IMMY CrAg Lateral Flow Assay

Prescription-use laboratory assay aids in the diagnosis of crytococcosis

Catalog Number	Mfr. No.	Quantity	Type
22-122-321	IMMY GLF065	6.5 mL	Cryptococcus Antigen LF Specimen Diluent
22-122-320	IMMY CR2003US	50 Tests	Cryptococcus Antigen Assay Strips

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)

Specifications

• Content And Storage: 22°C to 25°C