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

Viruses

卷:12

on behalf of INMI ReCOVeRI Study Group¹  Emanuele Nicastri²  Andrea Antinori²  Nicola Petrosillo²  Luisa Marchioni²  Evangelo Boumis²  Franco Locatelli³  Alimuddin Zumla⁴  Pierluca Piselli⁵  Francesca Colavita⁶  Licia Bordi⁶  Giuseppe Sberna⁶  Maria Rosaria Capobianchi⁶  Eleonora Lalle⁶  Concetta Castilletti⁶  Giulia Minnucci⁷  Elena D’Agostini⁷  Giuseppe Ippolito⁸ 

[1] ;

[2] Clinical Department, National Institute for Infectious Diseases “L. Spallanzani” IRCCS, 00149 Rome, Italy;

[3] Department of Pediatric Hematology and Oncology, IRCCS Ospedale Pediatrico Bambino Gesù, 00165 Rome, Italy;

[4] Division of Infection and Immunity, University College London, London WC1E 6BT, UK;

[5] Epidemiology Department, National Institute for Infectious Diseases “L. Spallanzani” IRCCS, 00149 Rome, Italy;

[6] Laboratory of Virology, National Institute for Infectious Diseases “L. Spallanzani” IRCCS, 00149 Rome, Italy;

[7] R&D Department, DiaSorin Molecular LLC, Cypress, CA 90630, USA;

[8] Scientific Direction, National Institute for Infectious Diseases “L. Spallanzani” IRCCS, 00149 Rome, Italy;

关键词: SARS-CoV-2 RNA;    oral fluid;    real time RT-PCR;    direct assay;   

DOI  :  10.3390/v12101184

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown