Blood Hepatitis B surface Antigen Hbsag rapid test
1. INTEDED USE
This kit is suitable for the qualitative detection of hepatitis B virus surface antigen in human serum/plasma/whole blood samples as an aid in the diagnosis of hepatitis B virus infection. This kit provides only the results of the hepatitis B virus surface antigen test and the results obtained should be analyzed in conjunction with other clinical information. It is intended for use by medical professionals only
2. PRODUCT SPECIFICATION
| Model No. | Hbsag |
| Methodology | Colloidal Gold |
| Sample Type | Serum/Plasma/Whole blood |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485 |
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MAIN KIT COMPONENTS *Test device *Sample diluents *Disposable pipette *Instructions for Use |
Packing *20 test /kit *Aluminum foil bag labeling *shrink wrap
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3.TEST METHOD
| 1 | Before the experiment, remove the test reagent and the sample to be tested from the storage condition and equilibrate to room temperature. |
| 2 | Open the reagent foil bag package, take out the reagent card, place it horizontally on the lab bench and mark the sample well. |
| 3 | For serum and plasma samples, use a disposable pipette to take 2 drops and add them to the spiked wells; for whole blood samples, use a disposable pipette to take 2 drops and add them to the spiked wells, then add 1 drop of sample diluent |
| 4 | Test results should be read within 15-20 minutes, if more than 20 minutes to read the results invalid. |
4.RESULT EVALUATION AND EXPLANATION
5.CLINICAL PERFORMANCE
| Baysen Result of HBsAg | Test result of Reference reagent | Positive coincidence rate：99.06% （95%C.I. 96.64%~99.74%） Negative coincidence rate：98.69% （95%C.I.96.68%~99.49%） Total coincidence rate：98.84%（ 95%C.I.97.50%~99.47%） |
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| Positive | Negative | Total | ||
| Positive | 211 | 4 | 215 | |
| Negative | 2 | 301 | 303 | |
| Total | 213 | 305 | 518 | |
