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

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving luciferase

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435 30, 4352876, 4352877, 4352882, 4352887, 4353091, C12Q 166, C12M 130

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058276750

DESCRIPTION:

BRIEF SUMMARY
DESCRIPTION



REFERENCE TO PRIOR APPLICATIONS

This application claims the benefit of provisional U.S. patent application Ser. No. 60/001,081 filed Jul. 12, 1995, and also the benefit of provisional patent application Ser. No. 60/007,585, filed Nov. 27, 1995.


BACKGROUND OF THE INVENTION

It is desired to provide for a rapid and efficient test for the detection of various test samples from materials or surfaces. Various test apparatuses and test methods have been developed for that purpose. For example, it is widely desirable to determine or to test through quantitative and qualitative tests body fluids, such as blood, and urine, and milk and the like, as well as food, such as meat products, fruit, vegetables, and to detect for alkaline phosphatase, salmonella, drugs, and antibiotics, such as; for example, sulfa drugs, beta-lactam drugs, organophosphates, carbamates and active metabolites, various bacteria and pathogenic combinations, either in materials or on the surface of materials, or both.
For illustration only, the detection and characterization, qualitatively and qualitatively, through the employment of a color change or a bioluminescence test, for the detection of the alkaline phosphatase, such as for example, the detection of ATP on or in materials, is most desirable for providing a measure of immunoeffectiveness, so that a rapid determination can be made of whether a processing or surface area is adequately hygienically clean and free of, for example, alkaline phosphatase, so that corrective or disinfectant action can be instituted.
Typically, the detection of ATP is by bioluminescence assay, which is a standard test which will detect food residue, bacteria, yeast, mold, by measuring the ATP on a surface. The method comprises obtaining a test sample, for example, on the surface of the material, such as by non-laboratory or out-of-laboratory or at field locations, the activating of the test sample in the presence of test reagents, and then later employing a luminometer to determine test results, which can be compared with a controlled sample or controlled environment.
The detection of a phosphatase, like ATP, may be made in a dimensional color test and method. However, such a test is time consuming and requires laboratory trained personnel. The present commercial tests are generally directed to a bioluminescence test, which ordinarily takes less than five minutes and employs premeasured and prepackaged separate test reagents and employs a luminometer to detect test results. Generally, a portable luminometer, as used in the field, with the use of test containers, such as various test tubes or plates. The concentration of the phosphatase has been determined by measuring or counting of the bioluminescence, determined by the reagents mixing with the test sample, and comparing the count against certain accepted control standards, or a threshold of a control standard.
There are various ATP tests available in the field, and one bioluminescent ATP monitoring test in present use is described in "The Handbook of ATP-Hygiene Monitoring" by Bio-Orbit Oy of Turku, Finland, while another luminescent ATP hygiene monitoring test in use is called the Charm ABC Swab Test.TM., sold by Charm Sciences, Inc., of Malden, Mass., both of which tests and literature are hereby incorporated by reference.
Another portable swab-type device for use in an ATP bioluminescent test for measuring cleaning effectiveness is distributed under the mark Lightning.TM., swab device by Idexx Laboratories, Inc., of Westbrook, Me. (Lightning.TM. is a trademark of Idexx). The Lightning.TM. device consists of an integral swab design, which contains a unit dose of reagents in use with a portable luminometer. The device employs an elongated tube with a cover on it at one end and an elongated, extended premoistened wetting agent on a premoistened swab, and with such end containing a buffer in a bulb, while the opposite read chamber end, where the test results are read, comprises a glass ampoule. The ampoule contains a luciferin and luciferase re

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