Detection of SARS-CoV-2 using a laboratory-developed ultra-fast NextGenPCR test versus a conventional RT-PCR test

Abstract

The reverse transcription polymerase chain reaction (RT-PCR) is considered the gold standard method for the detection of viruses in a clinic. The aim of this study was to compare the ability of conventional RT-PCR test (FTDTM SARS-CoV-2 Test) and laboratory-developed ultra-fast PCR test (NextGenPCRTM SARS-CoV-2 RT-PCR Reagent Kit) to detect the coronavirus SARS-CoV-2 causing COVID-19. A total of 318 nasopharyngeal swab specimens were collected from people under investigation for COVID-19. Despite the collection of two swab specimens from each patient and their different processing, the analysis showed an overall agreement of 95.9% between the conventional and laboratory-developed tests. The positive percentage agreement was 90.5% (114/126) and the negative percentage agreement was 99.5% (191/192). The ultra-fast NextGenPCR method does not require the isolation of RNA, provides a result of 20–96 specimens within 57–82 min after sampling, and offers a simple procedure of sample processing, analysis, and evaluation. Our results indicate that this method can be considered a potential diagnostic method for the detection of SARS-CoV-2 virus in hospitals, healthcare facilities, and research laboratories.