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Evaluation of a saliva molecular point of care for the detection of SARS-CoV-2 in ambulatory care.
LeGoff, Jérôme; Kernéis, Solen; Elie, Caroline; Mercier-Delarue, Séverine; Gastli, Nabil; Choupeaux, Laure; Fourgeaud, Jacques; Alby, Marie-Laure; Quentin, Pierre; Pavie, Juliette; Brazille, Patricia; Néré, Marie Laure; Minier, Marine; Gabassi, Audrey; Leroy, Chrystel; Parfait, Béatrice; Tréluyer, Jean-Marc; Delaugerre, Constance.
  • LeGoff J; Virologie, AP-HP, Hôpital Saint Louis, 1 Avenue Claude Vellefaux, 75010, Paris, France. jerome.le-goff@aphp.fr.
  • Kernéis S; INSERM, Equipe INSIGHT, U976, 75010, Université de Paris, Paris, France. jerome.le-goff@aphp.fr.
  • Elie C; INSERM, IAME, Université de Paris, 75018, Paris, France.
  • Mercier-Delarue S; Equipe de Prévention du Risque Infectieux, AP-HP, Hôpital Bichat, 75018, Paris, France.
  • Gastli N; Institut Pasteur, Epidemiology and Modelling of Antibiotic Evasion, 75015, Paris, France.
  • Choupeaux L; Clinical Research Unit / Clinical Investigation Center, APHP, Necker-Enfants Malades Hospital, 75015, Paris, France.
  • Fourgeaud J; EA 7323 Pharmacologie et Thérapeutique de l'enfant et de la Femme Enceinte, Université de Paris, 75015, Paris, France.
  • Alby ML; Virologie, AP-HP, Hôpital Saint Louis, 1 Avenue Claude Vellefaux, 75010, Paris, France.
  • Quentin P; Plateforme Covid IDF, AP-HP Centre, 75014, Paris, France.
  • Pavie J; Clinical Research Unit / Clinical Investigation Center, APHP, Necker-Enfants Malades Hospital, 75015, Paris, France.
  • Brazille P; Virologie, AP-HP, Hôpital Necker-Enfants Malades, 75015, Paris, France.
  • Néré ML; Centre de Dépistage COVISAN 13 14 15, Communauté Professionnelle de Territoire de Santé, 75014, Paris, France.
  • Minier M; Centre de Dépistage COVISAN 13 14 15, Communauté Professionnelle de Territoire de Santé, 75014, Paris, France.
  • Gabassi A; Immuno-Infectiologie, AP-HP, Hôtel Dieu, 75004, Paris, France.
  • Leroy C; Centre de Dépistage COVISAN, AP-HP, Hôtel-Dieu, 75004, Paris, France.
  • Parfait B; Immuno-Infectiologie, AP-HP, Hôtel Dieu, 75004, Paris, France.
  • Tréluyer JM; Centre de Dépistage COVISAN, AP-HP, Hôtel-Dieu, 75004, Paris, France.
  • Delaugerre C; Virologie, AP-HP, Hôpital Saint Louis, 1 Avenue Claude Vellefaux, 75010, Paris, France.
Sci Rep ; 11(1): 21126, 2021 10 26.
Article in English | MEDLINE | ID: covidwho-1493210
ABSTRACT
Rapid identification of SARS-CoV-2-infected individuals is a cornerstone for the control of virus spread. The sensitivity of SARS-CoV-2 RNA detection by RT-PCR is similar in saliva and nasopharyngeal swabs. Rapid molecular point-of-care tests in saliva could facilitate, broaden and speed up the diagnosis. We conducted a prospective study in two community COVID-19 screening centers to evaluate the performances of a CE-marked RT-LAMP assay (EasyCoV) designed for the detection of SARS-CoV2 RNA from fresh saliva samples, compared to nasopharyngeal RT-PCR, to saliva RT-PCR and to nasopharyngeal antigen testing. Overall, 117 of the 1718 participants (7%) tested positive with nasopharyngeal RT-PCR. Compared to nasopharyngeal RT-PCR, the sensitivity and specificity of the RT-LAMP assay in saliva were 34% and 97%, respectively. The Ct values of nasopharyngeal RT-PCR were significantly lower in the 40 true positive subjects with saliva RT-LAMP (Ct 25.9) than in the 48 false negative subjects with saliva RT-LAMP (Ct 28.4) (p = 0.028). Considering six alternate criteria for reference tests, including saliva RT-PCR and nasopharyngeal antigen, the sensitivity of saliva RT-LAMP ranged between 27 and 44%. The detection of SARS-CoV-2 in crude saliva samples with an RT-LAMP assay had a lower sensitivity than nasopharyngeal RT-PCR, saliva RT-PCR and nasopharyngeal antigen testing.Registration number NCT04578509.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Saliva / Ambulatory Care / COVID-19 Nucleic Acid Testing / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-00560-8

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Saliva / Ambulatory Care / COVID-19 Nucleic Acid Testing / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-00560-8