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; (C) a sample integrity monitoring system, the system comprising:
(a) a carrier membrane lying parallel to 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 of claims 6 through 9, wherein each binder is specific for a different drug of abuse.
- 11. The device according to any 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 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 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, barbituate, trichloroacetic acid and benzodiazepine.
- 14. 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 a 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 the analyte test strip protrudes out of the open end of the slot; (C) a sample integrity monitoring system, the system comprising:
(a) a carrier membrane inserted into a slot of the base; (b) a sample integrity determinant pad in fluid communication with the carrier membrane; (c) determinants incorporated into the sample 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 sample integrity determinant pad are in appreciable fluid communication with any of the analyte test strips; and, (D) a cap enclosing the protruding ends of the analyte test strips, the cap comprising:
(a) a sample port formed through which fluid analyte sample may be applied to the protruding ends of the analyte test strips; and, (b) a floor opposing the sample port, the floor comprising a wall having a raised bar therein which defines a fluid reservoir beneath the sample port.
- 15. The device according to claim 14 wherein the cap is removable from the device.
- 16. The device according to claim 14 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
- 17. The device according to claim 14 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
- 18. The device according to claim 14 wherein the carrier membrane of the sample integrity monitoring system occupies a different slot than the slot occupied by the analyte test strip.
- 19. The device according to claim 14, 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.
- 20. The device according to claim 16, further comprising a multiplicity of analyte test strips which occupy each slot 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.
- 21. The device according to claim 17, further comprising a multiplicity of analyte test strips which occupy each slot 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.
- 22. The device according to claim 18, 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.
- 23. The device according to any of claims 19 through 22, wherein each binder is specific for a different drug of abuse.
- 24. The device according to any of claims 19 through 22, 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.
- 25. The device according to any of claims 19 through 22, 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.
- 26. The device according to any of claims 19 through 22, 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, barbituate, trichloroacetic acid and benzodiazepine.
- 27. The device according to claim 1 or claim 14, wherein the parameter indicative of the condition of the analyte sample fluid evaluated is selected from the group of such parameters consisting of pH, osmolality, albumin level, creatinine level, glutaraldehye level and nitrite level.
- 28. The device according to claim 1 or claim 14, 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.
- 29. The device according to claim 28, wherein the fluid barrier is a hydrophobic film.
- 30. The device according to claim 28, wherein the fluid barrier is a physical gap between the downstream end of each analyte test strip and the integrity determinant pad.
- 31. The device according to claim 28, wherein the fluid barrier is an absorbent pad.
- 32. The device according to claim 31, wherein a hydrophobic material is incorporated into the absorbent pad.
- 33. An assay system 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 an analyte, the assay system comprising:
(A) an analyte test strip having an upstream and a downstream end, (B) a sample integrity monitoring system at the downstream end of the analyte test strip, the sample integrity monitoring system comprising:
(a) a carrier membrane; (b) a sample integrity determinant pad in fluid communication with the carrier membrane; and, (c) determinants incorporated into the sample integrity determinant pad, which determinants provide a detectable signal for a parameter indicative of the condition of the fluid; wherein the sample integrity monitoring system is not in appreciable fluid communication with the analyte test strip.
- 34. The device according to claim 33, 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.
- 35. The device according to claim 34, wherein the fluid barrier is a hydrophobic film.
- 36. The device according to claim 34, wherein the fluid barrier is a physical gap between the downstream end of each analyte test strip and the integrity determinant pad.
- 37. The device according to claim 34, wherein the fluid barrier is an absorbent pad.
- 38. The device according to claim 37, wherein a hydrophobic material is incorporated into the absorbent pad.
- 39. 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.
- 40. 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) applying fluid analyte sample through the sample port of the cover of the device of claim 14 to contact the analyte test strips of the device; (B) reading the assay results visible on the analyte test strips; and, (C) reading the results obtained by the sample integrity monitoring system.
- 41. The method according to claim 39 or claim 40, 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.
- 42. The method according to claim 39 or claim 40, wherein the parameter indicative of the condition of the analyte sample fluid evaluated is selected from the group of such parameters consisting of pH, osmolality, albumin level, creatinine level, glutaraldehye level and nitrite level.
CROSS-REFERENCE TO RELATED PATENT APPLICATION
[0001] This is a continuation-in-part (for purposes of U.S. patent prosecution) of International Application No. PCT/US98/15369, designating the United States, still pending.