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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