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The HBsAg Rapid Test is a Chromatographic immunoassay (CIA) for direct qualitative detection of Hepatitis B type virus surface antigen (HBsAg) in human serum /plasma and whole blood.
The HBsAg RST is a chromatographic immunoassay (CIA) for the detection of surface antigens of Hepatitis B in human serum/plasma and whole blood. Specific antibody against HBsAg is pre-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with anotherr specific antibody. If HBsAg is present, a pink colored band will develop on the membrane in proportion to the amount of HBsAg presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence or absence of HBsAg.
REAGENTS AND MATERIALS PROVIDED
1.One sealed pouched cassette with desiccant and a disposable pipette..
2.Blood diluent in a dropper bottle. Store at 2-8°C.
3.One piece of operating instruction with 40 test pouches..
WARNING AND PRECAUTIONS
1. FOR IN VITRO DIAGNOSTIC USES ONLY
2. All patient samples should be treated as if capable of transmitting diseases.
3. Do not interchange reagents from different lots or use test kit beyond expiration date.
4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
The kits should be stored at temperature 4-30°C,( the sealed pouch) for the duration of the shelf life (24 months).
SAMPLE COLLECTION AND PREPARATION
Whole Blood ( Fingerstick Specimens)
Clean the area to be lanced with an alcohol swab.
Contact Person: Ms. Anna Lee