Assessment of the Effective Sensitivity of SARS-CoV-2 Sample Pooling Based on a Large-Scale Screening Experience: Retrospective Analysis.

BACKGROUND: The development of new large-scale saliva pooling detection strategies can significantly enhance testing capacity and frequency for asymptomatic individuals, which is crucial for containing SARS-CoV-2. OBJECTIVE: This study aims to implement and scale-up a SARS-CoV-2 screening method using pooled saliva samples to control the virus in critical areas and assess its effectiveness in detecting asymptomatic infections. METHODS: Between August 2020 and February 2022, our laboratory received a total of 928,357 samples. Participants collected at least 1 mL of saliva using a self-sampling kit and registered their samples via a smartphone app. All samples were directly processed using AutoMate 2550 for preanalytical steps and then transferred to Microlab STAR, managed with the HAMILTON Pooling software for pooling. The standard pool preset size was 20 samples but was adjusted to 5 when the prevalence exceeded 2% in any group. Real-time polymerase chain reaction (RT-PCR) was conducted using the Allplex SARS-CoV-2 Assay until July 2021, followed by the Allplex SARS-CoV-2 FluA/FluB/RSV assay for the remainder of the study period. RESULTS: Of the 928,357 samples received, 887,926 (95.64%) were fully processed into 56,126 pools. Of these pools, 4863 tested positive, detecting 5720 asymptomatic infections. This allowed for a comprehensive analysis of pooling's impact on RT-PCR sensitivity and false-negative rate (FNR), including data on positive samples per pool (PPP). We defined Ctref as the minimum cycle threshold (Ct) of each data set from a sample or pool and compared these Ctref results from pooled samples with those of the individual tests (ΔCtP). We then examined their deviation from the expected offset due to dilution [ΔΔCtP = ΔCtP - log2]. In this work, the ΔCtP and ΔΔCtP were 2.23 versus 3.33 and -0.89 versus 0.23, respectively, comparing global results with results for pools with 1 positive sample per pool. Therefore, depending on the number of genes used in the test and the size of the pool, we can evaluate the FNR and effective sensitivity (1 - FNR) of the test configuration. In our scenario, with a maximum of 20 samples per pool and 3 target genes, statistical observations indicated an effective sensitivity exceeding 99%. From an economic perspective, the focus is on pooling efficiency, measured by the effective number of persons that can be tested with 1 test, referred to as persons per test (PPT). In this study, the global PPT was 8.66, reflecting savings of over 20 million euros (US $22 million) based on our reagent prices. CONCLUSIONS: Our results demonstrate that, as expected, pooling reduces the sensitivity of RT-PCR. However, with the appropriate pool size and the use of multiple target genes, effective sensitivity can remain above 99%. Saliva pooling may be a valuable tool for screening and surveillance in asymptomatic individuals and can aid in controlling SARS-CoV-2 transmission. Further studies are needed to assess the effectiveness of these strategies for SARS-CoV-2 and their application to other microorganisms or biomarkers detected by PCR.

Æ©S COVID-19 is a rapid high throughput and sensitive one-step quadruplex real-time RT-PCR assay.

Real-time reverse transcription polymerase chain reaction (RT-PCR), a standard method recommended for the diagnosis of coronavirus disease 2019 (COVID-19) requires 2-4 h to get the result. Although antigen test kit (ATK) is used for COVID-19 screening within 15-30 min, the drawback is its limited sensitivity. Hence, a rapid one-step quadruplex real-time RT-PCR assay: termed Æ©S COVID-19 targeting ORF1ab, ORF3a, and N genes of SARS-CoV-2; and Avocado sunblotch viroid (ASBVd) as an internal control was developed. Based on strategies including designing high melting temperature primers with short amplicons, applying a fast ramp rate, minimizing hold time, and reducing the range between denaturation and annealing/extension temperatures; the assay could be accomplished within 25 min. The limit of detection of ORF1ab, ORF3a, and N genes were 1.835, 1.310, and 1 copy/reaction, respectively. Validation was performed in 205 combined nasopharyngeal and oropharyngeal swabs. The sensitivity, specificity, positive predictive value, and negative predictive value were 92.8%, 100%, 100%, and 97.1%, respectively with 96.7% accuracy. Cohen's Kappa was 0.93. The newly developed rapid real-time RT-PCR assay was highly sensitive, specific, and fast, making it suitable for use as an alternative method to support laboratory diagnosis of COVID-19 in outpatient and emergency departments.

Consecutive positive nucleic acid tests in COVID-19 patients: a retrospective cohort study in Fangcang hospitals, Shanghai.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) spread rapidly in Shanghai in February 2022. Patients with asymptomatic and mild symptoms were admitted to Fangcang shelter hospitals for centralized quarantine. METHODOLOGY: A total of 5,217 non-severe patients hospitalized in the Longyao Fangcang and Shilong Fangcang hospitals were included in the study. Demographic and clinical characteristics, comorbidity, exposure history, treatment and disease duration were analyzed. Univariate analysis and binomial logistic regression analysis were performed to identify the factors influencing nucleic acid change from positive to negative over 14 days. RESULTS: Consecutive positive nucleic acid test results (days) were significantly associated with advanced age (OR = 1.343, 95% CI 1.143 to 1.578, p < 0.001), smoking (OR = 0.510, 95% CI 0.327 to 0.796, p = 0.003) and vaccination (OR = 0.728, 95% CI 0.641 to 0.827, p < 0.001). However, there was no significant difference between asymptomatic and mild symptomatic patients (p = 0.187). In univariate analysis, comorbidities including diabetes, hypertension, cardiovascular system, malignant tumors, autoimmune diseases and cerebral apoplexy were associated with consecutive positive nucleic acid test results, but there was no significant difference in binomial logistics regression analysis. CONCLUSIONS: Aging and comorbid conditions lead to the prolongation of positive nucleic acid test results for several days. Improving vaccination coverage is beneficial for prevention and control of the epidemic. The management and treatment methods of Shanghai Fangcang shelter hospitals had important referential significance, which can provide valuable guidance for the prevention and control of the COVID-19 epidemic in the future.

Dual structure-switching aptamer-mediated signal amplification cascade for SARS-CoV-2 detection.

