Invited Product Profile Alere RALS Connectivity for Point-of-Care Testing

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 μL) of whole blood sample for the detection of hCG, making it suitable for capillary blood testing. Comparison with Access Total βhCG (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.