About: Performance characteristics of a high throughput automated transcription mediated amplification test for SARS-CoV-2 detection

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About: Performance characteristics of a high throughput automated transcription mediated amplification test for SARS-CoV-2 detection Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Performance characteristics of a high throughput automated transcription mediated amplification test for SARS-CoV-2 detection
Creator	Getman, Damon Williams, Analee Nguyen, Catherine Fox, Amy Gendlina, Inessa Goldstein, D Mitchell, James Morales, Jose Clark, Craig Darby, Paul Eaton, Barbara Harrington, Karen Hovey, Hudson, Angela Hunsicker, Melissa Majlessi, Mehrdad Mchardy, Meyer, Sarah Moberly, Joshua Pham, Jimmykim Walcher, Marion Worlock, Andrew
Source	MedRxiv
abstract	The COVID19 pandemic caused by the new SARSCoV2 coronavirus has imposed severe challenges on laboratories in their effort to achieve sufficient diagnostic testing capability for identifying infected individuals. In this study we report the analytical and clinical performance characteristics of a new, high throughput, fully automated nucleic acid amplification test system for the detection of SARSCoV2. The assay utilizes target capture, transcription mediated amplification, and acridinium ester labeled probe chemistry on the automated Panther System to directly amplify and detect two separate target sequences in the ORF1ab region of the SARSCoV2 RNA genome. The probit 95% limit of detection of the assay was determined to be 0.004 TCID50/ml using inactivated virus, and 25 c/ml using synthetic in vitro transcript RNA targets. Analytical sensitivity (100% detection) was confirmed to be 83 to 194 c/ml using three commercially available SARSCoV2 nucleic acid controls. No cross reactivity or interference was observed with testing six related human coronaviruses, as well as 24 other viral, fungal, and bacterial pathogens, at high titer. Clinical nasopharyngeal swab specimen testing (N=140) showed 100%, 98.7%, and 99.3% positive, negative, and overall agreement, respectively, with a validated reverse transcription PCR NAAT for SARSCoV2 RNA. These results provide validation evidence for a sensitive and specific method for pandemic-scale automated molecular diagnostic testing for SARSCoV2.
has issue date	2020-07-10(xsd:dateTime)
bibo:doi	10.1101/2020.07.06.20143719
has license	medrxiv
sha1sum (hex)	87e07b2eb2685537171a5ed058aa976bce7912a9
schema:url	https://doi.org/10.1101/2020.07.06.20143719
resource representing a document's title	Performance characteristics of a high throughput automated transcription mediated amplification test for SARS-CoV-2 detection
resource representing a document's body	covid:87e07b2eb2685537171a5ed058aa976bce7912a9#body_text
is schema:about of	named entity 'SARS-CoV-2' named entity 'SARS-CoV-2' named entity 'automated' named entity 'transcription' named entity 'probe' named entity 'pandemic' named entity 'automated' named entity 'detection' named entity 'acid' named entity 'sensitivity' named entity 'Analytical' named entity 'performance' named entity 'nucleic acid amplification test' named entity 'SARS-CoV-2' named entity 'Performance characteristics' named entity 'TMA' named entity 'tissue culture infectious dose' named entity 'magnetic bead-based' named entity 'high-throughput' named entity 'microorganisms' named entity 'nasal swab' named entity 'respiratory symptoms' named entity 'TCID50' named entity 'TCID50' named entity 'Wuhan' named entity 'preprint' named entity 'CC-BY-ND' named entity 'virus' named entity '95% CI' named entity 'SARS-CoV-2' named entity 'SARS-CoV-2' named entity 'CC-BY-ND' named entity 'nasopharyngeal swab' named entity 'SARS-CoV-2' named entity 'SARS-CoV-2' named entity 'TCID50' named entity 'RNA' named entity 'medRxiv' named entity 'preprint' named entity 'medRxiv' named entity 'CC-BY-ND' named entity 'RT-PCR' named entity 'COVID19' named entity 'SARS-CoV-2' named entity 'infection control' named entity 'medRxiv' named entity 'TMA' named entity 'microorganisms' named entity 'TCID50' named entity '95% confidence interval' named entity 'infection' named entity 'SARS-CoV-2' named entity 'SARS-CoV-2 virus' named entity 'preprint' named entity 'SARS-CoV-2' named entity 'ester' named entity 'preprint' named entity 'preprint' named entity 'peer review' named entity 'preprint' named entity 'SARS-CoV-2 virus' named entity 'San Diego' named entity 'SARS-CoV-2 virus' named entity 'RT-PCR'

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