Evaluation of the Aptima™ transcription-mediated amplification assay (Hologic®) for detecting SARS-CoV-2 in clinical specimens

Background: The spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which appeared in late 2019, has been limited by isolating infected individuals. However, identifying such individuals requires accurate diagnostic tools. Objective: This study evaluates the capacity of the Aptima (TM) Transcription-Mediated Amplification (TMA) assay (Hologic (R) Panther System) to detect the virus in clinical samples. Study design: We compared the Aptima (TM) assay to two in-house real-time RT-PCR techniques, one running on the Panther Fusion (TM) module and the other on the MagNA Pure 96 and Light-Cycler 480 instruments. We included a total of 200 respiratory specimens: 100 tested prospectively and 100 retrospectively (25 -ve/75 +ve). Results: The final Cohen's kappa coefficients were:kappa = 0.978 between the Aptima (TM) and Panther Fusion (TM) assays, kappa = 0.945 between the Aptima (TM) and MagNA/LC480 assays and kappa = 0.956 between the MagNA/LC480 and Panther Fusion (TM) assays. Conclusion: These findings indicate that the Aptima (TM) SARS-CoV-2 TMA assay data agree well with those obtained with our routine methods and that this assay can be used to diagnose coronavirus disease 2019 (COVID-19).