COVID-19: Asociación entre la clasificación de riesgo y el Modified Early Warning Score y los resultados hospitalarios / COVID-19: Association of risk classification with the Modified Early Warning Score and hospital outcomes / COVID-19: Associação da classificação de risco com o Modified Early Warning Score e os desfechos hospitalares

Objetivo: evaluar la asociación entre las categorías de clasificación de riesgo y el Modified Early Warning Score y los resultados de los pacientes con COVID-19 en el servicio de emergencia Método: estudio transversal, realizado con 372 pacientes hospitalizados con diagnóstico de COVID-19 atendidos en la Recepción con Clasificación de Riesgo en Urgencias. En este estudio, el Modified Early Warning Score de los pacientes se clasificó como sin y con deterioro clínico, de 0 a 4 y de 5 a 9, respectivamente. Se consideró que había deterioro clínico cuando presentaban insuficiencia respiratoria aguda, shock y paro cardiorrespiratorio. Resultados: el Modified Early Warning Score promedio fue de 3,34. En cuanto al deterioro clínico de los pacientes, se observó que en el 43% de los casos el tiempo de deterioro fue menor a 24 horas y que el 65,9% ocurrió en urgencias. El deterioro más frecuente fue la insuficiencia respiratoria aguda (69,9%) y el resultado fue alta hospitalaria (70,3%). Conclusión: los pacientes con COVID-19 que presentaban Modified Early Warning Score 4 se asociaron a las categorías de clasificación de riesgo urgente, muy urgente y emergente y tuvieron más deterioro clínico, como insuficiencia respiratoria y shock, y murieron, lo que demuestra que el Protocolo de Clasificación de Riesgo priorizó correctamente a los pacientes con riesgo vital.

Objective: to evaluate the association of the risk classification categories with the Modified Early Warning Score and the outcomes of COVID-19 patients in the emergency service Method: a crosssectional study carried out with 372 patients hospitalized with a COVID-19 diagnosis and treated at the Risk Classification Welcoming area from the Emergency Room. In this study, the patients' Modified Early Warning Score was categorized into without and with clinical deterioration, from 0 to 4 and from 5 to 9, respectively. Clinical deterioration was considered to be acute respiratory failure, shock and cardiopulmonary arrest Results: the mean Modified Early Warning Score was 3.34. In relation to the patients' clinical deterioration, it was observed that, in 43%, the time for deterioration was less than 24 hours and that 65.9% occurred in the Emergency Room. The most frequent deterioration was acute respiratory failure (69.9%) and the outcome was hospital discharge (70.3%). Conclusion: COVID-19 patients who had a Modified Early Warning Scores > 4 were associated with the urgent, very urgent and emergency risk classification categories, had more clinical deterioration, such as respiratory failure and shock, and evolved more to death, which shows that the Risk Classification Protocol correctly prioritized patients at risk of life.

Objetivo: avaliar a associação das categorias de classificação de risco com o Modified Early Warning Score e os desfechos dos pacientes com COVID-19 no serviço de emergência Método: estudo transversal, realizado com 372 pacientes internados com diagnóstico de COVID-19 atendidos no Acolhimento com Classificação de Risco no Pronto-Atendimento. Neste estudo, o Modified Early Warning Score dos pacientes foi categorizado em sem e com deterioração clínica, de 0 a 4 e de 5 a 9, respectivamente. Foram consideradas deteriorações clínicas a insuficiência respiratória aguda, choque e parada cardiorrespiratória. Resultados: o Modified Early Warning Score médio foi de 3,34. Em relação à deterioração clínica dos pacientes, observou-se que em 43% o tempo para deterioração foi menor de 24 horas e que 65,9% delas ocorreu no pronto-socorro. A deterioração mais frequente foi a insuficiência respiratória aguda (69,9%) e o desfecho foi o de alta hospitalar (70,3%). Conclusão: pacientes com COVID-19 que tiveram Modified Early Warning Score 4 foram associados às categorias da classificação de risco urgente, muito urgente e emergente e tiveram mais deterioração clínica, como a insuficiência respiratória e o choque, e evoluíram mais a óbito, o que demonstra que o Protocolo de Classificação de Risco priorizou corretamente os pacientes com risco de vida.

