The HBsAG Rapid Test Cassette is a rapid chromatographic immunoassay fort the qualitative detection of Hepatitis B Surface Antigen in serum or plasma.
The HBsAG Rapid Test Cassette is a quantitative, solid phase, two-sirte sandwich immunoassay for the detection of HbsAg in serum or plasma. The membrane is pre-coated with anti-HbsAg antibodies on the test line region of the cassette. During testing, the serum or plasma specimen reacts with the particle coated with anti-HBsAG antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBsAG antibodies on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result. To serve as a procedural control, a colored line will always appear in the control line region indicating that propet volume of specimen has been added and membrane wicking has occurred.
This test device contains anti-HBsAG particles and anti-HBsAG coated on the membrane.
- Test cassette
- Instructions for use
Material required but not provided
- Specimen collection containers
Storage and stability
Store as packaged at room temperature or refrigerated (2-30 °C)
- Remove the test cassette from the sealed foil pouch and use ita s soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouc.
- For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 120 nl) to the specimen well of test device and start the timer. See illustration below.
- Wait for the colorated line is appeared. The result should be read at 15-30 minutes. Do not interpret the result afeter 30 minutes.
Interpretation of serults
Psotive:* Two distinct colored lines appear. One colorated line should be in the control region (C) and another colored line should be in the test region (T).
*note: The intesity of the colo in the test line region (T) will vary depending on the concetration of HBsAG present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T)
INVALID: A colored line appears in the control region (T). No colored line appears. Retest.