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CE0123 HCG Pregnancy Rapid Test 50Pcs Urine Pregnancy Test Strip

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Contact name:Edward YU

Hangzhou Aichek Medical Technology Co.,Ltd

CE0123 HCG Pregnancy Rapid Test 50Pcs Urine Pregnancy Test Strip

Country/Region	china
City & Province	hangzhou zhejiang

Product Details

Easy to use high Accuracy Pregnancy home rapid Test CE certificate

Product Name	Easy to use high Accuracy Pregnancy home rapid Test CE certificate
Formats	Strip(3mm)Device(4mm) Midstream(5mm)
Place of Origen	China
Specimen	Urine
Read Time	5 minutes
Shelf life	2 years
Package	25 device/box or 50 strip/Box
Storage	2℃-30℃

The hCG One Step Pregnancy Test Strip (Urine) is a rapid, one-step lateral flow immunoassay in strip format for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by immersing the end of the strip in urine, and obtaining the result from the colored lines.

Accuracy

A multi-center clinical evaluation was conducted comparing the results obtained using the hCG One Step Pregnancy Test Device (Urine) to another commercially available urine membrane hCG test. The study included 159 urine specimens, and both assays identified 88 negative and 71 positive results. The results demonstrated >99% overall accuracy of the hCG One Step Pregnancy Test Device (Urine) when compared to the other urine membrane hCG test.

hCG Reference Method

Method		Other hCG Rapid Test			Total Results
hCG Test Device	Results	Positive		Negative
	Positive	78		0	78
	Negative	0		72	72
Total Results		78		72	150
Sensitivity: 100% (95%-100%)*			Specificity: 100% (95%-100%)*
Accuracy: 100% (98%-100%)*			* 95% Confidence Intervals