The estimation of diagnostic accuracy of tests for COVID-19: A scoping review - 31/10/20
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Highlights |
• | SARS-CoV-2 tests in the studies in this scoping review are lacking rigorous evaluationnecessary for standard FDA approval due to the emergency state generated by the COVID-19 pandemic. |
• | Reports of performance test characteristics in the literature should be interpreted carefully given the heterogeneity among available studies in terms of test types, reference standards, metrics, and details of study design and methodology. |
• | Future studies would benefit from employing statistical methods such as latent class analysis and other methods referenced above to accurately analyze their data. |
• | Ensuring that national requirements for test performance analysis and reporting on diagnostic tests, perhaps based on the existing FDA guidelines, particularly as commercialization of these tests move forward would help ensure the appropriate settings for test utilization (i.e. individual asymptomatic screening, pool community screening, surveillance testing, or diagnostic testing). |
Summary |
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.
Le texte complet de cet article est disponible en PDF.Keywords : SARS-CoV-2, COVID-19, Diagnostic accuracy, Sensitivity, Specificity, QUADAS-2
Plan
Vol 81 - N° 5
P. 681-697 - novembre 2020 Retour au numéro
Article précédent
- Editorial Board
- Meningococcal disease surveillance in the Asia–Pacific region (2020): The global meningococcal initiative
- Aye Mya Min Aye, Xilian Bai, Ray Borrow, Sotharith Bory, Josefina Carlos, Dominique A. Caugant, Chien-Shun Chiou, Vo Thi Trang Dai, Ener Cagri Dinleyici, Prakash Ghimire, Setyo Handryastuti, Jung Yeon Heo, Amy Jennison, Hajime Kamiya, Loong Tonnii Sia, Jay Lucidarme, Helen Marshall, Nina Dwi Putri, Senjuti Saha, Zhujun Shao, James Heng Chiak Sim, Vinny Smith, Muhamed-Kheir Taha, Phan Van Thanh, Usa Thisyakorn, Kinley Tshering, Julio Vázquez, Balaji Veeraraghavan, Saber Yezli, Bingqing Zhu
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