Estudio comparativo entre un test de antígeno y la prueba de la reacción en cadena de la polimerasa en tiempo real (RT-PCR) para el diagnóstico de infección por COVID-19 en pediatría / Comparative study between an antigen test and the reverse transcription-polymerase chain reaction (RT-PCR) test for the diagnosis of COVID-19 in pediatrics

Introducción. La pandemia por COVID-19 ha puesto de manifiesto la necesidad de pruebas diagnósticas rápidas. La prueba de referencia es la reacción en cadena de la polimerasa en tiempo real (RT-PCR). Requiere un equipo y personal capacitado, y su resultado puede llevar un tiempo de espera prolongado. El sistema BD Veritor® es el método rápido cromatográfico utilizado para la detección del antígeno del coronavirus de tipo 2 del síndrome respiratorio agudo grave, en individuos sintomáticos. El objetivo primario del siguiente trabajo es evaluar sensibilidad y especificidad del test de antígeno (TA) comparadas con la RT-PCR en población pediátrica. Población y métodos. Estudio prospectivo, de prueba diagnóstica. Se incluyó a todo menor de 17 años en los primeros 5 días de inicio de síntomas, que consultó desde julio de 2021 hasta febrero de 2022. Se calculó un mínimo de 300 muestras para lograr una precisión de ± 8,76 % y de ± 3,68 % para sensibilidad y especificidad respectivamente. Se analizaron en paralelo las muestras por ambas metodologías. Resultados. De 316 muestras pareadas, 33 fueron positivas por ambos métodos; 6 fueron positivas solo por RT-PCR. La especificidad del TA fue del 100 %; la sensibilidad, del 84,6 %, con un valor predictivo positivo y negativo del 100 % y del 98 % respectivamente. Conclusiones. El TA demostró ser útil en el diagnóstico de pacientes pediátricos con COVID-19 en los primeros 5 días de inicio de síntomas, aunque aquellos con TA negativo y alta sospecha clínica deberían confirmar su resultado con la RT-PCR.

Introduction. The COVID-19 pandemic has brought to light the need for rapid diagnostic tests. The gold standard test is reverse transcription-polymerase chain reaction (RT-PCR). RT-PCR requires equipment and trained personnel, and results may take a long waiting time. The BD Veritor® System is a rapid chromatographic method used for the detection of severe acute respiratory syndrome coronavirus 2 antigen in symptomatic individuals. The primary objective of this study is to assess the sensitivity and specificity of the antigen test (AT) compared to the RT-PCR in the pediatric population. Population and methods. Prospective study with a diagnostic test. All children younger than 17 years in the first 5 days of symptom onset, who consulted between July 2021 and February 2022, were included. A minimum of 300 specimens was estimated to achieve an accuracy of ±8.76% and ±3.68% for sensitivity and specificity, respectively. Specimens were analyzed in parallel using both methodologies. Results. Of 316 paired samples, 33 were positive by both methods; 6 were positive only by RT-PCR. The specificity of the AT was 100%; sensitivity was 84.6%, with a positive and negative predictive value of 100% and 98%, respectively. Conclusions. The AT proved to be useful in the diagnosis of pediatric patients with COVID-19 in the first 5 days of symptom onset, although those with a negative AT and high clinical suspicion should confirm their result with a RT-PCR.

Caracterización epidemiológica de pacientes con COVID-19 en la Región Sanitaria de Francisco Morazán, Honduras / Epidemiological characterization of patients with COVID-19 in the Sanitary Region of Francisco Morazán, Honduras

Antecedentes: La infección por el virus SARS- CoV-2 causa la enfermedad por coronavirus 2019 ( COVID-19). Objetivo: Caracterizar epidemiológicamente al paciente con COVID-19, Región Sanitaria Departamental de Francisco Morazán (RSDFM), Honduras, marzo 2020-enero 2021. Métodos: Estudio descriptivo retrospectivo. Incluyó n=11,401 usuarios a quienes se les realizó confirmación diagnóstica en la RSDFM. Se calculó incidencia general y mensual de COVID-19 como tasas por 10,000 habitantes, tasas de incidencia municipal (casos positivos/10,000) y tasa de letalidad (fallecidos/100 casos positivos). Resultados: Del total de 3,680 usuarios, el promedio de edad de los casos positivos fue 36.8 años (DS+/-17.9); sexo femenino 53.3% (1,962), procedencia Valle de Ángeles 20.4% (752). El nexo epidemiológico fue contacto con familiar o amigo positivo o fallecido por COVID-19 en 96.3% (3,544). La tasa general de incidencia fue 92.4/10,000. El municipio de Valle de Ángeles presentó la tasa de incidencia más elevada 366.1/10,000. La tasa de letalidad fue 1.8% (68/3680). Discusión: Los hallazgos de este estudio son compatibles con otros autores con respecto a las características epidemiológicas y sintomatología, identificando mayor riesgo de mortalidad en los individuos con edad ≥60 años (35/418 vs <60 años 32/3194; p=0.000, OR: 8.60, IC95%: 5.15-14.37), así como para el sexo masculino (48/1670 vs 20/1942; p=0.000, OR:2.79, IC95%: 1.61- 4.89). Los meses de mayor incidencia de casos en la RSDFM fueron los meses de junio a julio del 2020 y diciembre del 2020 a enero del 2021. Estudios de este tipo fortalecen el abordaje epidemiológico de las epidemias/pandemias...(AU)

