Express Test cassette for hepatitis B virus surface antigen in blood No. 1

The Express Test is a rapid test for the diagnosis of hepatitis B virus. It is a test cassette for the qualitative detection of hepatitis B antigen (HBsAg) in whole blood, serum or plasma samples.

Viral hepatitis is a systemic disease that primarily affects the liver. Most cases of acute viral hepatitis are caused by hepatitis A virus, hepatitis B virus (HBV), or hepatitis C virus.

The test uses a combination of dual monoclonal antibodies to selectively detect elevated levels of HBsAg pre-coated on a membrane at the test line region, which is reacted with by the hepatitis B surface antigen when tested on a blood sample. The mixture migrates up the membrane by capillary action, reacting with the antibodies. The presence of the antigen is indicative of active hepatitis B.

In a typical hepatitis B infection, it will be detected 2-4 weeks before ALT (alanine aminotransferase) levels become abnormal and 3-5 weeks before symptoms or jaundice appear.

The test has a high sensitivity of 99.4%, which allows it to determine the presence of the virus with an accuracy of 99.5%.

Equipment

The package consists of:

1. Sachet package containing: test cassette - 1 pc, pipette - 1 pc, desiccant - 1 pc
2. Buffer - 1 pc.
3. Non-sterile medical examination gloves - 1 pair
4. Sterile disposable lancet 1 pc.
5. Instructions for use – 1 pc.
6. Alcohol wipes - 2 pcs.

Method of application

1. Remove the test cassette from the sealed package and use it as soon as possible.
2. Add 2 drops of whole blood from a finger or vein to the sample well (S), then 1 drop of buffer and wait for the result.
3. The test evaluation result is available in 15 minutes, but no later than the specified time.

Evaluation of results:

• POSITIVE: 2 clear red lines appear. One should be in the control region (C) and the other line should be in the test region (T).
• NEGATIVE: One red line appears in the control region (C). No visible red or pink line appears in the test region (T).
• INVALID: Control line does not appear. Review the instructions and repeat the test with a new test cassette.

Expiration date

24 months.

Storage conditions

Store at a temperature of +2 °C to +30 °C.