Accu-Tell^® HAV IgG/IgM Rapid Test Cassette (Serum/Plasma)

CATALOG

KEY POINTS

Detection for: antibodies (IgG and IgM) to Hepatitis A virus in serum or plasma;

Specimen volume: 1 μl;

Reading time: 15 minutes;

Accuracy of HAV IgM: 98.1%;

Accuracy of HAV IgG: 98.1%;

INTRODUCTION

Hepatitis A is a self-limited disease and chronic stage or other complications are rare. Infections occur early in life in areas where sanitation is poor and living conditions are crowded. With improved sanitation and hygiene, infections are delayed and consequently the number of persons susceptible to the disease increases. Because the disease is transmitted through the fecal-oral route in dense populated regions, an outbreak can arise from single contaminated source. The cause of hepatitis A is hepatitis A virus (HAV)-non enveloped positive strand RNA virus with a linear single

strand genome, encoding for only one known serotype. HAV has four major, structural polypeptides and it localizes exclusively in the cytoplasm of human hepatocytes. The infection with HAV induces strong immunological response and elevated levels first of IgM and then IgG are detectable within a few days after the onset of the symptoms. The presence of anti–HAV IgM is an important serological marker for early detection and observation of the clinical manifestation of the disease. Increasing levels of anti-HAV IgM are detectable about three weeks after exposure with highest titter after four to six weeks later. Within six months after infection IgM concentration declines to non-detectable levels. At the onset of

disease, the presence of IgG anti-HAV is always accompanied by the presence of IgM anti-HAV. At the onset of disease, the presence of IgG anti-HAV is always accompanied by the presence of IgM anti-HAV. Even after more than 10 years the IgG anti-HAV titers usually remain at more than 1 to 10 IU/ml.

INTENDED USE

ACCU-TELL^® HAV IgM/IgG Cassette (Serum/Plasma) is a single use, rapid device intended for qualitative and differential detection of IgG-class antibodies and IgM-class antibodies to hepatitis A virus (HAV) in human serum or plasma samples. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HAV. Any reactive specimen with the ACCU-TELL® HAV IgM/IgG Cassette (Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.

TEST PROCEDURE

Allow test cassette, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1.  Add 6 drops (about 250 μL) of buffer to a extraction tube.
2. Add 1 μL of specimen into the extraction tube by pipette and mix completely.
3. Remove the device from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
4. Place the test device on a clean and level surface.
5. Holding the dropper vertically, dispense 2-3 drops (about 70-100μL) of test sample into the sample well(S) . Then start the timer. Wait for the red line(s) to appear. The result should be read in 15 minutes. Do not interpret the result after 15 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

Clinical Performance for IgM Test

A total of 425 samples from susceptible subjects were tested by the ACCU-TELL® HAV IgM/IgG Cassette (Serum/Plasma) and by a commercial HAV IgM EIA test. Comparison for all subjects is showed in the following table:

ACCU-TELL® HAV IgM/IgG Cassette (Serum/Plasma) vs. HAV IgM EIA test

Relative sensitivity: (203/206)*100%=98.5%

Relative sensitivity: (214/219)*100%=97.7%

Accuracy: (203+214)/(206+219)*100%=98.1%

Clinical Performance for IgG Test

A total of 425 samples from susceptible subjects were tested by the ACCU-TELL® HAV IgM/IgG Cassette (Serum/Plasma) and by a commercial HAV Igg EIA test. Comparison for all subjects is showed in the following table:

ACCU-TELL® HAV IgM/IgG Cassette (Serum/Plasma) vs. HAV IgG EIA test

Relative sensitivity: (203/206)*100%=98.5%

Relative sensitivity: (214/219)*100%=97.7%

Accuracy: (203+214)/(206+219)*100%=98.1%

LIMITATIONS

1. The test procedure, precautions and interpretation of results for this test must be followed strictly when testing. Failure to follow the procedure may give inaccurate results.

2. ACCU-TELL^® HAV IgM/IgG Cassette (Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of HAV antibodies in human serum or plasma specimens only.

3. This test detects the presence of antibodies to Hepatitis A virus in the specimen and should not be used as the sole criterion for the diagnosis of Hepatitis A virus infection.

4. 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.

5. A negative result can occur if the quantity of the IgG and/or IgM anti-HAV present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.

6. As with many very sensitive rapid diagnostic tests, false positive results can occur due to the several reasons, most of which are related but not limited to the quality of the sample and exposition of the test to humidity.

7. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.