Since the outbreak of the novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) at the end of 2019, the spread of the virus has posed a significant threat to public health and the global economy. This work proposed a one-step, dual-structure-switching aptamer-mediated signal amplification cascade for rapid and sensitive detection of the SARS-CoV-2 nucleocapsid protein. This system consisted of two DNA aptamers with structure-switching functionality and fuel DNA, where a cascade of strand hybridization and displacement triggered fluorescence generation and signal amplification. This aptamer-based amplification cascade required neither an amplification stage using enzymes nor pre-processing steps such as washing, viral isolation, and gene extraction. The assay could distinguish SARS-CoV-2 from other respiratory viruses and detect up to 1.0 PFU/assay of SARS-CoV-2 within 30 min at room temperature. In 35 nasopharyngeal clinical samples, the assay accurately assessed 25 positive and 10 negative clinical swab samples, which were confirmed using quantitative polymerase chain reaction. The strategy reported herein can help detect newly emerging pathogens and biomarkers of various diseases in liquid samples. In addition, the developed detection system consisting of only DNA and fluorophores can be widely integrated into liquid biopsy platforms for disease diagnosis.

Evaluations of modes of pooling specimens for COVID-19 screened by quantitative PCR and droplet digital PCR.

Though pooling samples for SARS-CoV-2 detection has effectively met the need for rapid diagnostic and screening tests, many factors can influence the sensitivity of a pooled test. In this study, we conducted a simulation experiment to evaluate modes of pooling specimens and aimed at formulating an optimal pooling strategy. We focussed on the type of swab, their solvent adsorption ability, pool size, pooling volume, and different factors affecting the quality of preserving RNA by different virus solutions. Both quantitative PCR and digital PCR were used to evaluate the sampling performance. In addition, we determined the detection limit by sampling which is simulated from the virus of different titers and evaluated the effect of sample-storage conditions by determining the viral load after storage. We found that flocked swabs were better than fibre swabs. The RNA-preserving ability of the non-inactivating virus solution was slightly better than that of the inactivating virus solution. The optimal pooling strategy was a pool size of 10 samples in a total volume of 9 mL. Storing the collected samples at 4 °C or 25 °C for up to 48 h had little effect on the detection sensitivity. Further, we observed that our optimal pooling strategy performed equally well as the single-tube test did. In clinical applications, we recommend adopting this pooling strategy for low-risk populations to improve screening efficiency and shape future strategies for detecting and managing other respiratory pathogens, thus contributing to preparedness for future public health challenges.

SARS-CoV-2 Test-to-Stay in Daycare.

BACKGROUND AND OBJECTIVES: Test-to-stay concepts apply serial testing of children in daycare after exposure to SARS-CoV-2 without use of quarantine. This study aims to assess the safety of a test-to-stay screening in daycare facilities. METHODS: 714 daycare facilities and approximately 50 000 children ≤6 years in Cologne, Germany participated in a SARS-CoV-2 Pool-polymerase chain reaction (PCR) screening from March 2021 to April 2022. The screening initially comprised post-exposure quarantine and was adapted to a test-to-stay approach during its course. To assess safety of the test-to-stay approach, we explored potential changes in frequencies of infections among children after the adaptation to the test-to-stay approach by applying regression discontinuity in time (RDiT) analyses. To this end, PCR-test data were linked with routinely collected data on reported infections in children and analyzed using ordinary least squares regressions. RESULTS: 219 885 Pool-PCRs and 352 305 Single-PCRs were performed. 6440 (2.93%) Pool-PCRs tested positive, and 17 208 infections in children were reported. We estimated that during a period of 30 weeks, the test-to-stay concept avoided between 7 and 20 days of quarantine per eligible daycare child. RDiT revealed a 26% reduction (Exp. Coef: 0.74, confidence interval 0.52-1.06) in infection frequency among children and indicated no significant increase attributable to the test-to-stay approach. This result was not sensitive to adjustments for 7-day incidence, season, SARS-CoV-2 variant, and socioeconomic status. CONCLUSIONS: Our analyses provide evidence that suggest safety of the test-to-stay approach compared with quarantine measures. This approach offers a promising option to avoid use of quarantine after exposure to respiratory pathogens in daycare settings.

Clinical Evaluation of the BIOFIRE SPOTFIRE Respiratory Panel.

The BIOFIRE SPOTFIRE Respiratory (R) Panel is a novel, in vitro diagnostic PCR assay with 15 pathogen targets. The runtime is about 15 min which is the shortest among similar panels in the market. We evaluated the performance of the SPOTFIRE R Panel with 151 specimens, including 133 collected from the upper respiratory tract (URT), 13 from the lower respiratory tract (LRT) and 5 external quality assessment program (EQAP) samples. The respiratory specimens were enrolled throughout the first two post-COVID-19 influenza seasons in Hong Kong (March to December 2023). For URT specimens, full concordance was observed between the SPOTFIRE R Panel and the standard-of-care FilmArray Respiratory 2.1 plus Panel (RP2.1plus) for 109 specimens (109/133, 81.95%). After discrepant analysis, the SPOTFIRE R Panel identified more pathogens than the RP2.1plus in 15 specimens and vice versa in 3 specimens. The per-target negative and positive percentage agreement (NPA and PPA) were 92.86-100% except the PPA of adenovirus (88.24%). For LRT and EQAP samples, all results were fully concordant. To conclude, the performance of the SPOTFIRE R Panel was comparable to the RP2.1plus.

Quantitative SARS-CoV-2 RT-PCR and Bronchoalveolar Cytokine Concentrations Redefine the COVID-19 Phenotypes in Critically Ill Patients.

RATIONALE: Recent studies suggest that both hypo- and hyperinflammatory acute respiratory distress syndrome (ARDS) phenotypes characterize severe COVID-19-related pneumonia. The role of lung Severe Acute Respiratory Syndrome - Coronavirus 2 (SARS-CoV-2) viral load in contributing to these phenotypes remains unknown. OBJECTIVES: To redefine COVID-19 ARDS phenotypes when considering quantitative SARS-CoV-2 RT-PCR in the bronchoalveolar lavage of intubated patients. To compare the relevance of deep respiratory samples versus plasma in linking the immune response and the quantitative viral loads. METHODS: Eligible subjects were adults diagnosed with COVID-19 ARDS who required mechanical ventilation and underwent bronchoscopy. We recorded the immune response in the bronchoalveolar lavage and plasma and the quantitative SARS-CoV-2 RT-PCR in the bronchoalveolar lavage. Hierarchical clustering on principal components was applied separately on the 2 compartments' datasets. Baseline characteristics were compared between clusters. MEASUREMENTS AND RESULTS: Twenty subjects were enrolled between August 2020 and March 2021. Subjects underwent bronchoscopy on average 3.6 days after intubation. All subjects were treated with dexamethasone prior to bronchoscopy, 11 of 20 (55.6%) received remdesivir and 1 of 20 (5%) received tocilizumab. Adding viral load information to the classic 2-cluster model of ARDS revealed a new cluster characterized by hypoinflammatory responses and high viral load in 23.1% of the cohort. Hyperinflammatory ARDS was noted in 15.4% of subjects. Bronchoalveolar lavage clusters were more stable compared to plasma. CONCLUSIONS: We identified a unique group of critically ill subjects with COVID-19 ARDS who exhibit hypoinflammatory responses but high viral loads in the lower airways. These clusters may warrant different treatment approaches to improve clinical outcomes.

