostic assays.
In some embodiments, the solid support unit may comprise at least two standards arranged in different dosage zones. Such a solid support unit advantageously allows a semi-quantitative determination of the ligand. In some embodiments, the solid support unit may comprise at least three standards arranged in different dosage zones. Such a solid support unit advantageously allows a quantitative determination of the ligand. In some embodiments, the solid support unit may comprise at least three standards for a calibration curve, the read value (e.g., color) of the standards increasing with increasing concentration. For example, the solid support unit as defined herein may comprise three or more standards located in different analysis areas. For example, the solid support unit as defined herein may include at least four, at least five, at least six, at least seven, at least eight, at least nine, at least ten, at least eleven, or at least twelve standards arranged in different analysis zones for a calibration curve, the value read (for example the color) of the standards increasing with increasing concentration.
In some embodiments, the solid support unit may include a cookie for validating the correct handling. In certain embodiments, the solid support unit may comprise at least three controls arranged in different analysis zones, such as at least one control for the validation of the correct manipulation, at least one control for the validation of operation. and / or the type of tracer used, and at least one witness for the validation of the signal development system.
Ligands and / or standards and / or controls may be applied to different areas of analysis (such as dots) on the solid support unit. In some embodiments, the solid support unit may include scan areas in a matrix network. In some embodiments, the solid support unit may comprise two times two (i.e. 2x2), three times three (i.e., 3x3), four times four (i.e. ie 4x4), or five times five (ie 5x5) scan areas in a matrix network. For example, the solid support unit can comprise two times two (ie 2x2) points, three times three (ie 3x3) points, four times four (ie say 4x4) points, or five times five (ie 5x5) points. For example, the solid support unit as defined herein may comprise a ligand, a positive control and a negative control, the ligand, the positive control and the negative control being present in triplicate at the same concentration on the support unit. solid, and the solid support unit may comprise three times three (i.e. 3x3) analysis areas in a matrix network. Analysis areas (such as dots) should be machine readable, preferably optically readable.
The standards, the positive control and the negative control may be chosen from: an antibody comprising a monoclonal antibody raised against one or more antigens present in the sample or in any reagent required for carrying out the assay, for example human proteins or animal, including antibodies, or a hapten or other organic or inorganic molecules; an antigen, specific for one or more antibodies present in the sample or in any reagent required to perform the assay; a protein, such as protein A, protein G or protein L, capable of binding to the Fc fragment of certain immunoglobulins, a natural or synthetic amino acid sequence capable of entering into specific interactions with certain organic molecules for example a synthetic peptide, a hapten or other organic or inorganic molecules; a natural or synthetic nucleotide sequence, such as a single-stranded or double-stranded DNA or RNA, capable of entering into specific interactions with a complementary nucleotide sequence; an enzyme or any organic or inorganic molecule, whether or not linked to another organic or inorganic molecule, capable of generating a detectable signal, either in the presence of a signal generating source, or in an inherently inherent manner, for example a alkaline phosphatase or peroxidase, fluorescent dyes, colloidal metal particles or luminescent molecules; or a combination of any two, any three, any four, any five or any six thereof.
In some embodiments, the assay may be an immunoassay. In some embodiments of the kits, USS strips, uses, or methods, as taught herein, each solid support unit may comprise an immunoassay.
As used herein, the term "immunoassay" means an assay comprising at least one antigen specific for at least one antibody to be detected, or comprising at least one antibody specific for at least one antigen to be detected.
In some embodiments, the immunoassay may comprise at least one antigen specific for at least one antibody to be detected. In certain preferred embodiments, the immunoassay may comprise at least one autoantigen specific for at least one autoantibody to be detected.
As mentioned above, each solid support unit may comprise a reinforcing layer and a dosing membrane placed on the reinforcing layer. In some embodiments, the assay membrane may be a membrane for immunoassay. Thus, in some embodiments, each solid support unit may comprise an immunoassay membrane.
As used herein, the term "membrane for immunoassay" refers to a dosage membrane comprising at least one antigen specific for at least one antibody to be detected, or comprising at least one antibody specific for at least one antigen to be detected.
In some embodiments, the immunoassay membrane may comprise at least one antigen specific for at least one antibody to be detected. In certain preferred embodiments, the immunoassay membrane may comprise at least one autoantigen specific for at least one autoantibody to be detected.
As used herein, the term "autoantigen" means an antigen (such as a protein or protein complex or a DNA or RNA) that is recognized by the immune system of patients suffering from an autoimmune disease. the antigen is not, under non-pathological conditions, the target of the immune system. For example, due to genetic and / or environmental factors, normal immunological tolerance to an autoantigen has been lost in patients with autoimmune disease.
In some embodiments, the antigen may be selected from the group consisting of or consisting of double-stranded DNA (dsDNA), Sm (D and BB 'proteins of U1-U6 snRNP complexes), RNP (68kD and / or A proteins). and / or C of the complex Ul-snRNP), SSA / Ro (Sjögren syndrome 60kD antigen A), SSB / La (50 kD Sjögren B antigen), JO-1 (histidyl-tRNA synthetase), and Scl- 70 (DNA topoisomerase I).
As previously mentioned, the present invention provides a USS strip comprising multiple solid support units arranged in tandem, each solid support unit being the same in the USS band and each solid support unit being detachable from the USSR strip. USS.
A solid support unit can be easily detached from the USS band, i.e. a solid support unit can be detached from the USS band (eg by the user or the consumer) manually without the need for tools, or with relatively simple tools, such as a utility knife. The terms "detachable", "non-permanent" or "separable" can be used interchangeably here. For example, a solid support unit may be detached from the USS tape (for example by the user or the consumer) by tearing a solid support unit of the USS tape or by breaking a unit. solid support of the USS tape, or a solid support unit can be detached from the USS tape (for example by the user or the consumer) by cutting a solid support unit from the tape of USS for example using a utility knife.
In some embodiments, the solid support unit may be separated from the USS by tearing or breaking.
In some embodiments, the solid support units (i.e., the two adjacent solid support units) may be at least partially associated or connected. For example, the solid support units as defined herein (i.e., two solid support units) may be associated or connected by at least a portion of the backing layer.
In some embodiments, the dosages of the solid support units may be completely separated, for example by means of a pre-notch or groove between the solid support units.
In some embodiments, the membranes of the solid support units (i.e., two solid support units) may be completely separated, for example by means of a pre-notch or a groove between the units. solid support. In some embodiments, the backing layer of the solid support units (i.e., two solid support units) may be partially divided for example by means of a groove between the solid support units. The association between adjacent solid support units is designed to be detachable (i.e., the association can be easily removed or broken by a user or consumer). Normally, the association can be manually deleted or broken by the user without the need for tools, or with relatively simple tools, such as a utility knife. For example, the association between the solid support units can be easily suppressed or broken by the user by separation of a solid support unit by tearing or breaking of the USS band, or the association between the units of the solid support unit. Solid support can be easily removed or broken by the user by separating a solid support unit by cutting the USS tape for example with a utility knife.
Another possibility is to detach the solid support unit from the USS tape (for example by a user or a consumer) by means of a loading device as described herein.
The USS band may comprise or contain two or more solid support units, for example the USS band may comprise or contain 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 30, 40 or 50 solid support units. Preferably, the USS band comprises or contains 24 solid support units. The USS band may have a longitudinal body. The USS band can be provided as a linear band; this configuration may be suitable for manual dispensing using a pen-like dispenser. The USS tape can be supplied on a roll; this configuration may be appropriate for automated distribution.
In some embodiments of the kits, USS strips, uses, or methods, as taught herein, the USS strip may comprise at one end a coupling member for coupling to a dispenser adapted to dispense a dispenser. solid support unit at a time. The coupling member may be any coupling member to a dispenser adapted to dispense a solid support unit at a time.
In some embodiments of the kits, USS strips, uses, or methods, as taught herein, the USS strip may be included in a dispenser adapted to dispense one solid support unit at a time.
Another correlated aspect of the invention provides a holding support for maintaining at least two solid support units, the holding support comprising a body having a generally longitudinal shape, said body being provided with at least two regions receptors, each receiving region being adapted to receive (and maintain) a solid support unit.
The body can define a longitudinal axis (A-A '). The body of the holding support has a front face, from which the solid support units held in the receiving regions can be examined or read, a back face opposite the front face, an apical end at a longitudinal end , and a basal end at the other longitudinal end. A pair of longitudinal side edges and a pair of side end edges connect the front face to the back face. The holding support is preferably adapted to robotic manipulation, for example for the automated processing of samples.
