For professional in vitro diagnostic use only.
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 Pakistan1-2.
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.
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
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.
Contact Rebecca Yan