About: Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2

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About: Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2 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	Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2
Creator	Hogan, Catherine Pinsky, Benjamin Sahoo, Malaya Garamani, Natasha Stevens, Bryan Zehnder, James Huang, Chunhong
topic	covid:8d469a4a8419ce08fff5bde139c86656775fe4dc#this
Source	Elsevier; Medline; PMC
abstract	BACKGROUND: Numerous nucleic acid amplification assays have recently received emergency use authorization (EUA) for the diagnosis of SARS-CoV-2 infection, and there is a need to assess their test performance relative to one another. OBJECTIVES: The aim of this study was to compare the test performance of the Hologic Panther Fusion SARS-CoV-2 assay targeting two regions of open reading frame 1ab (ORF1ab) to a high complexity molecular-based, laboratory-developed EUA from Stanford Health Care (SHC) targeting the SARS-CoV-2 envelope (E) gene. STUDY DESIGN: We performed a diagnostic comparison study by testing nasopharyngeal samples on the two assays. Assay agreement was assessed by overall percent agreement and Cohen’s kappa coefficient. RESULTS: A total of 184 nasopharyngeal samples were tested using the two assays, of which 180 showed valid results and were included for the comparative analysis. Overall percent agreement between the assays was 98.3 % (95 % confidence interval (CI) 95.2–99.7) and kappa coefficient was 0.97 (95 % CI 0.93–1.0). One sample was detected on the SHC laboratory developed test (LDT) and not on the Panther Fusion, and had a Ct of 35.9. Conversely, 2 samples were detected on the Panther Fusion and not on the LDT, and had Ct values of 37.2 and 36.6. CONCLUSION: The Panther Fusion SARS-CoV-2 assay and the SHC LDT perform similarly on clinical nasopharyngeal swab specimens. Other considerations, including reagent availability, turnaround time, labor requirements, cost and instrument throughput should guide the decision of which assay to perform.
has issue date	2020-04-24(xsd:dateTime)
bibo:doi	10.1016/j.jcv.2020.104383
bibo:pmid	32353760
has license	no-cc
sha1sum (hex)	8d469a4a8419ce08fff5bde139c86656775fe4dc
schema:url	https://doi.org/10.1016/j.jcv.2020.104383
resource representing a document's title	Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2
has PubMed Central identifier	PMC7195328
has PubMed identifier	32353760
schema:publication	J Clin Virol
resource representing a document's body	covid:8d469a4a8419ce08fff5bde139c86656775fe4dc#body_text
is http://vocab.deri.ie/void#inDataset of	https://covidontheweb.inria.fr:4443/about/id/http/ns.inria.fr/covid19/8d469a4a8419ce08fff5bde139c86656775fe4dc
is schema:about of	named entity 'authorization' named entity 'study' named entity 'total' named entity 'performance' named entity 'targeting' named entity 'SARS-COV-2' named entity 'HEALTH CARE' named entity 'HAVE' named entity 'MOLECULAR' named entity 'DIAGNOSTIC' named entity 'IS A' named entity 'CONCLUSION' named entity 'LDT' named entity 'OBJECTIVES' named entity 'KAPPA' named entity 'COMPARATIVE ANALYSIS' named entity 'COEFFICIENT' covid:arg/8d469a4a8419ce08fff5bde139c86656775fe4dc named entity 'test' named entity 'Panther' named entity 'EUA' named entity 'kappa' named entity 'performed' named entity 'Other' named entity 'Fusion' named entity 'performance' named entity 'Hologic' named entity 'emergency' named entity 'high' named entity 'Panther' named entity 'regions' named entity 'diagnosis' named entity 'LDT' named entity 'SHC' named entity 'assays' named entity 'Background' named entity 'LDT' named entity 'Assay' named entity 'nasopharyngeal' named entity 'emergency use authorization' named entity 'turnaround time' named entity 'Study design' named entity 'envelope' named entity 'fluorescence' named entity 'false-positive' named entity 'diagnostic testing' named entity 'northern California' named entity 'SARS-CoV-2' named entity 'conserved regions' named entity 'COVID' named entity 'Germantown, MD' named entity 'Clinical Virology' named entity 'coronavirus disease' named entity 'Nasopharyngeal' named entity 'SARS-CoV-2' named entity 'SARS-CoV-2' named entity 'EUA' named entity 'rRT-PCR' named entity 'Emergency Use Authorization' named entity 'patient specimens' named entity 'VTM' named entity 'gene' named entity 'SARS-CoV-2' named entity 'U.S Food and Drug Administration' named entity 'SARS-CoV-2' named entity 'gene' named entity 'SHC' named entity 'higher throughput' named entity 'SARS-CoV-2' named entity 'public health' named entity 'SHC' named entity 'Cohen's kappa' named entity 'conserved regions'

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