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. 2022 Jul;94(7):3399-3403.
doi: 10.1002/jmv.27675. Epub 2022 Mar 7.

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

Caroline Lefeuvre  1   2 , Adeline Pivert  1   2 , Emilie Przyrowski  1 , Elise Bouthry  1 , Estelle Darviot  3 , Rafaël Mahieu  4 , Françoise Lunel-Fabiani  1   2 , Alexandra Ducancelle  1   2 , Hélène Le Guillou-Guillemette  1   2
Affiliations

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

Caroline Lefeuvre et al. J Med Virol. 2022 Jul.

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.

Keywords: SARS-CoV-2; performance evaluation; respiratory tract samples; reverse transcriptase-polymerase chain reaction; transcription-mediated amplification assay; turnaround time.

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Conflict of interest statement

Hélène Le Guillou‐Guillemette has received honoraria from being a consultant or speaker from Hologic and research grants from Hologic (outside the context of the submitted work). Other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Workflow comparison of each assay. Dark gray color corresponds to hands‐on time and the light gray color corresponds to automation time. The workflow of each assay represented on the graph corresponds to the time for six specimens per run. The NucliSENS® easyMAG® system (the automated process of extraction) can extract 24 samples per run. To process the 120 samples, 5 extraction runs of 24 samples and 2 PCR runs must be considered, that is, a turnaround time of 16h13. LDT, Laboratory Developed Test; PCR, polymerase chain reaction
See this image and copyright information in PMC

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