HBsAb Rapid Test Strip

Cat. No.: RH0210S

FOR THE QUALITATIVE ASSESSMENT OF HBsAb IN HUMANSERUM, PLASMA OR WHOLE BLOOD

INTENDED USE

The HBsAb Gold Rapid Screen Test is a Chromatographic immunoassay for qualitative detection of hepatitis B virus (Anti-HBs) in human serum and plasma samples or whole blood

PRINCIPLE

Rapid HBsAb Test employs chromatographic lateral flow device. Colloidal gold conjugated surface antigen reactive to anti-HBs (sAg-Au) are dry-immobilized onto a nitrocellulose membrane strip. When the sample is added, it migrates by capillary diffusion through the strip rehydrating the gold conjugate. If present, anti-HBs will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by HBsAg immobilized there and a visible red line appears. If there is no anti-HBs in sample, no red line will appear in the Test Zone (T). The gold conjugate will continue to migrate alone until is captured in the Control Zone (C) from immobilized goat, anti-HBs antibody and aggregating in a red line, which indicates the validity of the test

REAGENTS AND MATERIALS PROVIDED

1. One pouched strip with desiccant.
2. Blood diluent in a dropper bottle, stored at 4-30°C.

3. One piece of operating instruction

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

Fingerstick Specimens (Whole Blood)

1. Clean the area to be lanced with an alcohol swab.

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

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

4. Use micropipet to obtain about 100ul fresh blood and add into sample well.

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

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

1. Allow the blood to clot.

2. Separate the serum by centrifugation.

3. 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

Collect 2 drops serum, plasma in a sample well or tube, then vertically stick the strip in the sample well or tube. Observe the result in 15 minutes.

Whole Blood Sample

Add 1 drop of whole blood into sample well, after all blood completely absorbed, add 1 drop of whole blood diluent. Observe the result in 5-30 minutes.

QUALITY CONTROL

An internal procedural control is included in the test. A red-purple line will appears in the control region (C), which confirms sufficient specimen volume and correct operation for the test.

INTERPRETATION OF RESULTS

Positive:

Two colored bands appear within 20 minutes. One colored band appears in the Control Zone (C) and another colored band appears in the Test Zone (T). The test result is positive and valid. No matter how faint the colored band appears in the Test Zone (T), the test result should be considered as positive result.

Negative:

One colored bands appears in the Control Zone (C) within 20 minutes. No colored band appears in the Test Zone (T). The test result is negative and valid.

Invalid result:

No colored band appears in the Control Zone (C) within 20 minutes. The test result is invalid. Repeat the test with a new test device.

LIMITATION

1. Negative results do not rule out the possibility of hepatitis B virus exposure or infection. Infection through recent exposure to HBV may not be detectable.

2. A test giving an invalid result should be repeated.

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10^th and 11^th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.

Our mission:

• Always best of all and always pay attention to innovation.
• Special customized service tightly following customers’ requests.
• Integrated excellent quality, competitive prices and super service together.