with dye will be captured by the antigen immobilized 4. Avoid splashing or aerosol formation.

One-step HAV-IgG/IgM on the membrane, then a color band can be seen in T 5. Do not use the Kit after the expiration date.
lines. 6. For in vitro diagnostic use only.
Serum/Plasma Test In the test procedure, the samples is added onto the T 7. The lysis samples might cause the false positive.
Cat. I-076 / I-077 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
INTENDED USE 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.
The test is a one-step test for the qualitative detection membrane through capillary action. If there is HAV
the HAV IgG or IgM antibody in human serum, and IgG or IgM antibody present in the sample, a rose color 1. Dispense 5 µl of specimen onto location of T line
plasma. band appears in the test window. In the absence of The T line region must be wetted by the sample
This test is intended primarily as an initial screening HAV IgG or IgM antibody, there is no formation of a added.
test and reactive samples should be confirmed by a rose-pink color band in the positive reaction zone. The 2. After 30 seconds, add 1-2 drops of Develop Buffer
supplemental assay. 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.
SUMMARY & EXPLANATION OF THE TEST control zone. Unbound conjugate binds to the Add Sample Add Buffer
reagents in the control zone, producing a rose-pink
This test is used to help diagnose a liver infection due color band, demonstrating that the reagents and
to the hepatitis A virus (HAV). There are several causes device are functioning correctly.
of hepatitis and the accompanying symptoms, so this
test is used to determine if your symptoms are due to MATERIALS PROVIDED
hepatitis A.
There are two versions of the test, and these are used 1. Test Devices.
detect two different types of hepatitis A antibodies. 2. Buffer
Hepatitis A IgM is the first antibody produced by the 3. Product Insert
body when it is exposed to hepatitis A. The hepatitis A T C
IgM test is used to screen for early detection of SAMPLE COLLECTION & STORAGE Correct amount of Sample
infection and is used to diagnose the disease in a
patients with evidence of acute hepatitis. 1. If serum/plasma specimens are not immediately
Hepatitis A IgG antibodies develop later and remain tested they should be refrigerated at 2-80C for up T C
present for many years, usually for life, and protect to 2 days or storage periods greater than 2 days, Not enough Samples
you against further infection by the same virus. There serum or plasma can be stored at –200 C.
is no test specifically for hepatitis A IgG antibodies; a 2. Specimens containing precipitate may yield
total antibody test (which detects both IgM and IgG inconsistent test results. Such specimens must be T C
antibodies) detects both current and previous infection clarified prior to assaying.
with hepatitis A and will also be positive after receiving Too much Sample
The test device may be stored at ambient temperature
the hepatitis A vaccine.
of 4 - 30ºC in the original unopened foil pouches. Each
A hepatitis A antibody test may be used to screen for INTERPRETATION OF RESULTS
Test Unit contains a desiccant. The test should be
exposure in those who are asymptomatic. INTERPRETATION
used without delay once the pouch has been opened.
This test may also be used to determine if you have
In case the temperature of the Test Unit is
produced antibodies and developed immunity in
considerably below room temperature and the
response to a hepatitis A vaccine or a previous
humidity of the air is high, it is advisable to let the
hepatitis A infection.
Test Unit reach room temperature before opening the
In acute hepatitis, other tests such as bilirubin, liver
pouch. The shelf-life of Test Unit may be 18 months
panel, ALT, and AST may be performed to help
from the date of manufacture. The expiration date is
diagnose the condition.
printed on the pouch.
PRINCIPLES OF THE TEST WARNINGS AND PRECAUTIONS
The two Test lines consist of a chromatographic
1. Wear disposable gloves while handling Specimens.
absorbent membrane strip with immobilized inactive
Wash hands thoroughly afterwards.
HAV antigen. The antibody in sample reacts with a
2. Wipe up spills thoroughly using an appropriate
colored conjugate anti-human IgM which pre-dried on
intermediate to high level disinfectant.
the strip, and an antigen-antibody complex is formed POSITIVE NEGATIVE INVALID
3. Decontaminate and autoclave all specimens,
when antibody is present in the sample. The mixture
reaction Kits and any potentially contaminated
then moves upward and the immune complex labeled
materials.
 region, the result should be considered invalid. Also,
POSITIVE RESULT: after performing the test, the result window (“T”)
should look clear white or uniform light pink. If the
If there is a rose-pink color band in the control region result window shows large red or purple streaks at the
(marked with a "C"), and a rose-pink color band in the end of 10 minutes, the test should be considered
test region (marked with a "T"), HAV IgG or IgM invalid. Repeat the test using a fresh test device.
antibody is present and the specimen is positive.

NEGATIVE RESULT:
REFERENCES
The absence of a color band in the test region indicates 1. J.V. PARRY, (1981). Hepatitis A infection: guidelines
the absence of any detectable HAV antibody. for development of satisfactory assays for laboratory
diagnosis. The Institute of Medical Laboratory
INVALID RESULT: Sciences 38, 303-311.
2. Lindberg J., Frosner G., Hansson B.G. et al.
If a color band does not appear in the control region Serologic markers of hepatitis A and B in chronic
"C", the test results are invalid. The sample may have active hepatitis. Scandinavian Journal of
been added to the wrong window, or the Test Device Gastroenterology, 13:525-527, 1978.
may have deteriorated. This specimen should be re- 3. Battegay M, Gust ID, and Feinstone SM. Hepatitis A
tested using a new Test Device. virus. In: Mandell GL, Bennett JE, and Dolin R, eds.
Principles and Practice of Infectious Diseases, 4th
Note: After performing the test, the result window Ed. New York, Churchill Livingstone, 1995:1636-
(“T”) should look clear (negative result) or uniform 1656.
line of rose pink (positive) at the end of 10 4. Sjogren MH, Tanno H, Fay O, et al. Hepatitis A virus
minutes. The test should not be considered as in stool during clinical relapse. Ann Intern Med
positive if the Test zone shows irregular spots or 1987; 106:221-6.
other shape line. 5. Lemon SM. The natural history of hepatitis A: the
potential for transmission by transfusion of blood or
LIMITATIONS OF THE TEST blood products. Vox Sang 1994; 67(suppl 4):19-23.
6. Bower WA, Nainan OV, Margolis HS. Duration of
1. HAV IgG or IgM Kit is limited to the detection of viremia in naturally-acquired hepatitis A viral
HAV IgG or IgM antibody only. Although the Kit is infections. [Abstract 103] In: Abstracts of the
very accurate in detect HAV antibody, a very low Infectious Diseases Society of America 35th Annual
incidence of false results might occur. Meeting. Alexandria, VA: Infectious Diseases Society
2. If negative or questionable results are obtained, of America, 1997.
and the infection is suspected, the test should be 7. Liaw YF, Yang CY, Chu CM, Huang MJ. Appearance
repeated on a fresh serum specimen. and persistence of hepatitis An IgM antibody in
4. As with all diagnostic tests, a definitive clinical acute clinical hepatitis A observed in an outbreak.
diagnosis should not be based on the results of a Infection 1986; 14:156-8.
single test, but should only be made by the 8. Stapleton JT. Host immune response to hepatitis A
physician after evaluation of all clinical and virus. J Infect Dis 1995; 171(suppl 1):S9-14.
laboratory findings.

EXTERNAL CONTROLS: MYM Revision Date: 05/12/2014

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