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Store the test device at 4 to 30°C. Do Not Freeze.
1. For in vitro diagnostic use only.
2. Do not use product beyond the expiration date.
3. Handle all specimens as potentially infectious.
1. Rapid HBsAb Test
2. Instructions for use
3.Disposable transfer pipet
3. Timer or clock
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
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.
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.
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.
In a clinical evaluations of the performance of the Rapid HBsAb Test:
1.Interferring factors Presence of 0.4g/dL hemoglobin, 20mg/dL bilirubin, 1.95nmol/L triglyceride, or 6.10nmol/L cholesterol don’t affect the detection of anti-HBs.
2.Comparison with the ELISA method
The results of the HBsAb test strip in total of 1249 samples (535 ELISA confirmed positive specimens and 714 ELISA confirmed negative specimens) is summarized.
|Positive agreement(%) Negative agreement(%) Accuracy (%)|
|97.6 (522/535) 98.2 (701/714) 97.9 (1223/1249)|
Contact Person: Ms. Anna Lee