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2.
Vaccimonitor (La Habana, Print) ; 30(3)2021. tab, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1341780

ABSTRACT

Contar con métodos diagnósticos que reúnan ciertos atributos es vital para guiar las decisiones sanitarias, el contexto actual lo amerita. Con el objetivo de validar la capacidad de dos pruebas rápidas para detectar anticuerpos debido a la infección por SARS-CoV-2 en la Isla de la Juventud, Cuba, de abril a mayo de 2020, se realizó un estudio descriptivo de corte transversal de evaluación de pruebas rápidas: Wondfo (SARS-CoV-2 antibody test) y Lungene covid-19 IgG/IgM rapid test, en comparación con la prueba de reacción en cadena de la polimerasa en tiempo real. Se construyeron dos muestras homogéneas de 250 cada una, determinándose indicadores de validación. Se obtuvieron valores de sensibilidad de 6,6 por ciento y 8,3 por ciento respectivamente para cada prueba, mientras que la especificidad resultó superior para Wondfo (95 por ciento). Los valores predictivos positivos resultaron muy bajos, los negativos adecuados, superior en Lungene con el 94,8 por ciento. Los valores de razón de verosimilitud fueron clasificados como inútiles. En diferentes escenarios en cuanto a casos sintomáticos, se alcanzó sensibilidad del 50 por ciento en intervalo de 1 a 7 días para Wondfo. El área bajo la curva ROC para Wondfo fue 0,50 (IC95 por ciento=0,46-0,55) y para Lungene 0,46 (IC95 por ciento=0,38-0,55). El índice kappa para Wondfo fue de 0,025 y 0,010 para Lungene. Las pruebas rápidas exploradas mostraron muy baja sensibilidad, valor predictivo positivo y razón de verosimilitud inadecuada. La validez global de las pruebas no demostró un buen desempeño diagnóstico, marcado por el valor del área bajo la curva ROC(AU)


Having diagnostic methods that meet certain attributes is vital to guide health decisions, the current context warrants it. In order to validate the capacity of two rapid tests to detect antibodies due to SARS-CoV-2 infection in Isla de la Juventud, Cuba, from April to May 2020, a descriptive cross-sectional evaluation study was carried out. Rapid tests: Wondfo (SARS-CoV-2 antibody test) and Lungene covid-19 IgG/IgM, were compared to the real-time polymerase chain reaction test. Two homogeneous samples of 250 each were constructed, determining validation indicators. Sensitivity values of 6.6 percent and 8.3 percent respectively were obtained for each test, while the specificity was higher for Wondfo (95 percent). The positive predictive values were very low, the negative ones were adequate, higher in Lungene with 94.8 percent. Likelihood ratio values were classified as useless. In different scenarios in terms of symptomatic cases, sensitivity of 50 percent was reached in an interval of 1 to 7 days for Wondfo. The area under the ROC curve for Wondfo was 0.50 (95 percent CI = 0.46-0.55) and 0.46 for Lungene (95 percent CI = 0.38-0.55). The kappa index for Wondfo was 0.025 and 0.010 for Lungene. The rapid tests explored showed very low sensitivity, positive predictive value, and inadequate likelihood ratio. The global validity of the tests did not demonstrate a good diagnostic performance, marked by the value of the area under the ROC curve. The degree of agreement was poor(AU)


Subject(s)
Humans , Validation Studies as Topic , COVID-19 Testing/methods , SARS-CoV-2 , COVID-19 , Enzyme-Linked Immunosorbent Assay/methods , Epidemiology, Descriptive , Cross-Sectional Studies , Cuba
3.
Medicina (B.Aires) ; 81(5): 695-702, oct. 2021. graf
Article in Spanish | LILACS | ID: biblio-1351040

