Intended Use

This kit is a rapid, serological, lateral flow chromatographic immunoassay for the qualitative detection of Chikungunya Virus (CHIK) E1 protein antigen in human whole blood , serum, or plasma specimens to aid in the diagnosis of infection with CHIK. The test only provides preliminary analysis results but not critical diagnosis criteria. Any reactive specimen with the Chikungunya Antigen Rapid Test must be analyzed and confirmed with alternative testing method(s) and clinical findings. The test is intended for healthcare professional use.

Principle

The Chikungunya Antigen Rapid Test Kit is a qualitative membrane-based immunoassay for the detection of chikungunya virus E1 protein antigen in human whole blood , serum, or plasma specimens. The test device consists of: 1) a burgundy-colored conjugate pad containing mouse anti-Chikungunya E1 antigen conjugated with colloid gold (Chikungunya Ab conjugates), 2) a nitrocellulose membrane strip containing a test line region (T) and a control line region (C). The test line region (T) is pre-coated with rabbit anti-Chikungunya E1 antigen, and the control line region (C) is pre-coated with goat anti-mouse IgG antibody. When an adequate volume of specimen is added to the specimen well (S) of the device, the specimen migrates by capillary action across the device and interacts with the immobilized antibodies. If the specimen contains sufficient chikungunya virus E1 protein antigen, the specimen will bind to the Chikungunya Ab conjugates. The immunocomplex will be then captured on the membrane by the precoated rabbit anti-Chikungunya E1 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 internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control lines,regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test device.

Chikungunya Antigen Rapid Test Kit – IFU