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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Comparison of a laboratory-developed test targeting the envelope gene with three nucleic acid amplification tests for detection of SARS-CoV-2

Detection Principle
NucleicAcid-PCR based
Target
E, S, N and ORF1ab
Testing Method Category
RT-PCR
Testing Method
high complexity laboratory-developed rRT-PCR EUA from Stanford Health Care (SHC) targeting the SARS-CoV-2 envelope (E) ; Atila isothermal amplification assay targeting the nucleocapsid (N) gene; Atila isothermal amplification assay targeting open reading frame 1ab (ORF1ab); pike (S) multiplex, real-time RT-PCR, and the US Centers for Disease Control; Prevention (CDC) N1 and N2 rRT-PCRs.
Testing Method - Additional Info
Comparing high complexity laboratory-developed rRT-PCR EUA from Stanford Health Care (SHC) with other kits
Reported Performance
PPA with the SHC EUA reference assay: 82.8 % (95 % confidence interval (CI) 65.0 to 92.9); PPA for Atila: 86.7 % (95 % CI 69.7 to 95.3); PPA for the Altona E: 86.7 % (95 % CI 69.7 to 95.3); PPA for Altona S targets:c90.0 % (95 % CI 73.6 to 97.3)
Sample Size
8 patients
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