Intended Use

This kit is a rapid, serological, lateral flow chromatographic immunoassay for the qualitative detection ofChikungunya Virus (CHlK) El protein antigen in human whole blood , serum, or plasma specimens toaid in the diagnosis of infection with CHlK, The test only provides preliminary analysis results but notcritical diagnosis criteria. Any reactive specimen with the Chikungunya Antigen Rapid Test must beanalyzed and confimed with alternative testing method(s) and clinical findings. The test is intended forhealthcare professional use.

Principle

The Chikungunya Antigen Rapid Test Kit is a qualitative membrane-based immunoassay for thedeteetion of chikungunya virus El protein antigen in human whole blood , serum, or plasma specimensThe test device consists of: 1 ) a burgundy-colored conjugate pad containing mouse anti-Chikungunya Eantigen conjugated with colloid gold (Chikungunya Ab conjugates), 2) a nitrocellulose membrane strigcontaining a test line region (T) and a control line region (C). The test line region (T) is pre-coated withrabbit anti-Chikungunya El antigen, and the control line region (C) is pre-coated with goat anti-mouseIgG antibody, When an adequate volume of’ specimen is added to the specimen well (S) of the device, thespecimen migrates by capillary action across the device and interacts with the immobilized antibodies. lfthe specimen contains sufficient chikungunya virus El protein antigen, the specimen will bind to theChikungunya Ab conjugates. The immunocomplex will be then captured on the membrane by theprecoated rabbit anti-Chikungunya El antibody, forming a burgundy-colored line in the test line region(T), indicating a Chikungunya Ag positive result. Absence of’ test line (T) suggests a negative result.An intemal quality control is ineluded in the test, in the form of a colored line appearing in the controlline region (C), indicating that the test is finetional, and proper and sufficient volume of specimen hasbeen applied to enable migration through the test and control lines,regardless of whether there is a testline or not. If’ the control line (C) does not appear within the testing time, test result is invalid and the testshould be repeated with a new test device.