Open AccessComparison of the diagnostic efficacy between two PCR test kits for SARS‐CoV‐2 nucleic acid detection
Author(s) -
Lu Yu,
Li Limin,
Ren Shan,
Liu Xin,
Zhang Lanzuo,
Li Wei,
Yu Hongli
Publication year - 2020
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.23554
Subject(s) - covid-19 , nucleic acid , nucleic acid detection , nucleic acid test , medicine , predictive value , real time polymerase chain reaction , polymerase chain reaction , kappa , throat , nucleic acid amplification tests , diagnostic test , reverse transcription polymerase chain reaction , virology , biology , veterinary medicine , gene , disease , infectious disease (medical specialty) , surgery , gene expression , biochemistry , linguistics , philosophy , chlamydia trachomatis
Background To compare the diagnostic efficacy between two different real‐time reverse transcription polymerase chain reaction (RT‐PCR) test kits for severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) nucleic acid detection and provide references for laboratories. Methods Throat swab samples from 18 hospitalized patients were clinically diagnosed with coronavirus disease 2019 (COVID‐19) and 100 hospitalized patients without COVID‐19 were collected. SARS‐CoV‐2 nucleic acid was detected in throat swab samples with RT‐PCR test kits from Sansure Biotech Inc (Hunan, China) and Shanghai BioGerm Medical Biotechnology Co., Ltd.(Shanghai, China). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa value were analyzed, and three parallel tests were performed with three weakly positive samples. Results The sensitivity, specificity, PPV, NPV, and kappa value of the Sansure PCR kit were 0.833, 1.000, 1.000, 0.971, and 0.894, respectively, and the sensitivity, specificity, PPV, NPV, and kappa value of the BioGerm PCR kit were 0.944, 1.000, 1.000, 0.990, and 0.966, respectively. For the three parallel tests, the coefficient of variation value of the BioGerm PCR kit in all three samples was the smallest for both the ORF1ab and N gene. Conclusion The detection efficacy of the BioGerm PCR kit for SARS‐CoV‐2 nucleic acid detection was relatively higher than that of the Sansure PCR kit.