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Objectives: To assess the methodologies used in the estimation of diagnostic accuracy of SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) and other nucleic acid amplification tests (NAATs) and to evaluate the quality and reliability of the studies employing those methods. Methods: We conducted a systematic search of English-language articles published December 31, 2019-June 19, 2020. Studies of any design that performed tests on ≥10 patients and reported or inferred correlative statistics were included. Studies were evaluated using elements of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) guidelines. Results: We conducted a narrative and tabular synthesis of studies organized by their reference standard strategy or comparative agreement method, resulting in six categorizations. Critical study details were frequently unreported, including the mechanism for patient/sample selection and researcher blinding to results, which lead to concern for bias. Conclusions: Current studies estimating test performance characteristics have imperfect study design and statistical methods for the estimation of test performance characteristics of SARS-CoV-2 tests. The included studies employ heterogeneous methods and overall have an increased risk of bias. Employing standardized guidelines for study designs and statistical methods will improve the process for developing and validating rRT-PCR and NAAT for the diagnosis of COVID-19.

Public discourse regarding coronavirus disease 2019 in the United States has transitioned to intense deliberation about the infeasibility of continuing to implement stay-at-home orders and uncertainty regarding whether socioculturally acceptable alternatives could be developed to manage COVID-19 with less severe economic repercussions. Besides ongoing scientific dialogue about the expansion of testing and tracing efforts, 1,2 comparatively little has been proposed in terms of tangible, but novel, complementary mitigation tactics, despite the national race to reopen. By late May, all states had started reopening, many without meeting recommended benchmarks, 3 while