Prevalência de covid-19 e fatores associados entre servidores públicos / Prevalencia de covid-19 y factores asociados entre servidores públicos / Prevalence of covid-19 and associated factors among public workers

Objetivo: identificar a prevalência da Covid-19 e fatores associados entre servidores públicos do município de João Pessoa, Paraíba. Método: estudo transversal, analítico, realizado com 373 servidores de João Pessoa, Paraíba. Utilizou-se informações do portal de Vigilância em Saúde do estado sobre a evolução da Covid-19. A população do estudo foram os servidores públicos que realizaram o teste RT-PCR para a Covid-19 entre abril e junho de 2021. Realizou-se estatística descritiva e inferencial. Resultados: prevalência de Covid-19 foi de 19,8%; sexo feminino tem chances reduzidas para apresentar diagnóstico positivo da doença; anosmia esteve associada com o diagnóstico da referida infecção. Conclusão: disponibilidade de equipamentos de proteção individual, medidas para higienização das mãos, estímulo a vacinação e reorganização do espaço são algumas das estratégias para a garantia da segurança dos trabalhadores no ambiente de trabalho.

Objetivo: to identify the prevalence of Covid-19 and associated factors among public workers in the city of João Pessoa, Paraíba. Método: cross-sectional, analytical study, conducted with 373 workers in João Pessoa, Paraíba. Information from the state's Health Surveillance portal on the evolution of Covid-19 was used. The study population were public workers who performed the RT-PCR test for Covid-19 between April and June 2021. Descriptive and inferential statistics were performed. Resultados: prevalence of Covid-19 was 19.8%; female gender has reduced chances to present a positive diagnosis of the disease; anosmia was associated with the diagnosis of the referred infection. Conclusión: availability of personal protective equipment, measures for hand hygiene, stimulation of vaccination and reorganization of space are some of the strategies for ensuring the safety of workers in the work environment.

Objective: identificar la prevalencia de la Covid-19 y factores asociados entre servidores públicos del municipio de João Pessoa, Paraíba. Method: estudio transversal, analítico, realizado con 373 servidores de João Pessoa, Paraíba. Se utilizó información del portal de Vigilancia en Salud del estado sobre la evolución de Covid-19. La población del estudio fueron los funcionarios públicos que realizaron la prueba RT-PCR para Covid-19 entre abril y junio de 2021. Se realizó estadística descriptiva e inferencial. Results: prevalencia de Covid-19 fue de 19,8%; sexo femenino tiene probabilidades reducidas para presentar diagnóstico positivo de la enfermedad; anosmia estuvo asociada con el diagnóstico de dicha infección. Conclusion: disponibilidad de equipos de protección individual, medidas para higienización de las manos, estímulo a la vacunación y reorganización del espacio son algunas de las estrategias para la garantía de la seguridad de los trabajadores en el ambiente de trabajo.

Overview of SARS-COV-2 infection at the Butantan Penitentiary Progression Center / Panorama da infecção pelo SARS-COV-2 no Centro de Progressão Penitenciária do Butantan

ABSTRACT OBJECTIVE To estimate the prevalence of exposure to the SARS-CoV-2 virus among individuals living in restricted freedom. METHODS A seroprevalence survey was carried out with the population of the female penitentiary of the Centro de Progressão Penitenciária (CPP) in Butantan (municipality of São Paulo), between June 24 and August 20, 2020. During this period, according to the Secretariat of Penitentiary Administration (SAP), the positivity of rapid tests among inmates ranged from 65% to 78%. The evaluation method used in the study was the "One Step COVID-19" rapid test (chromatography), from the company Wondfo, also using the RT-PCR method in symptomatic participants to confirm the viral condition. The study population consisted of 879 female inmates and 170 employees of the institution. RESULTS The prevalence of total antibodies (IgG/IgM) against the SARS-CoV-2 virus in the total population of 1049 study participants was 6.1%; among the population of 879 inmates,a prevalence of 5.8% was observed, and among the institution's employees, 7.5%. CONCLUSIONS The prevalence of covid-19 at the Butantan CPP was low, which is due to the implementation of simple prevention measures at the institution, such as the use of masks (with appropriate changes), emphasis on hygiene, hand washing and social distancing, in addition to other strategies, such as suspending inmates' visits from relatives and friends and cutting back on elective medical appointments and outside work.

