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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Using Prenatal Blood Samples to Evaluate COVID-19 Rapid Serologic Tests Specificity.

Detection Principle
IgM, IgG
Testing Method Category
Testing Method
rapid LFIA kits: RDT#1: Hightop COVID-19 IgM/IgG Ab Rapid Test Kit (Qingdao Hantang Biological Technology Co., Ltd., Qingdao, China); RDT#2: COVID-19 IgG/IgM Rapid Test Kit (Nantong Egens Biotechnology Co. Ltd., Nantong, China); RDT#3: Orient Gene COVID-19 IgG/IgM Rapid Test (Zhejiang Orient Gene Biotech Co. Ltd, Huzhou, China). RDT#4: Standard Q COVID-19 IgM/IgG Duo Test (SD Biosensor, Gyeonggi-do, Republic of Korea).
Testing Method - Additional Info
evaluation of specificity of rapid serologic tests in stored serum samples from 2018
Reported Performance
Specificity: 100% (RDTs #1, IgM and IgG), 100% (RDTs #2, IgM and IgG), 98.9% (RDTs #3, IgM), 94.4% (RDTs #3, IgG), 88.9% (RDTs #4, IgM), 100% (RDTs #4, IgG)
Sample Size
120 samples (RDTs #1), 80 samples (RDTs #2), 90 samples (RDTs #3 and #4)

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