TY - JOUR T1 - DIRECT RT-qPCR DETECTION OF SARS-CoV-2 RNA FROM PATIENT NASOPHARYNGEAL SWABS WITHOUT AN RNA EXTRACTION STEP JF - bioRxiv DO - 10.1101/2020.03.20.001008 SP - 2020.03.20.001008 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 Y1 - 2020/01/01 UR - http://biorxiv.org/content/early/2020/04/06/2020.03.20.001008.abstract N2 - 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. ER -