One Step HBeAb Rapid Diagnostic Test, to detect hepatitis B e antibody, 4mm cassette, quickly and easily

Intended Use:

The One Step casstte style HBeAb Test is a chromatographic immunoassay in-vitro diagnostic test combined with conjugated colloid gold technology for the qualitative detection of hepatitis B e antibody (HBeAb) in human serum specimen.This product is used to obtain a visual, qualitative results and is intended for professional use.

Summary:

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus (HAV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV). Hepatitis B e antibody is a viral protein secreted by HBV-infected cells. The presence of antibody against hepatitis B viral e antigen is used as an indicator for early HBs antigenemia before the peak of viral replication and early convalescence when HBeAg has declined below detectable levels. It is also useful to confirm a seroconversion. The seroconversion from HBeAg positive to anti-Hbe positive indicates a reduced level of infectious virus because virus replication has decreased. The HBeAbRapid Test Cassette (Serum/Plasma) is a rapid test to qualitatively detect the presence of HBeAb in serum or plasma specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBeAb in serum or plasma. This one step test is very sensitive and only takes about 10-20minutes. Test results are read visuallywithout any instrument.

TEST PRINCIPLE

The HBeAb test is immunoassay based on the principle of competitive binding. During testing, the mixture migratesupward on the membrane chromatographically by capillary action. The membrane is pre-coated with HBeAg on the test line region of the strip. During testing, if anti-HBe antibody present in the specimen, they will compete with particle coated anti-HBe antibody for limited amount of HBeAg on the membrane. No line will form in the test region. And a visible colored line will form in the test region if there is no anti-HBe antibody in the specimen because all the antibody coated particles will be captured by the antigen coated in the test line region. To serve as a procedural control, a colored line will alwaysappear in the control line region indicating that proper volume of specimen has been added andmembrane wicking has occurred.

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.