Analytic and Clinical Performance of Major Commercial Severe Acute Respiratory Syndrome Coronavirus 2 Molecular Assays in the United States

Overview

Journal Clin Lab Med

Specialty Pathology

Date 2022 May 31

PMID 35636818

Authors

Michelle R Campbell

Matthew J Binnicker

Affiliations

Soon will be listed here.

Abstract

The rapid development of commercially available molecular assays in response to the COVID-19 pandemic has been essential in identifying positive cases and guiding state and national response plans. With over 200 SARS-CoV-2 molecular tests having received emergency use authorization by the US Food and Drug Administration, numerous studies have been conducted to evaluate these methods and compare their analytical and clinical performance. By applying the lessons learned from the rapid development of molecular assays in response to the COVID-19 pandemic, the diagnostic industry will be better prepared to respond to future outbreaks of novel infectious diseases.

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References

Lee J, Song J . Diagnostic accuracy of the Cepheid Xpert Xpress and the Abbott ID NOW assay for rapid detection of SARS-CoV-2: A systematic review and meta-analysis. J Med Virol. 2021; 93(7):4523-4531. PMC: 8207078. DOI: 10.1002/jmv.26994. View

Fung B, Gopez A, Servellita V, Arevalo S, Ho C, Deucher A . Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays. J Clin Microbiol. 2020; 58(9). PMC: 7448668. DOI: 10.1128/JCM.01535-20. View

Bordi L, Piralla A, Lalle E, Giardina F, Colavita F, Tallarita M . Rapid and sensitive detection of SARS-CoV-2 RNA using the Simplexa™ COVID-19 direct assay. J Clin Virol. 2020; 128:104416. PMC: 7198196. DOI: 10.1016/j.jcv.2020.104416. View

Yanson K, Laviers W, Neely L, Lockamy E, Castillo-Hernandez L, Oldfied C . Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System. J Clin Microbiol. 2021; 59(12):e0101921. PMC: 8601249. DOI: 10.1128/JCM.01019-21. View

Zhen W, Manji R, Smith E, Berry G . Comparison of Four Molecular Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens. J Clin Microbiol. 2020; 58(8). PMC: 7383517. DOI: 10.1128/JCM.00743-20. View

Cradic K, Lockhart M, Ozbolt P, Fatica L, Landon L, Lieber M . Clinical Evaluation and Utilization of Multiple Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2. Am J Clin Pathol. 2020; 154(2):201-207. PMC: 7314271. DOI: 10.1093/ajcp/aqaa097. View

Matsumura Y, Shimizu T, Noguchi T, Nakano S, Yamamoto M, Nagao M . Comparison of 12 Molecular Detection Assays for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). J Mol Diagn. 2020; 23(2):164-170. PMC: 7699162. DOI: 10.1016/j.jmoldx.2020.11.007. View

Zhen W, Smith E, Manji R, Schron D, Berry G . Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2. J Clin Microbiol. 2020; 58(8). PMC: 7383520. DOI: 10.1128/JCM.00783-20. View

Loeffelholz M, Alland D, Butler-Wu S, Pandey U, Perno C, Nava A . Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test. J Clin Microbiol. 2020; 58(8). PMC: 7383535. DOI: 10.1128/JCM.00926-20. View

10.

Rhoads D, Cherian S, Roman K, Stempak L, Schmotzer C, Sadri N . Comparison of Abbott ID Now, DiaSorin Simplexa, and CDC FDA Emergency Use Authorization Methods for the Detection of SARS-CoV-2 from Nasopharyngeal and Nasal Swabs from Individuals Diagnosed with COVID-19. J Clin Microbiol. 2020; 58(8). PMC: 7383529. DOI: 10.1128/JCM.00760-20. View

11.

He X, Lau E, Wu P, Deng X, Wang J, Hao X . Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020; 26(5):672-675. DOI: 10.1038/s41591-020-0869-5. View

12.

Lee C, Tham J, Png S, Chai C, Ng S, Min Tan E . Clinical performance of Roche cobas 6800, Luminex ARIES, MiRXES Fortitude Kit 2.1, Altona RealStar, and Applied Biosystems TaqPath for SARS-CoV-2 detection in nasopharyngeal swabs. J Med Virol. 2021; 93(7):4603-4607. PMC: 8250924. DOI: 10.1002/jmv.26940. View

13.

Xie X, Zhong Z, Zhao W, Zheng C, Wang F, Liu J . Chest CT for Typical Coronavirus Disease 2019 (COVID-19) Pneumonia: Relationship to Negative RT-PCR Testing. Radiology. 2020; 296(2):E41-E45. PMC: 7233363. DOI: 10.1148/radiol.2020200343. View

14.

Younes N, Al-Sadeq D, Al-Jighefee H, Younes S, Al-Jamal O, Daas H . Challenges in Laboratory Diagnosis of the Novel Coronavirus SARS-CoV-2. Viruses. 2020; 12(6). PMC: 7354519. DOI: 10.3390/v12060582. View

15.

Thwe P, Ren P . How many are we missing with ID NOW COVID-19 assay using direct nasopharyngeal swabs? Findings from a mid-sized academic hospital clinical microbiology laboratory. Diagn Microbiol Infect Dis. 2020; 98(2):115123. PMC: 7334653. DOI: 10.1016/j.diagmicrobio.2020.115123. View

16.

Wolters F, van de Bovenkamp J, van den Bosch B, van den Brink S, Broeders M, Chung N . Multi-center evaluation of cepheid xpert® xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic. J Clin Virol. 2020; 128:104426. PMC: 7211760. DOI: 10.1016/j.jcv.2020.104426. View

17.

Smith E, Zhen W, Manji R, Schron D, Duong S, Berry G . Analytical and Clinical Comparison of Three Nucleic Acid Amplification Tests for SARS-CoV-2 Detection. J Clin Microbiol. 2020; 58(9). PMC: 7448672. DOI: 10.1128/JCM.01134-20. View

18.

Mitchell S, St George K . Evaluation of the COVID19 ID NOW EUA assay. J Clin Virol. 2020; 128:104429. PMC: 7227587. DOI: 10.1016/j.jcv.2020.104429. View

19.

Green D, Zucker J, Westblade L, Whittier S, Rennert H, Velu P . Clinical Performance of SARS-CoV-2 Molecular Tests. J Clin Microbiol. 2020; 58(8). PMC: 7383556. DOI: 10.1128/JCM.00995-20. View

20.

Wolfel R, Corman V, Guggemos W, Seilmaier M, Zange S, Muller M . Virological assessment of hospitalized patients with COVID-2019. Nature. 2020; 581(7809):465-469. DOI: 10.1038/s41586-020-2196-x. View