Test apparatus, system and method for the detection of test samples

• US 5,965,453 A
• Filed: 06/08/1998
• Issued: 10/12/1999
• Est. Priority Date: 07/12/1995
• Status: Expired due to Term

• Current Assignee: Charm Sciences, Inc.
• Original Assignee: Charm Sciences, Inc.
• Inventors: Zomer, Eliezer, Skiffington, Richard
• Primary Examiner(s): Beisner, William H.
• Application Number:
  US09/093,433
• Time in Patent Office: 491 Days
• Field of Search: 436/8, 436/21, 436/29, 436/32, 436/34, 436/30, 436/39, 436/287.4, 436/287.6, 436/288.1, 436/288.2, 436/288.7, 436/307.1, 436/309.1, 436/808, 436/810, 436/164 , 436/165, 436/172, 422/58-61, 422/52, 600/572, 600/569, 600/584
• US Class Current: 436/165
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: C12Q 1/00 Measuring or testing processes involving enzymes, nucleic acids or microorganisms measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M1/34; Compositions therefor; Processes of preparing such compositions
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: C12Q 1/10 Enterobacteria
• CPC Class Codes: C12Q 1/66 involving luciferase
• CPC Class Codes: C12Q 2304/60 Chemiluminescent detection using ATP-luciferin-luciferase system
• CPC Class Codes: G01N 2001/028 Sampling from a surface, swabbing, vaporising
• CPC Class Codes: G01N 2001/1056 Disposable (single-use) samplers
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/76 Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 33/04 Dairy products
• CPC Class Codes: G01N 33/12 Meat; fish
• CPC Class Codes: Y10S 435/81 Packaged device or kit

Abstract

The invention concerns a test apparatus for the testing of a test sample on or in a material, such as body fluids or food, particularly adapted to a bioluminescent test, such as for the detection of ATP or phosphatase or other materials. The test apparatus includes a transparent tube having at one end a sample unit and at the other end a detachable or nondetachable test unit which are connected, and which includes a cover with a probe containing a swab at one end. The test apparatus includes probe positioning marks on the exterior of the sample unit, so that the probe may be moved between selected test positions, and as it moves from a non-use to a use position, various test reagents which are sealed within the test unit are punctured by the probe, and the test sample and the test reagents are reacted together in the test unit.

Claims

1. A test apparatus for the color or luminescent detection of a test sample from or on a material, which apparatus comprises:

a) an elongated tubular sample unit having;

i) a probe means having a first and second end, with said first end to obtain a test sample in use to be collected from or on a material;

ii) a chamber having a first and second open end and adapted to receive and retain therein the probe means prior to use and after use;

iii) a cover adapted for the threadable movement on the chamber and over the first end of the chamber and the second end of the probe means secured for movement with the cover; and

iv) threadable means to move spirally, said cover and the first end of said probe means within said chamber to selected, controlled, sequential positions; and

b) a tubular test unit longitudinally aligned and attached to the second end of the chamber having;

i) a closed bottom end and a top end, said top end attached to said second open end of said chamber, said test unit composed of a transparent material adapted for use with or in a test instrument for the identification of a test sample therein by measurement of luminescence; and

ii) the test unit having a plurality of separate, aligned, sealed compartments formed of separate probe means puncturable membranes, each compartment containing a reagent means of a reagent or solution for use in combination in the detection of a test sample on the probe means, whereby the probe means with the test samples by threadable controlled, sequential movement, punctures the membranes to combine the test sample and reagents in the bottom end of the test unit for the measurement of luminescence or color.

2. The apparatus of claim 1 wherein the probe means comprises a premoistened test sample collecting swab at the first end.

3. The apparatus of claim 1 wherein the threadable means comprises external surface threads on an upper portion of the chamber and internal surface threads on the cover.

4. The apparatus of claim 1 wherein the tubular test unit is removably threadably secured at the top and to the second other end of the chamber.

5. The apparatus of claim 1 wherein the tubular test unit includes a foil cap over the top end of the tubular test unit.

6. The apparatus of claim 1 wherein said reagent means comprises a plurality of test reagents having at least one buffer solution with an indicator dye therein and at least one test reagent for detection of said test sample in the presence of the buffer and dye indicator.

7. The apparatus of claim 1 for the detection of ATP wherein said reagent means comprises a plurality of test reagents to include:

a) in one compartment, a buffer solution with a detergent; and

b) in another compartment, a tablet which comprises luciferase and a luciferin substrate for the detection of ATP in the samples.

8. In combination, the test apparatus of claim 1 and a luminometer as a test instrument to measure the luminescence in said tubular test unit for the detection of said test sample.

9. The combination of claim 8 wherein said test unit is not detached, and said test unit of the apparatus is placed in a luminometer measuring section for detection of luminescence.

10. The combination of claim 8 wherein said test unit is detached from said sample unit, a foil cap applied to the open top end, and the luminescence of the detached test unit is measured by the luminometer.