SARS-CoV-2 RT-PCR as a universal screening on planned admission in asymptomatic patients.

Universal screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on admission is reportedly beneficial in preventing nosocomial infections. However, some issues remain, including low positivity rate, cost, and time required for testing. We describe SARS-CoV-2 reverse transcription polymerase chain reaction (PCR) for universal screening in asymptomatic patients on planned admissions. In total, 14,574 patients were included between October 12, 2020, and June 23, 2022. The PCR-positive rate for the period was 0.44 % (64/14,574). The PCR positivity for the epidemic period by strain was 0.28 % (95 % confidence interval [CI] 0.12-0.56 %), 0.16 % (95 % CI 0.05-0.37 %), 0.21 % (95 % CI 0.09-0.41 %), and 0.9 % (95 % CI 0.65-1.2 %) for the wild-type strain, Alpha, Delta, and Omicron variants, respectively. The proportion of Ct values < 30 was higher in the first half of the epidemic (first vs. second, 29.4 % [95 % CI 16.9-44.8 %] vs. 16.7 % [95 % CI 6.0-28.5 %]), whereas that of Ct values ≥ 35 increased significantly in the second half (first vs. second, 32.4 % [95 % CI 19.3-47.8 %] vs. 70.0 % [95 % CI 53.5-83.4 %]). Of all positives, 50 % (32/64) had a coronavirus disease (COVID-19) history before PCR screening, with a median of 28 days (10-105) from COVID-19 onset or positive to PCR screening. PCR screening may help detect positives with high viral loads early in the epidemic for each mutant strain, with an increasing proportion of positives with low viral loads later in the epidemic. PCR testing may be unnecessary for recently diagnosed cases and patients in whom reinfection is unlikely.

Resultados terapêuticos da homeopatia em pacientes suspeitos ou confirmados de COVID-19: um estudo longitudinal prospectivo / Therapeutic results of homeopathy in suspected or confirmed COVID-19 patients: a longitudinal study

A infecção humana causada pelo vírus SARS-CoV-2 (COVID-19), diagnosticada como pneumonia de causa desconhecida originalmente na cidade de Wuhan (China), foi considerada como pandemia pela Organização Mundial da Saúde. Com a inexistência inicial de uma vacina para proteção dos sadios, foi adotada a estratégia de isolamento social e tratamento com medidas de suporte geral e/ou avançado. Neste contexto, coube investigar a contribuição da terapêutica homeopática no enfrentamento da doença, notadamente no alívio dos sintomas desconfortáveis por ela provocados em sua fase inicial, com acompanhamento e registro dos resultados obtidos pelos médicos homeopatas. MÉTODO: Este estudo coletou, durante o período de maio a setembro de 2020 (após aprovação pelo CEP), informações de pacientes diagnosticados com a doença, tratados por médicos homeopatas com medicamentos homeopáticos escolhidos de acordo com a sintomatologia apresentada pelo paciente. Foram avaliados os efeitos no estado de saúde do paciente, por meio de escores e escalas clínicas, bem como aspectos relacionados à segurança do medicamento, variação na duração da doença e medicamentos mais associados a eventuais sucessos terapêuticos. Questionário padronizado e específico para a COVID-19 foi elaborado e e aplicado para preenchimento dos médicos colaboradores do estudo durante o acompanhamento dos pacientes. Os dados foram armazenados em planilhas eletrônicas e analisados com técnicas estatísticas descritivas e inferenciais. Os pacientes selecionados eram colaboradores do Hospital Santo Antônio - Obras Sociais Irmã Dulce (OSID) e foram submetidos a uma avaliação preliminar presencial no ambulatório de Otorrinolaringologia deste hospital. As consultas homeopáticas foram realizadas por plataforma de Telemedicina para seguimento e acompanhamento do caso. Foram avaliados 116 colaboradores, com faixa etária que variou entre 21 e 66 anos, sendo a média de idade 38 anos; destes, 84 (72%) eram do gênero feminino e 32 (16%) gênero masculino; 53 pacientes (70% dos colaboradores atendidos) eram profissionais da saúde (médicos, enfermeiros e técnicos de enfermagem); 63 (30%) eram colaboradores de áreas administrativas ou técnicas; 50 pacientes tinham critérios para inclusão no grupo de risco (43%). Quanto ao resultado do RT-PCR: 58 pacientes (50%) tiveram RT-PCR detectado (confirmados); 58 pacientes (50%) tiveram RT-PCR não-detectado - destes, 18 pacientes (31%) apresentaram anosmia em sua evolução. Dos 116 pacientes do critério de inclusão, 77 estavam incluídos na síndrome clássica da COVID19. Destes 77 colaboradores, 3 não usaram o medicamento homeopático (N=74). Os medicamentos homeopáticos mais indicados foram: Arsenicum album (42%); Bryonia (24%), Phosphorus (15%); Gelsemium (15%); Pulsatilla (2%); outros (4%). O Score médio de sintomas antes do tratamento foi 12,27 e após o tratamento foi 0,52 (p < xxxxx). Dos 57 pacientes que tiveram anosmia, houve recuperação total em 43 (75%) dos casos no momento da reavaliação. O tempo médio decorrido entre o uso da medicação homeopática e a recuperação dos sintomas foi de 9 dias. Apenas 3 pacientes (3,9%) necessitaram de internamento hospitalar sem necessidade de intubação, sendo 2 deles pertencentes ao grupo de risco. apesar destes resultados serem parciais (pois ainda existem sujeitos da pesquisa ainda em fase de avaliação), os resultados sugerem que o tratamento homeopático promoveu o restabelecimento do quadro infeccioso sem necessidade de internamento em 97% dos pacientes. A anosmia teve recuperação completa em 75% dos pacientes. Arsenicum album, Bryonia e Phosphorus foram os medicamentos predominantemente eleitos para o tratamento, o que corrobora com outros estudos homeopáticos.