RESUMO OBJETIVO Estimar a prevalência da exposição ao vírus SARS-CoV-2 entre indivíduos vivendo em restrição de liberdade. MÉTODOS Foi realizado inquérito de soroprevalência com a população da penitenciária feminina do Centro de Progressão Penitenciária (CPP) do Butantan (município de São Paulo), entre 24 de junho e 20 de agosto de 2020. Nesse período, segundo a Secretaria de Administração Penitenciária (SAP), a positividade dos testes rápidos entre detentos variou de 65 a 78%. O método de avaliação utilizado no estudo foi o teste rápido "One Step COVID-19" (cromatografia), da empresa Wondfo, empregando-se também o método RT-PCR em participantes sintomáticos para confirmação do quadro viral. A população do estudo foi constituída por 879 reeducandas e 170 funcionários da instituição. RESULTADOS A prevalência de anticorpos totais (IgG/IgM) contra o vírus SARS-CoV-2 na população total de 1.049 participantes do estudo foi de 6,1%; entre a população de 879 reeducandas foi observada prevalência de 5,8% e entre os servidores da instituição, 7,5%. CONCLUSÃO Houve baixa prevalência de covid-19 no CPP do Butantan, o que se deve à implementação de medidas de prevenção simples na instituição, como o uso de máscaras (com trocas adequadas), ênfase na higiene, lavagem das mãos e distanciamento social, além de outras estratégias, como suspensão de visitas de familiares e amigos das reeducandas, cortes de consultas médicas eletivas e do trabalho externo.

Rapid detection and genotyping of SARS-CoV-2 Omicron BA.4/5 variants using a RT-PCR and CRISPR-Cas12a-based assay / 南方医科大学学报

OBJECTIVE@#To establish a rapid detection and genotyping method for SARS-CoV-2 Omicron BA.4/5 variants using CRISPPR-Cas12a gene editing technology.@*METHODS@#We combined reverse transcription-polymerase chain reaction (RT-PCR) and CRISPR gene editing technology and designed a specific CRISPPR RNA (crRNA) with suboptimal protospacer adjacent motifs (PAM) for rapid detection and genotyping of SARS- CoV-2 Omicron BA.4/5 variants. The performance of this RT- PCR/ CRISPPR-Cas12a assay was evaluated using 43 clinical samples of patients infected by wild-type SARS-CoV-2 and the Alpha, Beta, Delta, Omicron BA. 1 and BA. 4/5 variants and 20 SARS- CoV- 2-negative clinical samples infected with 11 respiratory pathogens. With Sanger sequencing method as the gold standard, the specificity, sensitivity, concordance (Kappa) and area under the ROC curve (AUC) of RT-PCR/CRISPPR-Cas12a assay were calculated.@*RESULTS@#This assay was capable of rapid and specific detection of SARS- CoV-2 Omicron BA.4/5 variant within 30 min with the lowest detection limit of 10 copies/μL, and no cross-reaction was observed in SARS-CoV-2-negative clinical samples infected with 11 common respiratory pathogens. The two Omicron BA.4/5 specific crRNAs (crRNA-1 and crRNA-2) allowed the assay to accurately distinguish Omicron BA.4/5 from BA.1 sublineage and other major SARS-CoV-2 variants of concern. For detection of SARS-CoV-2 Omicron BA.4/5 variants, the sensitivity of the established assay using crRNA-1 and crRNA-2 was 97.83% and 100% with specificity of 100% and AUC of 0.998 and 1.000, respectively, and their concordance rate with Sanger sequencing method was 92.83% and 96.41%, respectively.@*CONCLUSION@#By combining RT-PCR and CRISPPR-Cas12a gene editing technology, we successfully developed a new method for rapid detection and identification of SARS-CoV-2 Omicron BA.4/5 variants with a high sensitivity, specificity and reproducibility, which allows rapid detection and genotyping of SARS- CoV-2 variants and monitoring of the emerging variants and their dissemination.

Evaluation of COVID-19 Antigen Test Kit Assay Analytical and Clinical Performance / 中国医疗器械杂志

Objective To rapidly screen patients with novel coronavirus pneumonia (COVID-19) infection including asymptomatic ones. Method Established a rapid detection test kit, and evaluated analytical and clinical performance of it. Result The minimum limit of detection of the reagent was 9.75×102 TCID50/mL; there was no cross-reaction and interference in the high-concentration samples of 29 common respiratory pathogens tested. The diagnostic sensitivity of clinical samples was 98.56%, specificity was 99.00%, and the total coincidence rate was 98.85%; the consistency test Kappa value is 0.974 5. The stratified analysis of positive samples with different Ct values showed that the coincidence rate within each stratum was greater than 95%. Conclusion This COVID-19 antigen test kit with excellent detection performance, fast detection speed, and portable operation. It can be used as a supplementary method for existing nucleic acid detection methods for early screening of new coronavirus.

