One-Step HAV IgG/IgM Test
The One Step HAV IgG/IgM Test is a rapid chromatographic
immunoassay for the qualitative detection of antibodies (IgG and
IgM) to Hepatitis A Virus (HAV) in Whole Blood /Serum / Plasma to
aid in the diagnosis of Hepatitis A Virus.
Hepatitis A is an acute, usually self-limiting disease of the liver
caused by hepatitis A virus (HAV). HAV is transmitted from person
to person, primarily by the faecal-oral route. The incidence of
hepatitis A is closely related to socioeconomic development, and
seroepidemiological studies show that prevalence of anti-HAV
antibodies in the general population varies from 15% to close to
100% in different parts of the world. One step HAV IgG/IgM Test is
a simple, visual qualitative test that detects Hepatitis A Virus
antibodies in human Whole Blood /Serum / Plasma. The test is based
on immunochromatography and can give a result within 15 minutes.
The One Step HAV IgG/IgM Test is a qualitative membrane strip based
immunoassay for the detection of Hepatitis A Virus antibodies (IgG
and IgM) in Whole Blood /Serum / Plasma. The test device consists
of: 1) a burgundy colored conjugate pad containing HAV recombinant
envelope antigens conjugated with Colloid gold (HAV conjugates) and
rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip
containing two test bands (T1 and T2 bands) and a control band (C
band). The T1 band is pre-coated with the antibody for the
detection of IgM anti-HAV, T2 band is coated with antibody for the
detection of IgG anti-HAV, 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 test cassette, the specimen
migrates by capillary action across the cassette. IgG anti-HAV, if
present in the specimen, will bind to the HAV conjugates. The
immunocomplex is then captured by the reagent pre-coated on the T2
band, forming a burgundy colored T2 band, indicating a HAV IgG
positive test result and suggesting a recent or repeat infection.
IgM anti-HAV if present in the specimen will bind to the HAV
conjugates. The immunocomplex is then captured by the reagent
coated on the T1 band, forming a burgundy colored T1 band,
indicating a HAV IgM positive test result and suggesting a fresh
Absence of any T bands (T1 and T2) 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 any of the T bands. Otherwise, the test result is invalid and
the specimen must be retested with another device.
Storage and Stability
Store as packaged in the sealed pouch at room temperature or
refrigerated (4-30℃ or 40-86℉). The test device is stable through
the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Contact Rebecca Yan