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Comparison of the diagnostic efficacy among three test kits for SARS-CoV-2 nucleic acid detection
- ZHANG Hanyun, QIU Xiaoting, PENG Fang, WANG Min, WANG Weijia, TAN Zhixi
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2024, 50(9):
800-803.
doi:10.12183/j.scjpm.2024.0800
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Abstract
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Objective To compare and analyze the diagnostic efficacy of three different commercial test kits for SARS-CoV-2 nucleic acid detection. Methods Throat swab samples were collected from 49 COVID-19 patients and 11 healthy individuals. The SARS-CoV-2 nucleic acid was detected with RT-PCR test kits from Mde Biotech, Jiangsu Bioperfectus Technologies, and Coyote Biotech. The sensitivity, specificity, overall accuracy, positive predictive value (PPV), negative predictive value (NPV), and kappa value were analyzed, and three parallel tests were performed with three samples at different levels. The linear regression equation of Coyote quick detection value was established and verified, which to predict the conventional values of Mde and Bioperfectus. Results The sensitivity, specificity, overall accuracy, PPV, NPV, and kappa value of the Mde PCR kit were 0.98, 1.00, 0.98, 1.00, 0.92, and 0.95, respectively, and that of the Bioperfectus PCR kit were 0.96, 1.00, 0.97, 1.00, 0.85, and 0.90, respectively, and that of the Coyote PCR kit were 0.94, 1.00, 0.95, 1.00, 0.79, and 0.85. For the three parallel tests, the coefficient of variation value of the Mde and Bioperfectus PCR kit in all three samples were smaller than that of Coyote PCR kit for both the ORF1ab and N gene. The linear regression equation of Coyote quick detection value was established and verified successfully [Mde: YORF1ab = 1.049×XORF1ab(Coyote) + 13.20 (R2=0.937), YN = 1.101×X N(Coyote) + 13.06 (R2=0.940); Bioperfectus: YORF1ab = 1.066×X ORF1ab(Coyote) + 15.49 (R2=0.940), YN = 1.107×X N(Coyote) + 14.61 (R2=0.944)]. Conclusions The three test kits have good coincidence rate and consistency for the detection of SARS-CoV-2 nucleic acid. The linear regression equation established by the quick detection value of Coyote kit can better predict the routine value of Mde and Biopefectus.