Chemistry: molecular biology and microbiology – Apparatus – Including measuring or testing
Reexamination Certificate
1999-09-14
2001-01-30
Beisner, William H. (Department: 1744)
Chemistry: molecular biology and microbiology
Apparatus
Including measuring or testing
C435S287700, C435S288200, C435S288700, C435S810000, C435S008000
Reexamination Certificate
active
06180395
ABSTRACT:
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™, 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™ swab device by Idexx Laboratories, Inc., of Westbrook, Me. (Lightning™ is a trademark of Idexx). The Lightning™ 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 reagent material, with a glass ampoule separating the read chamber from the buffer end. The swab is removed from the tube and is used to obtain a test sample from a surface to be tested for ATP, and then the swab is reinserted within the tube.
The cover end of the device is then bent and squeezed to force out the buffer solution, while the opposite end containing the glass ampoule with the reagents, is crushed by the user, so that the buffer solution and the released luciferin-luciferase test reagents are then admixed within the tube with the test sample to form the reaction mixture, which would provide for the appropriate bioluminescence. The read chamber at one end is inserted into and read by the portable luminometer. Thus, the Lightning™ device provides a swab-type test probe requiring the bending and squeezing of one end and the crushing of a glass ampoule at another end of the device, then the admix of the materials prior to inserting the read chamber into a luminometer and then reading the test results. The Lightning™ swab device, together with its test methods, literature and equipment, is hereby incorporated by reference.
It is desirable to provide for a new and improved test apparatus, system and method adapted for use with a wide variety of known and unknown test methods for the detection of test materials on a material or on a surface. The improved test apparatus is greatly simplified in structure and is effective in use, eliminates possible operational mistakes by personnel in the field, does not require separate pipettes and test tubes, does not provide for the crushing of glass ampoules with its inherent danger, and provides excellent separate stability of test reagents which may be employed with the test results by specifically prepackaging the reagents, so that the test apparatus may be stored for long periods of time prior to use.
The device is particularly adapted for in-field or out of the laboratory testing by unsophisticated personnel, as well as the use by laboratory personnel, and further and importantly may have the test results determined by using the entire test results in one end thereof, or removing one end of the test unit for testing in a test instrument, which may be, for example, a visual change of color, or other property, in some tests, a use of a portable luminometer, or the use of other types of test instruments including radioactive detection devices, either alone or in any combination. The improved test device is particularly adaptable as a disposable, inexpensive, transparent, plastic pocket test apparatus.
SUMMARY OF THE INVENTION
The present invention concerns a test apparatus and a test system employing the test apparatus, and a test method employing the test apparatus and system, and in particular in one embodiment is directed to a bioluminescent type test for the detection of test samples from a material or material surface, by employing known test techniques.
The invention comprises a test apparatus composed of a sample unit and a test unit, which sample and test units may be generally longitudinally aligned and secured together generally in tubular form, and which may be integral or may be disposed for the removable detachment of the test unit by the user. The test apparatus is employed for the detection of the qualitative or quantitative, or for any analytical test of one or more test samples from or on a material or on a material surface.
The test apparatus comprises a sample unit having a probe means, such as an elongated element having a first and second end, with the first end adapted to obtain a test sample with a test collection swab or means at one end, and generally would comprise a probe-type collection means at one end, by which a test sample may be collected, and a sterile chamber having a first and second end and adapted to receive and retain therein prior to use, and optionally after use, the said probe means, and having a cover for the first end of said chamber to seal the end of the chamber.
The sample unit also includes means to retain said probe means within said chamber prior to use; that is, to render the test apparatus sterile prior to use, and without indiscriminate movement of the probe means within the chamber. The sample unit also includes a probe positioning means, comprising
Skiffington Richard
Zomer Eliezer
Beisner William H.
Charm Sciences Inc.
Crowley Richard P.
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