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10.1002/jcla.23605

http://scihub22266oqcxt.onion/10.1002/jcla.23605
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33320386!7843276!33320386
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suck abstract from ncbi


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pmid33320386      J+Clin+Lab+Anal 2021 ; 35 (1): e23605
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  • Comparison of four commercial RT-PCR diagnostic kits for COVID-19 in China #MMPMID33320386
  • Shen L; Cui S; Zhang D; Lin C; Chen L; Wang Q
  • J Clin Lab Anal 2021[Jan]; 35 (1): e23605 PMID33320386show ga
  • We compared the sensitivity and specificity of four commercial coronavirus disease (COVID-19) diagnostic kits using real-time reverse transcription-polymerase chain reaction (RT-PCR). Kits I-IV approved by the State Drug Administration of China were selected, and the detection targets were ORF1ab gene and N gene. Specificity was evaluated by detecting other respiratory viruses. The sensitivity and batch effect of each kit were evaluated by testing 10-fold dilutions of RNA. Clinical application was verified by testing nasopharyngeal swab and sputum specimens from COVID-19 patients. Among the 78 cases infected by other respiratory viruses, no amplification curve was observed using these four COVID-19 RT-PCR kits. The minimum detection limits of kits I-IV were 10(-6) , 10(-5) , 10(-5) , and 10(-6) dilutions, respectively, and concentrations were 10 copies/mL (10(-5) dilution) and 1 copies/mL (10(-6) dilution). The sensitivities of kits I-IV detected using 142 nasopharyngeal swab specimens from COVID-19 patients were 91.55%, 81.69%, 80.28%, and 90.85%, respectively, while they were 92.68%, 85.37%, 82.93%, and 93.90%, respectively, for the 82 sputum samples. The specificity of each kit was 100.00% (77/77). The total expected detection rate using sputum samples was 88.59% (691/780) higher than 86.15% (672/780) of nasopharyngeal swabs. Comparison of nasopharyngeal swab and sputum samples from the same COVID-19 patient led to the detection of ORF1ab and N genes in 16 (100%) sputum samples; only ORF1ab and N genes were detected in 12 (75%) and 14 (87.5%) nasopharyngeal swab specimens, respectively. In conclusion, comparison of commercial COVID-19 RT-PCR kits should be performed before using a new batch of such kits in routine diagnostics.
  • |COVID-19 Testing/*methods[MESH]
  • |China[MESH]
  • |Clinical Laboratory Techniques/methods[MESH]
  • |Humans[MESH]
  • |Nasopharynx/virology[MESH]
  • |Reagent Kits, Diagnostic[MESH]
  • |Real-Time Polymerase Chain Reaction/*methods[MESH]
  • |Reverse Transcriptase Polymerase Chain Reaction/*methods[MESH]
  • |SARS-CoV-2/genetics[MESH]
  • |Sensitivity and Specificity[MESH]


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  • suck abstract from ncbi

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