One Step HAV(hepatitis A virus) IgM Rapid , to detect hepatitis A virus acute break,gold colloidal method

Product Name:

One Step HAV(hepatitis A virus) IgM Rapid Diagnostic Test Cassette

Intended Use:

The HAV igM test is a rapid qualitative lateral flow test designed for the qualitative detection of hepatitis A virus infection (HAV) in serum/plasma.

Summary:

HAV is a positive RNA virus, a unique member of picornavirdae1.Its transmission depends primarily on serial transmission from person to person by the fecal-oral route. Although hepatitis A is not ordinarily a sexually transmitted disease, the infection rate is high among male homosexuals, as result of oral-anal contact2,3. The presence of specific anti-HAV IgM in blood samples suggests acute or recent HAV infection 4-6. The IgM antibody rapidly increases in titer over a period of 4-6 weeks post infection, and then declines to non-detectable levels within 3 to 6 months in most patients 7. The HAV IgM Rapid Test Cassette is to be used to detect anti-HAV IgM in less than 20 minutes by untrained or minimally skilled personnel, without cumbersome laboratory equipment

TEST PRINCIPLE

The quick one-step test utilizes a sandwich immunochromatographic detection assay,platform If HAV antibody IgM is present in the sample in concentration above the limit, a labeled antigen-dye complex will be formed. This complex is then captured by antibody immobilized in the Test Zone of the membrane, producing a visible pink-rose color band on the membrane. The color intensity will depend on the concentration of HAV antibody IgM present in the sample.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

PERFORMANCE CHARACTERS:

Sensitivity and Specificity

The HAV IgM Rapid Test Cassette (Serum/Plasma) was compared with a leading commercial ELISA HAV IgM test; the results show that The HAV IgM Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.

Relative Sensitivity: 99.9% (95%CI*: 94.2%-100%)

Relative Specificity: 99.5% (95%CI*: 98.3%-99.9%)

Accuracy: 95.6% (95%CI*: 98.5%-99.9%) *95% Confidence Intervals