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Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay.
Viruses. 2020 10 20; 12(10)V

Abstract

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.

Authors+Show Affiliations

Laboratory of Virology, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Laboratory of Virology, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Laboratory of Virology, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Epidemiology Department, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Laboratory of Virology, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Clinical Department, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Clinical Department, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Clinical Department, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Clinical Department, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Clinical Department, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.R&D Department, DiaSorin Molecular LLC, Cypress, CA 90630, USA.R&D Department, DiaSorin Molecular LLC, Cypress, CA 90630, USA.Laboratory of Virology, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Department of Pediatric Hematology and Oncology, IRCCS Ospedale Pediatrico Bambino Gesù, 00165 Rome, Italy.Division of Infection and Immunity, University College London, London WC1E 6BT, UK. NIHR Biomedical Research Centre, UCL Hospitals NHS Foundation Trust, London W1T 7DN, UK.Scientific Direction, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.Laboratory of Virology, National Institute for Infectious Diseases "L. Spallanzani" IRCCS, 00149 Rome, Italy.No affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33092065

Citation

Bordi, Licia, et al. "Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed By a Modified Commercial Rapid Molecular Assay." Viruses, vol. 12, no. 10, 2020.
Bordi L, Sberna G, Lalle E, et al. Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay. Viruses. 2020;12(10).
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, . (2020). Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay. Viruses, 12(10). https://doi.org/10.3390/v12101184
Bordi L, et al. Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed By a Modified Commercial Rapid Molecular Assay. Viruses. 2020 10 20;12(10) PubMed PMID: 33092065.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay. AU - Bordi,Licia, AU - Sberna,Giuseppe, AU - Lalle,Eleonora, AU - Piselli,Pierluca, AU - Colavita,Francesca, AU - Nicastri,Emanuele, AU - Antinori,Andrea, AU - Boumis,Evangelo, AU - Petrosillo,Nicola, AU - Marchioni,Luisa, AU - Minnucci,Giulia, AU - D'Agostini,Elena, AU - Castilletti,Concetta, AU - Locatelli,Franco, AU - Zumla,Alimuddin, AU - Ippolito,Giuseppe, AU - Capobianchi,Maria Rosaria, AU - On Behalf Of Inmi ReCOVeRI Study Group,, Y1 - 2020/10/20/ PY - 2020/08/24/received PY - 2020/10/14/revised PY - 2020/10/15/accepted PY - 2020/10/23/entrez PY - 2020/10/24/pubmed PY - 2020/11/6/medline KW - SARS-CoV-2 RNA KW - direct assay KW - oral fluid KW - real time RT-PCR JF - Viruses JO - Viruses VL - 12 IS - 10 N2 - 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. SN - 1999-4915 UR - https://www.unboundmedicine.com/medline/citation/33092065/Frequency_and_Duration_of_SARS_CoV_2_Shedding_in_Oral_Fluid_Samples_Assessed_by_a_Modified_Commercial_Rapid_Molecular_Assay_ L2 - https://www.mdpi.com/resolver?pii=v12101184 DB - PRIME DP - Unbound Medicine ER -