HBsAg Rapid Test Kit

Introduction: The HBsAg Rapid Test Kit is a qualitative immunoassay designed for the detection of Hepatitis B surface antigen (HBsAg) in human serum or plasma. It provides a rapid and reliable method for the diagnosis of Hepatitis B infection.

Intended Use: The HBsAg Rapid Test Kit is intended for healthcare professionals and laboratory use as an aid in the diagnosis of Hepatitis B virus (HBV) infection. It is not intended for self-testing at home.

Principle: The HBsAg Rapid Test Kit is based on the principle of lateral flow immunoassay. The test utilizes highly specific monoclonal antibodies to selectively detect HBsAg in the test sample. The test cassette contains a membrane strip pre-coated with anti-HBsAg antibodies and coloured particles conjugated with anti-HBsAg antibodies. When the test sample is added, if HBsAg is present, it binds to the conjugate, forming a coloured line in the test region. The control line serves as a procedural control to validate the test results.

Storage and Stability: The HBsAg Rapid Test Kit should be stored at room temperature (2-30ºC). The kit components are stable through the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. Do not freeze the test kit. Do not use beyond the expiration date.

Precautions: For in-vitro diagnostic use only. Use the test kit in a well-ventilated area. Handle all specimens and test components as if they contain infectious agents. Follow standard precautions for the disposal of used test components. Wear protective clothing, such as laboratory coats and disposable gloves, when handling specimens. Read the instructions carefully before performing the test.

Procedure: Allow the test cassette and specimens to equilibrate to room temperature (15-30ºC). Open the sealed pouch and remove the test cassette. Add the sample (serum or plasma) to the sample well on the test cassette. Wait for the coloured lines to appear in the result window within the specified time. Interpret the results according to the instructions provided.

Interpretation of Results: Positive Result: The presence of both the control line and the test line indicates the presence of HBsAg in the sample. Negative Result: Only the control line appears. This indicates the absence of HBsAg in the sample. Invalid Result: If no lines appear, or if only the test line appears without the control line, the result is invalid. Repeat the test with a new kit.

Limitations: The HBsAg Rapid Test Kit is a screening test and should be confirmed by additional testing methods if the results are positive or inconsistent with clinical evidence. False-negative or false-positive results may occur due to various factors, including improper sample collection, storage, or handling. Results should be interpreted in conjunction with clinical information and other diagnostic findings.