The receptor regions are disposed in a longitudinal direction along the body. Each receiving region is designed to receive a solid support unit. Each receiving region may be designed to maintain a solid support unit. Each receiving region is spatially separated from any adjacent or adjacent receiving region. Such a support bracket advantageously allows each solid support unit (maintained in a receiving region) to be separated from each adjacent solid support unit (maintained in an adjacent receiving region). More specifically, a receiving region is spatially separated from the next receiving region. Each receiving region may be a delimited area disposed along the longitudinal axis of the body. Each delimited area may be spatially separated from any adjacent receiving region by a body part. The delineation may provide an indication to the user of the position of each solid support unit. The delimitation can be essentially complementary in size and shape of a solid support unit.
There may be two or more receptor regions, such as two, three, four, five, six, seven, or eight receptor regions in a holder. Preferably there may be six receiving regions in a holding medium. Receiving regions may be disposed along the front face of the body. Receiving regions may be disposed within the body.
In some embodiments, the holding support is provided with at least one empty receiving region. Preferably all the receiving regions of the holding support are empty, i.e. free of solid support units. In some embodiments, the holder is provided with empty receiver regions.
In some embodiments of the kits, holders, uses, or methods, as taught herein, at least two receiving regions (of said at least two receiving regions) each maintain a solid support unit. In some embodiments, two or more receiver regions (of said at least two receiver regions) may each hold a solid support unit.
The holding support may further be provided with a sample chamber. The sample chamber can be placed anywhere in the body, but is preferably placed at the basal end of the body. The sample chamber includes a sample chamber main port that communicates the exterior of the body with the empty space of the chamber. Preferably, the main orifice of the chamber is on the front face of the body.
The sample chamber may include a secondary port that communicates the void space of the chamber with a side edge of the body, preferably with the side edge of the basal end. The secondary orifice may comprise a central axis (extending perpendicularly to the surface of the orifice), so that the axes of said two orifices are not coaxial.
The sample chamber is spatially separated from all the receiving regions. Preferably, the sample chamber has a neighboring receiving region. The sample chamber is preferably separated from all neighboring receiving regions by an immovable barrier. The barrier is preferably impervious to fluids.
The terms "immovable barrier", "permanent barrier" or "non-releasable barrier" may be used interchangeably here and generally refer to a barrier that can not be separated or disconnected from its association with another element, such as with the body support support.
The terms "fluid impermeable barrier" or "impermeable barrier" generally describe a barrier that does not permit the passage of a fluid, such as a liquid biological sample.
The irremovable barrier separating the sample chamber from the adjacent receiving region may be a wall of the sample chamber or a portion of said wall. Such a barrier advantageously allows the retention of a sample, such as a biological sample, in fluidic isolation from the adjacent receptor region (and from any other receptor region) before insertion of the solid support into a container comprising a fluid.
In one embodiment, the sample chamber has dimensions such that the sample is held in the sample chamber under the effect of capillarity and / or under the effect of the surface tension of the sample. In this regard, the sample chamber may have any suitable geometric shape, including, for example, a cubic, cuboid, triangular prism, cone, square-based pyramid, triangular-based pyramid, hemispherical, or cylindrical shape. . The chamber may define a void of between 1 mm and 50 mm, preferably between 1 mm and 40 mm, preferably between 3 mm and 30 mm, and more preferably between 1 and 25 mm by volume. For example, the cavity of the chamber can be sized to hold about 20 μΐ of liquid sample.
Preferably, the sample chamber has the shape of a trapezoid prism delimiting six surfaces of which four surfaces have an essentially rectangular shape and two surfaces have a substantially trapezoidal shape.
The orifices of the sample chamber may be of any shape to allow introduction and / or release of said sample. Preferably, said orifice is a round orifice, a square orifice or a rectangular orifice. Preferably, when the chamber comprises two orifices, one on the front face and one on the underside of the support, the orifice of the front face is round, and the orifice of the lower face is rectangular. Preferably, the wall surrounding the round orifice is inclined.
Neighboring receiving regions are spatially separated along the body of the holding support. In some embodiments, spatial separation may be assisted by one or more spacer elements placed on the support. A spacer element may be a passageway which passes through the body, that is to say it puts in communication the front face of the holding support with the rear face of the holding support. It preferably has a cuboid form. The passage reduces the size and weight of the body. It provides a plurality of flood zones, which are assistance in immersing the holding support in a liquid.
A spacer element is normally placed between a pair of adjacent receiver regions, or between a receiver region and a sample chamber. A spacer element is normally placed between each adjacent pair of receptor regions, and between the receiving region of the basal end and the sample chamber. When the side wall of a receiving region has an opening which connects opposite faces of said side wall to one another, the opening also connects the interior space of the receiving region to the cavity of the spacer member. . This assists uniform exposure of the solid support unit to the liquid upon immersion and also drainage after the holding support has been removed from the liquid.
The sample chamber is preferably completely spatially separated from any adjacent receiving region (s) by a spacer element. Preferably the sample chamber has an adjacent spacer element. The sample chamber is separated from any adjacent spacer element. The sample chamber is preferably separated from any adjacent spacer element by the irremovable barrier described above. The barrier is preferably impervious to fluids.
The body of the holding support may be any suitable material having the required properties of stability in analytical liquids, mechanical strength, and rigidity. The body is preferably made of a polymeric material, for example a polystyrene, polypropylene or polycarbonate plastic. The body can have a practically uniform degree of opacity. It can have any uniform color or preferably can be translucent or transparent. This is particularly advantageous when the back of a solid support unit is provided with an identification marking (for example a bar code or a QR code) readable by a camera, which can then be scanned while the latter is maintained in the receiving region.
The body of the holding support may further comprise a gripping part, placed at the apical end of the holding support, to allow grasping, grasping and / or moving of the holding support. Said gripping part can be entered manually or by means of an automated device.
According to one embodiment, the receiving region is an adhesive fixing surface on the front face of the holding support. The adhesive attachment surface is an area on the body that is designed to bond with a solid support unit using an adhesive attachment. The adhesive attachment surface may be suitable for receiving and holding a solid support unit provided with an adhesive backing. In such a case, the adhesive fixing surface may or may not be provided with an adhesive. When the adhesive attachment surface is not provided with an adhesive, it may be deprived of grease and / or have a glossy appearance which increases adhesion. Alternatively, the adhesive attachment surface may be coated with an adhesive designed to attach to a solid support unit. In such a case, the solid support unit is provided without an adhesive backing. If present, the adhesive back may be protected by a peelable backing sheet.
In a preferred embodiment, a receiving region may be a compartment within the body. A compartment may have an anterior port that opens onto the front side of the body. The size and shape of the anterior port are preferably designed to allow reading of the solid support unit (inserted in the holder), for example, for the detection of any color change and / or intensity. Preferably, the anterior orifice has a rectangular shape with equal or unequal sides. It may have rounded corners. The size and shape of the anterior port are designed to allow optical reading of the upper face of the solid support unit (such as the upper face of the solid support unit dosing membrane), for example to measure the color and / or intensity of the analysis zones. The compartment may be provided with a posterior wall, opposite to the anterior orifice. The posterior wall may include a window in the posterior wall, which places the empty space of the compartment in communication with the back side of the body. The size and shape of the posterior window are designed to allow optical reading of the underside of the solid support unit (inserted into the holder), for example, to identify a printed identification code. The window of the posterior wall may be an opening, or may be a solid structure that is transparent. When it is a solid structure, it can be made of the same material as the body of the holding support. Preferably, the window of the rear wall has a rectangular shape with equal or unequal sides. It may have rounded corners.
Preferably, the solid support unit (inserted in the holding support compartment) is supported by the posterior wall.
The compartment may further include one or more sidewalls that communicate the posterior wall with the anterior port. A side wall may have an opening that connects opposite sides of the wall to each other. The compartment has an empty space inside.
The compartment is designed to receive a USS. The compartment may have a receiver port designed to receive the USS.
The receiving region may constitute a compartment in the body of the holding bracket having a receiving port adapted to insertably receive the solid support unit, and the compartment being adapted to mechanically support the solid support unit. The receiving orifice may be the above-mentioned anterior orifice. In such a case, the solid support unit enters the compartment through the anterior orifice. The solid support unit can be squeezed into place by applying a force on the upper face of the USS. It is preferably pressed against the rear wall of the compartment. The receiving orifice may be a slot in a longitudinal side edge of the holding support, which communicates the outside of the body with the interior space of the compartment. The slot is preferably longitudinal. It is preferably longitudinal in the direction of the longitudinal length of the body. The size and shape of the slot are designed to insert a solid support unit. The solid support unit can be slid into the compartment through the slot. The solid support unit can be slid into the compartment with a dispenser as described herein.
