Ana Banko1, Gordana Petrovic2, Danijela Miljanovic1, Ana Loncar2, Marija Vukcevic2, Dragana Despot2, Andja Cirkovic3. 1. Institute of Microbiology and Immunology, Faculty of Medicine, University of Belgrade, 11000 Belgrade, Serbia. 2. Institute for Biocides and Medical Ecology, 11030 Belgrade, Serbia. 3. Institute for Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, 11000 Belgrade, Serbia.
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.
Real-time reverse transcription polymerase chain reaction (RT-qPCR) is the most sensitive and specific assay aene">nd, therefore, is the "gold staene">ndard" diagene">nostic method for the diagene">nosis of <n class="Chemical">span class="Disease">SARS-CoV-2 infection. The aim of this study was to compare and analyze the detection performance of three different commercially available <spn>an class="Species">SARS-CoV-2 nucleic acid detection kits: Sansure Biotech, GeneFinderTM, and TaqPathTM on 354 randomly selected samples from hospitalized COVID-19patients. 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.
Authors: Farzana Mim; Md Selim Reza; Mohammad Jahidur Rahman Khan; Nurul Karim; Mohammad A Rahman; Md Ibrahim Hossain; Rajib Biswas Journal: Cureus Date: 2021-12-22
Authors: Vibol Iem; Phonepadith Xangsayarath; Phonenaly Chittamany; Sakhone Suthepmany; Souvimone Siphanthong; Phimpha Paboriboune; Silaphet Somphavong; Kontogianni Konstantina; Jahangir A M Khan; Thomas Edwards; Tom Wingfield; Jacob Creswell; Jose Dominguez; Luis E Cuevas Journal: PLoS One Date: 2022-09-29 Impact factor: 3.752