DOI

Detection Principle

NucleicAcid-PCR based

Target

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

PCR_KIT

Testing Method

kits

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)

Peer-reviewed

yes