The compartment is designed to mechanically maintain the solid support unit. The solid support unit can be held in place by friction generated by the inner walls of the compartment. The solid support unit can be held or secured in place by a friction lock. Alternatively, or in addition, the solid support unit can be held in place by a solid support unit holding member. The compartment may include a solid support unit holding member, adapted to maintain a solid support unit after insertion into the compartment. The solid support unit holding member may include one or more projections in the side wall of the compartment, under which the solid support unit slides during insertion. The projections prevent or reduce the lifting of the solid support unit from the rear wall of the compartment. The projections may come into friction with the solid support unit to hold it in place. The solid support unit holding member may include one or more grooves in the side wall of the compartment, in which the solid support unit slides during insertion. The grooves also prevent or reduce the lifting of the solid support unit from the front wall of the compartment. The grooves may frictionally engage the solid support unit to hold it in place. The solid support unit can be held or secured in place by mechanical blocking or stopping. The mechanical lock may be the solid support unit holding member as defined herein. The mechanical lock may be a side wall of the holding bracket. The mechanical lock may be a hooking system such as a projection (engaging in a groove in the solid support unit), a groove (engaging with a projection on the solid support unit) , or a forceps. The solid support unit can be fixed in place by mechanical locking and / or mechanical stop.
As mentioned above, the authors of the present invention have realized that it is possible to combine a sustain medium and a USS band to allow the user or the consumer to prepare a custom analysis strip. Accordingly, another aspect of the invention provides the use of at least two different USS bands as defined herein and a support as defined herein for the preparation of an assay strip. for the detection of at least two analytes. Preferably, said at least two analytes are different.
Also provided herein is the use of a USS band as defined herein or a solid support unit as defined herein, for the preparation of an assay band for the detection of at least two analytes.
In addition, the use of a support as defined herein for the preparation of an assay band for the detection of at least two analytes is provided.
Another aspect relates to a custom analysis strip for the detection of at least two analytes, the analysis band comprising a support medium as defined herein and at least two solid support units as defined herein, each of said minus two solid support units being held in a receiving region of the holding support.
In other words, another aspect of the invention provides an assay band for the detection of at least two analytes, the assay band comprising a hold support as defined herein and at least two support units. solids as defined herein, said at least two solid support units each occupying a receiving region of the holding support.
As used herein, the term "assay band" refers to an assay strip prepared by the user or consumer, preferably a multiparameter assay strip prepared by the user or consumer. Advantageously, the present analysis band is personalized, for example the present analysis band can be adapted to the needs of the user or the consumer, or the present analysis band can be customized for a patient, for example adapted to the patient. patient.
The terms "assay strip", "assay strip", "assay stick" or "assay stick" may be used interchangeably herein.
In some embodiments, the analysis band may comprise, consist essentially of, or consist of, a holding support as defined herein and at least two solid support units as defined herein. For example, the analysis strip as taught herein may comprise, essentially consist of, or consist of, a holding support and two or more solid support units as defined herein, such as two, three, four, five , six, seven, or eight solid support units as defined herein, each of the two or more solid support units being held in a receiving region of the holding support. In a preferred embodiment, the analysis strip as taught herein may comprise, consist essentially of, or consist of, a holding support and six solid support units as defined herein, each of the six solid support units being maintained in a receiving region of the holding support.
Another aspect relates to an assay strip obtainable by the methods as taught herein.
The present invention also provides a method for the preparation of an assay band, comprising the steps of: (a) providing at least two different USS bands as defined herein, (b) providing at least one support of maintaining as defined herein, (c) depositing each USS strip of said at least two different USS strips in a receiving region of said at least one holding medium, and (d) detaching a solid support unit from each of said minus two different USS bands, thereby charging at least two receiving regions of said at least one sustain medium each with a different solid support unit.
In particular, the method for preparing an analysis band may comprise the steps of: (a) providing at least two different USS bands as defined herein, (b) providing at least one sustaining support for maintaining at least two solid support units, the holding support comprising a body having a generally longitudinal shape, said body being provided with at least two receiving regions, each receiving region being adapted to receive a solid support unit (c) inserting each USS strip of said at least two different USS strips into a receiving region of said at least one holding support, and (d) detaching a solid support unit from each of said at least two different carrier strips. USS, thereby charging at least two receiving regions of said at least one sustain medium each with a different solid support unit.
The method can be performed manually or in an automated manner.
In a preferred embodiment, step (c) can be performed by slidingly inserting each USS strip into a compartment of the holding support, the receiving region being a compartment as defined herein.
Step (d) can be performed by rotating each USS strip relative to the holding support. The USS strip can be rotated at least about 60 degrees from the holding support to break off the solid support unit from the USS web. Preferably, the dispenser can be rotated by at least about 90 °, at least about 135 °, or at least about 180 °, relative to the holder. The rotation of the USS band is around a longitudinal axis of the USS band.
Alternatively, the method for preparing an assay strip may comprise the steps of: (a1) providing at least two different solid support units as defined herein, (bi) providing at least one such support medium defined herein, and (ci) loading at least two receiving regions of said at least one holding medium each with a different solid support unit. Steps (ai), (bi) and (ci) replace steps (a), (b) and (c) above.
In particular, the method for preparing an assay strip may comprise the steps of: (a1) providing at least two different solid support units as defined herein, (bi) providing at least one holding support for maintaining at least two solid support units, the holding support comprising a body having a generally longitudinal shape, said body being provided with at least two receiving regions, each receiving region being adapted to receive a solid support unit, and (ci) loading at least two receiving regions of said at least one holding medium each with a different solid support unit. In some embodiments, the method may include the prior steps of: (a ') providing at least two different USS bands as defined herein, and (a') detaching a solid support unit from each of said minus two different USS strips, thereby providing said at least two different solid support units. Step (ci) can be performed by manually inserting each solid support unit into a receiving region of the holding support. Step (ci) can be performed by automatically introducing each solid support unit into a receiving region of the holding support.
In a preferred embodiment, step (ci) can be performed by inserting (sliding) each solid support unit into a receiving region (such as a compartment) of the holding support.
In some embodiments, the method may be performed to detect at least two analytes in a sample, such as a biological sample.
In some embodiments of the method for detecting at least two analytes in a biological sample, the method may further comprise the steps of: (d) introducing a biological sample into a sample chamber of said holding medium, e) inserting the holding support charged with step (d) into a container comprising at least one fluid, and (f) detecting at least two analytes in the biological sample.
In one embodiment, the method is an automated method.
In certain preferred embodiments of the method for the detection of at least two analytes in a biological sample, the method comprises the steps of: providing at least two different solid support units as defined herein, the solid support units comprising each at least one ligand that is specific for at least one analyte to be detected, provide a support as defined herein, load at least two receiving regions of the support each with a different solid support unit, introduce a biological sample in a sample chamber of said holding support, inserting the loaded holding support into at least one container comprising at least one fluid, thereby releasing said biological sample into said at least one fluid, contacting the biological sample in the fluid with said ligands, thereby to bind at least one analyte present in said sample With each ligand, label each analyte bound to each ligand, by means of a marker, and detect said marker, thereby determining a signal intensity of said marker.
The method of the present invention can be used to detect specific analytes in biological samples, so that the user or consumer can determine the association of analytes to be detected. For example, the method allows the user or consumer to detect an analyte combination that is personalized or tailored to a particular patient.
Immunological assays are preferably contemplated. These immunoassays can be used for semi-quantitative or quantitative analyte assays, with or without the use of a machine for automated detection. In one embodiment, the signal intensity of the label is directly proportional to the concentration of the analyte to be detected in the biological sample.
