The estimation of diagnostic accuracy of tests for COVID-19: A scoping review.
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.
['Axell-House|Dierdre B|DB|', 'Lavingia|Richa|R|', 'Rafferty|Megan|M|', 'Clark|Eva|E|', 'Amirian|E Susan|ES|', 'Chiao|Elizabeth Y|EY|']
D000293:Adolescent D000328:Adult D000368:Aged D000369:Aged, 80 and over D000073640:Betacoronavirus D000086382:COVID-19 D000086742:COVID-19 Testing D000086663:COVID-19 Vaccines D002648:Child D002675:Child, Preschool D019411:Clinical Laboratory Techniques D018352:Coronavirus Infections D000068598:Data Accuracy D003955:Diagnostic Tests, Routine D005260:Female D006801:Humans D007223:Infant D007231:Infant, Newborn D008297:Male D008875:Middle Aged D058873:Pandemics D011024:Pneumonia, Viral D060888:Real-Time Polymerase Chain Reaction D015203:Reproducibility of Results D020133:Reverse Transcriptase Polymerase Chain Reaction D000086402:SARS-CoV-2 D055815:Young Adult
Diagnostic accuracy COVID-19 SARS-CoV-2 QUADAS-2 Sensitivity Specificity