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CTK BIOTECH, INC.
Human Chorionic Gonadotropin Test
Model: OnSite hCG Combo Rapid Test
Description
The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, Human Chorionic Gonadotropin (hCG) in human serum, plasma, and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment.
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Features
• Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is: 100% sensitivity and 100% specificity in urine specimens; 100% sensitivity and 99.1% specificity in serum specimens
• Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens
• Analytical specificity: no cross-reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle-stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH)
• Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens
• Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert)
• Shelf life: 24 month
• Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens
• Analytical specificity: no cross-reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle-stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH)
• Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens
• Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert)
• Shelf life: 24 month
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Tags: [Point-Of-Care Testing],[Rapid Testing]
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