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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, &amp;lt;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 &amp;lt;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 &amp;gt;10 mIU/mL. Because of its rapid turnaround time and ease of use, further field testing in the clinical setting is warranted.

the journal of applied laboratory medicine

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