HBsAg/TP&HIV/HCV Rapid Combo Test
1. INTEDED USE
This kit is suitable for the in vitro qualitative determination of hepatitis B virus, syphilis spirochete, human immunodeficiency virus, and hepatitis C virus in human serum/plas- ma/whole blood samples for the auxiliary diagnosis of hepatitis B virus, syphilis spirochete, human immunodeficiency virus, and hepatitis C virus infections. The results obtained should be analyzed in conjunction with other clinical informatioon. It is intended for use by medical professionals only.
2. PRODUCT SPECIFICATION
| Model No. | HCV/HBSAG/HIV/TP-AB Combo |
| 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 | Read the instruction for use and in strict conformity with instruction for use required operation to avoidaffecting the accuracy of the test results. |
| 2 | Before the test, the kit and the sample are taken out from the storage condition and balanced to room temperature and mark it. |
| 3 | Tearing the packaging of the aluminum foil pouch, take out the test device and mark it, then place it horizontally on the test table. |
| 4 | Aspirate serum/plasma samples with a disposable dropper and add 2 drops in each of wells s1 and s2; add 3 drops in each of wells s1 and s2 for whole blood samples before adding 1~2 drops of rinse solution to each of wells s1 and s2 and the Timing is started. |
| 5 | Test results should be interpreted within 15~20 minutes, if more than 20 min interpreted results are invalid. |
| 6 | Visual interpretation can be used in result interpretation. |
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 | |
| Baysen Result of TP |
Test result of Reference reagent | Positive coincidence rate：96.18% （95%C.I. 91.38%~98.36%） Negative coincidence rate：97.67% （95%C.I.95.64%~98.77%） Total coincidence rate：97.30% （95%C.I.95.51%~98.38%） |
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| Positive | Negative | Total | ||
| Positive | 126 | 9 | 135 | |
| Negative | 5 | 378 | 383 | |
| Total | 115 | 387 | 518 | |
| Baysen Result of HIV | Test result of Reference reagent | Positive coincidence rate：96.81% （95%C.I. 91.03%~98.91%） Negative coincidence rate：99.76% （95%C.I.98.68%~99.96%） Total coincidence rate：99.23% （95%C.I.98.03%~99.70%） |
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| Positive | Negative | Total | ||
| Positive | 91 | 1 | 92 | |
| Negative | 3 | 423 | 426 | |
| Total | 94 | 424 | 518 | |
| Baysen Result of HCV | Test result of Reference reagent | Positive coincidence rate：93.44%（95%C.I. 84.32%~97.42%） Negative coincidence rate：99.56% （95%C.I.98.42%~99.88%） Total coincidence rate：98.84% （95%C.I.97.50%~99.47%） |
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| Positive | Negative | Total | ||
| Positive | 57 | 2 | 59 | |
| Negative | 4 | 455 | 459 | |
| Total | 61 | 457 | 518 | |