Comparing epidemiologic features, outcomes, and diagnostic and therapeutic procedures of traumatic patients before and during COVID-19 pandemic: Data from the National Trauma Registry of Iran / 中华创伤杂志(英文版)

PURPOSE@#To prepare for future possible communicable disease epidemics/pandemics, health care providers should know how the COVID-19 pandemic influenced injured patients. This study aimed to compare epidemiologic features, outcomes, and diagnostic and therapeutic procedures of trauma patients admitted to a university-affiliated hospital before and during the pandemic.@*METHODS@#This retrospective study was performed on data from the National Trauma Registry of Iran. All injured patients admitted to the hospital from July 25, 2016 to March 10, 2021 were included in the study. The patients were excluded if they had hospital length of stay less than 24 h. The injury outcomes, trauma mechanisms, and therapeutic and diagnostic procedures of the 2 periods: before (from July 25, 2016 to February 18, 2020) and during (from February 19, 2020 to March 10, 2021) COVID-19 pandemic were compared. All analyses were performed using STATA version 14.0 software (Stata Corporation, College Station, TX).@*RESULTS@#Totally, 5014 patients were included in the registry. Of them, 773 (15.4%) were registered after the beginning of the COVID-19 pandemic on February 19, 2020, while 4241 were registered before that. Gender, education level, and cause of injury were significantly different among the patients before and after the beginning of the pandemic (p < 0.001). In the ≤ 15 years and ≥ 65 years age groups, injuries decreased significantly during the COVID-19 pandemic (p < 0.001). The frequency of intensive care unit (ICU) admission decreased from 694 (16.4%) to 88 (11.4%) (p < 0.001). The mean length of stay at the hospital (days) and at the ICU (days) declined as follow: 8.3 (SD = 17.2) vs. 5.5 (SD = 6.1), p < 0.001 and 7.5 (SD = 11.5) vs. 4.5 (SD = 6.3), p < 0.022. The frequency of diagnostic and therapeutic procedures before and during the pandemic was as follows, respectively: ultrasonography 905 (21.3%) vs. 417 (53.9%) (p < 0.001), echocardiography 313 (7.4%) vs. 107 (13.8%) (p < 0.001), angiography 1597 (37.7%) vs. 534 (69.1%) (p < 0.001), MRI 166 (3.9%) vs. 51 (6.6%) (p < 0.001), surgery 3407 (80.3%) vs. 654 (84.6%) (p < 0.001), and internal/external fixation 1215 (28.6%) vs. 336 (43.5%) (p < 0.001).@*CONCLUSION@#The pandemic affected the epidemiology of traumatic patients in terms of gender, age, educational level, and trauma mechanism. It changed the outcomes of injured patients: ICU admission, length of stay at the hospital and ICU decreased. The patients received more diagnostic and therapeutic procedures during the pandemic. To be more precise, more research is needed on the details.

Expert consensus on diagnosis and treatment of COVID-19 infection related cough in children / 中华预防医学杂志

An epidemic outbreak of the corona virus disease 2019(COVID-19) Omicron variant occurred in most regions of China. Children are susceptible to COVID-19 and the vast majority of them suffer from upper respiratory tract infection. Cough is one of the most common symptoms. COVID-19 infection related cough includes acute cough, persistent cough and chronic cough, and children with original chronic cough or chronic lung disease can also induce or aggravate symptom of cough after infection, which has a great impact on children's physical and mental health. The treatment for COVID-19 infection related cough vary with the etiology. Improper treatment would delay the patient's condition and increase adverse drug reaction. Currently, there is no guideline or consensus on the diagnosis and treatment of COVID-19 infection related cough in children in China, therefore this consensus is drafted. Referring to the latest international research and the diagnostic and therapeutic strategy for COVID-19 infection (Tenth Edition For Trial Implementation), and combining with clinical diagnosis and treatment experience,the consensus elaborates the pathogenesis and etiology of COVID-19 infection related cough, the use of cough relievers and expectorants, as well as the key points of diagnosis and treatment of different etiological factors. It is expected to provide specific and feasible guidance scheme for pediatricians, general practitioners and clinical pharmacists.

Establishment and preliminary application of quantitative real-time PCR assay for the detection of SARS-CoV-2 subgenomic nucleocapsid RNA / 中华预防医学杂志

