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 |
![DIA-7](https://www.baysenmedical.com/uploads/DIA-7.jpg)
![DIA-6](https://www.baysenmedical.com/uploads/DIA-6.jpg)
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
![Test Result-Combo](https://www.baysenmedical.com/uploads/Test-Result-Combo.png)
![Test Result-Combo-02](https://www.baysenmedical.com/uploads/Test-Result-Combo-02.png)
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 |