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Comparative Analysis of Four Commercial RT-PCR Diagnostic Assay for Detection of Covid-19
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  • Sepideh Hasanzadeh,
  • Mahbubeh Jangi,
  • Ali Mehri,
  • Saeedeh Hajebi Khaniki4,
  • Behnam Azari,
  • Saeid Amel Jamehdar
Sepideh Hasanzadeh
Mashhad University of Medical Sciences
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Mahbubeh Jangi
Mashhad University of Medical Sciences
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Ali Mehri
Mashhad University of Medical Sciences
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Saeedeh Hajebi Khaniki4
Mashhad University of Medical Sciences Faculty of Medicine
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Behnam Azari
Varastegan Institute for Medical Sciences
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Saeid Amel Jamehdar
Mashhad University of Medical Sciences

Corresponding Author:[email protected]

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Abstract

SARS-CoV-2 real-time reverse-transcription PCR (rRT-PCR) is currently the only available yet effective testing system to fight COVID-19 epidemics as far as there’s not any treatment and vaccine. Moreover, many SARS-CoV-2 rRT-PCR kits are approved by the emergency-use-authorization (EUA) altogether over the world. In this article we’ve provided a comparison of important performance features of four commercial RT-PCR assays. A total of consecutive nasopharyngeal (NPS) samples and oropharyngeal (OP) swabs were collected from 50 COVID-19 patients for sensitivity and specificity analysis. Specificity of these assays were examined by using extractions of RNA from common human coronavirus cultures. All RT-PCR kits including in this study exhibited acceptable specificity over 90%, except for the Sansure and PowerCheck (88%). Pishtaz teb assays demonstrated a PPA of 95.24% (40/42), while the DaAn Gene, Sansure, Power check of SARS-CoV-2 panel showed the PPA of 85.7% (36/42), 66.66% (28/42), and 64.3% (27/42), respectively. An NPA of 100% (8/8) was observed for four molecular assays. This study gives a technical baseline of four distinct commercial PCR assays for detection of SARS-CoV-2, that can be practical and useful for laboratories interested in buying any of them for more clinical validation.