Chikungunya Ab WB/S/P Rapid Test (strip/Cassette/Uncut sheet)

Chikungunya Ab Rapid Test WB/S/P

Specimens: Whole Blood/Serum/Plasma

For professional in vitro diagnostic use only.

INTRODUCTION

The Chikungunya Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya virus (CHIK) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with CHIK. Any reactive specimen with the Chikungunya Ab Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

SPECIMEN COLLECTION & PREPARATION

Chikungunya is a rare viral infection transmitted by the bite of an infected Aedes aegypti mosquito. It is characterized by a rash, fever, and severe joint pain (arthralgias) that usually lasts for three to seven days. The name is derived from the Makonde word meaning "that which bends up" in reference to the stooped posture developed as a result of the arthritic symptoms of the disease. It occurs during the rainy season in tropical areas of the world, primarily in Africa, South-East Asia, southern India and Pakistan^1-2.

The symptoms are most often clinically indistinguishable form those observed in dengue fever. Indeed, dual infection of dengue and chikungunya has been reported in India³. Unlike dengue, hemorrhagic manifestations are relatively rare and most often the disease is a self limiting febrile illness. Therefore it is very important to clinically distinguish dengue from CHIK infection.

CHIK is diagnosed based on serological analysis and viral isolation in mice or tissue culture. An IgM immunoassay is the most practical lab test method⁴.

The Chikungunya Ab Rapid Test utilizes recombinant antigens derived from its structure protein⁵, it detects IgM anti-CHIK in patient serum or plasma within 15 minutes. The test can be performed by untrained or minimally skilled personnel, without cumbersome laboratory equipment.

TEST PROCEDURE

The Chikungunya Ab Rapid Test is a lateral flow chromatographic immunoassay based on the principle of the IgM capture assay. The test cassette consists of: 1) a burgundy colored conjugate pad containing CHIK antigens conjugated with colloid gold (CHIK conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with anti-human M antibody, and the C band is pre-coated with goat anti-rabbit IgG.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. The IgM antibody to CHIK, if present in the specimen will bind to the CHIK conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored T band, indicating a CHIK IgM positive test result.

Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti-rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another device.