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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.

Nasopharyngeal sampling for nucleic acid amplification testing (NAAT) is the standard diagnostic test of coronavirus disease 2019. Our objectives were to assess, in real-life conditions, the diagnostic accuracy of a nasopharyngeal point-of-care antigen (Ag) test and of saliva NAAT for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in ambulatory care. This was a prospective cohort study from 19 October through 18 December 2020 in two community COVID-19 screening centers in Paris, France. Two nasopharyngeal swabs and one saliva sample were simultaneously collected. Diagnostic accuracies of nasopharyngeal Ag testing and of three saliva NAAT methods were assessed as compared to nasopharyngeal NAAT. A total of 1452 ambulatory children and adults were included. Overall, 129/1443 (9%) participants tested positive on nasopharyngeal NAAT (102/564 [18%] in symptomatic and 27/879 [3%] in asymptomatic participants). Sensitivity was 94%, 23%, 96%, and 94% for the three different protocols of saliva NAAT and for the nasopharyngeal Ag test, respectively. Estimates of specificity were above 95% for all methods. Diagnostic accuracy was similar in symptomatic and asymptomatic individuals. Diagnostic accuracy of nasopharyngeal Ag testing and of saliva NAAT is similar to that of nasopharyngeal NAAT, subject to compliance with specific protocols for saliva. Registration number: NCT04578509 Supplementary Information The online version contains supplementary material available at 10.1007/s10096-021-04327-x.

Background 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 swab. Rapid molecular point-of-care tests in saliva could facilitate, broaden and speed up the diagnosis. Methods 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. Results Overall, 117 of the 1718 participants (7%) were 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 test, including saliva RT-PCR and nasopharyngeal antigen, the sensitivity of saliva RT-LAMP ranged between 27 and 44%. Conclusion The detection of SARS-CoV-2 from crude saliva samples with a RT-LAMP assay had a lower sensitivity than nasopharyngeal RT-PCR, saliva RT-PCR and nasopharyngeal antigen testing. Registration number : NCT04578509

BackgroundNasopharyngeal sampling for nucleic acid amplification testing (NAAT) is the current standard diagnostic test for of coronavirus disease 2019 (COVID-19). However, the NAAT technique is lengthy and nasopharyngeal sampling requires trained personnel. Saliva NAAT represents an interesting alternative but diagnostic performances vary widely between studies.ObjectiveTo assess the diagnostic accuracy of a nasopharyngeal point-of-care antigen (Ag) test and of saliva NAAT for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), as compared to nasopharyngeal NAAT.DesignProspective participant enrollment from 19 October through 18 December 2020.SettingTwo community COVID-19 screening centers in Paris, France.Participants1452 ambulatory children and adults referred for SARS-CoV-2 testing.InterventionsNAAT on a saliva sample (performed with three different protocols for pre-processing, amplification and detection of SARS-CoV-2) and Ag testing on a nasopharyngeal sample.MeasurementsPerformance of saliva NAAT and nasopharyngeal Ag testing.ResultsOverall, 129/1443 (9%) participants tested positive on nasopharyngeal NAAT (102/564 [18%] in symptomatic and 27/879 [3%] in asymptomatic participants). Sensitivity was of 94% (95% CI, 86% to 98%), 23% (CI, 14% to 35%), 94% (CI, 88% to 97%) and 96% (CI, 91% to 99%) for the nasopharyngeal Ag test and the three different protocols of saliva NAAT, respectively. Estimates of specificity were above 95% for all methods. Diagnostic accuracy was similar in symptomatic and asymptomatic individuals.LimitationsFew children (n=122, 8%) were included.ConclusionIn the ambulatory setting, diagnostic accuracy of nasopharyngeal Ag testing and of saliva NAAT seems similar to that of nasopharyngeal NAAT, subject to strict compliance with specific pre-processing and amplification protocols.Registration numberNCT04578509Funding SourcesFrench Ministry of Health and the Assistance Publique-Hôpitaux de Paris Foundation.

