AUTHOR=Chung Le Thi Kim , Vung Nguyen Dang , Uyen Ngo Thi , Hanh Bui Thi Minh , Huong Le Thi , Hien Pham Thi , Xuan Le Thi Thanh , Ha Nguyen Thuy , Dat Dao Xuan TITLE=A brief review on the validation of biology methods for COVID-19 detection JOURNAL=Frontiers in Tropical Diseases VOLUME=3 YEAR=2022 URL=https://www.frontiersin.org/journals/tropical-diseases/articles/10.3389/fitd.2022.1013130 DOI=10.3389/fitd.2022.1013130 ISSN=2673-7515 ABSTRACT=

The COVID-19 global pandemic has been going on for more than two years, and the evolution of SARS-CoV-2 with many variants of concern still poses a risk to public health. Sufficient access to qualified and validated testing plays an important role in detecting and alerting trends of the pandemic and provides evidence for making decisions in preventive strategies and policies. Depending on the method of testing and laboratory conditions, validation parameters (i.e., analytical sensitivity, limit of detection, diagnostic sensitivity, analytical specificity, diagnostic specificity, repeatability, reproducibility, robustness, positive predictive value, negative predictive value, applicability, practicability, and time to results) can be very different. With three main types of COVID-19 detection kits available, comprising nucleic acid, serological, and antigen detection, the kind of validation parameters that should be used becomes a complicated consideration and takes time to assess. Our review provides valuable and comprehensive information for laboratories in the assessment and selection of the optimal parameters to validate new COVID-19 test kits.