FOR THE QUALITATIVE ASSESSMENT OF HBsAg IN HUMAN SERUM, PLASMA OR WHOLE BLOOD

INTENDED USE

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.

PRINCIPLE

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.

STORAGE

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.

1.        Squeeze the end of the fingertip and pierce it with a sterile lancet.

2.        Wipe away the first drop of blood with sterile gauze or cotton.

3.        Use micropipette to obtain about 100ul fresh blood.

Plasma

1.        Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.

2.        Separate the plasma by centrifugation.

3.        Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.

Serum

1.        Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.

2.        Allow the blood to clot.

3.        Separate the serum by centrifugation.

4.        Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.