The human infection caused by the SARS-CoV-2 virus (COVID-19), originally diagnosed as pneumonia of unknown cause in the city of Wuhan (China), was considered a pandemic by the World Health Organization. With the initial lack of a vaccine to protect healthy people, the strategy relating to social isolation and treatment with general and/or advanced support measures was adopted. In this context, it was necessary to investigate the contribution of homeopathic therapy in coping with the disease, particularly in terms of relieving the uncomfortable symptoms caused by it in its initial phase, with monitoring and recording of the results obtained by homeopathic physicians. METHOD: This study collected information from patients diagnosed with the disease, treated by homeopathic physicians with homeopathic medications chosen according to the symptoms manifested by the patient, from May to September 2020 (after approval by the REC). The effects on the health conditions of patients were assessed using clinical scores and scales, as well as aspects related to the safety of the medication, variations in the duration of the disease and the medications most associated with any therapeutic successes. A standardized questionnaire specific to COVID-19 was drawn up and filled in by the physicians who collaborated in the study during patient monitoring. The data was stored in electronic spreadsheets and analyzed using descriptive and inferential statistical techniques. The selected patients were employees of Hospital Santo Antônio - Obras Sociais Irmã Dulce (OSID) and underwent a preliminary in-person assessment at the otolaryngology outpatient clinic of this hospital. The homeopathic consultations were carried out via a telemedicine platform to follow-up and monitor the case. A total of 116 employees were assessed, ranging in age from 21 to 66, with the average age being 38; of these, 84 (72%) were females and 32 (16%) males; 53 patients (70% of the employees cared for) were health care professionals (physicians, nurses and nursing technicians); 63 (30%) were employees from administrative or technical areas; 50 patients met the criteria for inclusion in the risk group (43%). As for the RT-PCR result: 58 patients (50%) had RT-PCR detected (confirmed); 58 patients (50%) had RT-PCR not detected - of these, 18 patients (31%) had anosmia during their evolution. Of the 116 patients who met the inclusion criteria, 77 were included in the classic COVID-19 syndrome. Of these 77 collaborators, 3 did not use homeopathic medication (N=74). The most indicated homeopathic medications were: Arsenicum album (42%); Bryonia (24%), Phosphorus (15%); Gelsemium (15%); Pulsatilla (2%); others (4%). The average symptom score before treatment was 12.27 and after treatment was 0.52 (p < xxxxx). Of the 57 patients who had anosmia, there was full recovery in 43 (75%) of the cases at the time of reassessment. The average time elapsed between the use of homeopathic medication and the recovery of symptoms was 9 days. Only 3 patients (3.9%) required hospitalization without the need for intubation, 2 of whom belonged to the risk group. Although these results are partial (as there are still research subjects in the evaluation phase), the results suggest that homeopathic treatment promoted the re-establishment of the infectious condition without the need for hospitalization in 97% of the patients. Anosmia recovered completely in 75% of the patients. Arsenicum album, Bryonia and Phosphorus were the drugs predominantly chosen for treatment, which corroborates other homeopathic studies.

Uma análise dos principais diagnósticos de Sars-cov-2 disponíveis no Brasil: uma revisão de literatura / Diagnosis and main types of coronavirus in humans: a narrative review / Diagnóstico y principales tipos de coronavirus en humanos: una revisión narrativa

Introdução: Com a emergência do SARS-CoV-2 foi disponibilizado uma grande quantidade de ferramentas de diagnóstico. Neste contexto, a falta de vacina, de tratamento e o grande número de casos graves e morte, possibilitou a aprovação emergencial de diversos testes, que ainda necessitam de estudos populacionais para seu registro definitivo. Objetivo: Realizar uma revisão de literatura para avaliar as metodologias de diagnóstico disponíveis no Brasil, de acordo com a realidade local de saúde, explorando o momento epidemiológico a complexidade do teste e a finalidade da sua aplicação. Metodologia: Trata-se de um estudo bibliográfico, descritivo do tipo revisão de literatura. Foram utilizadas as seguintes bases de dados científicos para buscas: PUBMED, MEDLINE, LILACS E COCHRANE LIBRARY, através de descritores selecionados na plataforma DECS. Resultados: O cenário de diversos ensaios, baseados em diferentes metodologias, como os testes baseados em RNA viral, em detecção de antígenos virais ou de anticorpos, associados ao conhecimento da história natural do vírus, possibilita uma análise crítica do melhor diagnóstico de acordo com a clínica do paciente, os epidemiológicos, o objetivo do diagnóstico e a acurácia do ensaio. Atualmente, há mudança no padrão imunológico da população e a descrição de tipos e subtipos de SARS-CoV-2 com mudanças gênicas, que podem levar a mudanças na acurácia diagnóstica ou a re-emergência em surtos de doença grave. Conclusão: Ainda é incerto o caminho evolutivo da história natural da Covid-19 e os ensaios diagnósticos estão em diferentes estágios de desenvolvimento, validação e produção e cada tipo de teste tem suas próprias vantagens e desvantagens distintas inerentes a plataforma tecnológica de origem e uma combinação de tipos de testes usados em momentos diferentes pode ser útil para a condução clínica dos pacientes e no controle da pandemia por SARS-CoV-2.

Introduction: With the emergence of SARS-CoV-2, a large number of diagnostic tools were made available. In this context, the lack of vaccine, treatment and the large number of severe cases and death, allowed the emergency approval of several tests, which still require population studies for their definitive registration. Objective: To carry out a literature review to evaluate the diagnostic methodologies available in Brazil, according to the local health reality, exploring the epidemiological moment, the complexity of the test and the purpose of its application. Methodology: This is a bibliographic, descriptive study of the literature review type. The following scientific databases were used for searches: PUBMED, MEDLINE, LILACS AND COCHRANE LIBRARY, through selected descriptors on the DECS platform. Results: The scenario of several tests, based on different methodologies, such as tests based on viral RNA, on detection of viral antigens or antibodies, associated with knowledge of the natural history of the virus, allows a critical analysis of the best diagnosis according to the patient's clinical, epidemiological, diagnostic objective and assay accuracy. Currently, there is a change in the immune pattern of the population and the description of types and subtypes of SARS-CoV-2 with genetic changes, which can lead to changes in diagnostic accuracy or the re-emergence in outbreaks of severe disease. Conclusion: The evolutionary path of the natural history of Covid-19 is still uncertain and diagnostic assays are at different stages of development, validation and production and each type of test has its own distinct advantages and disadvantages inherent in the technology platform of origin and a combination of types of tests used at different times can be useful for the clinical management of patients and in the control of the SARS-CoV-2 pandemic.

