Comparative Diagnostic Performance of a Novel Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) Kit for the Rapid Detection of SARS-CoV-2.

COVID-19 RT-LAMP RT-PCR SARS-CoV-2 diagnostic accuracy

Journal

Pathogens (Basel, Switzerland)
ISSN: 2076-0817
Titre abrégé: Pathogens
Pays: Switzerland
ID NLM: 101596317

Informations de publication

Date de publication:
15 Dec 2021
Historique:
received: 26 11 2021
revised: 09 12 2021
accepted: 14 12 2021
entrez: 28 12 2021
pubmed: 29 12 2021
medline: 29 12 2021
Statut: epublish

Résumé

Although the reverse transcription-polymerase chain reaction (RT-PCR) is considered a standard-of-care assay for the laboratory diagnosis of SARS-CoV-2, several limitations of this method have been described. Reverse transcription loop-mediated isothermal amplification (RT-LAMP) is an alternative molecular assay and is potentially able to overcome some intrinsic shortcomings of RT-PCR. In this study, we evaluated the diagnostic performance of the novel HG COVID-19 RT-LAMP assay. In this retrospective analysis, a total of 400 routinely collected leftover nasopharyngeal samples with a known RT-PCR result were tested by means of the HG COVID-19 RT-LAMP assay. The overall sensitivity and specificity values of HG COVID-19 RT-LAMP versus RT-PCR were 97.0% (95% CI: 93.6-98.9%) and 98.5% (95% CI: 95.7-99.7%), respectively. Inter-assay agreement was almost perfect (

Identifiants

pubmed: 34959584
pii: pathogens10121629
doi: 10.3390/pathogens10121629
pmc: PMC8706056
pii:
doi:

Types de publication

Journal Article

Langues

eng

Subventions

Organisme : European Commission
ID : 101003713

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Auteurs

Alexander Domnich (A)

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.

Andrea Orsi (A)

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.
Department of Health Sciences, University of Genoa, 16132 Genoa, Italy.

Donatella Panatto (D)

Department of Health Sciences, University of Genoa, 16132 Genoa, Italy.

Vanessa De Pace (V)

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.

Valentina Ricucci (V)

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.

Patrizia Caligiuri (P)

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.

Giulia Guarona (G)

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.

Valerio Chessa (V)

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.

Diego Ferone (D)

Department of Internal Medicine and Medical Specialties, University of Genoa, 16132 Genoa, Italy.
Endocrinology Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.

Simona Boccotti (S)

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.
Department of Health Sciences, University of Genoa, 16132 Genoa, Italy.

Bianca Bruzzone (B)

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.

Giancarlo Icardi (G)

Hygiene Unit, San Martino Policlinico Hospital-IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.
Department of Health Sciences, University of Genoa, 16132 Genoa, Italy.

Classifications MeSH