tetano
Editor, Senior Moderator
J Clin Lab Anal
. 2020 Dec 15;e23605.
doi: 10.1002/jcla.23605. Online ahead of print.
Comparison of four commercial RT-PCR diagnostic kits for COVID-19 in China
Lingyu Shen[SUP] 1 [/SUP], Shujuan Cui[SUP] 1 [/SUP], Daitao Zhang[SUP] 1 [/SUP], Changying Lin[SUP] 1 [/SUP], Lijuan Chen[SUP] 1 [/SUP], Quanyi Wang[SUP] 1 [/SUP]
Affiliations
Abstract
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[SUP]-6[/SUP] , 10[SUP]-5[/SUP] , 10[SUP]-5[/SUP] , and 10[SUP]-6[/SUP] dilutions, respectively, and concentrations were 10 copies/mL (10[SUP]-5[/SUP] dilution) and 1 copies/mL (10[SUP]-6[/SUP] 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.
Keywords: COVID-19; RT-PCR; sensitivity; specificity.
. 2020 Dec 15;e23605.
doi: 10.1002/jcla.23605. Online ahead of print.
Comparison of four commercial RT-PCR diagnostic kits for COVID-19 in China
Lingyu Shen[SUP] 1 [/SUP], Shujuan Cui[SUP] 1 [/SUP], Daitao Zhang[SUP] 1 [/SUP], Changying Lin[SUP] 1 [/SUP], Lijuan Chen[SUP] 1 [/SUP], Quanyi Wang[SUP] 1 [/SUP]
Affiliations
- PMID: 33320386
- DOI: 10.1002/jcla.23605
Abstract
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[SUP]-6[/SUP] , 10[SUP]-5[/SUP] , 10[SUP]-5[/SUP] , and 10[SUP]-6[/SUP] dilutions, respectively, and concentrations were 10 copies/mL (10[SUP]-5[/SUP] dilution) and 1 copies/mL (10[SUP]-6[/SUP] 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.
Keywords: COVID-19; RT-PCR; sensitivity; specificity.