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The Binax NOW Streptococcus pneumoniae test is an immunochromatographic membrane assay used to detect pneumococcal soluble antigen in human urine and cerebrospinal fluid. Rabbit anti-Streptococcus pneumoniae and antispecies antibodies are conjugated to visualizing particles that are dried onto an inert fibrous support. The resulting conjugate pad and the striped membrane are combined to construct the test strip.
To perform the test, a swab is dipped into the specimen, removed, and then inserted into the test device. Reagent A, a buffer solution is added from a dropper bottle. The device is then closed, bringing the sample into contact with the test strip. Pneumococcal antigen present in the sample reacts to bind anti-Streptococcus pneumonia-conjugated antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-Streptococcus pneumoniae-conjugated antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-Streptococcus pneumoniae antibody, forming the sample line. Immobilized control antibody captures antispecies conjugate forming the control line.
Test results are interpreted by the presence or absence of visually detectable pink-to-purple colored lines. A positive test result, read in > or =15 minutes depending on the concentration of antigen present in the sample, will include the detection of both a sample and control line. A negative test result, read in 15 minutes, will produce only a control line, indicating that Streptococcus pneumoniae antigen was not detected in the sample. Failure of the control line to appear, whether the sample line is present or not, indicates an invalid assay.(Package insert: NOW Streptococcus pneumoniae Test. Binax, Inc., Portland, ME, 1998)
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