Comparison and Sensitivity Evaluation of Three Different Commercial Real-Time Quantitative PCR Kits for SARS-CoV-2 Detection
Open Access
- 8 July 2021
- Vol. 13 (7), 1321
- https://doi.org/10.3390/v13071321
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.Keywords
This publication has 20 references indexed in Scilit:
- Predicting Infectious Severe Acute Respiratory Syndrome Coronavirus 2 From Diagnostic SamplesClinical Infectious Diseases, 2020
- Comparison of seven commercial RT-PCR diagnostic kits for COVID-19Journal of Clinical Virology, 2020
- Gene of the month: the 2019-nCoV/SARS-CoV-2 novel coronavirus spike proteinJournal of Clinical Pathology, 2020
- Viral RNA load as determined by cell culture as a management tool for discharge of SARS-CoV-2 patients from infectious disease wardsEuropean Journal of Clinical Microbiology & Infectious Diseases, 2020
- The Architecture of SARS-CoV-2 TranscriptomeCell, 2020
- A Novel Coronavirus from Patients with Pneumonia in China, 2019The New England Journal of Medicine, 2020
- Laboratory readiness and response for novel coronavirus (2019-nCoV) in expert laboratories in 30 EU/EEA countries, January 2020Eurosurveillance, 2020
- A new coronavirus associated with human respiratory disease in ChinaNature, 2020
- Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCREurosurveillance, 2020
- Computing Inter-Rater Reliability for Observational Data: An Overview and TutorialTutorials in Quantitative Methods for Psychology, 2012