HAV IgG/IgM Rapid Detection Kit (Colloidal Gold Method)

INTENDED USE
HAV IgG/IgM Rapid Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay for the qualitative detection of antibodies (IgG and IgM) to Hepatitis A Virus (HAV) in serum, plasma or whole blood samples. It is intended to be used as a screening test and provides a preliminary test result for early diagnosis and management of patients related to infection with Hepatitis A Virus.
Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be combined to confirm the test result obtained by this device.

SUMMARY AND EXPLANATION
Hepatitis A is an infectious disease caused by Hepatitis A virus (HAV), which is an inflammatory lesion of the liver and is transmitted through the fecal-oral route. The main manifestation is acute hepatitis, and asymptomatic infection is common. The disease can occur at any age, but is mainly seen in children and adolescents.

Test Principle
This kit adopts colloidal gold-immunochromatography assay (GICA).
The test card contains:
1. Colloidal gold-labeled antigen and quality control antibody complex.
2. Nitrocellulose membranes immobilized with two test lines (IgG line and IgM line) and one quality control line (C line).
When an appropriate amount of sample is added to the sample well of the test card, the sample will move forward along the test card under capillary action.
If the sample contains an IgG/IgM antibody of HAV, the antibody will bind to the colloidal gold-labeled HAV antigen, and the immune complex will be captured by the monoclonal anti-human IgG/IgM antibody immobilized on the nitrocellulose membrane to form a purple/red T line , showing that the sample is positive for IgG/IgM antibody.

SPECIMEN COLLECTION AND PREPARATION

1. This test can be performed using either human serum, plasma or whole blood samples, including peripheral blood, plasma prepared from clinically used anticoagulants (EDTA, heparin, sodium citrate), etc.
2. Separate serum or plasma from blood as soon as possible to avoid hemolysis.
3. Serum and plasma samples may be stored at 2-8°C for up to 5 days if not tested immediately. For long-term storage, it should be stored at -20°C. Avoid multiple freeze-thaw cycles. Anticoagulated whole blood samples should not be stored for more than 72 hours at room temperature; not more than7 days at 2～8℃.
4. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.
5. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation. 

Materials Provided: 

Specification: 1T/box,20T/box,25T/box,50T/box

 Results

NEGATIVE:
If only the quality control line C appears, and the test lines M and G are not purple/red, it indicates that no antibody is detected, and the result is negative.
POSITIVE:
IgM positive: If both the quality control line C and the test line M appear purple/red, it indicates that the IgM antibody is detected, and the result is positive for IgM antibody.
IgG positive: If both the quality control line C and the test line G appear purple/red, it indicates that the IgG antibody is detected, and the result is positive for IgG antibody.
IgM and IgG positive: If the quality control line C and the test lines M and G all appear purple/red, it indicates that the IgM and IgG antibodies are detected, and the result is positive for both IgM and IgG antibodies.
INVALID:
If the quality control line C is not displayed, the test result is invalid regardless of whether there is a purple/red test line, and it should