Diagnostic Test Devices HCG Pregnancy Test Kit With CE Mark

Specifications

HCG Pregnancy test strip(CE)
1.CE CERTIFICATE
2.Multiple independent clinical studies(US FDA 510K)
3.ACCURACY:99%

HCG Pregnancy Test Strip(CE)

CE CERTIFICATE

Advantages:

1. CE Certificate: CE 0123

2. Multiple independent clinical studies (US FDA 510K)

 Features:

Sample Collection:

Collect the urine specimen in a clean, dry glass or plastic container. Urine specimens can be collected at any time of the day. It is not necessary to obtain a first morning specimen, however concentrations of hCG may be higher in this specimen.

The sample can be refrigerated up to 72 hours prior to testing. A refrigerated sample must be allowed to warm to room temperature and mixed before testing.

Performance Characteristics:

Sensitivity:

The Advanced Quality Pregnancy Test detects urine hCG concentrations of 25 mIU/ml. A total of 180 tests were performed, at the three hCG concentrations. hCG specimens were prepared at the following concentrations using hCG free urine; 0 mIU/ml,25 mIU/ml and 600,000 mIU/ml. All tests were negative with the hCG negative urine and positive with the 25 mIU/ml and 600,000 mIU/ml samples.

Accuracy:

The accuracy of the Advanced Quality Pregnancy Test was determined by comparing with the results of a reference laboratory test, as follows: Urine samples from normal women (n=61) and pregnant women (n=66) were tested with the Advanced Quality Pregnancy Test and the reference laboratory test. A 100% correlation was observed between the two tests. No false positive or false negative results were obtained. The accuracy of the InTec test was >99% in urine.

Specificity:

The specificity of the Advanced Quality Pregnancy Test was determined from cross reaction studies with known amounts of Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH), and Thyroid Stimulating Hormone (hTSH). Samples containing 300 mIU/ml hLH, 1000 mIU/ml hFSH and 1000 mIU/ml hTSH all gave negative results.