Hepatitis A virus IgM antibody detection reagent (colloidal gold method)

Common name: Hepatitis A virus IgM antibody detection kit (colloidal gold method)

25 servings/box

Main components

1. Detection reagents (T-line coated with recombinant hepatitis A virus VP3-VP4 antigen, C-line coated with sheep anti mouse IgG antibody, coating buffer: 0.05M PBS pH 7.4, gold labeled mouse anti human IgM coated on a gold pad): 1 human dose x 20 (detection card); 1 person x 25 (test strips); 1 person x 50 (test strips).

2. Sample diluent: 20 servings (cards) per box, 1 bottle x 5mL; 25 servings (strips) per box, 1 bottle x 5mL; 50 servings (strips) per box, 1 bottle x 7mL.

Storage conditions and expiration date

Dry and store in the dark at 4~30 ℃, with a shelf life of 12 months. When the humidity is below 60%, use within 1 hour after opening. When the humidity is above 60%, use immediately after opening.

Production date and expiration date: see label.

Limitations of Inspection Methods

1. The test results of this product are observed and interpreted by the naked eye, and are easily affected by visual errors or subjective judgments. Therefore, when the color of the strip is difficult to determine clearly, it is recommended to repeat the test.

2. This test card is used as one of the auxiliary diagnostic tools, and the test results are for reference only and cannot be used as a basis for clinical diagnosis and treatment. Positive results need to be further confirmed by other methods. Due to the limitation of detection sensitivity, negative results may be caused by antibody concentration lower than the sensitivity of product analysis. Clinical diagnosis should be combined with clinical examination, medical history, and other tests.

3. In the early stage of infection, the absence or low titer of IgM may lead to negative results. Patients should be advised to have a follow-up examination within 7-14 days, and the last collected specimen should be tested in parallel to confirm whether there is a seroconversion or significant increase in titer.

Patients with impaired immune function or receiving immunosuppressive therapy have limited reference values for serological antibody testing.

5. IgM antibody positivity not only occurs in primary infections, but also in secondary infections where IgM reactions can be observed.

6. This reagent is for qualitative testing and cannot be used to determine antibody content.

7. This reagent is used for the detection of personal serum or plasma samples, and should not be used for the detection of saliva, urine, or other bodily fluids.

【 Precautions 】

The positive results obtained from the application of this reagent kit need to be further confirmed by other methods.

2. The reagent kit should be sealed and stored to prevent moisture. When the humidity is below 60%, use within 1 hour after opening. When the humidity is above 60%, use immediately after opening. Avoid leaving it in the air for too long, which may cause moisture and affect the test results.

The depth of the color of the detection line is not necessarily related to the titer of antibodies in the sample, and the result obtained after 20 minutes is invalid.

When the content of hepatitis A virus IgM antibody in the sample is high, the C-line band may weaken, which is a normal phenomenon.

5. The components of the reagent kit and the waste generated from testing are treated as infectious pollutants.

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