Preferably, the method according to the invention comprises an immunoblot assay. Suitable, non-limiting examples of immunoblot technology include kits for the detection of autoantibodies in patient serum, for example, BlueDot technology (D-Tek, Mons, Belgium).
In one embodiment, the assay strip as taught herein may be used in a method for the detection of autoantibodies in a biological sample (eg, serum) of a patient, said method comprising the steps of following: provision of at least two different solid support units as defined herein, the solid support units each comprising at least one autoantigen which is specific for at least one autoantibody to be detected, disposition of a support as defined herein, loading at least two receiving regions of the holding support each with a different solid support unit, to obtain an assay strip, introducing the biological sample into a holding chamber. sample of said holding support, insertion of said analysis band into at least one container comprising at least one fluid, which releases said biological sample in said at least one fluid specific binding of the autoantibodies present in the patient's sample with autoantigens attached to each solid support unit of the assay band, which binds the autoantibodies to each solid support unit, washing the solid support units, and autoantibodies attached thereto for removing the sample, adding a conjugate, comprising a secondary antibody directed against the autoantibodies and said secondary antibody being bound to an enzyme, for obtaining auto-antibody complexes; antibodies, washing said solid support units and complexes of autoantibodies attached thereto to remove unbound secondary antibody, incubating solid support units and auto-antibody complexes attached thereto with a colorimetric substrate, binding of the colorimetric substrate with the enzyme bound to the secondary antibodies of the autoantibody complexes, leading to the development of a specific color. The appearance of a specific color on the solid supports indicates the presence of autoantibodies in the patient's serum and therefore the presence of an autoimmune disease.
The assay strips can be interpreted, for example visually, by comparing the intensity obtained for the analyte (autoantibodies for example) with the intensity of a negative control and / or a positive control. If the intensity is greater than that of the negative control, the signal is considered positive. If the intensity is equal to or less than that of the negative control, the signal is considered negative. The present invention enables qualitative detection, but additionally provides a semi-quantitative measurement of the concentration of analytes present in the sample. Semi-quantitative measurements are possible because each solid support may contain a positive control. Quantitative measurements are possible because each solid support may contain standards.
The present invention also provides a dispenser adapted to dispense a solid support unit from a USS band as defined herein.
In particular, the present invention provides a dispenser for dispensing a solid support unit from a USS band as defined herein, said dispenser having a distal dispensing end and a proximal end opposite the distal end, dispenser comprising: a first longitudinal member having an edge at least partially serrated by a plurality of notches arranged in tandem, a second fixed longitudinal member having an edge at least partially serrated by a plurality of notches arranged in tandem positioned parallel to the first longitudinal member, so that the first longitudinal member is in sliding relation with the second longitudinal member, and a transmission member provided with a coupling for attachment to the USS band, a pair of ratchets designed to engage with the serrated edges, said transmission member being adapted to transmit motion bidirectional sliding of the first longitudinal member to a unidirectional movement of the coupling.
Advantageously, the present dispenser is designed to advance one solid support unit at a time, which solid support unit can be inserted into the holding bracket described herein. The dispenser has at one longitudinal end a distal (dispenser) end, through which the solid support unit is advanced for dispensing, and at the other end, a proximal end. The elements that constitute the dispenser may likewise have a distal end or a proximal end, the orientation of which corresponds respectively to the distal end or the proximal end of the dispenser.
In some embodiments, the dispenser includes a USS band as defined herein.
In some embodiments, the transmission member, the first longitudinal member, and the second longitudinal member are so designed that: the transmission member slides against the serrated edge of a first proximally-sliding longitudinal member; transmission member engages the serrated edge of a first distally-sliding longitudinal member, the serrated edge of the second longitudinal member slides against a distally-sliding transmission element, the serrated edge of the second longitudinal member engages with the forced transmission element in a proximal direction.
The dispenser includes a first longitudinal member, a second longitudinal member, a transmission member. There may be, attached to the first longitudinal member, an actuator element such as a pusher, for controlling a sliding movement of the first longitudinal member. The dispenser may further comprise a longitudinal housing for accommodating one or more of the elements. The housing is normally provided with a slot at the distal end, through which the solid support unit is dispensed. The housing can have any suitable shape. For example, the housing may be cylindrical.
The first longitudinal member (PML) of the holding support has an edge that is at least partially serrated. By serrated means that it is provided with a multitude of notches distinct, arranged in tandem. The first longitudinal member is slidably mounted relative to the second longitudinal member. The first longitudinal member is preferably slidably mounted relative to the housing. The first longitudinal member is movable slidable between two stop positions, that is to say a forward position and a recoil position. The advancing position is closer to the distal end, while the recoil position is closer to the proximal end. Moving the first longitudinal member from the retracted position to the advancing position advances the USS band of a solid support unit in the direction of the distal end.
The second longitudinal member (SML) of the holding support is also provided with an edge which is at least partially serrated. The serrated edge preferably has notches of the same size, shape and spacing as the first longitudinal member. The second longitudinal member is mounted to be fixed relative to the housing (i.e., in a fixed relationship with the housing). The first and second longitudinal members are arranged parallel to each other, preferably in the housing. The serrated edges are preferably mutually adjacent. The transmission member includes a coupling for a removable or non-removable attachment to a USS tape as described herein. The coupling maintains the USS band in fixed relationship with the transmission member. The transmission element is designed to transmit the forward movement by the first longitudinal member, but not the recoil motion by the first longitudinal member, to the USS band. More specifically, the transmission member engages with the first longitudinal member and advances jointly with a first longitudinal member advancing, but slips against the first longitudinal member and remains substantially static with respect to a first longitudinal member retreating. Said transmission element is therefore designed to transmit bidirectional sliding movement of the first longitudinal member to a unidirectional movement of the coupling. At least a portion of the transmission member fills the space between the first and second longitudinal members arranged parallel to each other. The transmission element preferably comprises a longitudinal body comprising a first and a second pawl. A "ratchet" is a "tooth" or projection from the transmission member, sized to fit and engage a notch. The pawls are preferably arranged such that they are symmetrical with respect to a central longitudinal axis of the transmission element. The pawls are preferably projecting outwards. The pawls are preferably mounted on springs in relation to each other. Each pawl engages with the serrated edge of the first and second longitudinal members respectively. Specifically, a pawl engages in a notch of a serrated edge. The transmission member is preferably adapted to exert a thrust force between the first and second longitudinal members, for example, by means of a spring or a suitable member. The pushing force holds the transmission means in a fixed position between opposed notches.
The serrated edge of the first and second longitudinal members is provided with a plurality of notches, arranged in tandem. This arrangement is similar to that of a rack of a rack and pinion mechanism, except that the teeth of this rack, or more precisely the notches, are formed so as to transmit forces to and from an element of the rack. transmission in one direction of movement, but not in the other direction. Each notch provides a clue for the positioning of the transmission element. As a result, when the transmission element is advanced one notch, it is effectively advanced by an index that concomitantly advances the USS band of a solid support unit. Since the second longitudinal member is fixed relative to the housing, the index can be read on the notches of the second longitudinal member. The notch of a longitudinal limb comprises, at the proximal end of the notch, a notch thrust surface (notch SP), and at the distal end a sliding surface of the notch notch (notch SC). A notch generally has an asymmetrical V-shaped profile.
The pawl of a transmission member comprises, at the proximal end of the pawl, a pawl pushing surface (ratchet SP), and at the distal end a sliding surface of the notch (SC). notch). The tip of a ratchet generally has an asymmetrical V-shaped profile.
The notch SP is adapted to engage with the ratchet SP, so that a force in a distal direction, applied by the first longitudinal member, is transmitted to the transmission member via notch SP interaction - Ratchet SP. Similarly, the notch SP of the second longitudinal member is adapted to engage with the ratchet SP, so that a force in a proximal direction, applied by the transmission member, is transmitted to the second longitudinal member via SP notch interaction - ratchet SP.
Notch SP is designed to engage with ratchet SP; this commitment allows the transfer of forces between the pawl and the notch.
At least a portion of the notch SP and / or ratchet SP may be flat and perpendicular to the directional movement of the first longitudinal member. This reduces slippage between the respective thrust surfaces. To further reduce slippage, the notch SP and / or ratchet SP may be at least partially provided with an anti-slip coating. Alternatively, at least a portion of the notch SP may be flat and inclined against the directional movement of the first longitudinal member 371. In other words, and with reference to FIG. 7A, the notch SP 384, at the extreme edge 386, can touch a dummy line 387 which is parallel to the direction of movement of the transmission member 373, at an angle ar measured from the distal side 302 from the angle. The angle ar can be between 10 ° and 90 °, preferably between 40 ° and 50 °.