Introducción: Con la aparición del SARS-CoV-2, se dispuso de un gran número de herramientas diagnósticas. En este contexto, la falta de vacuna, tratamiento y el gran número de casos graves y muerte, permitieron la aprobación de urgencia de varias pruebas, que aún requieren estudios poblacionales para su registro definitivo. Objetivo: Realizar una revisión bibliográfica para evaluar las metodologías diagnósticas disponibles en Brasil, de acuerdo con la realidad sanitaria local, explorando el momento epidemiológico, la complejidad de la prueba y la finalidad de su aplicación. Metodología: Se trata de un estudio bibliográfico, descriptivo, del tipo revisión de literatura. Para las búsquedas se utilizaron las siguientes bases de datos científicas PUBMED, MEDLINE, LILACS Y COCHRANE LIBRARY, a través de descriptores seleccionados en la plataforma DECS. Resultados: El escenario de varias pruebas, basadas en diferentes metodologías, como pruebas basadas en el ARN viral, en la detección de antígenos virales o anticuerpos, asociado al conocimiento de la historia natural del virus, permite un análisis crítico del mejor diagnóstico de acuerdo con la clínica del paciente, epidemiológica, objetivo diagnóstico y precisión de la prueba. Actualmente, hay un cambio en el patrón inmunológico de la población y la descripción de tipos y subtipos de SARS-CoV-2 con cambios genéticos, que pueden conducir a cambios en la precisión diagnóstica o la reaparición en brotes de enfermedad grave. Conclusiones: El camino evolutivo de la historia natural del Covid-19 es aún incierto y los ensayos de diagnóstico se encuentran en diferentes etapas de desarrollo, validación y producción y cada tipo de prueba tiene sus propias ventajas y desventajas distintas inherentes a la plataforma tecnológica de origen y una combinación de tipos de pruebas utilizadas en diferentes momentos puede ser útil para el manejo clínico de los pacientes y en el control de la pandemia de SARS- CoV-2.

Saúde mental e atuação de psicólogos hospitalares brasileiros na pandemia da covid-19 / Health and works of brazilian hospital psychologists in the covid-19 pandemic / Salud mental y actuación de psicólogos en hospitales brasileños en la pandemia del covid-19

Em março de 2020 a situação causada pela covid-19 foi elevada à categoria de pandemia, impactando de inúmeras formas a vida em sociedade. O objetivo deste estudo foi compreender os impactos da pandemia na atuação e saúde mental do psicólogo hospitalar, profissional que atua nos espaços de saúde e tem experienciado mais de perto o sofrimento dos doentes e dos profissionais de saúde frente à covid-19. Trata-se de um estudo exploratório-descritivo com 131 psicólogos que atuam em hospitais. Os profissionais foram convidados a participar através de redes sociais e redes de contatos das pesquisadoras, utilizando-se a técnica Bola de Neve. Foram utilizados dois questionários, disponibilizados na plataforma Google Forms, um abordando os impactos da pandemia sentidos pelos profissionais e outro referente ao sofrimento psíquico. Os dados foram analisados a partir de estatísticas descritivas e inferenciais. Foram observados impactos na atuação de quase a totalidade dos participantes, constatada a necessidade de preparação dos profissionais para o novo cenário, a percepção de pouco apoio institucional e quase metade da população estudada referiu-se a sintomas de sofrimento psíquico considerável desde o início da pandemia. É fundamental dar atenção a sinais e sintomas de sofrimento psíquico, procurando evitar o adoecimento de uma categoria profissional que se encontra na linha de frente do combate aos danos psicológicos da pandemia e cuja própria saúde mental é pouco abordada na literatura.(AU)

In March 2020, the COVID-19 pandemic breakout hugely impacted life in society. This study analyzes how the pandemic impacted hospital psychologists' mental health and performance, professional who more closely experienced the suffering of patients and health professionals in this period. An exploratory and descriptive study was conducted with 131 hospital psychologists. Professionals were invited to participate through the researchers' social and contact networks using the Snowball technique. Data were collected by two questionnaires available on the Google Forms platform, one addressing the impacts felt by professionals and the other regarding psychic suffering, and analyzed by descriptive and inferential statistics. Results showed that almost all participants had their performance affected by the need to prepare for the new scenario, the perceived little institutional support. Almost half of the study sample reported considerable psychological distress symptoms since the beginning of the pandemic. Paying attention to signs and symptoms of psychic suffering is fundamental to avoid compromising a professional category that is on the front line of combating the psychological damage caused by the pandemic and whose own mental health is little addressed by the literature.(AU)

En marzo de 2020, la situación provocada por el COVID-19 se caracterizó como pandemia e impactó el mundo de diversas maneras. El objetivo de este estudio fue comprender los impactos de la pandemia en la salud mental y la actuación del psicólogo en los hospitales, uno de los profesionales que trabaja en espacios sanitarios y que ha experimentado más de cerca el sufrimiento de pacientes y profesionales sanitarios frente al COVID-19. Este es un estudio exploratorio descriptivo, realizado con 131 psicólogos que trabajan en hospitales. Los profesionales recibieron la invitación a participar a través de las redes sociales y redes de contactos de las investigadoras, mediante la técnica snowball. Se utilizaron dos cuestionarios disponibles en la plataforma Google Forms: uno sobre los impactos de la pandemia en los profesionales y el otro sobre el sufrimiento psíquico. Los datos se analizaron a partir de estadísticas descriptivas e inferenciales. Se observaron impactos en el trabajo de casi todos los participantes, la necesidad de preparación de los profesionales para este nuevo escenario, la percepción de poco apoyo institucional, y casi la mitad de la población estudiada reportaron sentir síntomas de considerable angustia psicológica desde el inicio de la pandemia. Es esencial prestar atención a los signos y síntomas del sufrimiento psíquico, buscando evitar la enfermedad de una categoría profesional que está a la vanguardia de la lucha contra el daño psicológico de la pandemia y cuya propia salud mental se aborda poco en la literatura.(AU)

