3. Verification of realtime rt-pcr for detection of sars-cov-2
Main Article Content
Abstract
Realtime RT-PCR is considered one of the best methods to detect SARS-CoV-2. Because of complex specifications, Realtime RT-PCR assays require verification and rigorous quality control. This study verified the One-Step RT-PCR COVID-19 Kit THAI DUONG Multiplex-3 target genes kit at the SARS-CoV-2 Lab Unit of Hanoi Medical University by using 30 respiratory biospecimens that were isolated and confirmed by the LightMix SarbecoV E-gene plus EAV control Kit according to the WHO recommended procedure and met the sampling criteria’s. Experiments were conducted according to the recommendations of the American Society for Microbiology (ASM) for evaluate of precision and accuracy. The assay precision reached CV% values for short-term and long-term precision in accordance with the manufacturer's recommendation. The accuracy of the positive and negative consensus test reached 100%. This study was able to conduct the precision and accuracy verification presented by the manufacturer.
Article Details
Keywords
SARS-CoV-2, verification, Realtime RT-PCR
References
2. Sule WF, Oluwayelu DO. Real-time RT-PCR for COVID-19 diagnosis: Challenges and prospects. The Pan African medical journal. 2020; 35(Suppl 2): 121.
3. La Marca A, Capuzzo M, Paglia T, Roli L, Trenti T, Nelson SM. Testing for SARS-CoV-2 (COVID-19): A systematic review and clinical guide to molecular and serological in-vitro diagnostic assays. Reproductive biomedicine online. 2020; 41(3): 483-499.
4. Xu M, Wang D, Wang H, et al. COVID-19 diagnostic testing: Technology perspective. Clinical and translational medicine. 2020; 10(4): e158.
5. Tahamtan A, Ardebili A. Real-time RT-PCR in COVID-19 detection: Issues affecting the results. Expert review of molecular diagnostics. 2020; 20(5): 453-454.
6. Umakanthan S, Sahu P, Ranade AV, et al. Origin, transmission, diagnosis and management of coronavirus disease 2019 (COVID-19). Postgraduate medical journal. 2020; 96(1142): 753-758.
7. Mitchell SL, St George K, Rhoads DD, et al. Understanding, verifying, and implementing emergency use authorization molecular diagnostics for the detection of SARS-CoV-2 RNA. Journal of clinical microbiology. 2020; 58(8).
8. Buckingham L. Molecular diagnostics: Fundamentals, methods, and clinical applications. 2019.