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J Clin Virol 2020[Aug]; 129 (?): 104541 PMID32659713show ga
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 Transcription-Mediated Amplification (TMA) assay (Hologic(R) Panther System) to detect the virus in clinical samples. STUDY DESIGN: We compared the Aptima assay to two in-house real-time RT-PCR techniques, one running on the Panther Fusion 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 and Panther Fusion assays, kappa?=?0.945 between the Aptima and MagNA/LC480 assays and kappa?=?0.956 between the MagNA/LC480 and Panther Fusion assays. CONCLUSION: These findings indicate that the Aptima 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).