IMMY CrAg Lateral Flow Assay

Description

• Immochromatographic test system for qualitative or semi-quantitative detection of capsular antigens of Cryptococcus species complex in serum and cerebral spinal fluid
• No specimen treatment needed 10-Minute total test time High sensitivity and specificity — twice as fast, and with greater sensitivity, compared to latex agglutination Dipstick sandwich immunochromatographic assay Specimens and specimen diluent are added into a test tube or other reservoir Lateral flow device is placed into the reservoir Specimen wicking captures gold-conjugated, anti-CrAg monoclonal antibodies and gold-conjugated control antibodies deposited on test membrane CrAg present in the specimen binds to the gold-conjugated, anti-CrAg antibodies Antibody-antigen complex continues to wick up the membrane and interacts with test line containg immobilized anti-CrAg monoclonal antibodies Gold-labeled antibody-antigen complex forms a sandwich at the test line causing a visible line to form Positive test results create two lines (test and control) Negative test results form only one line (control) Failed test exists if a control line fails to develop Assay Kit Content 6.5mL LF Specimen Diluent: Glycine-buffered saline containing blocking agents and a preservative Pack of 50 CrAg LF Test Strips in desiccant vial 1mL CrAg Positive Control: Glycine- buffered saline spiked with cryptococcal antigen (strain 184A – clinical isolate from Tulane University (Infection & Immunity, June 1983, p
• 1052-1059)) Package insert For optimal results, sterile nonhemolyzed serum should be used
• Certifications FDA-cleared test (510k # K112422)