Comparison of Two Different Commercial SARS-CoV-2 PCR Diagnostic Kits

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Introduction: In our country RT-PCR is the only method used to diagnose COVID-19 infection, caused by SARS-CoV-2, one of the greatest epidemic in world history. In this study we aimed to compare two most frequently used commercial diagnostic kits. Materials and Methods: A total of 100 samples which were referred to our laboratory were used in this study. These nucleic acid samples were diagnosed as positive (50) or negative (50) by Coronex (R) COVID-19 (Ver.2.0) Multipleks RT-qPCR Diagnosis Kit (DS Bio and Nano Technology, Ankara, Turkey) and kept at -20 degrees C. The samples were cross checked with RealStar (R) SARS-CoV-2 RT-PCR Kit 1.0 (Altona Diagnostic, Hamburg, Germany). Extraction of the samples was performed by QlAsymphony (Qiagen, Hollanda). Data was evaluated with kappa analysis and t test. Results: All of the 50 positive samples were positive with Real Star (R) as well. Two of the negative samples were found positive when studied with Real Star (R) . There was a high concordance between the two kits (Kappa= 0.96). Mean Ct values were found as 24.1 +/- 4.9 and 19.6 +/- 4.2 for Real Stat (R) and Coronex (R), respectively. The Ct value was found less than 20 in 51.9% of the 52 positive samples studied with Real Star (R). Conclusion: There is a high concordance between the two commercial kits. Both kits may be used with confidence in symptomatic patients for the diagnosis of COVID-19.

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