Invited Product Profile ADEXUSDx hCG Capillary Blood Test

Abstract

Abstract Although many qualitative point-of-care tests are commercially available for detection of pregnancy including urine and serum human chorionic gonadotropin (hCG) tests, these products are often associated with higher risk of false-negative results and are not easy to use. The ADEXUSDx hCG Test uses only 1 drop (35–40 &mgr;L) of whole blood sample for the detection of hCG, making it suitable for capillary blood testing. Comparison with Access Total &bgr;hCG (5th IS) assay using 392 finger stick samples from women of child-bearing age demonstrated an overall agreement of 98.1%. Performance of the ADEXUSDx hCG Test was prospectively evaluated in 40 pregnant and 40 nonpregnant women aged 18 to 44 years. The hCG test generated 100% sensitivity and 100% specificity. Study of additional 318 nonpregnant women in various age groups demonstrated 99.7% specificity. The ADEXUSDx hCG Test is a rapid test (10 minutes) with demonstrated ease of use and clinical performance, making it a useful point-of-care test as well as over-the-counter test.