CDIA™ Cryptococcus Capsular Polysaccharide Antigen Test Kit - Creative Diagnostics

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CDIATM Cryptococcus Capsular polysaccharide antigen Test Kit (DTS737)

Intended Use

The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
  • Serum and cerebral spinal fluid
  • Kit
  • Sensitivity in serum is 100%(calculated) and 96%-100%(95% Cl)Sensitivity in CSF is 100%(calculated) and 94.4%-100%(95% Cl)

Product Introduction

General Description
Cryptococcosis is caused by both species of the Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii). Individuals with impaired cell-mediated immunity are at greatest risk of infection. Cryptococcosis is one of the most common opportunistic infections in AIDS patients. Detection of cryptococcal antigen (CrAg) in serum and CSF has been extensively utilized with very high sensitivity and specificity.
Principle of The Test
The CrAg Lateral Flow Assay is a dipstick sandwich immunochromatographic assay. Specimens and specimen diluent are added into an appropriate reservoir, such as a test tube, and the lateral flow device is placed into the reservoir. The test uses specimen wicking to capture gold-conjugated, anti-CrAg monoclonal antibodies and gold-conjugated control antibodies deposited on the test membrane. If CrAg is present in the specimen, then it binds to the gold-conjugated, anti-CrAg antibodies. The gold-labeled antibody-antigen complex continues to wick up the membrane where it will interact with the test line, which has immobilized anti-CrAg monoclonal antibodies. The gold-labeled antibody-antigen complex forms a sandwich at the test line causing a visible line to form. With proper flow and reagent reactivity, the wicking of any specimen, positive or negative, will cause the gold-conjugated control antibody to move to the control line. Immobilized antibodies at the control line will bind to the gold-conjugated control antibody and form a visible control line. Positive test results create two lines (test and control). Negative test results form only one line (control). If a control line fails to develop then the test is not valid.

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