Artron Hepatitis B Virus Surface Antigen Test
Catalog Number: A02-01-222 (cassette)/ A02-01-213 (strip)
INTENDED USE:
Artron One Step Hepatitis B Surface Antigen (HBsAg) Test is a rapid and convenient immunochromatographic assay for the qualitative detection of HBsAg in human serum or plasma samples. It is intended for professional use as an aid in the diagnosis of Hepatitis B virus (HBV) infection. 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 HBsAg test is an antigen-capture immunochromatographic assay, it detects the presence of HBsAg in serum or plasma samples. Monoclonal antibodies specifically against HBsAg 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-antibody conjugate. If HBsAg is present in the sample, it will interact with the gold-conjugated antibodies. The antigen-antibody-gold complex will migrate towards the test window until the Test Zone (T) where they will be captured by immobilized antibodies, forming a visible red line (Test band) indicating a positive result. If HBsAg is absent in the sample, no red line will appear in the Test Zone (T) indicating a negative result.
To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. The absence of a colored control line in the Control Zone is an indication of an invalid result.
To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. The absence of a colored control line in the Control Zone is an indication of an invalid result.
SAMPLE TYPE:
Time to Results:
10-20 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:
n/a
Analytical Specificity:
No cross reactions were observed from all tested specimens
Interference:
No interference from common biological and chemical analytes
Diagnostic Sensitivity:
99.82%
Diagnostic Specificity:
99.89%
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:
36 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.