Objective: To establish a rapid and specific quantitative real-time PCR (qPCR) method for the detection of SARS-CoV-2 subgenomic nucleocapsid RNA (SgN) in patients with COVID-19 or environmental samples. Methods: The qPCR assay was established by designing specific primers and TaqMan probe based on the SARS-CoV-2 genomic sequence in Global Initiative of Sharing All Influenza Data (GISAID) database. The reaction conditions were optimized by using different annealing temperature, different primers and probe concentrations and the standard curve was established. Further, the specificity, sensitivity and repeatability were also assessed. The established SgN and genomic RNA (gRNA) qPCR assays were both applied to detect 21 environmental samples and 351 clinical samples containing 48 recovered patients. In the specimens with both positive gRNA and positive SgN, 25 specimens were inoculated on cells. Results: The primers and probes of SgN had good specificity for SARS-CoV-2. The minimum detection limit of the preliminarily established qPCR detection method for SgN was 1.5×102 copies/ml, with a coefficient of variation less than 1%. The positive rate of gRNA in 372 samples was 97.04% (361/372). The positive rates of SgN in positive environmental samples and positive clinical samples were 36.84% (7/19) and 49.42% (169/342), respectively. The positive rate and copy number of SgN in Wild strain were lower than those of SARS-CoV-2 Delta strain. Among the 25 SgN positive samples, 12 samples within 5 days of sampling time were all isolated with virus; 13 samples sampled for more than 12 days had no cytopathic effect. Conclusion: A qPCR method for the detection of SARS-CoV-2 SgN has been successfully established. The sensitivity, specificity and repeatability of this method are good.

Diagnosis and treatment of adult tumor patients with COVID-19 / 中华肿瘤杂志

After the first outbreak of corona virus disease 2019 (COVID-19) at the end of 2019, it has caused multiple rounds of transmission in many countries around the world. Cancer patients are mainly elderly people, and the immunosuppression state caused by the tumor itself and anti-tumor treatment, more accompanying underlying diseases, and more hospital environmental exposure leading to a higher incidence of COVID-19 infection. The proportion of severe cases after infection is high, and the mortality is high. Therefore, based on the domestic and foreign research and clinical practice, the Expert Committee of Geriatric Cancer Prevention and Treatment of Chinese Society of Clinical Oncology launched a discussion based on the characteristics of cancer patients, including the epidemiology, clinical manifestations, differential diagnosis, definition and risk factors of severe cases, diagnosis and treatment recommendations, recovery of anti-tumor treatment and vaccination recommendations. To provide the corresponding suggestions for the clinical diagnosis and treatment of such patients.

Evolution of the newest diagnostic methods for COVID-19: a Chinese perspective / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

Coronavirus disease 2019 (COVID-19) has continued to spread globally since late 2019, representing a formidable challenge to the world's healthcare systems, wreaking havoc, and spreading rapidly through human contact. With fever, fatigue, and a persistent dry cough being the hallmark symptoms, this disease threatened to destabilize the delicate balance of our global community. Rapid and accurate diagnosis of COVID-19 is a prerequisite for understanding the number of confirmed cases in the world or a region, and an important factor in epidemic assessment and the development of control measures. It also plays a crucial role in ensuring that patients receive the appropriate medical treatment, leading to optimal patient care. Reverse transcription-polymerase chain reaction (RT-PCR) technology is currently the most mature method for detecting viral nucleic acids, but it has many drawbacks. Meanwhile, a variety of COVID-19 detection methods, including molecular biological diagnostic, immunodiagnostic, imaging, and artificial intelligence methods have been developed and applied in clinical practice to meet diverse scenarios and needs. These methods can help clinicians diagnose and treat COVID-19 patients. This review describes the variety of such methods used in China, providing an important reference in the field of the clinical diagnosis of COVID-19.

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.

A ocorrência de infecção por COVID-19 em pacientes assintomáticos na testagem pré-operatória / The occurrence of COVID-19 infection in preoperative testing of asymptomatic patients / La ocurrencia de infección por COVID-19 en pruebas preoperatorias de pacientes asintomáticos

Objetivo: Analisar a ocorrência de pacientes cirúrgicos assintomáticos com teste para COVID-19 positivo, delimitar o perfil epidemiológico, identificar o tipo de cirurgia e a especialidade, bem como determinar o tempo de execução do procedimento cirúrgico após testagem positiva. Método: Trata-se de um estudo de coorte retrospectiva, em um hospital de grande porte, filantrópico, de São Paulo, realizado no período de março a setembro de 2020, baseado na análise de dados de prontuário. Resultados: Foram 4.870 procedimentos cirúrgicos, dos quais 3.688 pacientes tiveram coleta de exame PCR. A ocorrência de pacientes cirúrgicos posi-tivos e assintomáticos foi de 1,7%; no perfil epidemiológico, observa-se predominância de sexo masculino, meia-idade, com classificação de risco anestésico ASA II e em procedimentos das especialidades de ortopedia, urologia, ginecologia e gastroenterologia. A execução do teste foi de dois dias pré-procedimento e a presença de pacientes com sintomas em até 14 dias após testagem foi de 0,5%. Conclusão: A ocorrência de pacientes cirúrgicos positivos e assintomáticos foi pequena dentro do quantitativo analisado, os achados deste estudo são similares aos de estudos nacionais e internacionais em relação a especialidade, comorbidades e idade