ABSTRACT

Resumen Los pacientes con cáncer y COVID-19 tienen más complicaciones que la población general. Comunicamos una cohorte de 74 pacientes con cáncer y COVID-19 internados en una institución on cológica. El 87.8% tenía diagnóstico de tumores sólidos y 12.2% oncohematológicos. Entre los tumores sólidos, el 61.5% presentó enfermedad metastásica. El 78.3% (N = 58) tenía infiltrados pulmonares al diagnóstico de COVID-19. La infección fue intrahospitalaria en 20 pacientes. Habían recibido tratamiento antineoplásico den tro de los 30 días anteriores al diagnóstico 39 pacientes (52.7%); uno se encontraba recibiendo radioterapia. Veinticuatro pacientes (32.4%) se derivaron a terapia intensiva (UTI) y 18 (75%) de ellos requirieron asistencia respiratoria mecánica (ARM). La mortalidad general durante la internación fue 32.4% (N = 24). La mortalidad en UTI fue 62.5% (N = 15). La mortalidad en ARM fue 72.2% (N = 13). La edad, recuento de neutrófilos, índice neutrófilo/linfocito, dímero D, ferritina, tabaquismo y haber adquirido la infección durante la internación resultaron estadísticamente significativos en el análisis univariado para mortalidad. No hallamos diferencias en mortalidad por estadio de enfermedad, en los pacientes con tumores sólidos, ni por haber recibido tratamiento antineoplá sico dentro de los 30 días del diagnóstico de COVID-19. En el análisis multivariado con el modelo de regresión logística, solo la edad y el tabaquismo fueron predictores de mortalidad. Los odds ratios (IC 95) ajustados para la edad ≥65 años y el tabaquismo fueron 8.87 (1.35-58.02) y 8.64 (1.32-56.64), respectivamente. Este trabajo puede resultar de utilidad para instituciones polivalentes que asistan pacientes oncológicos durante la pandemia.


Abstract Cancer patients are exposed to more complications from COVID-19 than non-cancer patients. We report a cohort of 74 cancer patients (87.8% with solid neoplasia and 12.2% with hematological diseases) with COVID-19 infection admitted to a tertiary medical cancer center in Argentina. Pulmonary infiltrates were diagnosed at admission in 78.3% (N = 58) of the cases. COVID-19 infection was hospital-acquired in 20 (27.0%) patients. Thirty-nine patients (52.7%) received anticancer therapy within the 30 days prior to COVID-19 diagnosis; one was on radiation therapy. Twenty-four (32.4%) patients were admitted in the intensive care unit (ICU) and 18 (75.0%) required mechanical ventilation. All cause in-hospital mortality was 32.4% (N = 24) and ICU mortality was 62.5% (N = 15). Mortality under me chanical ventilation was 72.2% (N = 13). In the univariate analysis age, neutrophil count, neutrophil/lymphocyte index, D-dimer, ferritin, smoking, and nosocomial acquired infection were associated with in-hospital mortality. There were no statistically significant differences in mortality related to disease stage for solid tumors, neither cancer treatment within 30 days of COVID-19 diagnosis. Age and smoking were associated with mortality in the multivariate analysis. The adjusted odds ratios (95 CI) for age ≥ 65 years and smoking were 8.87 (1.35-58.02) and 8.64 (1.32 - 56.64), respectively. Our experience can be useful for other institutions that assist cancer patients during the pandemic.


Subject(s)
Humans , Aged , COVID-19 , Neoplasms/therapy , Hospital Mortality , COVID-19 Testing , SARS-CoV-2
4.
Medicina (B.Aires) ; 81(4): 536-545, ago. 2021. graf
Article in English | LILACS | ID: biblio-1346504

ABSTRACT

Abstract Individuals with malignancies and COVID-19 have a lower survival compared with the general population. However, the information about the impact of COVID-19 on the whole hematological population is scarce. We aimed to describe the 30th day overall survival (OS) after COVID-19 infection in pa tients with a hematological disease in Argentina. A completely anonymous survey from the Argentine Society of Hematology was delivered to all the hematologists in Argentina; it started in April 2020. A cut-off to analyze the data was performed in December 2020 and, finally, 419 patients were reported and suitable for the analysis (average age: 58 years, 90% with malignant diseases). After the COVID-19 diagnosis, the 30-day OS for the whole population was 80.2%. From the entire group (419), 101 (24.1%) individuals required intensive care unit admission, where the 30-day OS was 46.6%. Among allogeneic stem cell transplant recipients, the 30-day OS was 70.3%. Factors associated with a low OS were two or more comorbidities, an active hematological disease and history of chemotherapy. In individuals with the three factors, the 30-day OS was 49.6% while the 30-day OS in those without those factors was 100%. Patients with hematological diseases have a higher mortality than the general population. This group represents a challenge and requires careful decision-making of the treatment in order not to compromise the chances of cure.


