One Step HAV IgG/IgM Test
Cat. No.: RH1102
(Whole Blood /Serum/Plasma)
FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY

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 infection. 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.

• 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.

Materials Provided
Ÿ Test devices Ÿ Disposable specimen droppers
Ÿ Buffer Ÿ Package insert
Materials Required But Not Provided
Ÿ Timer Ÿ Centrifuge
Ÿ Specimen collection containers

• For professional in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens and kits are handled.
• Handle all specimens as if they contain infectious agents.
• Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Follow standard biosafety guidelines for handling and disposal of potential infective material.
• Humidity and temperature can adversely affect results.

1. The One Step HAV IgG/IgM Test can be performed used on Whole Blood /Serum / Plasma.
2. To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures.
3. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.
4. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8℃ for up to 3 days. For long term storage, specimens should be kept below -20℃. Whole blood should be stored at 2-8℃ if the test is to be run within 2 days of collection. Do not freeze whole blood specimens.
5. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

Allow the test, specimen, buffer and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. Hold the dropper vertically and transfer 1 drop of specimen (approximately 10μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 70μl) and start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.

Notes:
Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of buffer to the specimen well.

Positive: Control line and at least one test line appear on the membrane. The appearance of T2 test line indicates the presence of HAV specific IgG antibodies. The appearance of T1 test line indicates the presence of HAV specific IgM antibodies. And if both T1 and T2 line appear, it indicates that the presence of both HAV specific IgG and IgM antibodies. The lower the antibody concentration is, the weaker the result line is.
Negative: One colored line appears in the control region(C).No apparent colored line appear in the test line region.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

1. The One Step HAV IgG/IgM Test is for in vitro diagnostic use only. The test should be used for the detection of HAV antibodies in Whole Blood /Serum / Plasma specimens only. Neither the quantitative value nor the rate of increase in HAV antibodies can be determined by this qualitative test.
2. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
3. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of HAV infection.