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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 seven commercial SARS-CoV-2 RNA detection kits based on real-time polymerase chain reaction (PCR) in China

Detection Principle
NucleicAcid-PCR based
Target
N, ORF1ab, E genes
Testing Method Category
PCR_KIT
Testing Method
kit A (BGI Biotech Co., Ltd, Wuhan, China), kit B (Outdo Biotech Co., Ltd, Shanghai, China), kit C (Sansure Biotech Inc., Changsha, China), kit D (Perkin Elmer Medical Diagnostic Products, Co., Ltd, Shanghai, China), kit E (Daan Gene Co., Ltd. Of Sun Yat-Sen University, Guangzhou, China), kit F (Jiangsu Bioperfectus Technologies Co., Ltd, Taizhou, China), and kit G (Fosun Long March Medical Science Co., Ltd, Shanghai, China).
Reported Performance
PPV: 100% (all kits) ; sensitivity: 90.48% (A, F), 92.86% (B), 83.33% (C), 97.62% (D), 78.57% (E), 76.19% (G) ; Specificity: 100% (all) ; NPA: 98.04% (A,F), 98.52% (B), 96.62% (C), 99.50% (D), 95.69% (E), 95.24% (G)
Sample Size
242 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