One Step HBeAg Rapid Diagnostic Test , to detect hepatitis B e antigen ,gold colloidal method, quickly and easily

Product Name:

One Step HBeAg Rapid Diagnostic Test Cassette

Intended Use:

The One Step casstte style HBeAg Test is a chromatographic immunoassay in-vitro diagnostic test combined with conjugated colloid gold technology for the qualitative detection of hepatitis B e antigen (HBeAg) in human serum specimen.Two monoclonal antibodies are employed to identify HBeAg specifically.

Summary:

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. Hepatitis B e antigen is a viral protein secreted by HBV-infected cells. Its presence indicates high levels of virus in the blood, and it is an indicator of the infectiousness of the carrier. If this test is negative, but a person is known to be HBsAg positive, then it indicates low levels of virus in the blood or an "integrated phase" of HBV in which the virus is integrated into the host’s DNA. This test is often used to monitor the effectiveness of some HBV therapies, whose goal is to convert an actively replicating state to "e-antigen negative" state. The HBeAg One Step Hepatitis B e Antigen Test Device (Serum/Plasma) is a rapid test to qualitatively detect the presence of HBeAg in serum or plasma specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBeAg in serum or plasma. This one step test is very sensitive and only takes about 10-20minutes. Test results are read visually without any instrument.

TEST PRINCIPLE

The HBeAg test is a qualitative, solid phase, two-site sandwich immunoassay for the detection of HBeAg in serum or plasma. The membrane is pre-coated with anti-HBeAg antibodies on the test line region of the strip. Du ring testing, the serum or plasma specimen reacts with the particle coated with anti-HBeAg antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBeAg antibodies on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane 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.