Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Calorimeter
Patent
1997-11-26
2000-12-26
Alexander, Lyle A.
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Calorimeter
422 61, 422100, 422104, 436169, 436178, G01N 3348
Patent
active
061654167
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates to a device for collecting a sample, such as a biological sample, for subsequent use in the detection of an analyte in the sample. In one particular embodiment, this invention relates to a device for collecting a faecal sample for the purposes of subsequent occult blood detection in the sample. It is to be understood however that the device of this invention may be used in the collection of other biological samples such as blood, urine, saliva samples and the like, as well as in the collection of non-biological samples such as water samples for detection of pollutants and the like.
The present invention also extends to an assay device based on this sample collection device.
BACKGROUND OF THE INVENTION
A well known and widely-used clinical reagent for the detection of occult blood in a sample, particularly a faecal sample, is guaiac (also known as gum guaiac or resin guaiac). When used in association with an appropriate developer solution, guaiac provides a calorimetric assay system for detecting haemoglobin in the sample. Such tests are commercially available, for example, Hemoccult II and Hemoccult II Sensa (SmithKline Diagnostics, San Jose, Calif., USA).
Prior Australian Patent Application No. 21852/92 (International Patent Application No. PCT/US92/04425) notes that among the many analytical systems used for detection and/or determination of analytes, particularly analytes of biological interest, are chromatographic assay systems. Among the analytes of biological interest frequently assayed with such systems are: as a marker of human pregnancy; protozoan pathogens, such as Streptococcus, hepatitis virus, and Giardia; with pathogens, such as antibody to the bacterium Helicobacter pylori and to human immunodeficiency virus (HIV); determinations of faecal occult blood, an early indicator of gastrointestinal disorders such as colon cancer; alkaline phosphatase, and glutamate dehydrogenase, frequently assayed as indicators of physiological function and tissue damage; anticonvulsants, and illegal drugs of abuse, such as cocaine, heroin, and marijuana; and
Such chromatographic systems are frequently used by physicians and medical technicians for rapid in-office diagnosis and therapeutic monitoring of a variety of conditions and disorders. They are also increasingly used by patients themselves for at-home monitoring of such conditions and disorders.
Among the most important of such chromatographic systems are the "thin layer" systems in which a solvent moves as a solvent front across a thin, flat absorbent medium. Among the most important of tests that can be performed with such thin layer systems are immunoassays, which depend on the specific interaction between an antigen or hapten and a corresponding antibody. The use of immunoassays as a means of testing for the presence and/or amount of clinically important molecules has been known for some time.
Chromatographic techniques used in conjunction with immunoassays include a procedure known as immunochromatography. In general, this technique uses a disclosing reagent or particle that has been linked to an antibody to the analyte to be assayed, forming a conjugate. This conjugate is then mixed with a specimen and, if the analyte to be assayed is present in the specimen, the disclosing reagent-linked antibodies bind to the analyte to be assayed, thereby giving an indication that the analyte to be assayed is present. The disclosing reagent or particle can be identifiable by colour, magnetic properties, radioactivity, specific reactivity with another molecule, or another physical or chemical property. The specific reactions that are employed vary with the nature of the analyte being assayed and the sample to be tested.
Although useful, currently available chromatographic techniques using test strips have a number of drawbacks. Many samples, such as faecal samples, contain particulate matter that can clog the pores of the chromatographic medium, greatly hindering the immunochromatographic process. Other samples, such
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