Abstract
Real-time reverse transcription polymerase chain reaction (RT-qPCR) is the most sensitive and specific assay and, therefore, is the “gold standard” diagnostic method for the diagnosis of SARS-CoV-2 infection. The aim of this study was to compare and analyze the detection performance of three different commercially available SARS-CoV-2 nucleic acid detection kits: Sansure Biotech, GeneFinderTM, and TaqPathTM on 354 randomly selected samples from hospitalized COVID-19 patients. All PCR reactions were performed using the same RNA isolates and one real-time PCR machine. The final result of the three evaluated kits was not statistically different (p = 0.107), and also had a strong positive association and high Cohen’s κ coefficient. In contrast, the average Ct values that refer to the ORF1ab and N gene amplification were significantly different (p < 0.001 and p < 0.001, respectively), with the lowest obtained by the TaqPathTM for the ORF1ab and by the Sansure Biotech for the N gene. The results show a high similarity in the analytical sensitivities for SARS-CoV-2 detection, which indicates that the diagnostic accuracy of the three assays is comparable. However, the SanSure Biotech kit showed a bit better diagnostic performance. Our findings suggest that the imperative for improvement should address the determination of cut-off Ct values and rapid modification of the primer sets along with the appearance of new variants.
Highlights
From the first case of coronavirus disease 2019 (COVID-19) in December 2019 until mid-April 2021, there were more than 147 million confirmed cases and 3.1 million deaths.According to exponential growth in the number of infections globally, COVID-19 has become one of the greatest pandemics in modern history
It is caused by a novel virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which belongs to the family Coronaviridae, subfamily Coronavirinae, and genus betacoronavirus
We provide a comparison of three available COVID-19 RT-qPCR kits from
Summary
According to exponential growth in the number of infections globally, COVID-19 has become one of the greatest pandemics in modern history. It is caused by a novel virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which belongs to the family Coronaviridae, subfamily Coronavirinae, and genus betacoronavirus. The genome consists of several genes that encode non-structural, structural, and accessory proteins [1]. The ORF1a and ORF1b genes encode two polyproteins that are cleaved into 16 non-structural proteins, such as RNA-dependent RNA polymerase (RdRp), helicase, and various proteases [2]. In the last third of the genome, genes for four structural proteins (spike surface glycoprotein S, envelope E, membrane M, and nucleocapsid N) and several accessory proteins are located [3]. In some set-ups, the E or RdRp gene primers are specific for bat (-related) betacoronaviruses, for SARS-CoV-2 [4]
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