with dye will be captured by the antigen immobilized 4.
One-step HAV-IgG/IgM on the membrane, then a color band can be seen in T
Serum/Plasma Test
Cat. I-076 / I-077
INTENDED USE
The test is a one-step test for the qualitative detection
the HAV IgG or IgM antibody in human serum, and
plasma.
This test is intended primarily as an initial screening
test and reactive samples should be confirmed by a
supplemental assay.
SUMMARY & EXPLANATION OF THE TEST
This test is used to help diagnose a liver infection due
to the hepatitis A virus (HAV). There are several causes
of hepatitis and the accompanying symptoms, so this
test is used to determine if your symptoms are due to
hepatitis A.
There are two versions of the test, and these are used
detect two different types of hepatitis A antibodies.
Hepatitis A IgM is the first antibody produced by the
body when it is exposed to hepatitis A. The hepatitis A
IgM test is used to screen for early detection of
infection and is used to diagnose the disease in a
patients with evidence of acute hepatitis.
Hepatitis A IgG antibodies develop later and remain
present for many years, usually for life, and protect
you against further infection by the same virus. There
is no test specifically for hepatitis A IgG antibodies; a
total antibody test (which detects both IgM and IgG
antibodies) detects both current and previous infection
with hepatitis A and will also be positive after receiving
the hepatitis A vaccine.
A hepatitis A antibody test may be used to screen for
exposure in those who are asymptomatic.
This test may also be used to determine if you have
produced antibodies and developed immunity in
response to a hepatitis A vaccine or a previous
hepatitis A infection.
In acute hepatitis, other tests such as bilirubin, liver
panel, ALT, and AST may be performed to help
diagnose the condition.
PRINCIPLES OF THE TEST
The two Test lines consist of a chromatographic
absorbent membrane strip with immobilized inactive
HAV antigen. The antibody in sample reacts with a
colored conjugate anti-human IgM which pre-dried on
the strip, and an antigen-antibody complex is formed
when antibody is present in the sample. The mixture
then moves upward and the immune complex labeled
Avoid splashing or aerosol formation.
5. Do not use the Kit after the expiration date.
lines. 6. For in vitro diagnostic use only.
In the test procedure, the samples is added onto the T 7. The lysis samples might cause the false positive.
line, then add the develop Buffer into sample well with
the aid of a dropper, and allowed to migrate through TEST PROCEDURE
the absorbent device. The labeled antibody-dye
conjugate binds to HAV IgG or IgM antibody in the Prior to use, bring all test components and patient
serum and migrates along the chromatographic samples to room temperature.
membrane through capillary action. If there is HAV
IgG or IgM antibody present in the sample, a rose color 1. Dispense 5 µl of specimen onto location of T line
band appears in the test window. In the absence of The T line region must be wetted by the sample
HAV IgG or IgM antibody, there is no formation of a added.
rose-pink color band in the positive reaction zone. The 2. After 30 seconds, add 1-2 drops of Develop Buffer
reaction mixture continues flowing through the into sample well. And start timing.
absorbent device past the positive reaction zone to the 3. Read results in 10 minutes.
control zone. Unbound conjugate binds to the Add Sample Add Buffer
reagents in the control zone, producing a rose-pink
color band, demonstrating that the reagents and
device are functioning correctly.
MATERIALS PROVIDED
1. Test Devices.
2. Buffer
3. Product Insert
T C
SAMPLE COLLECTION & STORAGE Correct amount of Sample
1. If serum/plasma specimens are not immediately
tested they should be refrigerated at 2-80C for up T C
to 2 days or storage periods greater than 2 days, Not enough Samples
serum or plasma can be stored at –200 C.
2. Specimens containing precipitate may yield
inconsistent test results. Such specimens must be T C
clarified prior to assaying.
Too much Sample
The test device may be stored at ambient temperature
of 4 - 30ºC in the original unopened foil pouches. Each
INTERPRETATION OF RESULTS
Test Unit contains a desiccant. The test should be
INTERPRETATION
used without delay once the pouch has been opened.
In case the temperature of the Test Unit is
considerably below room temperature and the
humidity of the air is high, it is advisable to let the
Test Unit reach room temperature before opening the
pouch. The shelf-life of Test Unit may be 18 months
from the date of manufacture. The expiration date is
printed on the pouch.