Factores asociados a la positividad de la PCR para SARS-CoV-2 en menores de 15 años / Related PCR positivity factors for SARS-CoV-2 in children under 15 years of age / Fatores associados à positividade da PCR para SARS-CoV-2 em crianças menores de 15 anos de idade

Introducción: la infección por SARS-CoV-2 en niños representa un porcentaje menor en la incidencia global de pacientes infectados por este virus. La prueba de reacción en cadena de polimerasa (PCR) para SARS-CoV-2 en muestra de secreciones nasofaríngeas es considerada como estándar de referencia, con niveles de sensibilidad y especificidad superiores a otras técnicas. Objetivo: describir las características de los pacientes menores de 15 años a los que se realizó PCR para SARS-CoV-2 en un prestador privado de salud del interior del país entre el 1° julio 2020 y el 30 de abril 2021. Analizar posibles factores asociados a la positividad de la prueba. Describir las características de los casos con PCR positiva Metodología: estudio observacional prospectivo con un análisis retrospectivo de tipo caso-control, a partir del seguimiento de una cohorte de menores de 15 años a los que se les realizó una prueba de PCR para SARS-CoV-2 en el período analizado, en un prestador integral de salud privado del interior del país. Se recabaron datos durante el seguimiento de los pacientes de acuerdo a un protocolo institucional que incluye: datos patronímicos, causa de la solicitud de la PCR, características del contacto, resultado de PCR y umbral de ciclo (CT), manifestaciones clínicas y evolución. Resultados: se solicitaron 2.361 PCR a menores de 15 años (15% del total de las PCR de la institución). Promedio de edad: 8,6 años (rango 7 días-14 años y 11 meses); 49% niñas y 51% varones. Motivo de solicitud de la prueba: 78,4% para estudio de contacto, 14,3% por síntomas sin noción de contacto y 7,3% previo a ingreso hospitalario (de urgencia o coordinación). Porcentaje de positividad de todo el período: 14,7%, con una importante variabilidad mensual (5,6% en diciembre y 27% en abril). La PCR fue positiva en 346 casos, con CT promedio de 27, y rango entre 16,8 y 37,3. No se encontraron diferencias estadísticas en relación a la edad y sexo entre casos positivos y negativos. Solo un caso fue PCR positivo previo al ingreso hospitalario (OR 0,03; IC 95% 0,004-0,22) y 20 de las 611 PCR solicitadas por contacto institucional (escolar, deportivo, etc.), siendo la diferencia estadísticamente significativa cuando el caso era mayor de 15 años (p 0,029). Del estudio retrospectivo de casos (PCR positiva) y controles (PCR negativa) surge una asociación estadísticamente significativa (p<0,000001) con la causa de solicitud por contacto en comparación con otra causa (OR 5,2; IC 95% 3,28-8,26), que el caso índice sea mayor de 15 años (OR 4,57 IC 95% 2,95 - 7,10) y que sea conviviente (OR 5,28 IC 95% 3,97 - 7,04). No hubo hospitalizaciones ni fallecimientos por COVID en la población analizada. Conclusiones: el testeo de niños y adolescentes en busca de COVID 19 continúa siendo una estrategia válida cuando existen síntomas sugestivos o contacto con un caso confirmado. En este estudio, los niños con antecedente de contacto con conviviente positivo, y mayor de 15 años, mostraron una mayor proporción de resultados positivos de PCR para SARS-CoV-2.

Introduction: the SARS-CoV-2 infection has shown a lower percentage in children compared to the global incidence of patients infected by this virus. The Polymerase Chain Reaction (PCR) test for SARS-CoV-2 in a sample of nasopharyngeal secretions is considered the reference standard test, and it has shown higher sensitivity and specificity levels than other techniques. Objective: describe the characteristics of patients under 15 years of age who underwent PCR for SARS-CoV-2 in a private health provider in the interior of the country between July 1, 2020 and April 30, 2021. Analyze possible factors linked to test positivity. Describe the characteristics of cases with positive PCR Methodology: prospective observational study with a retrospective case-control analysis based on the follow-up of a cohort of children under 15 years of age who underwent a PCR test for SARS-CoV-2 in the period analyzed, at a private health provider in the interior of Uruguay. Data were collected during patients' follow-up according to the institutional protocol that includes: personal data, reason for requesting the PCR, contact data, PCR result and cycle threshold (CT), clinical manifestations and evolution. Results: 2,361 PCRs were performed to children of under 15 years of age (15% of all PCRs in the institution). Average age 8.6 years (range 7 days - 14 years and 11 months); 49% girls and 51% boys. Reason for requesting the test: 78.4% due to previous contact, 14.3% due to symptoms without knowledge of contact and 7.3% prior to hospital admission (emergency or scheduled). Positivity percentage for the entire period 14.7% with significant monthly variability (5.6% in December and 27% in April). The PCR was positive in 346 cases, with a mean CT of 27, and a range between 16.8 and 37.3. No statistical differences were found regarding age and sex between positive and negative cases. Only 1 case was positive PCR prior to hospital admission (OR 0.03 95% CI 0.004 - 0.22) and 20 out of the 611 PCR were requested due to prior institutional contact (school, sports centers, etc.), the difference being statistically significant when the patient was older than 15 years (p 0.029). From the retrospective study of cases (PCR positive) and controls (PCR negative), a statistically significant link (p<0.000001) arose regarding: when the request resulted from a prior contact compared to other causes (OR 5.2 CI 95% 3.28-8.26), when the index case was older than 15 years of age (OR 4.57 95% CI 2.95-7.10) and when the patient and the contact had cohabited (OR 5.28 95% CI 3.97-7.04). There were no hospitalizations or deaths from COVID in the population analyzed. Conclusions: testing children and adolescents for COVID 19 continues to be a valid strategy in case of suggestive symptoms or contact with a confirmed positive case. In this study, children with a history of contact with a positive case, and older than 15 years, showed a higher proportion of positive PCR results for SARS-CoV-2.

