Next Article in Journal
A Decade in Review: A Systematic Review of Universal Influenza Vaccines in Clinical Trials during the 2010 Decade
Next Article in Special Issue
The Importance of Research on the Origin of SARS-CoV-2
Previous Article in Journal
Deletion of CD2-Like (CD2v) and C-Type Lectin-Like (EP153R) Genes from African Swine Fever Virus Georgia-∆9GL Abrogates Its Effectiveness as an Experimental Vaccine
Previous Article in Special Issue
Expression Pattern of the SARS-CoV-2 Entry Genes ACE2 and TMPRSS2 in the Respiratory Tract
Open AccessArticle

Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay

1
Laboratory of Virology, National Institute for Infectious Diseases “L. Spallanzani” IRCCS, 00149 Rome, Italy
2
Epidemiology Department, National Institute for Infectious Diseases “L. Spallanzani” IRCCS, 00149 Rome, Italy
3
Clinical Department, National Institute for Infectious Diseases “L. Spallanzani” IRCCS, 00149 Rome, Italy
4
R&D Department, DiaSorin Molecular LLC, Cypress, CA 90630, USA
5
Department of Pediatric Hematology and Oncology, IRCCS Ospedale Pediatrico Bambino Gesù, 00165 Rome, Italy
6
Division of Infection and Immunity, University College London, London WC1E 6BT, UK
7
NIHR Biomedical Research Centre, UCL Hospitals NHS Foundation Trust, London W1T 7DN, UK
8
Scientific Direction, National Institute for Infectious Diseases “L. Spallanzani” IRCCS, 00149 Rome, Italy
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Membership of the INMI ReCOVeRI Study Group is provided in the Acknowledgments.
Viruses 2020, 12(10), 1184; https://doi.org/10.3390/v12101184
Received: 24 August 2020 / Revised: 14 October 2020 / Accepted: 15 October 2020 / Published: 20 October 2020
(This article belongs to the Collection Coronaviruses)
Background: RT-PCR on nasopharyngeal (NPS)/oropharyngeal swabs is the gold standard for diagnosis of SARS-CoV-2 infection and viral load monitoring. Oral fluid (OF) is an alternate clinical sample, easy and safer to collect and could be useful for COVID-19 diagnosis, monitoring viral load and shedding. Methods: Optimal assay conditions and analytical sensitivity were established for the commercial Simplexa™ COVID-19 Direct assay adapted to OF matrix. The assay was used to test 337 OF and NPS specimens collected in parallel from 164 hospitalized patients; 50 bronchoalveolar lavage (BAL) specimens from a subgroup of severe COVID-19 cases were also analysed. Results: Using Simplexa™ COVID-19 Direct on OF matrix, 100% analytical detection down to 1 TCID50/mL (corresponding to 4 × 103 copies (cp)/mL) was observed. No crossreaction with other viruses transmitted through the respiratory toute was observed. Parallel testing of 337 OF and NPS samples showed highly concordant results (κ = 0.831; 95 % CI = 0.771–0.891), and high correlation of Ct values (r = 0.921; p < 0.0001). High concordance and elevated correlation was observed also between OF and BAL. Prolonged viral RNA shedding was observed up to 100 days from symptoms onset (DSO), with 32% and 29% positivity observed in OF and NPS samples, respectively, collected between 60 and 100 DSO. Conclusions: Simplexa™ COVID-19 Direct assays on OF have high sensitivity and specificity to detect SARS-CoV-2 RNA and provide an alternative to NPS for diagnosis and monitoring SARS-CoV-2 shedding. View Full-Text
Keywords: SARS-CoV-2 RNA; oral fluid; real time RT-PCR; direct assay SARS-CoV-2 RNA; oral fluid; real time RT-PCR; direct assay
Show Figures

Figure 1

MDPI and ACS Style

Bordi, L.; Sberna, G.; Lalle, E.; Piselli, P.; Colavita, F.; Nicastri, E.; Antinori, A.; Boumis, E.; Petrosillo, N.; Marchioni, L.; Minnucci, G.; D’Agostini, E.; Castilletti, C.; Locatelli, F.; Zumla, A.; Ippolito, G.; Capobianchi, M.R.; on behalf of INMI ReCOVeRI Study Group. Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay. Viruses 2020, 12, 1184.

AMA Style

Bordi L, Sberna G, Lalle E, Piselli P, Colavita F, Nicastri E, Antinori A, Boumis E, Petrosillo N, Marchioni L, Minnucci G, D’Agostini E, Castilletti C, Locatelli F, Zumla A, Ippolito G, Capobianchi MR, on behalf of INMI ReCOVeRI Study Group. Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay. Viruses. 2020; 12(10):1184.

Chicago/Turabian Style

Bordi, Licia; Sberna, Giuseppe; Lalle, Eleonora; Piselli, Pierluca; Colavita, Francesca; Nicastri, Emanuele; Antinori, Andrea; Boumis, Evangelo; Petrosillo, Nicola; Marchioni, Luisa; Minnucci, Giulia; D’Agostini, Elena; Castilletti, Concetta; Locatelli, Franco; Zumla, Alimuddin; Ippolito, Giuseppe; Capobianchi, Maria R.; on behalf of INMI ReCOVeRI Study Group. 2020. "Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay" Viruses 12, no. 10: 1184.

Find Other Styles
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Search more from Scilit
 
Search
Back to TopTop