Evaluation of the COVID19 ID NOW EUA assay.

Mitchell, Stephanie L; George, Kirsten St; Mitchell, Stephanie L.; George, Kirsten St.

BACKGROUND The SARS-CoV-2 pandemic caused a major surge in needed diagnostic capacity. In response, many EUA assays have become available for clinical laboratories, and more recently, the point of care device, Abbott ID NOW. OBJECTIVES To determine the analytical performance of the ID NOW assay for detecting SARS-CoV-2. STUDY DESIGN Residual NP samples collected in viral transport media were tested by the ID NOW platform in two independent laboratories. Results were compared to either the CDC or New York EUA assays, which served as reference methods. RESULTS Overall agreement of ID NOW was 78.7%. Sensitivity was 71.7% and specificity was 100%. Notably, all false-negative results correlated to those samples that were weakly positive. CONCLUSIONS ID NOW performs well for strong and moderately positive samples but has reduced sensitivity for weakly positive samples. This sensitivity, among other concerns, should be taken into consideration when using this test for patients with a low suspicion for COVID-19 disease.