Introdução: a infecção por SARS-CoV-2 em crianças representa um percentual menor do que na incidência global de pacientes infectados por esse vírus. O teste de reação em cadeia da polimerase (PCR) para SARS-CoV-2 em uma amostra de secreções nasofaríngeas é considerado o padrão de referência, com níveis de sensibilidade e especificidade mais elevados do que outras técnicas. Objetivo: descrever as características dos pacientes menores de 15 anos de idade que realizaram PCR para SARS-CoV-2 em uma prestadora de saúde privada do interior do país entre 1º de julho de 2020 e 30 de abril de 2021. Analisar possíveis fatores associados à positividade do teste. Descrever as características dos casos com PCR positivo. Metodologia: estudo observacional prospectivo com análise retrospectiva caso-controle a partir do acompanhamento de uma coorte de crianças menores de 15 anos que realizaram teste de PCR para SARS-CoV 2 no período analisado, em uma assistência médica de saúde no interior do país. Os dados foram coletados durante o acompanhamento dos pacientes de acordo com o protocolo institucional e incluíram: informação pessoal, motivo da solicitação do PCR, características do contato, resultado do PCR e limiar de ciclo (CT), manifestações clínicas e evolução. Resultados: foram solicitados 2.361 PCRs de menores de 15 anos (15% do total de PCRs da instituição). Idade média 8,6 anos (variação 7 dias - 14 anos e 11 meses); 49% meninas e 51% meninos. Motivo do pedido do exame: 78,4% por estudo de contato, 14,3% por sintomas sem conhecimento de contato e 7,3% antes da internação (por emergência ou coordenação). Porcentagem de positividade para todo o período 14,7% com significativa variabilidade mensal (5,6% em dezembro e 27% em abril). O PCR foi positivo em 346 casos, com média de TC de 27 e variação entre 16,8 e 37,3. Não foram encontradas diferenças estatísticas em relação à idade e sexo entre os casos positivos e negativos. Apenas 1 caso foi PCR positivo antes da admissão hospitalar (OR 0,03 IC 95% 0,004 - 0,22) e 20 dos 611 PCR solicitados por contato institucional (escola, centros de esportes, etc.), sendo a diferença estatisticamente significativa para os casos que tinham mais de 15 anos de idade (p 0,029). Do estudo retrospectivo de casos (PCR positivo) e controles (PCR negativo), emergiu uma associação estatisticamente significativa (p <0,000001) quando: a causa da solicitação do teste tinha sido um contato positivo prévio em relação a outra causa (OR 5,2 IC 95% 3,28 - 8,26), e quando o caso índice era mais velho do que 15 anos (OR 4,57 IC 95% 2,95 - 7,10) ou coabitava com o paciente (OR 5,28 IC 95% 3,97 - 7,04). Não houve internações ou óbitos por COVID na população analisada. Conclusões: a testagem de crianças e adolescentes em busca de COVID-19 continua sendo uma estratégia válida quando há sintomas sugestivos ou contato com um caso positivo confirmado. Neste estudo, crianças com histórico de contato com casos positivos na mesma casa e mais velhos do que 15 anos de idade apresentaram maior proporção de resultados positivos de PCR para SARS-CoV-2.

El dilema en los laboratorios de Koch, ¿Cultivar o no Cultivar? / The Dilemma in Koch's Laboratories, To Cultivate or Not to Cultivate?

La nueva norma técnica para el control y la eliminación de la tuberculosis es un gran avance para el diagnóstico de este microorganismo en Chile. Actualmente la principal técnica microbiológica para el diagnóstico de laboratorio es la biología molecular, que reduce el tiempo del resultado a tan solo un par de horas. La normativa actual indica que en el paciente caso presuntivo de tuberculosis (CPT) la técnica exclusiva a realizar es Biología molecular. La literatura indica que la detección a través de amplificación de material genético de la micobacteria tiene un límite de detección de 15,6 UFC/ ml, por tanto, todas las muestras bajo ese límite umbral potencialmente podrían no ser diagnosticadas bajo esta estructura emanada por el ministerio de Salud en Chile. Nuestra recomendación es continuar con el estudio de cultivo en medios líquidos o sólidos para todas las muestras hasta obtener literatura que avale lo contrario

The new technical standard for the control and elimination of tuberculosis in Chile is a great advance for the diagnosis of this microorganism. Currently the main microbiological technique for laboratory diagnosis is PCR, which reduces the time to result to just a couple of hours. The current regulations indicate that in the patient with a presumptive case of tuberculosis (CPT) t he exclusive technique to be performed is PCR. The literature indicates that the detection through amplification of genetic material of the mycobacterium has a detection limit of 15.6 CFU/ml, therefore, all samples under this threshold limit could potentially not be diagnosed under this structure emanated by the Ministry of Health in Chile. Our recommendation is to continue with the study of culture in liquid or solid media for all samples until literature confirms otherwise

Aportes de la biotecnología en el diagnóstico de COVID-19 / Biotechnology contributions in COVID-19 diagnosis

Introducción: en diciembre del año 2019 surgió en China una neumonía viral; el virus fue identificado como un coronavirus SARS-CoV-2, que se propagó rápidamente de tal manera que se convirtió en pandemia. La alta contagiosidad y la presencia de portadores asintomáticos dificultaron el diagnóstico de la infección y la toma de decisiones sanitarias. Objetivo: el objetivo de esta revisión bibliográfica es presentar y describir las principales técnicas utilizadas actualmente para el diagnóstico de COVID-19 y establecer su relación con los conocimientos de distintas disciplinas y tecnologías emergentes que confluyen en la Biotecnología bioquímico-farmacéutica orientada a la Salud humana. Metodología: se realizó una revisión de la bibliografía disponible en PubMed a partir de enero de 2020 sobre las pruebas diagnósticas que se encuentran actualmente en uso, en el ámbito sanitario, para la detección y seguimiento de la enfermedad COVID-19. También se realizaron búsquedas a través de Google y Google Académico para publicaciones de organismos de Salud en referencia a métodos diagnósticos. Resultados: se presenta una importante cantidad de pruebas diagnósticas, basadas en diferentes tecnologías, que desempeñan un papel clave en la pandemia de COVID-19. Algunas de ellas muy sofisticadas, como la secuenciación genómica de próxima generación, otras más estándar, pero igualmente robustas, como la reacción en cadena de la polimerasa (PCR). También otras adaptadas para el brote pandémico, como la amplificación isotérmica de ácidos nucleicos mediada por bucle. Todas las mencionadas se consideran de tipo molecular, pero también existen las pruebas serológicas, como ELISA, que incluyen ensayos en plasma o de tipo inmunológico. Estas sirven para detectar anticuerpos frente a la exposición al virus o antígenos en personas potencialmente infectadas. Conclusiones: los procesos de investigación y desarrollo biotecnológicos aplicados al diagnóstico y los conocimientos científicos previos permitieron una respuesta tanto nacional como internacional rápida y eficaz en medio de una inédita pandemia global. En esta revisión destacamos las principales técnicas, en qué estadio se deben usar y qué información nos aportan. (AU)

