The Infectious Diseases Society of America Guidelines on the Diagnosis of Coronavirus Disease 2019 (COVID-19): Antigen Testing

Abstract Immunoassays designed to detect SARS-CoV-2 protein antigens are now commercially available. The most widely used tests rapid lateral flow assays that generate results in ~15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based antigen (Ag) have also been developed. overall accuracy of Ag tests, however, is not well defined. Infectious Diseases Society America (IDSA) convened an expert panel perform a systematic review literature and develop best-practice guidance related testing. This guideline third series rapid, frequently updated COVID-19 diagnostic guidelines developed by IDSA. IDSA’s goal was evidence-based recommendations or suggestions assist clinicians, clinical laboratories, patients, public health authorities, administrators, policymakers decisions optimal use both medical nonmedical settings. A multidisciplinary infectious diseases microbiologists, experts identified prioritized questions tests. Grading Recommendations Assessment, Development, Evaluation (GRADE) methodology assess certainty evidence make testing recommendations. agreed on 5 These address symptomatic asymptomatic individuals as single versus repeat strategies. Data performance US Food Drug Administration with Emergency Use Authorization mostly limited single, one-time standard nucleic acid amplification (NAAT) reference standard. Rapid high specificity low modest sensitivity compared NAAT methods. Antigen test heavily dependent viral load, differences observed between time post-onset symptoms. Based these observations, reverse transcriptase–polymerase chain reaction (RT-PCR) remain methods choice diagnosing infection. However, when molecular readily available logistically infeasible, can help identify some quality supporting graded very moderate.