Objective: To analyze the occurrence of asymptomatic surgical patients with a positive COVID-19 test, delimit the epidemiological profile, iden-tify the type of surgery and specialty, as well as determine the time for performing the surgical procedure after a positive test. Method: This is a retrospective cohort study, in a large, philanthropic hospital in São Paulo, carried out from March to September 2020, based on the analysis of medical records. Results:There were 4,870 surgical procedures, of which 3,688 patients underwent a PCR test. The occurrence of positive and asymptomatic surgical patients was 1.7%; in the epidemiological profile, there is a predominance of males, middle-aged, with ASA II anesthetic risk classification and in procedures of the spe-cialties of orthopedics, urology, gynecology, and gastroenterology. The test was carried out two days before the procedure and the presence of patients with symptoms within 14 days after testing was 0.5%. Conclusion: The occurrence of positive and asymptomatic surgical patients was small within the quantita-tive analyzed, the findings of this study are similar to those of national and international studies in relation to specialty, comorbidities, and age

Objetivo: Analizar la ocurrencia de pacientes quirúrgicos asintomáticos con prueba COVID-19 positiva, delimitar el perfil epidemiológico, iden-tificar el tipo de cirugía y especialidad, así como determinar el tiempo para realizar el procedimiento quirúrgico luego de una prueba positiva. Método:Este es un estudio de cohorte retrospectivo, en un gran hospital filantrópico de São Paulo, realizado de marzo a septiembre de 2020, basado en el análi-sis de registros médicos. Resultados: Se realizaron 4.870 procedimientos quirúrgicos, de los cuales se recolectó examen PCR a 3.688 pacientes. La ocur-rencia de pacientes quirúrgicos positivos y asintomáticos fue de 1,7%; en el perfil epidemiológico predomina el sexo masculino, de mediana edad, con clasificación de riesgo anestésico ASA II y en procedimientos de las especialidades de ortopedia, urología, ginecología y gastroenterología. La prueba se realizó dos días antes del procedimiento y la presencia de pacientes con síntomas dentro de los 14 días posteriores a la prueba fue del 0,5%. Conclusión:La ocurrencia de pacientes quirúrgicos positivos y asintomáticos fue pequeña dentro de lo cuantitativo analizado, los hallazgos de este estudio son simi-lares a los de estudios nacionales e internacionales en relación a especialidad, comorbilidades y edad

Concordancia entre métodos diagnósticos de infección por SARS-CoV-2 en niños asistidos en el departamento de urgencias de un hospital pediátrico / Agreement between diagnostic methods for SARS-CoV-2 infection in children seen at the Emergency Department of a children's hospital

Introducción. Los inmunoensayos de detección rápida de antígenos (TRA) del SARS-CoV-2, son considerados adecuados para el diagnóstico en el punto de atención. El objetivo fue conocer la concordancia entre la reacción en cadena de la polimerasa en tiempo real con transcriptasa inversa (RT-qPCR, por su sigla en inglés) y los TRA en población pediátrica. Población y métodos. Se reclutaron todos los pacientes entre 1 mes y 17 años 11 meses de edad atendidos en la Unidad Febril de Urgencia de un hospital pediátrico entre el 11 de junio y el 3 de octubre de 2021. Se utilizó el TRA Panbio COVID-19 Ag® (Abbott Diagnostic) y, comométodo de referencia, la RT-qPCR (según el protocolo de los Centros para el Control y la Prevención de Enfermedades). Resultados. Se incluyeron 6491 pacientes. La prevalencia de COVID-19 fue del 2,8 %. El92,1 % de los sujetos presentaron síntomas. La sensibilidad, la especificidad y el índice kappa de concordancia para el TRA fueron del 71,0 %, 99,9 % y 0,813, respectivamente. El índice kappa yla sensibilidad del TRA fueron significativamentemayores en el grupo de 13 a 17 años (0,89 y 82,4 %,respectivamente) cuando se los comparó con los grupos de 0 a 5 y de 6 a 12 años. Esto podría deberse a la menor carga viral observada en los pacientes menores de 12 años. Conclusión. Si bien los TRA permiten acortar el tiempo de obtención de los resultados y mejorar la estrategia de aislamiento de pacientes con COVID-19, la sensibilidad en niños menores de 12 años o asintomáticos no se encontraría dentro de los rangos recomendados, sobre todo enperíodos de baja prevalencia de la enfermedad.