International audience; Progress leads to increase life duration at the metastatic stage but metastatic disease is most often lethal. Decision-making is necessary for an increasing period of care, beyond evidence-based medicine, dealing with complexity and uncertain benefit/risk ratio. This requires to inform the patient realistically, to discuss prognostication, to develop anticipated written preferences. These changes mean to pass from a medicine based on informed consent to medicine based on respect of the patient wishes even if it can be complex to determine. A new multidisciplinarity is needed, centered on the meaning of the care, the proportionality of the care, the anticipated patient trajectory. The ASCO has published recommendations on early palliative care. The timing and the quality of the discussion between palliative care specialists and oncologists is crucial. We propose 10 steps to organize a multidisciplinary onco-palliative meeting, as it appears the key for the organization of care in non-curable disease.; Le progrès conduit à allonger la durée de vie de la maladie cancéreuse métastatique, qui demeure le plus souvent une maladie évolutive et mortelle. Les soins se réalisent pendant une durée croissante au-delà des preuves fournies par les études cliniques, donc dans la complexité et l’incertitude sur les rapports bénéfice/risque. Respecter le cadre éthique, renforcé par la loi Claeys-Leonetti de février 2016, pour une maladie évolutive potentiellement mortelle, conduit à informer le patient de manière réaliste, évoquer le pronostic, développer les discussions anticipées, recueillir et respecter ses préférences. Ces évolutions conduisent à passer d’une médecine du consentement éclairé à une médecine du respect de la volonté, avec toute la complexité que suppose la détermination de cette dernière. Tandis que s’est structurée la pluridisciplinarité au diagnostic par l’association des expertises diagnostiques et thérapeutiques vis-à-vis de la maladie tumorale, émerge ainsi un besoin de structuration d’une autre pluridisciplinarité, interrogeant le sens pour la personne, la proportionnalité du soin, la trajectoire personnelle et la sécurisation du parcours de soins. Pour atteindre cet objectif, la précocité de l’alliance des expertises complémentaires est décisive. Ceci a conduit à des recommandations de la Société américaine d’oncologie clinique (ASCO). L’introduction de l’équipe de soins palliatifs est un temps essentiel et la qualité de la concertation onco-palliative est déterminante. Nous décrivons notre préconisation pour mettre en pratique une réunion de concertation (RCP) onco-palliative, véritable pivot d’un changement d’organisation du soin en situation d’incurabilité.

Progress leads to increase life duration at the metastatic stage but metastatic disease is most often lethal. Decision-making is necessary for an increasing period of care, beyond evidence-based medicine, dealing with complexity and uncertain benefit/risk ratio. This requires to inform the patient realistically, to discuss prognostication, to develop anticipated written preferences. These changes mean to pass from a medicine based on informed consent to medicine based on respect of the patient wishes even if it can be complex to determine. A new multidisciplinarity is needed, centered on the meaning of the care, the proportionality of the care, the anticipated patient trajectory. The ASCO has published recommendations on early palliative care. The timing and the quality of the discussion between palliative care specialists and oncologists is crucial. We propose 10 steps to organize a multidisciplinary onco-palliative meeting, as it appears the key for the organization of care in non-curable disease.

JL Gallais ML Alby Resume. – La prevalence des troubles psychiques dans la population et la place de la medecine generale dans les soins medicaux primaires conduisent le medecin generaliste a etre implique dans tous les champs de la sante mentale. Les questions de prevention, de soins et de reinsertion sont interdependantes. Elles constituent les multiples facettes d’interventions dans lesquelles les donnees somatiques, familiales et sociales sont intriquees. Les strategies explicites et implicites mises en œuvre s’appuient sur les specificites de la medecine generale. A cote de l’approche pharmacologique des soins, de la psychotherapie de soutien par le medecin generaliste, nombre de ces situations et patients peuvent beneficier de l’apport d’autres professionnels specialises en sante mentale. La redefinition du contenu de la formation universitaire en medecine generale, la clarification des competences et tâches respectives des acteurs en presence sont indispensables, comme l’evolution du role et de la responsabilisation du patient lui-meme. Les changements en cours vers une organisation structurelle et fonctionnelle plus synergique de l’offre de soins permettront de mieux traiter la souffrance psychique et d’aborder la sante mentale dans ses divers aspects individuels et de sante publique.