OEM/ODM China Psa Test Kit - Infectious HIV HCV HBSAG AND Syphilish Rapid Combo Test – Baysen
OEM/ODM China Psa Test Kit - Infectious HIV HCV HBSAG AND Syphilish Rapid Combo Test – Baysen Detail:
PRODUCTION INFORMATION
Model Number | HBsAg/TP&HIV/HCV | Packing | 20 Tests/ kit, 30kits/CTN |
Name | HBsAg/TP&HIV/HCV Rapid Combo Test | Instrument classification | Class III |
Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
Accuracy | > 97% | Shelf life | Two Years |
Methodology | Colloidal Gold | OEM/ODM service | Avaliable |
INTENDED 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 information. It is intended for use by medical professionals only.
Test procedure
1 | Read the instruction for use and in strict conformity with instruction for use required operation to avoid affecting the accuracy of the test results |
2 | Before the test, the kit and the sample are taken out from thestorage 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. |
Note: each sample shall be pipetted by clean disposable pipette to avoid cross contamination.
CLINICAL PERFORMANCE
WIZ Results ofHBsag | 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% |
||
Positive | Negative | Total | ||
Positve | 211 | 4 | 215 | |
Negative | 2 | 301 | 303 | |
Total | 213 | 305 | 518 |
WIZ Results ofTP | 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%) |
||
Positive | Negative | Total | ||
Positve | 126 | 9 | 135 | |
Negative | 5 | 378 | 383 | |
Total | 131 | 387 | 518 |
WIZ Results ofHCV | 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%) |
||
Positive | Negative | Total | ||
Positve | 57 | 2 | 59 | |
Negative | 4 | 455 | 459 | |
Total | 61 | 457 | 518 |
WIZ Results ofHIV | 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 | ||
Positve | 91 | 1 | 92 | |
Negative | 3 | 423 | 446 | |
Total | 94 | 424 | 518 |
Product detail pictures:
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The key to our success is "Good Products Good quality, Reasonable Value and Efficient Service" for OEM/ODM China Psa Test Kit - Infectious HIV HCV HBSAG AND Syphilish Rapid Combo Test – Baysen , The product will supply to all over the world, such as: Mauritius, Jordan, Malta, We can give our clients absolute advantages in product quality and cost control, and we have full range of molds from up to one hundred of factories. As product updating fast, we succeed in developing many high quality products for our clients and get high reputation.
By Audrey from Gambia - 2016.04.08 14:55
We always believe that the details decides the company's product quality, in this respect, the company conform our requirements and the goods are meet our expectations.
By Sharon from Bahamas - 2016.04.18 16:45