April 22, 2021

An International, Interlaboratory Ring Trial Confirms the Feasibility of an Open-Source, Extraction-Less “Direct” RT-QPCR Method for Reliable Detection of SARS-CoV-2 RNA in Clinical Samples

Category: Article Summary

Topic: Testing and Treatment

Keywords (Tags): testing

• [Pre-print, not peer-reviewed] An international interlaboratory trial observed 100% concordance in using “direct” RT-PCR across the 10 included laboratories (3 in US, including the University of Washington Virology Lab [UWVL]). “Direct” or “extraction-less” RT-PCR is an inexpensive alternative to conventional RT-qPCR that does not require a resource intensive RNA extraction step. The assay was found to have 99.6% sensitivity and 100% specificity across participating laboratories in discerning 5 negative and 25 positive samples prepared by the UWVL. There was high intralaboratory correlation for cycle threshold (Ct value), including samples with low concentrations of virus (high Ct values).

Mills et al. (Apr 16, 2021). An International, Interlaboratory Ring Trial Confirms the Feasibility of an Open-Source, Extraction-Less “Direct” RT-QPCR Method for Reliable Detection of SARS-CoV-2 RNA in Clinical Samples. Pre-print downloaded Apr 22 from https://pubmed.ncbi.nlm.nih.gov/33880478/