Blood HBsAg&HCV Rapid Combo Test
1. INTEDED USE
This kit is applicable to in vitro qualitative detection of hepatitis B virus and hepatitisC virus in human serum/plasma/whole blood sample, and it's suitable for auxiliary diagnosisof hepatitis B virus and hepatitis C virus infections, and is not suitable for blood screening. Theresults obtained should be analyzed in conjunction with other clinical information. ltis intended for use by medical professionals only.
2. PRODUCT SPECIFICATION
| Model No. | Hbsag+HCV combo test |
| 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 | The sample to be tested (serum/plasma) was added to S1 and S2 wells with 2 drops orthe sample to be tested (whole blood) was added to S1 and s2 wells with 3 drops. After thesample is added, 1 ~ 2 drops of sample dilution are added to the S1 and S2 wells and thetiming is started. |
| 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 :99.48%(95%C.1.97.09%~99.91%)Negative coincidence rate .99.25%(95%C.1.97.32%~99.80%)Total coincidence rate :99.35%(95%C.1.9810%~99.78%) | ||
| Positive | Negative | Total | ||
| Positive | 190 | 2 | 215 | |
| Negative | 1 | 266 | 303 | |
| Total | 191 | 268 | 518 | |
| Baysen Result of HCV | Test result of Reference reagent | Positive coincidence rate :96.55%(95%C.1.88.27%~99.05%)Negative coincidence rate .99.50%(95%C1.98.20%~99.86%)Total coincidence rate :9913%(95%C.1.97.78%~99.66%) | ||
| Positive | Negative | Total | ||
| Positive | 56 | 2 | 58 | |
| Negative | 2 | 399 | 401 | |
| Total | 58 | 401 | 459 | |