Introduction. Rapid antigen tests (RAgTs) for SARS-CoV-2 are considered adequate for diagnosis at the point of care. Our objective was to establish the agreement between reverse transcription-quantitative polymerase chain reaction (RT-qPCR) and RAgTs in the pediatric population. Population and methods. All patients aged 1 month to 17 years and 11 months seen at the Emergency Fever Unit of a children's hospital between 6-11-2021 and 10-3-2021 were recruited. The Panbio COVID-19 Ag® test (Abbott Diagnostic) was compared to the reference method RT-qPCR (as per the protocol suggested by the United States Centers for Disease Control and Prevention). Results. A total of 6491 patients were included. The prevalence of COVID-19 was 2.8%. Symptoms were observed in 92.1%. Sensitivity, specificity, and the kappa index of agreement for the RAgT were 71.0%, 99.9%, and 0.813, respectively. The kappa index and the RAgT sensitivity were significantly higher in the group aged 13­17 years (0.89 and 82.4%, respectively) compared to the groups aged 0­5 and 6­12 years. This may be due to the lower viral load observed in patients younger than 12 years. Conclusion. Although RAgTs shorten the time to result and improve the isolation strategy for COVID-19 patients, their sensitivity in children younger than 12 years or asymptomatic children is not within the recommended ranges, especially during periods of low disease prevalence.

Comparación del test de antígeno y la reacción en cadena de polimerasa para SARS-CoV-2 en niños menores de 12 años / Comparison of antigen test and polymerase chain reaction for SARS-CoV-2 in children younger than 12 years

Frenar la propagación de la enfermedad por el coronavirus 2019 (COVID-19, por su sigla en inglés) es fundamental, y se puede realizar mediante técnicas de detección rápidas y efectivas. El objetivo fue comparar la precisión diagnóstica de un test rápido de antígeno (TRAg,) con la reacción en cadena de polimerasa con retrotranscripción (RT-qPCR, por su sigla en inglés) y describir los umbrales de amplificación (Ct, por su sigla en inglés). Participaron niños de 1 mes a 11 años que tuvieran menos de 7 días de síntomas, sin resultado detectable en los últimos 90 días, e inmunocompetentes. Se incluyeron 1855 pacientes con una prevalencia de COVID-19 del 4,7 %. La sensibilidad global del TRAg fue del 60,2 % y su especificidad, del 99,8 %; en niños mayores de 5 años los valores fueron de 69,8 % y 99,8 %, respectivamente. Los valores de Ct de las muestras discordantes fueron más altos. En conclusión, la precisión diagnóstica muestra que TRAg tiene una especificidad similar a la RT-qPCR, pero una sensibilidad considerablemente menor, sobre todo en niños de menos de 5 años.

Stopping the spread of coronavirus disease 2019 (COVID-19) is critical and can be achieved through rapid and effective detection techniques. Our objective was to compare the diagnostic accuracy of rapid antigen tests (RAgT) and reverse transcription quantitative polymerase chain reaction (RT-qPCR) and to describe amplification cycle thresholds (Cts). Participants were children aged 1 month to 11 years with symptoms for less than 7 days, who did not have a detectable result in the past 90 days, and were immunocompetent. A total of 1855 patients were included; the prevalence of COVID-19 was 4.7%. For the RAgT, overall sensitivity was 60.2% and specificity, 99.8%; in children older than 5 years, values were 69.8% and 99.8%, respectively. Ct values for discordant samples were higher. To conclude, the diagnostic accuracy indicated that the specificity of RAgT is similar to that of RT-qPCR, but its sensitivity is notably lower,especially in children younger than 5 years.

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)

Evaluación de la salud sexual, mental y sueño en hombres chilenos posterior a infección por SARS-CoV-2 / Sexual, physical, mental and sleep sequelae four months after SARS-CoV-2 disease

BACKGROUND: Long term sequelae can be observed after SARS-CoV2. AIM: To describe the sexual, physical, mental and sleep sequelae four months after SARS-CoV2 diagnosis. PATIENTS AND METHODS: Patients recovering from SARS-CoV2 with different degrees of disease severity were consecutively included and separated in two study groups, namely Group 1 including patients that had an acute respiratory distress syndrome (ARDS) and Group 2 including those with mild or moderate COVID-19. Handgrip strength, respiratory polygraphy (RP), Quality of life using the SF-12 questionnaire, and the international index of erectile (IIEF-5) function were assessed. RESULTS: Twenty patients who had ARDS, and 10 without ARDS were included. Erectile dysfunction was observed in 77 and 10% of patients with and without ARDS, respectively (p < 0.01). The figures for sleep obstructive apnea were 82 and 40% respectively (p = 0.02) and for the physical domain SF-12 score were 39.2 and 47.9 points respectively (p = 0.01). No differences in muscle strength were observed. After a multivariable analysis, previous ARDS due to COVID-19 was independently associated with erectile dysfunction, with an odds ratio of 30.6 (95% confidence intervals, 3.08300.3, p = 0.003). CONCLUSIONS: Among men with ARDS due to COVID-19, the prevalence of erectile dysfunction was high and independently associated with a severe disease four months after discharge.