# US 5,707,818 A · Device and method for simultaneously performing multiple competitive immunoassays

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- Number: US 5,707,818 A
- Document ID: US5707818A
- Status: Granted
- Kind: A
- Application number: 08/354,953
- Filed: 1994-12-13
- Granted: 1998-01-13
- Earliest claimed: 1994-12-13
- Assignees: BSI Corporation
- Inventors: Stephen J. Chudzik; Martha J. Hamilton
- Web page: https://patentgrep.com/patent/US5707818A

## CPC

- G01N 33/54366: {Apparatus specially adapted for solid-phase testing}
- G01N 33/54389: {with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones}
- Y10S 435/81: Packaged device or kit
- Y10S 435/97: Test strip or test slide
- Y10S 435/973: Simultaneous determination of more than one analyte
- Y10S 436/805: Optical property
- Y10S 436/81: Tube, bottle, or dipstick
- Y10S 436/815: Test for named compound or class of compounds
- Y10S 436/816: Alkaloids, amphetamines, and barbiturates
- Y10S 436/901: Drugs of abuse, e.g. narcotics, amphetamine
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

A device and related method for simultaneously performing a plurality of immunoassays to detect the presence of respective analytes in a sample. The device involves the use of a unitary bibulous material providing one or more flow paths having a common origin site and a plurality of respective reagent zones providing the reagents necessary for performing a visual read-out, competitive immunoassay for the presence of the respective analyte.

## Claims

### Claim 1

A device for simultaneously performing a plurality of competitive immunoassays to provide a positive readout for the presence of respective monoepitopic analytes in a sample, the device comprising a unitary bibulous material providing one or more flow paths, each flow path comprising:
(a) a common origin site on the bibulous material for the simultaneous application of a fluid sample,
(b) a plurality of respective reagent zones downstream from the origin site, the reagent zones of each immunoassay providing the reagents necessary for performing a visual read-out, competitive immunoassay for the presence of the respective analyte, the zones comprising, in order and in the direction of flow:
(i) a competition zone comprising a detectable analyte-conjugate composed of analyte and label, and a first binding partner for the analyte, both being diffusively positioned in such a manner that any free analyte present in the sample is capable of binding to the first binding partner in a competitive manner with the analyte conjugate;
(ii) a retention zone comprising an excess amount of a second, nondiffusively bound reagent capable of binding to free or bound first binding partner in order to remove it from continued flow in the flow path; and
(iii) a read out zone comprising nondiffusively bound receptor capable of binding in a detectable manner to the analyte-conjugate but not capable of binding to unconjugated analyte.

### Claim 2 (depends on 1)

A device according to claim 1 further comprising, along the flow path, one or more positive and/or negative procedural control zones and reagents.

### Claim 3 (depends on 2)

A device according to claim 2 wherein the positive control zone comprises a terminal site downstream from the sequential reagent zones and comprising an indicator reagent for confirming the completion of the respective assay.

### Claim 4 (depends on 1)

A device according to claim 1 further comprising an inert holder comprising top and bottom portions for supporting the bibulous material, the top portion providing an opening for fluid sample access to the common origin, as well as openings for viewing the respective read-out and terminal indicator sites along each flow path.

### Claim 5 (depends on 1)

A device according to claim 1 wherein the device provides a separate, discrete flow path for each analyte, the flow paths being positioned to extend in a radial direction from the common origin.

### Claim 6 (depends on 5)

A device according to claim 5 wherein the device is capable of differentially detecting the presence of one to four drug(s) in a single sample of urine or serum.

### Claim 7 (depends on 6)

A device according to claim 6 wherein the analytes are selected from the group consisting of tetrahydrocannabinol, cocaine, opiates, and amphetamines.

### Claim 8 (depends on 1)

A device according to claim 1 wherein a spacer moiety is used to conjugate the analyte to the label, and the nondiffusively bound receptor is capable of binding to the spacer moiety.

### Claim 9 (depends on 8)

A device according to claim 8 wherein the label comprises a colloidal metal particle.

### Claim 10 (depends on 1)

A method for simultaneously performing a plurality of competitive immunoassays to detect the presence of respective monoepitopic analytes in a sample, the method comprising the steps of providing a device according to claim 1 and using the device in the following manner:
(a) applying an aqueous sample to the unitary bibulous material at a common origin site of one or more flow paths,
(b) allowing the sample to simultaneously flow through each flow path and sequentially through a plurality of respective reagent zones providing the reagents necessary for performing a visual read-out, competitive immunoassay to provide a positive readout for the presence of the respective analyte, the zones comprising, in order and in the direction of flow:
a competition zone comprising a detectable analyte-conjugate and first binding partner for the analyte, both being diffusively positioned in such a manner that any free analyte present in the sample is capable of binding to the first binding partner in a competitive manner with the analyte conjugate;
a retention zone comprising an excess amount of a second, non-diffusively bound reagent capable of binding to free or bound first binding partner in order to remove it from continued flow in the flow path; and
a read out zone comprising nondiffusively bound receptor capable of binding in a detectable manner to analyte-conjugate but not capable of binding to unconjugated analyte.

### Claim 11 (depends on 10)

A method according to claim 10 wherein the method is capable of simultaneously performing a plurality of immunoassays to detect the presence of respective analytes in a sample, wherein the presence of increasing amounts of free analyte in a sample leads to the binding of less analyte-conjugate to the first binding partner.