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This kit is a single use, rapid test device intended to use for the qualitative detection of IgM-class antibodies of hepatitis A virus (HAV) present in the serum or plasma samples. It is used in the clinical laboratories for diagnosis of acute hepatitis A and management of patients infected with hepatitis A virus.
Hepatitis A is a self-limited disease and a chronic stage. Infections occur in the early stage of life and are spread in areas where sanitation is poor and the place is crowded. With improved sanitation and hygiene, these infections are delayed and consequently the number of persons susceptible to the disease decreases. As the disease is transmitted through the fecal-oral way in densely populated regions, an outbreak can arise from a single contaminated source.
The cause of hepatitis A is hepatitis A virus (HAV) it is a non enveloped positive-strand RNA virus with a linear single strand genome, encoding for only one known serotype. HAV has 4 major structural polypeptides and it localizes exclusively in the cytoplasm of human hepatocytes. The infection induces a strong immunological response and elevates the levels of IgM and then IgG, these are detectable within a few days after the onset of symptoms. The presence of antiâHAV IgM is an important serological marker for early detection of the clinical manifestation of the disease. Increasing levels of anti-HAV IgM are detectable about three weeks after exposure with the highest titter. Within 6 months after the infection IgM concentration declines to non-detectable levels.
PRINCIPLE OF THE ASSAY
This test uses chromatographic lateral flow device in cassette format. Colloidal gold-conjugated recombinants antigens (Au-Ag) correspond to HAV antigens that are dry-immobilized at the end of the nitrocellulose membrane strip. IgM (anti-Î¼ chain) are bonded at the Test Zone (T) and goat-anti-mouse IgG antibodies are bonded at the Control Zone (C). When the sample is added it migrates by the capillary diffusion and rehydrates the gold-conjugate. The HAV IgM antibodies then bind with the gold conjugated antigens forming particles. These particles then continue to migrate along the strip till the Test Zone (T) where they are captured by the anti-human IgM (anti-Î¼ chain) generating a visible red line. If there are no antibodies in the sample, no red line is formed. The gold conjugates continue to migrate alone untill it is captured in the Control Zone(C) by the goat-anti-mouse IgG antibodies aggregating in a red line, which indicates the validity of the test.
40 HAV IgM colloidal gold rapid test strips, each placed in a white plastic cassette and is packed in a foil pouch
Instructions for use
1Ã6 ml vial of sample diluents
Materials required but not provided: clock or timer, safety lancets, alcohol prep-pad, specimen collection container, disposable pipettes, centrifuge, biohazard waste container, sterile gauze or cotton.
Fresh serum or plasma samples can be used for testing. No special preparation is required for the patient. Ensure full clotting of blood and remove any visible particulate matter present in the sample by centrifugation or filtration. Avoid the use of highly hemolytic, microorganism contaminated samples or those samples which are stored for over 30 days. Store the samples at 2 to 8°C; if the samples are not required for assay within 3 days then it should be frozen under -20°C or lower. Avoid sample deterioration by multiple freeze-thaw cycles.
Plasma: Collect the whole blood into a collection tube (containing EDTA, citrate or heparin, respectively) by venipuncture and separate the plasma by centrifugation.
Serum: Collect the whole blood into a collection tube (containing no anticoagulants) by venipuncture and allow the blood to clot. Separate it by centrifugation.
The original samples should not be tested directly; it must be diluted with the sample diluents before testing.
STORAGE AND STABILITY
This test kit can be stored at room temperature 2 to 30°C, do not freeze. It can be used for about 24 months from the date of manufacture (see the label on pouch). Use it immediately after opening.
PRECAUTIONS AND SAFETY
This test is for In Vitro and for professional use only.
All the waste and sample should be treated as contagious and must be properly disinfected (autoclaving is preferred) before disposing of.
Once opened the pouch, carry out your testing as early as possible, not more than 20 minutes to avoid any moisture absorption. The nitrocellulose membrane can absorb water that can affect the test chromatography performance.
To obtain accurate results, the test results must be read within 10 minutes. Results read after 10 minutes can lead to incorrect interpretation.
Make sure that the test is within the indicated validity.
If using an automatic pipette, calibrate it frequently to assure the accuracy of dispensing. Use different disposable pipette tips for each sample in order to avoid Cross-contaminations.
Do not modify the test procedure.
Do not reuse the test cassettes, autoclave before disposal.
An invalid test result should be repeated.
Blood that has been chemically treated, diluted, heated, or modified may give inaccurate results.
Allow the test cassette to reach room temperature, keep for 30 minutes before opening the pouch.
Add 10Î¼L serum or plasma sample into the sample well and then add 100 Î¼L of sample dilution immediately
Open the pouch and pipette add 80Î¼l of diluted sample into the sample window (S). Avoid dropping the sample into the observation window and do not allow the sample to overflow.
Place the cassette on a horizontal surface and read the results within15-20 minutes.
A positive test line may appear after 20 minutes; this is a false positive result. Do not read the results after 10minutes.
Invalid Results: One red line will always appear next to the Control Zone(C) indicates the validity of the test. If no red line appears, the test is invalid, discard the test and repeat with a new sample and cassette.
Positive Results: One red line next to the Test Zone (T) indicates that IgM antibodies to HAV have been detected.
Negative Results: No red line appears within 20 minutes next to the Test Zone (T) indicates that no IgM antibodies to HAV have been detected.
However, this does not exclude the possibility of infection with HAV.
The positive result obtained with this test kit alone cannot be the final diagnosis of HAV. Any positive result must be interpreted in conjunction with the patientâs clinical history and other laboratory testing. Follow-up and supplementary testing of any positive samples with other analytical systems (e.g. ELISA, WB) is required to confirm the positivity.
Negative results do not exclude the possibility of HAV exposure or infection.
Infection through recent exposure (seroconversion) to HAV may not be detectable.
For positive results, line intensity cannot be used to evaluate the HAV IgM antibody levels. A test should be repeated if giving an invalid result.
After retesting of the initially reactive samples, the test results are negative; these samples should be considered as non-repeatable (false positive) and interpreted as negative.
As with many 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 exposure of the test to the humidity.
For more information and further assistance contact BIONEOVAN.CO. LTD technical support.
This test kit is intended only for testing serum or plasma samples. Do not use it for testing of cadaver samples, urine, saliva, or other body fluids, or pooled (mixed) blood.
This is a qualitative assay and the results cannot be used to measure the antibodies concentrations.