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HCG Card (Pregnancy Test)
Product Specification
- Sensitivity: The analytical sensitivity of the hCG Pregnancy Test Cassette is 25mIU/ml. The sensitivity was established by repetitive testing of samples containing 25mIU/ml hCG during a period of several weeks.
- Specificity: The specificity of The Pregnancy One Step Rapid Test Cassette was determined from cross-reactivity studies with known amounts of Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH), and Thyroid Stimulating Hormone (hTSH). Negative results were obtained from all tests conducted with 300 mIU/ml hLH, 1000 mIU/ml hFSH , 1000 IU/ml hTSH and negative hCG Specimen.
- Precision: A study was conducted which consisted of performing a series of replicate assays using 25 mIU/ml and 100 mIU/ml hCG in urine. All the test results were consistent .
- Diagnostic sensitivity and specificity : Studies were performed which consisted of testing 48 positive and 52 negative specimens using the hCG Pregnancy Test Cassette versus a reference hCG immunoassay. Both of these studies demonstrate 100% (relative) correlation
- Pack Size: 50 Test/100 Test