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

被引:33
作者
Tremeaux, Pauline [1 ]
Lhomme, Sebastien [1 ,2 ]
Abravanel, Florence [1 ,2 ]
Raymond, Stephanie [1 ,2 ]
Mengelle, Catherine [1 ]
Mansuy, Jean-Michel [1 ]
Izopet, Jacques [1 ,2 ]
机构
[1] CHU Purpan, Dept Virol, Toulouse, France
[2] Toulouse III Univ Paul Sabatier, Ctr Pathophysiol Toulouse Purpan, INSERM, UMR1043,CNRS,UMR5282, Toulouse, France
基金
英国科研创新办公室;
关键词
SARS-CoV-2; COVID-19; Coronavirus; Hologic (R) Panther System;
D O I
10.1016/j.jcv.2020.104541
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
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).
引用
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页数:3
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