One Step HEV IgM Rapid Test
The One Step HEV IgM Test is a rapid chromatographic immunoassay
for the qualitative detection of IgM antibodies to Hepatitis E
Virus (HEV) in Whole Blood /Serum / Plasma to aid in the diagnosis
of Hepatitis E Virus.
Hepatitis E is an acute, usually self-limiting disease of the liver
caused by hepatitis E virus (HEV). HEV is transmitted from person
to person, primarily by the faecal-oral route. The incidence of
hepatitis E is closely related to socioeconomic development, and
seroepidemiological studies show that prevalence of anti-HEV
antibodies in the general population varies from 15% to close to
100% in different parts of the world. One step HEV IgM Test is a
simple, visual qualitative test that detects Hepatitis E Virus IgM
antibodies in human Whole Blood /Serum / Plasma. The test is based
on immunochromatography and can give a result within 15 minutes.
The One Step HEV IgM Test is a qualitative membrane strip based
immunoassay for the detection of Hepatitis E Virus IgM antibodies
in Whole Blood /Serum / Plasma. The test device consists of: 1) a
burgundy colored conjugate pad containing HEV recombinant envelope
antigens conjugated with Colloid gold (HEV 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 the antibody for the detection of IgM anti-HEV, 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 strip, the specimen migrates by capillary action across
the strip. IgM anti-HEV if present in the specimen will bind to the
HEV conjugates. The immunocomplex is then captured by the reagent
coated on the T band, forming a burgundy colored T band, indicating
a HEV IgM positive test result and suggesting a fresh infection.
Absence of 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 of the T band.
Otherwise, the test result is invalid and the specimen must be
retested with another strip.
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