Comparative Analysis of Five Commercial RT-PCR Diagnostic Assay for Detection of Covid-19
Sepideh Hasanzadeh1,2 ORCID 0000-0001-6287-0800 · Ali Mehri3 · Saeedeh Hajebi Khaniki4 ORCID 0000-0001-7041-3802 · Behnam Azari5 ORCID 0000-0001-6612-1209 · Mahbubeh Jangi1 · Kiarash Ghazvivni1,6 · Saeid Amel Jamehdar1,6Corresponding ORCID 0000-0003-4813-6399
- 1Antimicrobial Resistance Research Centre, Mashhad University of Medical Sciences, Mashhad, Iran
- 2Department of Medical Laboratory Sciences, Varastegan Institute for Medical Sciences, Mashhad, Iran
- 3Endoscopic and Minimally Invasive Surgery research center, Mashhad University of Medical Sciences, Mashhad, Iran
- 4Student Research Committee, Department of biostatics, school of health, Mashhad University of Medical Sciences, Iran
- 5Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
- 6Depa rtment of Microbiology and virology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Abstract, as published 8 September 2023
SARS-CoV-2 real-time reverse-transcription PCR (rRT-PCR) is the most effective testing system available to combat COVID-19, given the absence of any specific treatment or vaccine. Moreover, numerous SARS-CoV-2 rRT-PCR kits have been approved under emergency-use-authorization (EUA) worldwide. In this article, we present a comparison of important performance features among five commercial RT-PCR assays. A total of consecutive nasopharyngeal (NPS) samples and oropharyngeal (OP) swabs were collected from 50 COVID-19 patients to analyze sensitivity and specificity. The results showed variations in sensitivity among all the RT-PCR kits examined. The Pishtaz teb assays demonstrated the highest positive percent agreement (PPA) of 95.2% (40/42), followed by Covitech (90.5% - 38/42), DaAn Gene (83.3% - 35/42), Sansure (66.66% - 28/42), and Power check of SARS- CoV-2 panel (64.3% - 27/42). Conversely, all five molecular assays demonstrated a negative percent agreement (NPA) of 100% (8/8). These findings provide a technical baseline for assessing the performance of five distinct commercial PCR assays for detecting SARS-CoV-2. They could prove practical and useful for laboratories seeking to purchase any of these assays for further clinical validation.
Highlights
·Compared five COVID-19 RT-PCR kits approved and available by Iran Ministry of Health. ·Pishtaz teb's kit identified the highest number of positive clinical samples.
- Severe acute respiratory syndrome coronavirus
- In vitro diagnostics
- Coronavirus
- SARS-CoV-2
- Real Time RT-PCR.