Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay.
Adult
Aged
Betacoronavirus
/ genetics
Body Fluids
/ virology
COVID-19
COVID-19 Testing
COVID-19 Vaccines
Clinical Laboratory Techniques
/ methods
Coronavirus Infections
/ diagnosis
Diagnostic Tests, Routine
Female
Humans
Male
Middle Aged
Molecular Diagnostic Techniques
/ methods
Pandemics
Pharynx
/ virology
Pneumonia, Viral
/ diagnosis
RNA, Viral
/ analysis
SARS-CoV-2
Sensitivity and Specificity
Specimen Handling
Viral Load
Virus Shedding
/ physiology
SARS-CoV-2 RNA
direct assay
oral fluid
real time RT-PCR
Journal
Viruses
ISSN: 1999-4915
Titre abrégé: Viruses
Pays: Switzerland
ID NLM: 101509722
Informations de publication
Date de publication:
20 10 2020
20 10 2020
Historique:
received:
24
08
2020
revised:
14
10
2020
accepted:
15
10
2020
entrez:
23
10
2020
pubmed:
24
10
2020
medline:
6
11
2020
Statut:
epublish
Résumé
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. 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. Using Simplexa™ COVID-19 Direct on OF matrix, 100% analytical detection down to 1 TCID50/mL (corresponding to 4 × 10 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.
Sections du résumé
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 × 10
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.
Identifiants
pubmed: 33092065
pii: v12101184
doi: 10.3390/v12101184
pmc: PMC7589602
pii:
doi:
Substances chimiques
COVID-19 Vaccines
0
Covid-19 aAPC vaccine
0
RNA, Viral
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Références
J Infect. 2020 Sep;81(3):e48-e50
pubmed: 32593658
N Engl J Med. 2020 Mar 26;382(13):1199-1207
pubmed: 31995857
JAMA. 2020 Mar 17;323(11):1061-1069
pubmed: 32031570
J Infect. 2020 Aug;81(2):e145-e147
pubmed: 32504740
J Infect Chemother. 2020 Oct;26(10):1086-1089
pubmed: 32571647
J Infect. 2020 Jul;81(1):e45-e50
pubmed: 32298676
Eur J Dent. 2020 Jun 03;:
pubmed: 32492721
Lancet Infect Dis. 2020 May;20(5):565-574
pubmed: 32213337
Clin Infect Dis. 2020 Jul 28;71(15):841-843
pubmed: 32047895
J Clin Microbiol. 2020 Sep 22;58(10):
pubmed: 32703816
Biometrics. 1977 Mar;33(1):159-74
pubmed: 843571
J Clin Virol. 2020 Jul;128:104416
pubmed: 32388470
Euro Surveill. 2020 Jan;25(3):
pubmed: 31992387
N Engl J Med. 2020 Feb 20;382(8):727-733
pubmed: 31978945
Front Med (Lausanne). 2020 Aug 04;7:465
pubmed: 32903849
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32317257
J Clin Virol. 2020 Jun;127:104384
pubmed: 32361285
J Clin Microbiol. 2020 Aug 24;58(9):
pubmed: 32636214
Clin Microbiol Infect. 2020 May 15;:
pubmed: 32422408
Clin Microbiol Infect. 2020 Jul;26(7):954-956
pubmed: 32229288