HBcAb Rapid Test Strip

HBcAb Rapid Test Strip

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

Intended Use

The One Step HBcAb Test is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B virus core antibody (HBcAb/anti-HBc) in Whole Blood /Serum / Plasma.

Principle

The One Step HBcAb Test is a competitive immunoassay. Colloidal gold conjugated anti-HBcAg antibody complexes are dry-immobilized in the test device. When the specimen is added, it migrates with the gold conjugate complexes by capillary diffusion through the strip. If present, HBcAb will compete with gold conjugate complexes for the limited amount HBcAg immobilized in the Test Zone (T). It will prevent the gold conjugate complexes from reacting with HBcAg and no red line appears in the Test Zone (T). If there is no HBcAb in the specimens, gold conjugate complexes will react with HBcAg and a visible red line appears. To serve as a procedural control, a red line will always appears in the Control Zone (C) which indicates the validity of the test.

Storage and Stability

• Store as packaged in the saled pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
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Additional Special Equipment

Materials Provided

Ÿ Test devices Ÿ Disposable specimen droppers

Ÿ Package insert Ÿ Buffer(for whole blood only)

Materials Required But Not Provided

Ÿ Timer Ÿ Centrifuge

Ÿ Specimen collection containers

Precautions

• For professional in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens and kits are handled.
• Handle all specimens as if they contain infectious agents.
• Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Follow standard biosafety guidelines for handling and disposal of potential infective material.
• Humidity and temperature can adversely affect results.

Specimen Collection and Preparation

1. The One Step HBcAb Test can be performed used on Whole Blood /Serum / Plasma.
2. To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures.
3. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.
4. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8℃ for up to 3 days. For long term storage, specimens should be kept below -20℃. Whole blood should be stored at 2-8℃ if the test is to be run within 2 days of collection. Do not freeze whole blood specimens.
5. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

Test Procedure

Allow the test, specimen and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen pad of the test device, then start the timer. See illustration below.
4. For Whole blood specimen:Hold the dropper vertically and transfer 1 drop of specimen (100μl) to the specimen pad of the test device, then add 2 drops of buffer (approximately 70μl) and start the timer. See illustration below.
5. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.

Notes:

Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of specimen to the specimen well.

Interpretation of Results

Positive: One colored line appears in the control region(C).No apparent colored line appear in the test line region.

Negative: Two lines appear. One line should always appear in the control line region(C), and another one apparent colored line should appear in the test line region.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

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.