Comparison and Sensitivity Evaluation of Three Different Commercial Real-Time Quantitative PCR Kits for SARS-CoV-2 Detection

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.

Towards Label-free detection of viral disease agents through their cell surface proteins: Rapid screening SARS-CoV-2 in biological specimens

“…The detection of viral infections, such as SARS-CoV-2 infections, by antigen tests has been recommended by the world health organisation (WHO) as a cheap and rapid alternative for the RT-qPCR test [26] . The detection of the virus spike protein has been one of the useful approaches to develop new antigen tests for SARS-CoV-2 infections [ 10 , 23 , [27] , [28] , [29] , [30] , [31] ]. Many of the current antigen tests are designed to detect the spike protein through the change of the electric or optical properties of a sensor [Table S1].…”

“…Multiple analytical techniques have been demonstrated for the detection of SARS-CoV-2 virus in clinical specimens [ 8 , 9 ]. The gold standard for the detection of viral infections is RT-qPCR [10] . However, this method is time consuming, expensive and requires highly trained personnel to carry out the test.…”

Evaluation of Sensitivity and Specificity of Three Commercial Real-Time Quantitative Polymerase Chain Reaction Kits for Detecting SARS-CoV-2 in Bangladesh

“…Banko et al performed a comparative study with three PCR kits, namely, Sansure Biotech (Sansure Biotech Inc., China), GeneFinderTM (OSANG Healthcare Co., Seongnam, Korea), and TaqPathTM (Thermo Fisher Scientific, Waltham, MA, USA). They showed that the Sansure Biotech assay had greater diagnostic performance than the other two PCR kits [ 8 ]. Moore et al performed another comparative study with two PCR kits, namely, Sansure Biotech and BioGerm (Shanghai, China).…”

“…To battle the COVID-19 pandemic, accurate detection tests for SARS-CoV-2 are crucial. During this emergency, several companies developed diagnostic kits for detecting SARS-CoV-2 within a short time by compromising on kit sensitivity and specificity [ 8 ].…”

A paper-based optical sensor for the screening of viruses through the cysteine residues of their surface proteins: A proof of concept on the detection of coronavirus infection

“…The gold standard for the diagnosis of SARS-CoV-2 infections is the qRT-PCR test that identifies the virus genetic material in nasopharyngeal swabs [ [6] , [7] , [8] , [9] ]. However, this method is time-consuming, expensive and requires well-trained technicians, sophisticated lab-based equipment [ [10] , [11] , [12] ].…”