WARNINGS AND PRECAUTIONS
1. Wear disposable gloves while handling Specimens.
Wash hands thoroughly afterwards.
2. Wipe up spills thoroughly using an appropriate
intermediate to high level disinfectant.
POSITIVE NEGATIVE INVALID
3. Decontaminate and autoclave all specimens,
reaction Kits and any potentially contaminated
materials.

POSITIVE RESULT:
If there is a rose-pink color band in the control region
(marked with a "C"), and a rose-pink color band in the
test region (marked with a "T"), HAV IgG or IgM
antibody is present and the specimen is positive.
NEGATIVE RESULT:
The absence of a color band in the test region indicates
the absence of any detectable HAV antibody.
INVALID RESULT:
If a color band does not appear in the control region
"C", the test results are invalid. The sample may have
been added to the wrong window, or the Test Device
may have deteriorated. This specimen should be re-
tested using a new Test Device.
Note: After performing the test, the result window
(“T”) should look clear (negative result) or uniform
line of rose pink (positive) at the end of 10
minutes. The test should not be considered as
positive if the Test zone shows irregular spots or
other shape line.
LIMITATIONS OF THE TEST
1. HAV IgG or IgM Kit is limited to the detection of
HAV IgG or IgM antibody only. Although the Kit is
very accurate in detect HAV antibody, a very low
incidence of false results might occur.
2. If negative or questionable results are obtained,
and the infection is suspected, the test should be
repeated on a fresh serum specimen.
4. As with all diagnostic tests, a definitive clinical
diagnosis should not be based on the results of a
single test, but should only be made by the
physician after evaluation of all clinical and
laboratory findings.
EXTERNAL CONTROLS:
Like any in vitro device, performance of HAV IgG or IgM
should be checked for accuracy and batch to batch
variation by using known serum pools. These sera
should be used in the same way as described in the
assay procedure for serum samples. It is
recommended that these control sera be used at least
once with every batch or new shipment.
INTERNAL CONTROLS:
In addition to the external controls the test device has
built-in controls. With each testing there should
always be a rose-pink color band in the control region
(“C”). If the color band does not appear in the control
region, the result should be considered invalid. Also,
after performing the test, the result window (“T”)
should look clear white or uniform light pink. If the
result window shows large red or purple streaks at the
end of 10 minutes, the test should be considered
invalid. Repeat the test using a fresh test device.
REFERENCES
1. J.V. PARRY, (1981). Hepatitis A infection: guidelines
for development of satisfactory assays for laboratory
diagnosis. The Institute of Medical Laboratory
Sciences 38, 303-311.
2. Lindberg J., Frosner G., Hansson B.G. et al.
Serologic markers of hepatitis A and B in chronic
active hepatitis. Scandinavian Journal of
Gastroenterology, 13:525-527, 1978.
3. Battegay M, Gust ID, and Feinstone SM. Hepatitis A
virus. In: Mandell GL, Bennett JE, and Dolin R, eds.
Principles and Practice of Infectious Diseases, 4th
Ed. New York, Churchill Livingstone, 1995:1636-
1656.
4. Sjogren MH, Tanno H, Fay O, et al. Hepatitis A virus
in stool during clinical relapse. Ann Intern Med
1987; 106:221-6.
5. Lemon SM. The natural history of hepatitis A: the
potential for transmission by transfusion of blood or
blood products. Vox Sang 1994; 67(suppl 4):19-23.
6. Bower WA, Nainan OV, Margolis HS. Duration of
viremia in naturally-acquired hepatitis A viral
infections. [Abstract 103] In: Abstracts of the
Infectious Diseases Society of America 35th Annual
Meeting. Alexandria, VA: Infectious Diseases Society
of America, 1997.
7. Liaw YF, Yang CY, Chu CM, Huang MJ. Appearance
and persistence of hepatitis An IgM antibody in
acute clinical hepatitis A observed in an outbreak.
Infection 1986; 14:156-8.
8. Stapleton JT. Host immune response to hepatitis A
virus. J Infect Dis 1995; 171(suppl 1):S9-14.
MYM Revision Date: 05/12/2014
Export Only. Not for sales in USA