tetano
Editor, Senior Moderator
J Clin Microbiol. 2020 May 7. pii: JCM.00890-20. doi: 10.1128/JCM.00890-20. [Epub ahead of print]
Comparison of Two High-Throughput Reverse Transcription-Polymerase Chain Reaction Systems for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2.
Craney AR[SUP]1[/SUP], Velu P[SUP]1[/SUP], Satlin MJ[SUP]2[/SUP], Fauntleroy KA[SUP]3[/SUP], Callan K[SUP]3[/SUP], Robertson A[SUP]3[/SUP], La Spina M[SUP]3[/SUP], Lei B[SUP]3[/SUP], Chen A[SUP]3[/SUP], Alston T[SUP]3[/SUP], Rozman A[SUP]3[/SUP], Loda M[SUP]1[/SUP], Rennert H[SUP]1[/SUP], Cushing M[SUP]1[/SUP], Westblade LF[SUP]4,[/SUP][SUP]2[/SUP].
Author information
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as the cause of a worldwide pandemic. Many commercial SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) assays have received Emergency Use Authorization from the United States Food and Drug Administration. However, there are limited data describing their performance, in particular the performance of high-throughput SARS-CoV-2 RT-PCR systems. We analyzed the diagnostic performance of two high-throughput systems: cobas 6800 and Panther Fusion, and their associated RT-PCR assays with a collection of 389 nasopharyngeal specimens. The overall percent agreement between the platforms was 96.4% (375/389). Cohen's kappa analysis rated the strength of agreement between the two platforms as "almost perfect" (κ = 0.922; standard error, 0.051). Furthermore, there was no significant difference between corresponding cycle threshold values generated on the two systems (P value = 0.88; Student's t test). Taken together, these data imply both platforms can be considered comparable in terms of their clinical performance. We believe this information will be useful for those who have already adopted these platforms or are seeking to implement high-throughput RT-PCR testing to stem the SARS-CoV-2 pandemic.
Copyright ? 2020 American Society for Microbiology.
PMID:32381643DOI:10.1128/JCM.00890-20
Comparison of Two High-Throughput Reverse Transcription-Polymerase Chain Reaction Systems for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2.
Craney AR[SUP]1[/SUP], Velu P[SUP]1[/SUP], Satlin MJ[SUP]2[/SUP], Fauntleroy KA[SUP]3[/SUP], Callan K[SUP]3[/SUP], Robertson A[SUP]3[/SUP], La Spina M[SUP]3[/SUP], Lei B[SUP]3[/SUP], Chen A[SUP]3[/SUP], Alston T[SUP]3[/SUP], Rozman A[SUP]3[/SUP], Loda M[SUP]1[/SUP], Rennert H[SUP]1[/SUP], Cushing M[SUP]1[/SUP], Westblade LF[SUP]4,[/SUP][SUP]2[/SUP].
Author information
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as the cause of a worldwide pandemic. Many commercial SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) assays have received Emergency Use Authorization from the United States Food and Drug Administration. However, there are limited data describing their performance, in particular the performance of high-throughput SARS-CoV-2 RT-PCR systems. We analyzed the diagnostic performance of two high-throughput systems: cobas 6800 and Panther Fusion, and their associated RT-PCR assays with a collection of 389 nasopharyngeal specimens. The overall percent agreement between the platforms was 96.4% (375/389). Cohen's kappa analysis rated the strength of agreement between the two platforms as "almost perfect" (κ = 0.922; standard error, 0.051). Furthermore, there was no significant difference between corresponding cycle threshold values generated on the two systems (P value = 0.88; Student's t test). Taken together, these data imply both platforms can be considered comparable in terms of their clinical performance. We believe this information will be useful for those who have already adopted these platforms or are seeking to implement high-throughput RT-PCR testing to stem the SARS-CoV-2 pandemic.
Copyright ? 2020 American Society for Microbiology.
PMID:32381643DOI:10.1128/JCM.00890-20