Importance

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Abstract

A test device which includes a housing having an immunochromatographic test strip therein is disclosed. The test strip is color-coded so that the presence or absence of a substance or substances in a fluid sample may be detected and identified. The strip also indicates the locations of the immunoreactions that will take place on the test strip by means of colored lines. Sample is applied onto the strip through a window and is spontaneously wicked up the test strip mobilizing a dye-microspherical antibody located in a first zone on the strip. The dye particles then move along the membrane strip by capillary action to a second zone. In the absence of specific antigen in the sample, the dye-microsphere particles attach to the antigen in the second and third zones through immunocomplexation, forming definite, visible lines. This is a negative test. In the presence of the specific antigen and/or its major metabolites in a sample, the binding of the antigen-conjugate to the antigens in the second and third zones is blocked by the sample. Thus, the immune complex formation between the antigens in the second and third zones and the dye-microsphere antibody conjugate is prevented. This is a positive test and lines will not form in the second and third zones. Multiple tests may also be performed on one test strip. The strip also contains a reference zone indicated by a visible line which is present in both positive and negative tests.

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First Claim