Referring to FIG. 8A, the ratchet SP 374, at the extreme edge 376, can touch a dummy line 377 which is parallel to the direction of movement of the transmission member 373, at an angle α from the distal side 302 of angle. The angle ap can be between 10 ° and 90 °, preferably between 40 ° and 50 °.
The notch SC is adapted to slide on the ratchet SC; the force in the proximal direction, applied by the first longitudinal member, does not cause movement of the transmission element to another index position, while the SC of the PML slides on the respective ratchet SC. A force in the distal direction, applied by the transmission member, allows the transmission member to slide on the second longitudinal member, while the SC of the SML slides on the ratchet SC.
The notch SC is designed to be in sliding relationship with the ratchet SC; this sliding configuration allows the transmission element to advance on the second stationary longitudinal member (during dispensing) and the first longitudinal member to slide on the stationary transmission element during the recoil of the first longitudinal member . At least a portion of the notch SC and / or ratchet SC may be inclined in the direction of movement of the first longitudinal member. This increases the slip between the respective sliding surfaces.
In other words, and referring to FIG. 7B, the notch SC 385, at the extreme edge 386, can touch a dummy line 387 which is parallel to the direction of movement of the transmission member 373, at an angle βΓ measured from the distal side 302 from the angle. The angle βΓ may be between 10 ° and 80 °, preferably between 40 ° and 50 °.
Referring to FIG. 8B, the ratchet SC 375, at the extreme edge 376, can touch a dummy line 377 which is parallel to the direction of movement of the transmission member 373, by making an angle βρ measured from the distal side 302 of angle. The angle βρ can be between 10 ° and 80 °, preferably between 40 ° and 50 °. To further increase slippage, the notch SC 385 and / or the ratchet SC 375 may be provided at least partially with a slip-facilitating coating.
Referring to FIGs. 9-12, another aspect of the invention provides a method of dispensing a solid support unit (111) from a USS band (1) using a dispenser (2). as defined herein, comprising the step of sliding the first longitudinal limb (371) forward in the distal direction (203), the advancing movement by the first longitudinal member (371) being transmitted via the transmitting (373) to the coupling (376), and the advancing USS band of a solid support unit, which dispenses a solid support unit.
In some embodiments of the method for dispensing a solid support unit, the method further comprises the step of moving the first longitudinal member (371) rearwardly in the proximal direction, thereby moving the first member longitudinal (371), the recoil movement by the first longitudinal member (371) not being transmitted to the transmission element, whose recoil motion is prevented by engagement of the second extrusion with the serrated edge of the second longitudinal member (372).
In some embodiments of the method for dispensing a solid support unit, the USS band moves only in the forward direction.
Another aspect provides a loading device adapted to load a receiving region of a holding support as defined herein with a solid support unit as defined herein, the loading device comprising a longitudinal section for receiving the holding support. , a housing member for receiving a dispenser, and at least one loading door adapted to receive by insertion the distal end (dispenser) of a dispenser, the loading door communicating said longitudinal section with the dispensing element; housing. The loading door may be a longitudinal void space adapted to receive by insertion the distal dispensing end of the dispenser. The loading door may have any suitable shape complementary to the shape of the dispenser, in particular complementary to the shape of the distal dispensing end of the dispenser. For example, the loading door may be a cylindrical longitudinal void configured to receive by insertion the distal dispensing end of the cylindrical dispenser.
The loading device facilitates the loading of a receiving region of a holding support with a solid support unit, thereby reducing the time required to load the holding support and thereby reducing costs.
A related aspect provides a method for loading a receiving region of a holding medium as defined herein, with a solid support unit as defined herein, comprising the steps of: providing a holding support (partially or completely empty) as defined herein, providing a loading device as defined herein, inserting the holding support (partially or totally empty) as defined herein in the loading device as defined herein, providing at least one web of USS as defined herein, the USS strip being inserted into a dispenser adapted to dispense one solid support unit at a time, inserting the distal end (dispenser) of the dispenser into a loading door of the loading device, moving the dispenser first longitudinal member of the dispenser for advancing a solid support unit of the USS band across the distal end (dispenser) in a region r receiving the holding support, and rotating the dispenser to detach the solid support unit from the USS web, thereby loading the receiving region of the holding support with the solid support unit.
The dispenser can be rotated at an angle of at least about 60 ° with respect to the holding support to detach the solid support unit by breaking the USS band. Preferably, the dispenser can be rotated by at least about 90 °, at least about 135 °, or at least about 180 °, with respect to the support.
In a certain embodiment of the method for loading a receiving region of a holding medium as defined herein with a solid support unit as defined herein, the method may be executed manually. In one embodiment of the method for loading a receiving region of a holding medium as defined herein with a solid support unit as defined herein, the method may be automated.
The present invention further provides a kit comprising at least one USS strip as defined herein and at least one dispenser as defined herein. The USS tape can be mounted inside the dispenser. The kit may further include the holder as described herein.
The present invention further provides a kit comprising at least one dispenser as defined herein, and at least one holding support as defined herein.
Non-limiting examples of a USS strip, a holder, a dispenser, a loading device, and a method for dispensing a solid support unit according to the present invention are illustrated on FIGs. 1 to 14B.
Referring to FIG. 1A, this represents a USS 1 band comprising multiple solid support units (USS) 111 arranged in tandem, each solid support unit 111 being the same in the USS band and each solid support unit 111 being The USS strip 1 has at one end 118 a coupling member 117 for coupling to a dispenser adapted to dispense a solid support unit 111 at a time. The other longitudinal end of the strip is the dispensing end 119. Preferably, each solid support unit 111 comprises a membrane 112 (preferably a membrane for immunoassay) provided with a reinforcing layer (not shown). Each solid support unit 111 may include an identification element 114 and an orientation or positioning element 115. The identification element allows the user to visually inspect or verify which type of unit (s) is ) of solid support (s) has / have been inserted into the holding support. The orientation or positioning element allows an interpretation or automatic reading system to identify a reference position from which the different positions of the separate analysis areas to be assayed on the solid support unit can be extrapolated. Each solid support unit 111 is connected to its neighboring solid support unit in the portion 116.
Referring to FIG. IB, a side view of a USS band 1 is shown. The USS band 1 comprises a multitude of solid support units arranged in tandem, and connected to each other. Preferably, each solid support unit comprises a membrane 112 (preferably an immunoassay membrane) provided with a reinforcing layer 113. The USS band has an upper face 12 and a lower face 14.
Referring to FIG. IC, an enlarged side view of an end portion of a USS band 1 is shown, each solid support unit 111 comprising a membrane 112 provided with a reinforcing layer 113. An upper face 12 and a lower face 14 of each solid support unit 111 are indicated.
Referring to FIG. 1D, an enlarged side view of an end portion of a USS 1 web is shown, the last solid support unit 111 being partially torn from the USS web and being connected to its adjacent solid support unit in the web. part 116 by the solid support reinforcement 113.
If we refer to FIG. 2, a holding support 2 is shown, the holding support 2 comprising a longitudinal body 250 having an axis (A-A '). The holding support 2 has a front face 211, a back face 212, an apical end 213, a basal end 214. A longitudinal side edge 215a and a basal end lateral edge 216a are shown.
A plurality (a pair) of receiving regions is shown, consisting of compartments 220, 220 'spatially separated and disposed within the body 250. The compartments 220, 220' are shown towards the base end 214 of the carrier. 2. Other compartments 220 '', 220 '' 'are only indicated in phantom. The pair of compartments 220, 220 'is divided by a spacer member 230' which is a through passage between the front face 211 and the back face 212 of the body. Each compartment includes a front port 228 which is an opening in the front face 211 of the body, a rear wall 225 provided with a rear wall window 226, and has an interior space 229.
Each compartment is provided with a receiving port which is a slot 227, 227 'in the longitudinal side edge 215a of the body 250. The slot 227, 227' is adapted to slidably receive a solid support unit for insertion into space inside compartment 229.
A sample chamber 242 is placed toward the base 214 of the holding support 2. The sample chamber 242 is provided with a secondary orifice 241 which places the empty space of the chamber in communication with the lateral edge 216 a of the end. The spacer element 230 spatially separates the sample chamber 242 from the most terminal compartment 220.
The holding support 2 is provided with a catching portion 246 at the apical end 213 of the body 250.
If we refer to FIG. 3, this represents a holding support 21, the holding support 21 comprising a longitudinal body 250 having a longitudinal axis (A-A '). The holding support 21 has a front face 211, a back face 212, an apical end 213, a basal end 214. A longitudinal side edge 215a and a basal end lateral edge 216a are shown.
