INTENDED USE The StrongStep^® Cryptococcal Antigen Rapid Test Device is a rapid immunechromatographic assay for the detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum, plasma, whole blood and cerebral spinal fluid (CSF). The assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis. INTRODUCTION 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 in serum and CSF has been extensively utilized with very high sensitivity and specificity. PRINCIPLE The StrongStep^® Cryptococcal Antigen Rapid Test Device has been designed to detect Cryptococcus species complex through visual interpretation of color development in the internal strip. The membrane was immobilized with anti Cryptococcal monoclonal antibody on the test region. During the test, the specimen is allowed to react with monoclonal anti-Cryptococcal antibody colored particals conjugates, which were precoated on the conjugate pad of the test. The mixture then moves on the membrane by capillary action, and interact with reagents on the membrane. If there were enough Cryptococcal antigens in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicatesthat proper volume of specimen has been added and membrane wicking has occurred. PRECAUTIONS ■ This kit is for IN VITRO diagnostic use only. ■ This kit is for PROFESSIONAL use only. ■ Read the instructions carefully before performing the test. ■ This product does not contain any human source materials. ■ Do not use kit contents after the expiration date. ■ Handle all specimens as potentially infectious. ■ Follow standard Lab procedure and biosafety guidelines for handling and disposal of potentially infective material. When the assay procedure is complete, dispose specimens after autoclaving them at 121℃ for at least 20 min. Alternatively, they can be treated with 0.5% Sodium Hypochlorite for hours before disposal. ■ Do not pipette reagent by mouth and no smoking or eating while performing assays. ■ Wear gloves during the whole procedure.Instructions