HBsAb Rapid Test Cassette

HBsAb Rapid Test Cassette

INTENDED USE

Rapid HBsAb Test is a chromatographic immunoassay for qualitative detection of the surface antibody of hepatitis B virus (Anti-HBs) in human whole blood samples. It is intended for use in medical institution as an aid for diagnosis and management of patients related to infection with hepatitis B as well for screening of blood donors or blood products.

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

STORAGE

Store the test device at 4 to 30°C. Do Not Freeze.

WARNING AND PRECAUTIONS

1. For in vitro diagnostic use only.

2. Do not use product beyond the expiration date.

3. Handle all specimens as potentially infectious.

REAGENTS AND MATERIALS PROVIDED

1. Rapid HBsAb Test

2. Instructions for use

3.Disposable transfer pipet

MATERIALS REQUIRED BUT NOT PROVIDED

1. Whole blood or plasma: Vacutainer tube, or other appropriate tube, containing heparin or EDTA as an anticoagulant

2.Serum: Vacutainer tube, or other appropriate tube, without anticoagulant

3. Timer or clock

SAMPLE COLLECTION AND PREPARATION

1.The serum, plasma or whole blood specimen should be collected under standard laboratory conditions.

2.Heat inactivation of specimens, which may cause hemolysis and protein denaturation, should be avoided.

3.Patient samples performed best when tested immediately after collection. If specimans are to be stored, the red blood cells should be removed to avoid hemolysis. If the sample cannot be tested within 24 hours, serum or plasma should be frozen until the test can be performed. Allow sample to reach room temperature before proceeding.

4.Sodium azide can be added as a preservative up to 0.1% without effecting the test results.

ASSAY PROCEDURE

1. Bring all materials and specimens to room temperature.

2. Remove the test cassette from the sealed foil pouch.

3. Label the test cassette with specimen identity by writing the ID on the top label of the strip.

4. Place the test cassette on a flat horizontal surface.

5. Using the transfer pipet to draw up the sample.

6. Hold the transfer pipet in a vertical position over the sample pad and dispense 2-3 drops (80-120 ml) of sample onto the sample pad.

7. Read the result at 20 minutes after adding the sample.

Note: Some positive samples may show positive results before 20 minutes. Results after 30 minutes may not be accurate.

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.

Rebecca Yan