A plurality of receptor regions which are adhesion-attachment surfaces 260, 260 ', 260' ', 260' '' are disposed along the longitudinal axis AA 'of the body 250. Each adhesion-fixing surface (e.g. 260) is adapted to receive a solid support unit and hold it by adhesion. Each adhering attachment surface (e.g. 260) is a delimited area disposed along the longitudinal axis AA 'of the body 250. The boundaries 260a, 260a', 260a '', 260a '' 'provide an indication to the user on the position of each solid support unit. The boundaries (e.g., 260a) are essentially complementary in size and shape to a solid support unit. Each adhesively bonded surface is spatially separated by a body portion from any adjacent adhesion bonding surface. The adhesion-fixing surfaces 260, 260 ', 260' ', 260' '' are disposed along the front face 211 of the body 250. The defined areas 260a, 260a ', 260a' ', 260a' '' may comprising an adhesive, such as a tape or a tacky coating, for attaching a solid support unit.
A sample chamber 242 is provided towards the basal end 214 of the holding support 21. The sample chamber 242 is provided with a secondary orifice 241 which places the empty space of the chamber in communication with the lateral edge 216a of the basal end 214.
The holding support 21 is provided with a portion allowing the catch 246 at the apical end 213 of the body 250.
If we refer to FIG. 4A, this shows a view of the front face 211 of an enlarged portion of a holding bracket 2 of FIG. 2. Four compartments (220, 220 ', 220' ', 220' '') are shown. Each adjacent pair of compartments is divided by a spacer element (230 ', 230' ', 230' ''). The sample chamber 242 is also separated from the most terminal compartment 220 by a spacer member 230. On the most terminal compartment 220 are shown the back wall 225, and the window 226 of the back wall, and the side walls. 221, 222, 223, 224 of the compartment 220. The longitudinal side edges 215a, 215b and the basal end lateral edge 216a are indicated.
Referring to FIG. 4B, this represents a view of the rear face 212 of an enlarged portion of a holding support 2. The rear of four compartments are shown (220, 220 ', 220' ', 220' ''), each adjacent pair of compartments being divided by a spacer element (230 ', 230' ', 230' ''). The solid base of the sample chamber 242, the longitudinal side edges 215a, 215b, and the basal end lateral edge 216a are indicated. On the most terminal compartment 220 are indicated the rear wall 225, and the rear wall window 226, and the side walls 221, 222, 223, 224 which enclose the compartment 220, indicated through the back face 212 of the body 250.
If we refer to FIG. 4C, this is a view of the longitudinal side edge 215a of an enlarged portion of a holding bracket 2. In this figure are shown four receiving orifices 227, 227 ', 227' ', 227' '' which are slots which place the longitudinal side edge 215a in communication with the respective compartments (220, 220 ', 220' ', 220' ''). On the most terminal compartment 220 are indicated two side walls 221, 222 which partially limit the compartment 220 and are located behind the lateral edge 215a of the body 250.
Referring to FIG. 4D, this represents a view of the other longitudinal lateral edge 215b of an enlarged portion of a holding support 2. There are no receiving orifices on this side edge 215b. An indication of the four receiving orifices 227, 227 ', 227' ', 227' '' on the other side edge 215a is shown in phantom. On the most terminal compartment 220 are indicated two side walls 221, 222 which limit the compartment 220 and are located behind the lateral edge 215b of the body 250.
If we refer to FIG. 4E, this represents a sectional view along the longitudinal axis AA 'of an enlarged part of a holding support 2. Four compartments (220, 220', 220 '', 220 '' ') are shown, each having a front opening (228, 228 ', 228' ', 228' "), a back wall (225, 225 ', 225", 225 "'), and an interior space (229, 229 ' , 229 '', 229 '"). Each adjacent pair of compartments is divided by a spacer element (230 ', 230' ', 230' '), which is a through passage between the front face 211 and the back face 212 of the body. separated from the most terminal compartment 220 also by a spacer element 230. The sample chamber 242 is provided with a main orifice 244 and a secondary orifice 241 which places the empty space 243 of the chamber in communication with the edge lateral (216a) of the basal end 214.
On the most terminal compartment 220 are indicated the back wall 225, and the window 226 of the back wall, and two side walls 221, 222 which partially limit the compartment 220. The longitudinal side edges 215a, 215b, and the edge lateral 216a of the basal end are indicated. The side walls 221, 222 of the compartment each comprise an opening 221a, 222a joining one to the other the opposite sides of said wall, that is to say putting in communication the cavity of the spacer element 230 with the compartment interior space 229.
FIG. 4F is the same view as that shown in FIG. 3E, each compartment 220 of the holding support 2 comprising a solid support unit 111, 111 ', 111' ', 111' ''.
FIG. 5 schematically shows a distributor 3 according to one embodiment of the invention. The USS band 301 comprising multiple solid support units arranged in tandem is inserted into the dispenser 3 designed to dispense a solid support unit 311 at a time. The dispenser 3 has, at one longitudinal end, a distal end (dispenser) 302, through which the solid support unit 311 is advanced for dispensing, and at the other end, a proximal end 304. The dispenser 3 comprises a first longitudinal member 371, a second longitudinal member 372, a transmission member 373, and a longitudinal casing 374. In attachment fixed to the first longitudinal member 371 is a pusher 370, for controlling a sliding movement of the first longitudinal member 371. The first longitudinal member 371 and the second longitudinal member 372 of the dispenser 3 each have an edge which is at least partially serrated. They are arranged parallel to each other in the housing 374. The serrated edges are mutually adjacent.
FIG. 6 shows a transmission element 373 placed in a space between the first longitudinal member 371 and the second longitudinal member 372. It comprises a coupling 376 for the removable or non-removable attachment to the USS band 301 (not shown). The transmission member 373 includes a first pawl 378f and a second pawl 378s, which each engage with the serrated edge of the first 371 and second 372 longitudinal members, respectively. The first pawl 378f engages with a notch 380f (I) of the serrated edge of the first longitudinal member 371; a neighboring notch 380f (II) is indicated. The second pawl 378s engages with a notch 380s (II) of the serrated edge of the second longitudinal member 372; a neighboring notch 380s (II) is indicated. The transmission member 373 is compliant, and exerts a force between the opposing notches.
FIGs. 7, 7A and 7B show in detail a serrated edge, more particularly a notch 380. The notch of a longitudinal member comprises, at the proximal end 304 of the notch, a thrust surface 384 of the notch (SP notch), and at the distal end 302, a sliding surface 385 of the notch (notch SC).
FIGs. 8, 8A and 8B show in detail a pawl 378 of a transmission element. It comprises, at the proximal end 304 of the pawl, a pushing surface 374 of the ratchet (ratchet SP), and at the distal end 302, a sliding surface 375 of the notch (notch SC).
FIGs. 9 to 12 show a sequence of unidirectional forward movement by the transmission member 373 in response to forward and backward movements of the first longitudinal member 371.
In FIG. 9, the forward movement of the first longitudinal member 371 is transmitted to the coupling 376; via a 384f slot interaction (I) - SP first pawl 374f. The transmission member 373 slides on the notch 380s (I) of the second longitudinal member 372 due to the sliding arrangement between the notch SC 385s of the second longitudinal member 372 and the SC of the second ratchet 375s of the second member. transmission. These surfaces have angles allowing sliding on one after the other. Sliding is facilitated by the conformity of the transmission element. FIG. 10 shows the result of the movement; the transmission element 373 has advanced an index (from I to II) relative to the second longitudinal member 372.
In FIG. 11, a recoil movement of the first longitudinal member 371 is not transmitted to the coupling 376. The transmission member 373 slides on the notch 380f (I) of the first longitudinal member 371 due to the sliding arrangement between the Notch SC 385f (I) of the first longitudinal member 371 and the SC 374f of the first pawl of the transmission member. These surfaces have angles allowing sliding on one after the other. Sliding is facilitated by the compliance of the transmission element. The retraction of the transmission element is further prevented by the interaction between the notch SP 384s (II) and the SP of the second pawl 374s; notch SP 384s (II) is an effective stopping element.
FIG. 12 shows the result of the movement; the transmission element 373 is still at the index II of the second longitudinal member 372, but is now at the index II of the first longitudinal member 372. A repetition of the forward movement by the first longitudinal member 371 will advance the element transmission at the index position III.
FIG. 13 schematically shows a distributor 3, 133 according to one embodiment of the invention. The USS band 1, 131 is inserted into the dispenser 3, 133 designed to dispense one solid support unit at a time. The dispenser 3, 133 has, at a longitudinal end, a distal (dispenser) end 134 through which the solid support units are advanced for dispensing one solid support unit at a time. The housing 135 of the distributor 3, 133 is cylindrical.
FIG. 14A schematically represents an assembly comprising a holding support 2, 142 according to an embodiment of the present invention, a distributor 3, 133 according to an embodiment of the present invention, and a loading device 145 according to an embodiment of the invention. the present invention.
FIG. 14B schematically represents a view of the assembly of FIG. 14A along the longitudinal axis of the dispenser 3, 133. The loading device 145 is adapted to load a receiving region of the holding support 2, 142 with a solid support unit as defined herein. The loading device 145 comprises a longitudinal section 146 intended to receive the holding support 2, 142, a housing element 147 intended to receive a distributor 3, 133, and at least one loading door 148 for the insertion reception of the distal end (dispenser) of the dispenser 3, 133. The loading device 145 comprises a longitudinal section 146 containing the holding support 2, 142. The loading device 145 further comprises six housing members 147, each for the reception of 3, 133. The loading device 145 also comprises six loading doors 148 intended to receive by insertion the distal end (distributor) of the distributor 3, 133. A housing element 147 in front of the loading door 148 (indicated by the numeral 5) contains the dispenser 3, 133. The loading door 148 (indicated by the numeral 5) contains the distal end of the dispenser 3, 133 The loading door 148 communicates said longitudinal section 146 with the housing member 147. The loading door 148 is a cylindrical longitudinal empty space designed to receive by insertion the cylindrical distal dispensing end of the dispenser 3, 133.

