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OEM/ODM China Psa Test Kit - Infectious HIV HCV HBSAG AND Syphilish Rapid Combo Test – Baysen

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  • 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

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OEM/ODM China Psa Test Kit - Infectious HIV HCV HBSAG AND Syphilish Rapid Combo Test – Baysen Detail:


发起询盘设置链接结尾3

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

 


发起询盘设置链接结尾3_副本

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%）
Positive Negative Total
 Positve  91  1  92
Negative  3  423  446
 Total  94  424  518
Product detail pictures:

OEM/ODM China Psa Test Kit - Infectious HIV HCV HBSAG AND Syphilish Rapid Combo Test – Baysen detail pictures

OEM/ODM China Psa Test Kit - Infectious HIV HCV HBSAG AND Syphilish Rapid Combo Test – Baysen detail pictures

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Gaining client pleasure is our company's aim without end. We are going to make excellent efforts to create new and top-quality goods, meet your special requirements and provide you with pre-sale, on-sale and after-sale companies 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: Swedish, Jeddah, Auckland, So that you can utilize the resource from the expanding info in international trade, we welcome shoppers from everywhere on-line and offline. In spite of the good quality solutions we provide, effective and satisfying consultation service is supplied by our professional after-sale service team. Product lists and detailed parameters and any other info weil be sent to you timely for your inquiries. So you should make contact with us by sending us emails or call us if you have any questions about our corporation. ou may also get our address info from our web page and come to our company to get a field survey of our merchandise. We've been confident that we have been going to share mutual achievement and create strong co-operation relations with our companions in this marketplace. We're searching forward for your inquiries.

    • Although we are a small company, we are also respected. Reliable quality, sincere service and good credit, we are honored to be able to work with you!
    5 Stars By Natividad from Swedish - 2015.12.11 11:26
    We have been cooperated with this company for many years, the company always ensure timely delivery ,good quality and correct number, we are good partners.
    5 Stars By Sara from Qatar - 2015.06.18 17:25

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