The OnSite hCG Combo Rapid Test Cassette is a lateral flow chromatographic immunoassay for the early detection of pregnancy by providing a quick direct visual test for the placental hormone 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.

The OnSite hCG Combo Rapid Test is not intended for quantitative results nor for over-the-counter (OTC) sales. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via the assay of hCG, a placental hormone that may be present in human serum, plasma, or urine.

The hCG detection limit of the OnSite hCG Combo Rapid Test is 12.5 mIU/mL in serum or plasma specimens and 25 mIU/mL in urine specimens. It is designed for professional use only and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

Product Features

Clinical accuracy: In comparison with a reference chemiluminescence, or ELISA, hCG detection has 100% sensitivity and 100% specificity in urine specimens and 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 months