权利要求:
Claims (17)
[1]
Amended claims
1. Required for the production of a custom analysis strip for the detection of at least two analytes, the kit comprising at least one solid support unit (USS) strip (1) and at least one holding support (2, 21), the USS band (1) comprising multiple solid support units (111) arranged in tandem, each solid support unit (111) being the same in the USS band (1) and each solid support unit (111) being detachable from the USS band (1), and the holding support (2, 21) comprising a body (250) having a generally longitudinal shape, said body (250) being provided with at least two receiving regions (220, 220 ', 260, 260'), each receiving region (220, 220 ', 260, 260') being adapted to receive a solid support unit (111).
[2]
A kit according to claim 1, wherein the holding support further comprises a sample chamber which is spatially separated from all the receiving regions.
[3]
3. Kit according to claim 1 or 2, the kit comprising at least two different strips of USS.
[4]
The kit of any one of claims 1 to 3, wherein each solid support unit (111) comprises an immunoassay.
[5]
5. Solid support unit (USS) band (1) for producing a custom analysis band for the detection of at least two analytes, the USS band (1) comprising multiple support units solids (111) arranged in tandem, each solid support unit (111) being the same in the USS band (1) and each solid support unit (111) being detachable from the USS band (1), in wherein each solid support unit (111) comprises an immunoassay.
[6]
A kit according to any one of claims 1 to 4, or USS band according to claim 5, wherein the USS band (1) comprises at one end a coupling member (117) for coupling a dispenser (3) for dispensing a solid support unit (111) at a time.
[7]
A kit according to any one of claims 1 to 4 and 6, or USS strip according to any of claims 5 or 6, wherein the USS strip is inserted into a dispenser adapted to dispense a dispensing unit. solid support at a time.
[8]
8. Holding bracket (2, 21) for holding at least two solid support units (111), the holding support (2, 21) comprising a body (250) having a generally longitudinal shape, said body ( 250) having at least two receiving regions (220, 220 ', 260, 260'), each receiving region (220, 220 ', 260, 260') being adapted to receive a solid support unit (111), and the receiving regions are disposed in a longitudinal direction along the body.
[9]
A kit according to any one of claims 1 to 4, 6 and 7, or holding support according to claim 8, wherein each receiving region comprises a compartment (220, 220 ') in the body (250) of the support of retainer (2) having a receiver port for inserting the solid support unit (111) by insertion, and the compartment being adapted to mechanically secure the solid support unit.
[10]
A kit according to claim 9, or a holding bracket according to claim 9, wherein the receiving port is a slot (227) in a longitudinal side wall (215a) of the body (250), which slot (227) is designed for slidingly receiving the solid support unit and communicating the exterior of the body with an interior empty space of the compartment (220, 220 ').
[11]
A kit according to any one of claims 1 to 4, 6 and 7, or holding support according to claim 8, wherein each receiving region comprises an adhesion-fixing surface (260, 260 ') on the body ( 250) of the holding support (2), adapted to adhesively secure the solid support unit (111).
[12]
A kit according to any one of claims 1 to 4, 6, 7 and 9, or holding support according to any one of claims 8 to 11, wherein at least two receiving regions are each provided with a unit of solid support (111).
[13]
13. Use of at least two different USS strips and a holding medium, for producing a custom analysis strip for the detection of at least two analytes, wherein the USS band comprising multiple solid support units arranged in tandem, each solid support unit being the same in the USS band and each solid support unit being detachable from the USS band, and wherein the holding support comprising a body having a generally longitudinal shape, said body being provided with at least two receiving regions, each receiving region being adapted to receive a solid support unit.
[14]
The use of claim 13, wherein the USS strips are defined as in any one of claims 5 to 7 and wherein the holding support is defined as in any one of claims 8 to 12. .
[15]
A method for producing a custom analysis strip, comprising the steps of: (a) providing at least two different solid support units (111), (b) providing a holding support (2, 21) comprising a body having a generally longitudinal shape, said body being provided with at least two receiving regions, each receiving region being adapted to receive a solid support unit, preferably a holding support as defined in any one of the claims 8-12, and (c) loading at least two receiving regions (220, 220 ', 260, 260') of the holding support (2, 21) each with a different solid support unit.
[16]
The method of claim 15, wherein each solid support unit comprises an immunoassay.
[17]
The method of claim 15 or 16 for detecting at least two analytes in a biological sample, the method further comprising the steps of: (d) loading a biological sample into a sample chamber of said holding medium (e) inserting the holding support loaded from step (d) into a container comprising at least one fluid, and (f) detecting at least two analytes in the biological sample.

