Patients requiring diagnostic testing for coronavirus disease 2019 (COVID-19) are routinely assessed by reverse-transcription quantitative polymerase chain reaction (RT-qPCR) amplification of Sars-CoV-2 virus RNA extracted from oro/nasopharyngeal swabs. Despite the good specificity of the assays certified for SARS-CoV-2 molecular detection, and a theoretical sensitivity of few viral gene copies per reaction, a relatively high rate of false negatives continues to be reported. This is an important challenge in the management of patients on hospital admission and for correct monitoring of the infectivity after the acute phase. In the present report, we show that the use of digital PCR, a high sensitivity method to detect low amplicon numbers, allowed us to correctly detecting infection in swab material in a significant number of false negatives. We show that the implementation of digital PCR methods in the diagnostic assessment of COVID-19 could resolve, at least in part, this timely issue.

Digital PCR for high sensitivity viral detection in false-negative SARS-CoV-2 patients / P. Poggio, P. Songia, C. Vavassori, V. Ricci, C. Banfi, S.S. Barbieri, G. Garoffolo, V.A. Myasoedova, L. Piacentini, A. Raucci, A. Scopece, E. Sommariva, M.C. Vinci, D. Carcione, M.L. Biondi, M.E. Mancini, A. Formenti, D. Andreini, E.M. Assanelli, P. Agostoni, M. Camera, G.I. Colombo, M. Pesce. - In: SCIENTIFIC REPORTS. - ISSN 2045-2322. - 11:1(2021 Feb 22).

Digital PCR for high sensitivity viral detection in false-negative SARS-CoV-2 patients

P. Songia
Secondo
;
C. Vavassori;S.S. Barbieri;L. Piacentini;D. Andreini;P. Agostoni;M. Camera;
2021-02-22

Abstract

Patients requiring diagnostic testing for coronavirus disease 2019 (COVID-19) are routinely assessed by reverse-transcription quantitative polymerase chain reaction (RT-qPCR) amplification of Sars-CoV-2 virus RNA extracted from oro/nasopharyngeal swabs. Despite the good specificity of the assays certified for SARS-CoV-2 molecular detection, and a theoretical sensitivity of few viral gene copies per reaction, a relatively high rate of false negatives continues to be reported. This is an important challenge in the management of patients on hospital admission and for correct monitoring of the infectivity after the acute phase. In the present report, we show that the use of digital PCR, a high sensitivity method to detect low amplicon numbers, allowed us to correctly detecting infection in swab material in a significant number of false negatives. We show that the implementation of digital PCR methods in the diagnostic assessment of COVID-19 could resolve, at least in part, this timely issue.
Adult; Aged; COVID-19; Diagnostic Tests, Routine; Female; Humans; Male; Middle Aged; Real-Time Polymerase Chain Reaction; SARS-CoV-2; Sensitivity and Specificity; Tomography, X-Ray Computed; False Negative Reactions
Settore MED/10 - Malattie dell'Apparato Respiratorio
Settore MED/36 - Diagnostica per Immagini e Radioterapia
Settore BIO/14 - Farmacologia
Settore MED/11 - Malattie dell'Apparato Cardiovascolare
Settore MED/04 - Patologia Generale
Article (author)
File in questo prodotto:
File Dimensione Formato  
Scientific reports.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 2.91 MB
Formato Adobe PDF
2.91 MB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/822606
Citazioni
  • ???jsp.display-item.citation.pmc??? 6
  • Scopus 9
  • ???jsp.display-item.citation.isi??? 10
social impact