1. Assessment of 12 qualitative RT‐PCR commercial kits for the detection of SARS‐CoV‐2
- Author
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Taghreed A. Alaifan, Fahad A. Alzahrani, Dalia A. Obeid, Ahmad M. Albarrag, Asmaa M. Altamimi, Moroje T. Taha, and Marwa T. Alhothali
- Subjects
2019-20 coronavirus outbreak ,RT‐PCR ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,coronavirus ,Real-Time Polymerase Chain Reaction ,medicine.disease_cause ,Sensitivity and Specificity ,SARS‐CoV‐2 ,03 medical and health sciences ,0302 clinical medicine ,COVID‐19 ,Virology ,medicine ,Humans ,Viral rna ,in vitro diagnostics ,030212 general & internal medicine ,Research Articles ,Coronavirus ,Reverse Transcriptase Polymerase Chain Reaction ,SARS-CoV-2 ,business.industry ,COVID-19 ,Infectious Diseases ,Real-time polymerase chain reaction ,nCoV‐2019 ,030211 gastroenterology & hepatology ,Reagent Kits, Diagnostic ,business ,Research Article - Abstract
The emergence of the novel coronavirus, the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) in the late months of 2019 had the officials to declare a public health emergency leading to a global response. Public measurements rely on an accurate diagnosis of individuals infected with the virus by using real‐time reverse transcriptase‐polymerase chain reaction (RT‐PCR). The aim of our study is to relate the fundamental clinical and analytical performance of SARS‐CoV‐2 (RT‐PCR) commercial kits. A total of 94 clinical samples were selected. Generally, 400 µl of each respiratory specimen was subjected to extraction using ExiPrep 96 Viral RNA Kit. All kits master mix preparation, cycling protocol, thermocycler, and results interpretation were carried out according to the manufacturer's instructions of use and recommendations. The performance of the kits was comparable except for the LYRA kit as it was less sensitive (F = 67, p, Highlights The aim of our study is to relate the fundamental clinical and analytical performance of SARS‐COV‐2 (RT‐PCR) commercial kits.Overall, four kits scored a sensitivity of 100% including: BGI, IQ Real, Sansure, and RADI. For specificity, all the tested kits scored above 95%.Whole‐genome sequencing was used to analysis the nucleotide and amino acid identity and the genetic diversity of G9P[8] RVAs in this study.The performance of these commercial kits by gene target showed no significant change in Ct values which indicates that kits disparities are mainly linked to the oligonucleotide of the gene target.We recommend including kits with multiple targets in order to monitor the virus changes over time.
- Published
- 2021
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