类似技术:

---

公开号 | 公开日 | 专利标题

---

RU2497100C2|2013-10-27|Frustrated total internal reflection biosensor container

---

EP1917529B1|2010-06-30|Analyte assaying by means of immunochromatography with lateral migration

---

AU2014238176B2|2019-07-04|Diagnostic test device with improved structure

---

Then et al.2015|Quantitative blood group typing using surface plasmon resonance

---

BE1024067B1|2017-11-10|NECESSARY, BAND OF SOLID SUPPORT UNITS, SUPPORT FOR HOLDING AND METHOD OF DETECTING AT LEAST TWO ANALYTES

---

EP1042663B1|2003-08-20|Device, method and apparatus for implementing the method, for dosing at least a particular constituent in a product sample

---

EP2942626B1|2018-10-31|Device and method for identifying and determining blood groups

---

EP2721412A1|2014-04-23|Device and method for immunoassays

---

CA2867835C|2020-07-14|Device for determining at least one analyte capable of being contained in a liquid sample

---

US20150369830A1|2015-12-24|Articles and methods for rapid thc detection

---

BE1022360B1|2016-03-24|MICROPLATE WELL, HOLDER AND METHOD FOR DETECTION OF ANALYTES

---

US8652407B1|2014-02-18|Self-contained assay device

---

WO2014102501A1|2014-07-03|Analysis bar including means for attaching a cone to said bar

---

FR2950699A1|2011-04-01|SINGLE USE DEVICE FOR DETECTION OF PARTICLES OF INTEREST, SUCH AS BIOLOGICAL ENTITIES, DETECTION SYSTEM COMPRISING SAID DEVICE AND METHOD FOR IMPLEMENTING SAME

---

WO2021250006A1|2021-12-16|System for rapid analysis of a biological sample, intended for detecting the presence of at least one analyte in the biological sample

---

WO2022029083A1|2022-02-10|System for rapid analysis of a biological sample, intended for detecting the presence of at least one analyte in the biological sample

---

KR102371415B1|2022-03-04|Rotatable cartridge with multiple metering chambers

---

KR20180055691A|2018-05-25|Rotatable cartridge with multiple metering chambers

---

FR3109636A1|2021-10-29|System and method for high capacity rapid analysis of biological samples

---

WO2017103522A1|2017-06-22|Analysis cuvette and derivatives with signal amplification

---

EP1101116A1|2001-05-23|Electrostatic device and method for immunological detection

---

WO2004099525A2|2004-11-18|Reaction module for biological analysis

同族专利:

---

公开号 | 公开日

---

ES2696677T3|2019-01-17|

---

BE1024067A1|2017-11-09|

---

WO2015074681A1|2015-05-28|

---

EP3071970B1|2018-08-29|

---

EP3071970A1|2016-09-28|

引用文献:

---

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

---

WO2004113901A1|2003-06-20|2004-12-29|Roche Diagnostics Gmbh|Test strip with slot vent opening|

---

US20050100880A1|2003-11-12|2005-05-12|Yu-Hong Chang|Biosensor test strips of multiple function for multiple uses|

---

US20080166820A1|2007-01-09|2008-07-10|Martin Gould|Extraction method and apparatus for high-sensitivity body fluid testing device|

---

WO2010022913A1|2008-08-26|2010-03-04|Roche Diagnostics Gmbh|Biosensor test strip cards|

---

WO2012066032A1|2010-11-16|2012-05-24|D-Tek S.A.|Solid support for use in analyte detection|

---

法律状态:
2018-02-08| FG| Patent granted|Effective date: 20171110 |

---

2021-04-23| HC| Change of name of the owners|Owner name: TEKINVEST SRL; BE Free format text: DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME; FORMER OWNER NAME: AUTEM MANAGEMENT SRL Effective date: 20210222 |

---

2021-04-23| PD| Change of ownership|Owner name: AUTEM MANAGEMENT SRL; BE Free format text: DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY; FORMER OWNER NAME: TEKINVEST SA Effective date: 20210222 |

优先权:

---

申请号 | 申请日 | 专利标题

---

EPPCT/EP2013/074190|2013-11-19|

---

PCT/EP2013/074190|WO2015074681A1|2013-11-19|2013-11-19|Kit, solid support unit strip, holder, and method for detecting at least two analytes|

---