One-Step HBcAb Rapid Test Uncut Sheet,WB/S/P

One-Step HBcAb Rapid Test 

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

INTENDED USE

Rapid HBcAb Test is an immunochromatography assay for the qualitative detection of Hepatitis B virus core antibody (HBcAb/anti-HBc) in human serum, plasma or whole blood specimen.

TEST PRINCIPLE

Rapid 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.

MATERIAL PROVIDED

1. Rapid HBcAb Test

2. Instructions for use

3.Disposable transfer pipet

MATERIALS REQUIRED BUT NOT SUPPLIED

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

STORAGE

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

PRECAUTIONS

1. For in vitro diagnostic use only.

2. Do not use product beyond the expiration date.

3. Handle all specimens as potentially infectious.

SPECIMEN 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.

PROCEDURE

1. Bring all materials and specimens to room temperature.

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

3. Label the test card with specimen identity on the “ID ____ ” area of the cassette.

4. Place the test card 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 well and dispense 2 drops (80-100 ml) of sample into the sample well.

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.

INTERPRETATION OF RESULTS

Positive:

Two colored bands form. The appearance of two colored bands, one in test line zone and the other in control line zone, indicates negative result for that particular test(s). The negative result does not indicate the absence of drug and their metabolites in the specimen, it only indicates the level of tested drug and their metabolites in the specimen is less than cut-off level.

Negative:

One colored band forms. One colored band appears in control line zone. No colored band is found in test line zone. This is an indication the level of tested drug and their metabolites in the specimen is above the cut-off level.

Invalid:

If there is no colored band in control line zone of any strip, the test result is invalid. Retest the sample with a new device.

Note: A borderline(±) in test line zone should be considered negative result.

PERFORMANCE CHARACTERISTICS:

Rapid HBcAb Test showed equivalent detectability to commercially available EIA for HBcAb. A result of 97.4% correlation with EIA was obtained from a clinical study of 1249 specimens.

LIMITATIONS

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.