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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Analytical and Clinical Comparison of Three Nucleic Acid Amplification Tests for SARS-CoV-2 Detection

Detection Principle
NucleicAcid-PCR based
Fusion: ORF1ab; Aptima: ORF1ab;Biofire: ORF1ab and ORF8
Testing Method Category
Testing Method
kits: the Hologic Panther Fusion SARS-CoV-2 assay (Fusion), the Hologic Aptima SARS-CoV-2 assay (Aptima), and the BioFire Defense COVID-19 test (BioFire)
Testing Method - Additional Info
comparative study
Reported Performance
LOD: Fusion: 62.5 copies/ml; Aptima: 62.5 copies/ml; Biofire: 125 copies/ml. Sensitivity: Fusion: 98.7%; Aptima: 94.7%; Biofire: 98.7%. Specificity: Fusion: 100%; Aptima: 100%; Biofire: 100%.
Sample Size
150 samples

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