11. The apparatus of claim 1 for the detection of phosphatase from a material or surface and wherein said reagent means comprises a plurality of test reagents to include in separate sequential compartments:

a) a water or saline buffer solution;

b) a tablet which comprises a luminescent phosphatase substrate to measure the phosphatase on said test sample; and

c) a biological buffer solution to stop the reaction of the phosphatase with the test sample.

12. The apparatus of claim 1 for the detection of chemical biocides or antibiotic test samples and wherein the reagent means comprises a plurality of test reagents to include in separate sequential compartments:

a) water or a buffer solution;

b) a tablet which comprises a microorganism, a nutrient for the microorganism and a growth-activity indicator; and

c) an enhancing reagent to enhance the test results and permit test measurement for detection.

13. In combination, the apparatus of claim 12 with a means to incubate said test unit with said test sample and test reagents prior to measurement of luminescence.

14. The apparatus of claim 1 wherein said reagent means includes naturally luminescent bacteria, genetically modified bacteria, growth and maintenance nutrient, and a chromogen, which in the presence of an enzyme, produces a detectable color or luminescence.

15. The apparatus of claim 1 which includes a visual probe identification means to identify the position of the first end of the probe means.

16. The apparatus of claim 1 wherein the tubular test unit includes a finger grip means to enable the user to detach the test unit.

17. The apparatus of claim 1 wherein the cover and chamber of the tubular sample unit and the test unit comprise a disposable, single use, molded thermoplastic material.

18. The apparatus of claim 1 wherein the reagent means comprises, in sequence from the top end of the test unit, at least one solution and at least one reagent containing tablet.

19. The apparatus of claim 1 wherein one compartment comprises an indicator dye solution to verify the admixture of the reagent means and the test sample and whether the apparatus has been used.

20. The apparatus of claim 1 for the detection of ATP in a test sample, wherein the reagent means includes in sequence in the membrane-puncturable compartments of the test unit:

a) an acidic buffer and detergent solution;

b) a neutralizer buffer solution; and

c) a luciferase-luciferin containing tablet.

21. The apparatus of claim 1 for the detection of phosphatase wherein the reagent means includes in sequence:

a) a water or saline buffer solution containing a preservative and a pH indicator;

b) a phosphatase-containing tablet; and

c) a buffer reaction-stopping solution.

22. The apparatus of claim 1 for the detection of residual chemicals and antibiotics in a test sample, wherein the reagent means includes in sequence:

a) water or a water buffer solution;

b) a tablet containing a luminescent dried bacteria, a bacteria nutrient, and a chromogen in the presence of an enzyme to produce color or luminescence; and

c) an enhancing reagent for the test, whereby the reagent means and admixed test sample in the test unit are incubated prior to detection of the color or luminescence.

23. A method for the color or luminescent detection of a test sample from or on a material, in which said test sample is combined with test reagents to provide test results, which method includes:

a) providing an elongated test apparatus with a sample unit constructed and arranged to obtain a test sample on a probe means therein, and a transparent test unit at the one end to provide admixture of the test sample with reagents and to provide test results therein;

b) removing said probe means and collecting a test sample on the probe means;

c) inserting said probe means within said test apparatus;

d) spirally moving said probe means in a controlled sequence in said test apparatus, with said test sample, to puncture aligned, sequential, puncturable membranes in the test unit, which define separate compartments with test reagents in the test unit, the test reagents selected for the particular test method for the test sample to provide a contacting of said test reagents and said test sample on said probe means in said test unit;

e) withdrawing the probe means from the test unit; and

f) observing said test results in said test unit.

24. The method of claim 23 which includes detaching the test unit only with the test sample and test reagents therein from said sample unit for use in a testing instrument.

25. The method of claim 23 which includes providing a plurality of packaged test reagents in said test unit having at least one buffer test reagent, an indicator dye therein, and at least one test reagent for reacting with said test sample in the presence of the buffer and dye indicator.

26. The method of claim 23 which includes providing a test method for the detection of ATP from a material surface, and wherein the test reagent comprises a plurality of test reagents to include:

a) a buffer solution with a detergent and an indicator dye;

b) a neutralizing buffer solution; and

c) a tablet which comprises luciferase and a luciferin substrate for the luminescent detection of ATP in the sample.

27. The test method of claim 23 which includes measuring the luminescence of the test sample.

28. The method of claim 23 for the detecting of phosphatase from the test sample comprising a plurality of test reagents including:

a) a water or saline buffer solution;

b) a tablet which comprises a luminescent phosphatase substrate to measure the phosphatase of the test sample; and

c) a biological buffer solution to stop the reaction of the phosphatase with the test sample.

29. The method of claim 23 for the detecting of chemicals and antibiotics from a test sample comprising a plurality of test reagents to include:

a) water or a buffer solution;

b) a tablet which comprises a microorganism, a nutrient for the microorganism and a growth or activity indicator; and

c) an enhancing reagent to enhance the test results and permit test measurement.

30. The method of claim 23 which includes timing and incubating said test unit with said admixed test sample and test reagents.