PT  - JOURNAL ARTICLE
AU  - Paul R Grant
AU  - Melanie A Turner
AU  - Gee Yen Shin
AU  - Eleni Nastouli
AU  - Lisa J Levett
TI  - Extraction-free COVID-19 (SARS-CoV-2) diagnosis by RT-PCR to increase capacity for national testing programmes during a pandemic
AID  - 10.1101/2020.04.06.028316
DP  - 2020 Jan 01
TA  - bioRxiv
PG  - 2020.04.06.028316
4099  - http://biorxiv.org/content/early/2020/04/08/2020.04.06.028316.short
4100  - http://biorxiv.org/content/early/2020/04/08/2020.04.06.028316.full
AB  - Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) causes Coronavirus disease 2019 (COVID-19), a respiratory tract infection. The standard molecular diagnostic test is a multistep process involving viral RNA extraction and real-time quantitative reverse transcriptase PCR (qRT-PCR). Laboratories across the globe face constraints on equipment and reagents during the COVID-19 pandemic. We have developed a simplified qRT-PCR assay that removes the need for an RNA extraction process and can be run on a real-time thermal cycler. The assay uses custom primers and probes, and maintains diagnostic sensitivity within 98.0% compared to the assay run on a high-throughput, random-access automated platform, the Panther Fusion (Hologic). This assay can be used to increase capacity for COVID-19 testing for national programmes worldwide.