About: Rapid and sensitive detection of SARS-CoV-2 RNA using the Simplexa™ COVID-19 direct assay

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About: Rapid and sensitive detection of SARS-CoV-2 RNA using the Simplexa™ COVID-19 direct assay Goto Sponge NotDistinct Permalink

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

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Rapid and sensitive detection of SARS-CoV-2 RNA using the Simplexa™ COVID-19 direct assay
Creator	Baldanti, Fausto Piralla, Antonio Bordi, Licia Castilletti, Concetta Colavita, Francesca Lalle, Eleonora Meschi, Silvia Giardina, Federica Capobianchi, Maria Novazzi, Federica Sberna, Giuseppe Tallarita, Monica Brisci, Angela Minnucci, Giulia Tettamanzi, Veronica
Source	Elsevier; Medline; PMC
abstract	BACKGROUND: So far, one of the major drawbacks of the available molecular assays for the diagnosis of severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) is the need for viral nucleic acid extraction from clinical specimens. OBJECTIVE: The aim of this study was to evaluate the performances of a newly designed real-time RT-PCR (Simplexa™ COVID-19 Direct assay), that is established with an all-in-one reagent mix and no separate extraction required. RESULTS: The lower limit of detection (LOD) for both target genes resulted the same: 3.2 (CI: 2.9–3.8) log10 cp/mL and 0.40 (CI: 0.2–1.5) TCID50/mL for S gene while 3.2 log10 (CI: 2.9–3.7) log10 cp/mL and 0.4 (CI: 0.2–1.3) TCID50/mL for ORF1ab. The LOD obtained with extracted viral RNA for both S gene or ORF1ab was 2.7 log10 cp/mL. Crossreactive analysis performed in 20 nasopharyngeal swabs confirmed a 100% of clinical specificity of the assay. Clinical performances of Simplexa™ COVID-19 Direct assay were assessed in 278 nasopharyngeal swabs tested in parallel with Corman's method. Concordance analysis showed an %22almost perfect%22 agreement in SARS-CoV-2 RNA detection between the two assays, being κ = 0.938; SE = 0.021; 95% CI = 0.896-0.980. CONCLUSIONS: The high sensitivity and specificity of this new assay indicate that it is promising for laboratory diagnosis, enabling highspeed detection in just over one hour, which is significantly faster than the up to five hours currently required by traditional extraction followed by amplification technologies, thus allowing prompt decision making regarding isolation of infected patients.
has issue date	2020-05-04(xsd:dateTime)
bibo:doi	10.1016/j.jcv.2020.104416
bibo:pmid	32388470
has license	no-cc
sha1sum (hex)	c0b0e8bd7eb13cce82b0a38e725205ee0190cdd0
schema:url	https://doi.org/10.1016/j.jcv.2020.104416
resource representing a document's title	Rapid and sensitive detection of SARS-CoV-2 RNA using the Simplexa™ COVID-19 direct assay
has PubMed Central identifier	PMC7198196
has PubMed identifier	32388470
schema:publication	J Clin Virol
resource representing a document's body	covid:c0b0e8bd7eb13cce82b0a38e725205ee0190cdd0#body_text
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