Span Biotech Ltd.

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.

ASSAY PROCEDURE

Serum or Plasma Sample                                                                                                                                                                                 

Add 70-100ul or 2-3 drops of serum or plasma into sample well. Observe the result in 5-20 minutes.

Whole Blood Sample

Add 1 drop of whole blood into sample well, after all blood is completely absorbed. Add 1 drop of whole blood diluent. Observe the result in 5-20 minutes.

INTERPRETATION OF RESULTS

Positive: In addition to the band in the control region (C), another pink band will appear in the test region (T). This indicates that the specimen contains HBsAg.

Negative: No band in the test region (T), only one pink band appears in the control region (C). This indicates that no HBsAg have been detected.

Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

PERFORMANCE CHARACTERISTICS

A total of 400 samples from susceptible subjects were tested by the HBsAg Rapid Test and by HBsAg ELISA kit with the test sensitivity at 1.0 ng/mL. The data showed the following.

Relative Sensitivity: 96%,

Relative Specificity: 100%,

overrall Agreement: 99.6%

Precision

Intra-assay

In the study, 30 replicate assays were performed with one positive and one negative specimen. Correct negative and positive results were registered in 100% of the assays.

Inter-assay

The study involved the same specimens containing one positive and one negative. The samples were analyzed in 30 independent assays with HIV-1/2 Rapid Screen Test. originating from three different lots at different times during two months. Again, expected negative and positive results were registered in 100% of the assays.

LIMITATIONS

1. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.

2. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.

3. The test is to be used for the qualitative detection of HBsAg.

4. A negative result does not rule out infection because HBsAg levels may be absent or not present in detectable quantities.

5. The test is to be used for the qualitative detection of HBsAg

PRODUCT DISCLAIMER

This product has been manufactured under strict GMP regulation so to ensure the diagnostic accuracy of the test. It is out of control of the manufacture when the test is performed in diverse environment and by diverse group of individuals which may affect the result to a certain degree.

NOTE

The manufacture, the Distributor or its associates will not be liable for any losses, claims, liability, costs or damages, whether direct or indirect or consequential arising out of or related to an incorrect diagnosis, whether a positive or negative by use of this product.