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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Scientific literature on COVID-19 Test Methods and Devices - detail

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

Detection Principle
NucleicAcid-Others
Target
transcription-mediated amplification (TMA) ORF1ab
Testing Method Category
Other
Testing Method
AptimaTM SARS-CoV-2 assay (Hologic Panther System)
Reported Performance
The AptimaTM and Panther FusionTM assays aCohen’s coefficient: ? = 0.978 [0.949–1.000], a positive percent agreement: 97.3 % [95.0–99.6 %], a negative percent agreement: 100 % [100?100%], an overall percent agreement = 99.0 % [97.6–100 %]
Sample Size
200 respiratory specimens
Peer-reviewed
yes

The database contains available information from scientific literature that is being updated periodically. Please note that the provided information (as retrieved from analysed papers) is provided only for devices commercially available with CE-IVD mark. Acknowledgements