One-Step HBsAb Rapid Test
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.
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
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.
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