Introduction: in December 2019, a viral pneumonia emerged in China, identifying the virus as a SARS-CoV-2 coronavirus, which spread rapidly in such a way that it became a pandemic. The high contagiousness and the presence of asymptomatic carriers make difficulted to diagnose the infection and to make health decisions. Target: the objective of this review is to present and describe the main techniques currently used for the diagnosis of COVID-19, and to establish their relationship with the knowledge of different disciplines and emerging technologies that converge in biochemical-pharmaceutical biotechnology oriented to human health. Methodology: a review of the literature available in Pubmed from January 2020 on the diagnostic tests that are currently in use in the health field, for the detection and monitoring of COVID-19 disease, was carried out. Searches were also carried out through Google and Google Scholar for publications of Health organizations in reference to diagnostic methods. Results: a significant number of diagnostic tests are presented, based on different technologies, which play a key role in the COVID-19 pandemic. Some of them are very sophisticated, such as next-generation genomic sequencing, others more standard, but equally robust, such as polymerase chain reaction. Also others adapted for the pandemic outbreak such as loop-mediated isothermal amplification of nucleic acids. All of the aforementioned are considered molecular, but there are also serological tests, such as ELISA, which include plasma or immunological tests. These serve to detect antibodies against exposure to the virus or antigens in potentially infected people. Conclusions: biotechnological research and development processes applied to diagnosis and previous scientific knowledge allowed a rapid and effective national and international response in the midst of an unprecedented global pandemic. In this review we highlight the main techniques, at what stage they should be used and what information they provide us. (AU)

COVID19: uncovering interindividual variability for tailoring appropriate therapeutic interventions / COVID19: a variabilidade individual da resposta imunoinflamatória

The severity of SARS-CoV2 infection, Covid19 disease, should account for the diversity of human individual immu-noinflammatory responses. Serum immunological markers during Covid19 illness may lead to individualized thera-peutics with better outcomes. Efficient treatment for Covid19 may require: 1) early disease detection, 2) combined drug therapy for 3) targeting the virus replication cycle, and 4) individualized drug treatment for specific immu-noinflammatory human profile responses administered in a 5) timely manner. Covid19 is unlikely to be the last emergent human disease with fast pandemic potential. Gathering knowledge on the individual human host profiles of immunoinflammatory responses is an opportunity that could lead us to understand individual differences in re-sponse to infection at the individual and population level, paving the way to faster, more efficient strategies to tack-le upcoming infectious diseases. This is a position paper based on an integrative non-exhaustive literature revision (AU)

A diversidade das respostas imunoinflamatórias individuais humanas muito provavelmente tem papel na gravidade da doença Covid19 causada pela infecção pelo vírus SARS-CoV2. Marcadores imunológicos séricos durante a Covid19 po-dem guiar a escolha de terapias individualizadas com melhores resultados. O tratamento eficiente para Covid19 pode exigir: 1) detecção precoce da doença, 2) terapia medicamentosa combinada com alvo ao 3) ciclo de replicação do ví-rus e 4) terapia anti-inflamatória individualizada para perfis de respostas imunoinflamatórias humanas, administradas em tempo hábil. É improvável que a Covid19 seja a última doença humana emergente com potencial de alastramento veloz pandêmico. Reunir conhecimento sobre perfis de respostas imunoinflamatórias individuais dos hospedeiros humanos é uma oportunidade ímpar que pode nos levar a entender as diferenças dessas respostas entre indivíduos, abrindo caminho para estratégias terapêuticas mais rápidas e eficientes no combate à futuras epidemias (AU)

Portable real-time colorimetric LAMP-device for rapid quantitative detection of nucleic acids in crude samples.

Loop-mediated isothermal amplification is known for its high sensitivity, specificity and tolerance to inhibiting-substances. In this work, we developed a device for performing real-time colorimetric LAMP combining the accuracy of lab-based quantitative analysis with the simplicity of point-of-care testing. The device innovation lies on the use of a plastic tube anchored vertically on a hot surface while the side walls are exposed to a mini camera able to take snapshots of the colour change in real time during LAMP amplification. Competitive features are the rapid analysis (< 30 min), quantification over 9 log-units, crude sample-compatibility (saliva, tissue, swabs), low detection limit (< 5 copies/reaction), smartphone-operation, fast prototyping (3D-printing) and ability to select the dye of interest (Phenol red, HNB). The device's clinical utility is demonstrated in cancer mutations-analysis during the detection of 0.01% of BRAF-V600E-to-wild-type molecules from tissue samples and COVID-19 testing with 97% (Ct < 36.8) and 98% (Ct < 30) sensitivity when using extracted RNA and nasopharyngeal-swabs, respectively. The device high technology-readiness-level makes it a suitable platform for performing any colorimetric LAMP assay; moreover, its simple and inexpensive fabrication holds promise for fast deployment and application in global diagnostics.

Performances of rapid and connected salivary RT-LAMP diagnostic test for SARS-CoV-2 infection in ambulatory screening.

In the context of social events reopening and economic relaunch, sanitary surveillance of SARS-CoV-2 infection is still required. Here, we evaluated the diagnostic performances of a rapid, extraction-free and connected reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assay on saliva. Nasopharyngeal (NP) swabs and saliva from 443 outpatients were collected simultaneously and tested by reverse-transcription quantitative PCR (RT-qPCR) as reference standard test. Seventy-one individuals (16.0%) were positive by NP and/or salivary RT-qPCR. Sensitivity and specificity of salivary RT-LAMP were 85.9% (95%CI 77.8-94.0%) and 99.5% (98.7-100%), respectively. Performances were similar for symptomatic and asymptomatic participants. Moreover, SARS-CoV-2 genetic variants were analyzed and no dominant mutation in RT-LAMP primer region was observed during the period of the study. We demonstrated that this RT-LAMP test on self-collected saliva is reliable for SARS-CoV-2 detection. This simple connected test with optional automatic results transfer to health authorities is unique and opens the way to secure professional and social events in actual context of economics restart.