Comparison of performance between three SARS‐CoV‐2 molecular assays (Aptima™, Laboratory Developed Test‐Fusion, and R‐GENE®) with special attention to turnaround time, a key point in laboratory management. Issue 7 (7th March 2022)

• Record Type: Journal Article
• Authors: Lefeuvre, Caroline; Pivert, Adeline; Przyrowski, Emilie; Bouthry, Elise; Darviot, Estelle; Mahieu, Rafaël; Lunel‐Fabiani, Françoise; Ducancelle, Alexandra; Le Guillou‐Guillemette, Hélène
• Is Part Of: Journal of medical virology. Volume 94:Issue 7(2022)
• Page Start: 3399
• Page End: 3403
• Publication Date: 2022-03-07
• Subjects: performance evaluation -- respiratory tract samples -- reverse transcriptase‐polymerase chain reaction -- SARS‐CoV‐2 -- transcription‐mediated amplification assay -- turnaround time; Virology -- Periodicals; 616
• DOI: 10.1002/jmv.27675
• Languages: English
• ISSNs: 0146-6615

Abstract

Abstract: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) highlights the importance of rapid diagnostic testing to identify individuals with SARS‐CoV‐2 infections and to limit the spread of the virus. Many molecular assays have become commercially available to cope with this surging demand for timely diagnosis of COVID‐19 cases, but identifying individuals requires accurate diagnostic tools. We compared the performance of three molecular SARS‐CoV‐2 assays: Aptima™ SARS‐CoV‐2 assay running on the Panther system (Hologic), an in‐house assay (Laboratory Developed Test, LDT) running on the Fusion module of the Panther Fusion system (LDT‐Fusion; Hologic), and the R‐GENE® SARS‐CoV‐2 assay (bioMérieux). In addition, we also evaluated the turnaround time. This parameter is crucial to managing the SARS‐CoV‐2 diagnosis and represents a key point in the quality management at the laboratory. Aptima™ and LDT‐Fusion assays exhibited an excellent positive percent agreement (PPA) (100.0%), while the R‐GENE® assay showed a slightly decreased PPA (98.2%). The Hologic assays have a higher throughput with less hands‐on time than the R‐GENE® assays (24–25 vs. 71 min). Both Hologic assays are used on a fully automated random‐access testing system with on‐demand testing capabilities that avoid run series, unlike the R‐GENE® assay. Automated random‐access testing systems should be preferred during periods of high SARS‐CoV‐2 prevalence.