Abstract
BackgroundThe coronavirus disease 2019 (COVID-19) pandemic has manifested into an unprecedented public health crisis. The rapid spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has facilitated reagent developers to customize and receive authorization for nucleic acid testing kits in a short period, which would have resulted in some shortcomings in the quality parameters of the kits. Consequently, in-house clinical validations of innovative real-time quantitative polymerase chain reaction (RT-qPCR) kits are required. This research aims to determine the sensitivity, specificity, and accuracy of various RT-qPCR kits available in Bangladesh.MethodologyA total of 150 samples were obtained from patients with suspected COVID-19 infection when the delta variant was predominant, followed by RNA extraction performed using a nucleic acid isolation kit. Subsequently, three commercially available PCR kits named Sansure (China), STAT-NATⒷ (Sentinel Diagnostics, Italy), and Roche Biochem (Switzerland) were applied to detect SARS-CoV-2.ResultsThe results showed that the STAT-NATⒷ kit is more sensitive than the other two, as indicated by the cycle threshold (Ct) values of respective genes. STAT-NATⒷ RT-qPCR can detect the ORF1ab gene sensitively (p < 0.001) compared to Sansure. STAT-NATⒷ was also capable of detecting E and RdRp genes more sensitively (p < 0.001) compared to Roche. Regarding specificity, STAT-NATⒷ (95% confidence interval [Cl] = 92.29-99.73%). RT-qPCR showed more accuracy than Sansure (95% Cl = 90.77-99.32%) and Roche (95% Cl = 81.17-94.38%). The area under the curve for E, ORF1ab, and RdRp genes of the STAT NATⒷ PCR kit was 0.952, 0.959, and 0.981, respectively.ConclusionsThis study concluded that STAT-NATⒷ is a better diagnostic RT-qPCR kit compared to Sansure and Roche for detecting SARS-CoV-2.
Highlights
The coronavirus disease 2019 (COVID-19) is an infectious disease initially discovered in December 2019 in Wuhan, China [1]
The results showed that the STAT-NAT kit is more sensitive than the other two, as indicated by the cycle threshold (Ct) values of respective genes
STAT-NAT was capable of detecting E and RdRp genes more sensitively (p < 0.001) compared to Roche
Summary
The coronavirus disease 2019 (COVID-19) is an infectious disease initially discovered in December 2019 in Wuhan, China [1]. On March 11, 2020, the World Health Organization (WHO) declared COVID-19 a pandemic due to the outbreak of a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [2]. The first case of SARS-CoV-2 infection in Bangladesh was reported on March 8, 2020 [4]. As of November 18, 2021, Bangladesh has reported 1,573,214 positive cases and 27,934 deaths from 10,653,924 lab tests [5]. The rapid spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has facilitated reagent developers to customize and receive authorization for nucleic acid testing kits in a short period, which would have resulted in some shortcomings in the quality parameters of the kits. This research aims to determine the sensitivity, specificity, and accuracy of various RT-qPCR kits available in Bangladesh
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