Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Comparison of nine different commercially available molecular assays for detection of SARS-CoV-2 RNA.

Detection Principle
NucleicAcid-PCR based
E, S (Altona); E, ORF1a (Mikrogen); RdRP, E (gerbion); ORF1ab/N (Fast track); ORF1ab, N, E (Shangai Fosun); N, ORF1a (SolGent); RdRP, E (WELLS BIO)
Testing Method Category
Testing Method
Testing Method - Additional Info
RealStar SARS-CoV-2 RT-PCR Kit RUO, Altona Diagnostics (Hamburg, Germany) ; Mikrogen diagnostic (Neuried, Germany) ; gerbion GmbH & Co KG (Kornwestheim, Germany); Primerdesign Ltd. (Camberley, UK); Fast Track Diagnostics (Esch-sur-Alzezze, Luxembourg); Shanghai Fosun Long March Medical Science Co., Ltd. (Shanghai, China); SolGent Co., Ltd. (Daejeon, Korea); WELLS BIO, INC. (Gangseo-gu, Republic of Korea); BGI (Wuhan, China)
Reported Performance
LOD: 10cpr (Altona, E), 100cpr (Altona, S), 10cpr (Mikrogen, E), 10cpr (Mikrogen, ORF1a), 6000cpr (gerbion, RdRP), 60cpr (Gerbion, E), 80cpr (Primerdesign), 100cpr (Fast Track, ORF1ab/N), 100cpr (Shanghai Fosun, ORF1ab), 10cpr (Shanghai Fosun, N), 10cpr (Shanghai Fosun, E), 50cpr (SolGent, N), 50cpr (SolGent, ORF1a), 100cpr (WELLS BIO, RdRP), 10cpr (WELLS BIO, E), 10cpr (BGI); Sensitivity: 90% (Altona, E), 97% (Altona, S), 97% (Mikrogen, E), 97% (Mikrogen, ORF1a), 49% (gerbion, RdRP), 82% (Gerbion, E), 87%(Primerdesign), 100%(Fast Track, ORF1ab/N), 94% (Shanghai Fosun, ORF1ab), 100% (Shanghai Fosun, N), 94% (Shanghai Fosun, E), 97% (SolGent, N), 92% (SolGent, ORF1a), 66%(WELLS BIO, RdRP), 62% (WELLS BIO, E), 95% (BGI); Specificity: 100% (Altona, E), 100% (Altona, S), 100% (Mikrogen, E), 100% (Mikrogen, ORF1a), 100% (gerbion, RdRP), 100%(Gerbion, E), 100% (Primerdesign), 100% (Fast Track, ORF1ab/N), 100% (Shanghai Fosun, ORF1ab), 100% (Shanghai Fosun, N), 100% (Shanghai Fosun, E), 100% (SolGent, N), 100% (SolGent, ORF1a), 100% (WELLS BIO, RdRP), 100% (WELLS BIO, E), 100% (BGI)
Sample Size
different sample size for kit (up to 39 positive & 29 negative)

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