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Deprecated: Implicit conversion from float 217.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 J+Clin+Lab+Anal 2021 ; 35 (1): e23605 Nephropedia Template TP
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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.