Artron Hepatitis B Surface Antibody (HBsAb) Test Kit
Catalog Number:A02-02-213 (strip)/ A02-02-222 (cassette)
INTENDED USE:
Artron One-Step Hepatitis B Virus Surface Antibody (HBsAb) Test Kit is a rapid and convenient immunochromatographic in vitro assay for the detection of HBsAb in human serum or plasma at or above the concentration of 20 mIU/ml. HBsAb is the antibody that best correlates with immunity to the hepatitis B virus (HBV). The three most common reasons for testing are to determine if a person: 1) known to have been infected with hepatitis B has resolved their infection and is no longer infectious; 2) who is a candidate for immunization with the hepatitis B vaccine has evidence of previous natural infection, and 3) immunized with hepatitis B vaccine has developed a protective antibody response. This assay provides only a preliminary result. Clinical expertise and professional judgment should be sought to further evaluate the result of the test.
DESCRIPTION:
Artron One-Step HBsAb Test is an antibody-capture immunochromatographic assay that detects the presence of HBsAb in serum or plasma samples. Specific HBV surface antigens are 1) conjugated with colloidal gold and deposited on the conjugate pad, and 2) immobilized on the test line on the nitrocellulose membrane. When a serum or plasma sample is added, it rehydrates the gold-antigen conjugate, and the HBsAb, if present in the sample, will bind to the gold-conjugated antigen. The antigen-antibody-gold complexes will migrate towards the test window until the test region (T) where they will be captured by the immobilized antigens, forming a visible pink/red line (test line), indicating a positive result. If HBsAb is absent from the sample, no pink/red line will appear in the test region (T), indicating a negative result.
To serve as an internal control, a control line should always appear in the control region (C) after the test has been completed. The absence of a pink/red control line in the control region is an indication of an invalid result.
The detection limit for the HBsAb Test Kit is 20 mIU/ml. Blood samples with concentrations of 20 mIU/ml or greater will test positive.
To serve as an internal control, a control line should always appear in the control region (C) after the test has been completed. The absence of a pink/red control line in the control region is an indication of an invalid result.
The detection limit for the HBsAb Test Kit is 20 mIU/ml. Blood samples with concentrations of 20 mIU/ml or greater will test positive.
SAMPLE TYPE:
Time to Results:
15-20 mins (Strong positive specimens may produce positive results in as little time as 1 minute. Confirm negatives in 10-20 minutes; for whole blood samples, confirm negatives in 20-30 minutes)
Analytical Sensitivity:
20 mIU/ml
Analytical Specificity:
No cross reactions were observed from all tested specimens
Interference:
No interference from common biological and chemical analytes
Diagnostic Sensitivity:
96.0%
Diagnostic Specificity:
99.4%
Accuracy:
Precision
The precision was determined by replicate assays of both positive and negative samples with devices from three different production lots. The resultant data indicated no appreciable between lot variation when testing both positive and negative samples across three different lots.
Storage condition:
Store at 2-30°C, avoid direct sunlight and freezing.
Shelf life:
18 months
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WARNINGS AND PRECAUTIONS
- For professional in vitro diagnostic use only.
- Do not reuse.
- Do not use if the product is sealed barrier or its packaging is compromised.
- Do not use it after the expiration date shown on the pouch.
- Do not mix and interchange different specimens.
- Wear protective clothing such as laboratory coats, disposable gloves, and eye protection while handling potentially infectious material and performing the assay.
- Wash hands thoroughly after finishing the tests.
- Do not eat, drink or smoke in the area where the specimens or kits are handled.
- Clean up spills thoroughly with appropriate disinfectants.
- Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing procedures.
- Dispose of all specimens and used devices in a proper bio-hazard container. The handling and disposal of hazardous materials should follow local, national, or regional regulations.
- Keep out of children’s reach.