PT  - JOURNAL ARTICLE
AU  - Emily A. Bruce
AU  - Meei-Li Huang
AU  - Garrett A. Perchetti
AU  - Scott Tighe
AU  - Pheobe Laaguiby
AU  - Jessica J. Hoffman
AU  - Diana L. Gerrard
AU  - Arun K. Nalla
AU  - Yulun Wei
AU  - Alexander L. Greninger
AU  - Sean A. Diehl
AU  - David J. Shirley
AU  - Debra G. B. Leonard
AU  - Christopher D. Huston
AU  - Beth D. Kirkpatrick
AU  - Julie A. Dragon
AU  - Jessica W. Crothers
AU  - Keith R. Jerome
AU  - Jason W. Botten
TI  - DIRECT RT-qPCR DETECTION OF SARS-CoV-2 RNA FROM PATIENT NASOPHARYNGEAL SWABS WITHOUT AN RNA EXTRACTION STEP
AID  - 10.1101/2020.03.20.001008
DP  - 2020 Jan 01
TA  - bioRxiv
PG  - 2020.03.20.001008
4099  - http://biorxiv.org/content/early/2020/04/06/2020.03.20.001008.short
4100  - http://biorxiv.org/content/early/2020/04/06/2020.03.20.001008.full
AB  - The ongoing COVID-19 pandemic has caused an unprecedented need for rapid diagnostic testing. The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) recommend a standard assay that includes an RNA extraction step from a nasopharyngeal (NP) swab followed by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) to detect the purified SARS-CoV-2 RNA. The current global shortage of RNA extraction kits has caused a severe bottleneck to COVID-19 testing. We hypothesized that SARS-CoV-2 RNA could be detected from NP samples via a direct RT-qPCR assay that omits the RNA extraction step altogether, and tested this hypothesis on a series of blinded clinical samples. The direct RT-qPCR approach correctly identified 92% of NP samples (n = 155) demonstrated to be positive for SARS-CoV-2 RNA by traditional clinical diagnostic RT-qPCR that included an RNA extraction. Thus, direct RT-qPCR could be a front-line approach to identify the substantial majority of COVID-19 patients, reserving a repeat test with RNA extraction for those individuals with high suspicion of infection but an initial negative result. This strategy would drastically ease supply chokepoints of COVID-19 testing and should be applicable throughout the world.