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

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:

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%
WIZ Results ofHBsag	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%）
WIZ Results ofTP	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%）
WIZ Results ofHCV	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%）
WIZ Results ofHIV	Positive	Negative	Total
Positve	91	1	92
Negative	3	423	446
Total	94	424	518

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We now have a skilled, performance team to supply good quality services for our consumer. We often follow the tenet of customer-oriented, details-focused 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: Peru, America, Montreal, During the 10 years of operating, our company always try our best to bring consumption satisfaction for user, built a brand name for ourselves and a solid position in the international market with major partners come from many countries such as Germany, Israel, Ukraine, United Kingdom, Italy, Argentina, France, Brazil, and so on. Last but not least, price of our products are very suitable and have fairly high competition with other companies.

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The factory technical staff not only have high level of technology, their English level is also very good, this is a great help to technology communication.

By Gill from Japan - 2015.10.01 14:14

Hope that the company could stick to the enterprise spirit of "Quality, Efficiency, Innovation and Integrity", it will be better and better in the future.

By Rosemary from Monaco - 2015.02.08 16:45