key: cord-311333-shvtfxog
authors: Fukumoto, Tatsuya; Iwasaki, Sumio; Fujisawa, Shinichi; Hayasaka, Kasumi; Sato, Kaori; Oguri, Satoshi; Taki, Keisuke; Nakakubo, Sho; Kamada, Keisuke; Yamashita, Yu; Konno, Satoshi; Nishida, Mutsumi; Sugita, Junichi; Teshima, Takanori
title: Efficacy of a novel SARS-CoV-2 detection kit without RNA extraction and purification
date: 2020-05-28
journal: bioRxiv
DOI: 10.1101/2020.05.27.120410
sha: 
doc_id: 311333
cord_uid: shvtfxog

Rapid detection of SARS-CoV-2 is critical for the diagnosis of coronavirus disease 2019 (COVID-19) and preventing the spread of the virus. A novel “2019 Novel Coronavirus Detection Kit (nCoV-DK)” halves detection time by eliminating the steps of RNA extraction and purification. We evaluated concordance between the nCoV-DK and direct PCR. The virus was detected in 53/71 fresh samples by the direct method and 55/71 corresponding frozen samples by the nCoV-DK. The overall concordance rate of the virus detection between the two methods was 94.4% (95% CI, 86.2-98.4). Concordance rates were 95.2% (95% CI, 83.8-99.4), 95.5% (95% CI, 77.2-99.9), 85.7% (95% CI, 42.1-99.6) in nasopharyngeal swab, saliva, and sputum samples, respectively. These results indicate that the nCoV-DK effectively detects SARS-CoV-2 in all types of the samples including saliva, while reducing time required for detection, labor, and risk of human error.

Nasopharyngeal swab, sputum and saliva samples were collected from 9 patients who 69 were admitted to our hospital after a diagnosis of COVID-19. A total of 71 samples were 70 selected for this study according to the availability of the frozen stock samples. This study 71 was approved by the Institutional Ethics Board and informed consent was obtained from all 72 patients. Nasopharyngeal samples were obtained using FLOQSwabs (COPAN, Murrieta, 73 CA, USA). Sputum and saliva samples were self-collected in a sterilized PP Screw cup 50 74 (Asiakizai Co., Ltd., Tokyo, Japan). 200 μL sputum or saliva were added to 600 μL PBS, 75 mixed vigorously, then centrifuged at 20,000 X g for 5 minutes at 4 o C, and and the 76 Hilden, Germany) from fresh samples. One-step RT-qPCR was performed using One-Step 

Correlation 150 of Chest CT and RT-PCR Testing

Report of 1014 Cases

SARS-CoV-2 Viral Load in 154

Upper Respiratory Specimens of Infected Patients

Saliva as a 187 non-invasive specimen for detection of SARS-CoV-2

Comparison of SARS-CoV-2 detection in nasopharyngeal swab and saliva

Detection of noroviruses in fecal specimens by direct RT-PCR 195 without RNA purification

High-yield RNA-extraction method 197 for saliva