Multiple analyte assay device with sample integrity monitoring system

• US 6,514,769 B2
• Filed: 07/29/1999
• Issued: 02/04/2003
• Est. Priority Date: 07/29/1999
• Status: Expired due to Fees

• Current Assignee: Assurance Biotech LLC
• Original Assignee: Jin Po Lee
• Inventors: Lee, Jin Po
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US09/364,277
• Publication Number:
  US 20020001854A1
• Time in Patent Office: 1,286 Days
• Field of Search: 436/518, 436/524, 436/538, 436/810, 435/7.1, 435/7.2, 435/174, 435/970, 435/971, 422/56, 422/58, 422/104, 422/110
• US Class Current: 436/518
• CPC Class Codes: B01L 1/52 Transportable laboratories; Field kits
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 2001/007 Devices specially adapted for forensic samples, e.g. tamper-proofing, sample tracking
• CPC Class Codes: G01N 2035/00118 for multiple tests
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/971 Capture of complex after antigen-antibody reaction
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

An assay device, a fluid analyte sample separator device and methods for use of thereof for determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of multiple analytes, such as drugs of abuse. The device is composed of a housing having separate slots therein for insertion of one or more analyte test strips, one end of which protrudes from the housing, and one or more units of a sample integrity monitoring system. The device may be used in dipstick or cassette form. An analyte sample separator for division of sample and retention of uncontaminated sample for further testing is also provided. The analyte test strips and sample integrity monitoring system are replaceable, so that the panel of analytes and of sample condition parameters tested can be customized.

Claims

1. A device for use in determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of multiple analytes, the device comprising:

(A) a base having adjacent slots therein of sufficient length for insertion of an analyte test strip therein, wherein each slot is defined by (a) a floor, (b) raised walls depending upwardly from the floor to separate each adjacent slot from the next, and (c) at least one open end;

(B) a multiplicity of analyte test strips having an upstream and a downstream end, wherein each analyte test strip occupies a separate slot of the base so the upstream end of each analyte test strip protrudes out of the open end of each slot for application of the fluid analyte sample;

(C) a sample integrity monitoring system, the system comprising;

(a) a carrier membrane which lies parallel with and underlies each analyte test strip;

(b) a sample integrity determinant pad in fluid communication with the carrier membrane; and

,

(c) determinants incorporated into the integrity determinant pad, which determinants provide a detectable signal for a parameter indicative of the condition of the fluid;

wherein neither the carrier membrane nor the integrity determinant pad are in appreciable fluid communication with any of the analyte test strips.

2. The device according to claim 1 further comprising a cap for insertion over the protruding ends of the analyte test strips.

3. The device according to claim 1, wherein the carrier membrane of the sample integrity monitoring system lies partially beneath and in a slot with the analyte test strip;

wherein further the carrier membrane extends in length beyond the downstream end of the analyte test strip to define a platform for the sample integrity monitoring pad; and

, wherein further the sample integrity determinant pad rests on top of such platform.

4. The device according to claim 1, wherein the carrier membrane of the sample integrity monitoring system lies partially above and in a slot with the analyte test strip;

wherein further the carrier membrane extends in length beyond the downstream end of the analyte test strip to define a platform for the sample integrity monitoring pad; and

, wherein further the sample integrity determinant pad rests below such platform.

5. The device according to claim 1 wherein the carrier membrane of the sample integrity monitoring system occupies a different slot than the slot occupied by the analyte test strip.

6. The device according to claim 1, further comprising a multiplicity of analyte test strips which occupy separate slots of the base, wherein each analyte test strip has a test zone therein and each test zone contains a binder specific for a different analyte.

7. The device according to claim 3, further comprising a multiplicity of analyte test strips which occupy separate slots of the base, wherein each analyte test strip has a test zone therein and each test zone contains a binder specific for a different analyte.

8. The device according to claim 4, further comprising a multiplicity of analyte test strips which occupy separate slots of the base, wherein each analyte test strip has a test zone therein and each test zone contains a binder specific for a different analyte.

9. The device according to claim 5, further comprising a multiplicity of analyte test strips which occupy separate slots of the base, wherein each analyte test strip has a test zone therein and each test zone contains a binder specific for a different analyte.

10. The device according to any one of claims 6 through 9, wherein each binder is specific for a different drug of abuse.

11. The device according to any one of claims 6 through 9, wherein the device includes a cover overlying the slots of the base and each test zone of the analyte test strips is visible through a transparent window through the cover.

12. The device according to any one of claims 6 through 9, wherein each analyte test strip further comprises a label downstream of the test zone, which label identifies the analyte for which the binder is specific.

13. The device according to any one of claims 6 through 9, wherein each binder is specific for a different drug of abuse selected from the group of drugs of abuse consisting of methamphetamine, opiates/morphine, marijuana/tetrahydrocannabinol, amphetamine, cocaine/benzoylecgonine, methadone, PCP, barbiturate, trichloroacetic acid and benzodiazepine.

14. The device according to claim 1, wherein the parameter indicative of the condition of the fluid analyte sample evaluated is selected from the group consisting of pH, osmolality, albumin level, creatinine level, glutaraldehyde level and nitrite level.

15. The device according to claim 1, wherein fluid communication between the sample integrity monitoring system and each analyte test strip is prevented by a fluid barrier disposed on the carrier membrane between the downstream end of each analyte test strip and the integrity determinant pad.

16. The device according to claim 15, wherein the fluid barrier is a hydrophobic film.

17. The device according to claim 15, wherein the fluid barrier is a physical gap between the downstream end of each analyte test strip and the integrity determinant pad.

18. The device according to claim 15, wherein the fluid barrier is an absorbent pad.

19. The device according to claim 18, wherein a hydrophobic material is incorporated into the absorbent pad.

20. A method for use in determining whether the integrity of a fluid analyte sample has been compromised and for contemporaneously assaying the sample for the presence or absence of multiple analytes, the method comprising:

(A) immersing the protruding ends of the analyte test strips of the device of claim 1 into the fluid analyte sample;

(B) reading the assay results visible on the analyte test strips; and

,

(C) reading the results obtained by the sample integrity monitoring system;

wherein a detectable signal on an analyte test strip is indicative of the presence or absence of the analyte being screened for in said sample by said analyte test strip; and

wherein a detectable signal on the sample integrity monitoring system is indicative of the presence or absence of adulteration in said sample.

21. The method according to claim 20, further comprising the step A′

, wherein the sample in a closed specimen collection cup having a separation device therein, the separation device comprising a V-shaped trough transversing a ring placable in the cup, wherein sample separation is accomplished by inverting the specimen collection cup to allow fluid analyte sample to flow into the collection chamber of the separator device; and

wherein further step A′

is performed by immersing the protruding ends of the analyte test strips into the fluid collected in the chamber.

22. The method according to claim 20, wherein the parameter indicative of the condition of the analyte sample fluid evaluated is selected from the group consisting of pH, osmolality, albumin level, creatinine level, glutaraldehye level and nitrite level.