Clinical Comparison of the NOWDiagnostics' ADEXUSDx Human Chorionic Gonadotropin Point-of-Care Test with the Roche Elecsys hCG + β2 for the Serum Measurement of Human Chorionic Gonadotropin

Abstract

Background: In the emergency and urgent care setting, point-of-care (POC) human chorionic gonadotropin (hCG) testing is a clinical tool used to determine pregnancy status for risk assessment of potentially fetotoxic treatments and procedures in female patients of child-bearing age. Methods: We reassayed a cohort of remnant blood samples (n = 283; hCG concentrations, <1 mIU/mL to 10-157500 mIU/mL) previously analyzed using a reference laboratory hCG immunoassay (Roche Elecsys) with a novel Food and Drug Administration-cleared rapid hCG POC assay, the NOWDiagnostics' ADEXUSDx™, to assess performance of the rapid test. Results: We obtained the following characteristics compared with the reference laboratory hCG values at <1 mIU/mL and from 10 to 157500 mIU/mL: sensitivity, 97.6%; specificity, 99.1% (positive predictive value, 99.4%; negative predictive value, 96.6%). Conclusions: The hCG point-of-care test assayed in this study accurately identified blood samples with hCG levels >10 mIU/mL. Because of its rapid turnaround time and ease of use, further field testing in the clinical setting is warranted.