Resumen El presente estudio tuvo por objetivo primario conocer la mortalidad de pacientes con enfermedad hematológica que presentaron infección por COVID-19 en Argentina. Para ello se difundió una encuesta desde la Sociedad Argentina de Hematología (SAH) entre los hematológos para informar sobre los pacientes con enfermedades hematológicas y diagnóstico de infección por SARS- CoV-2, entre el 19/4/2020, y el 7/12/2020. Se incluyeron individuos de todas las edades con diagnóstico de enfermedad hematológica benigna o maligna e infección por SARS-CoV-2 confirmada por técnica de RT-PCR. Se analizaron 419 pacientes (mediana 58 años; 90% enfermedades malignas). La supervivencia al día 30 fue de 80.2%. La supervivencia fue menor en aquellos que requirieron internación (74.2%), cuidados intensivos (46.6%) y asistencia respiratoria mecánica (36.8%). Entre los trasplantados alogénicos la supervivencia fue 70.3%. Los factores vinculados a la supervivencia global fueron las comorbilidades, el estado de la enfermedad al momento de la infección y el antecedente de quimioterapia. Se pudo establecer un score en el que aquellos que tuvieron un puntaje de 4 alcanzaron una supervivencia del 49.6% al día 30, mientras que la de los pacientes con score 0 fue del 100% a 30 días. En comparación con la población general, los pacientes con enfermedades hematológicas presentan una mayor mortalidad vinculada al COVID-19, motivo por el cual es primordial definir pautas destinadas a disminuir la exposición de los mismos sin comprometer las posibilidades de beneficiarse del tratamiento de la enfermedad de base.


Subject(s)
Humans , Middle Aged , COVID-19 , Hematology , Argentina/epidemiology , COVID-19 Testing , SARS-CoV-2
6.
Rev. bras. anal. clin ; 53(2): 167-174, 20210630. ilus, tab, graf
Article in Portuguese | LILACS | ID: biblio-1352925

ABSTRACT

A soroprevalência do SARS-CoV-2 foi determinada a partir de um inquérito epidemiológico transversal realizado no Hospital Universitário Gaffrée e Guinle, na cidade do Rio de Janeiro, Brasil, nos meses de outubro a novembro de 2020, durante a pandemia de COVID-19, na população de funcionários que exercia atividade laboral naquele período. A caracterização sociodemográfica foi realizada, além da análise das associações entre as variáveis de interesse ou exposição com a infecção pelo SARS-CoV-2, para estabelecer quais sinais e sintomas foram de maior prevalência. Para o estudo foram coletadas amostras de sangue e utilizados ensaios imunocromatográficos (COVID-19 IgG/IgM ECO Test® e Medtest® Coronavírus (COVID-19) IgG/IgM), para detectar IgG e IgM anti-SARS-CoV-2. Um cálculo amostral obtendo-se 391 profissionais de saúde demonstrou que 173 (44,2%) indivíduos apresentaram ao menos um resultado positivo para infecção pelo SARS-CoV-2. Não houve diferença significativa entre as medianas das idades dos pacientes que apresentaram infecção pelo SARS-CoV-2 (mediana 40 anos, IIQ 34-53) e dos que não apresentaram infecção (mediana 39 anos, IIQ 32-49), valor de P= 0,148. Também não houve diferença entre o sexo dos profissionais com infecção e sem infecção pelo SARS-CoV-2 (OR = 1,02; IC 95% 0,59 ­ 1,78). Dos 173 profissionais que apresentaram infecção pelo SARS-CoV-2, 70 (40,5%) relataram sintomas relacionados à COVID-19, enquanto 41 (23,7%) profissionais relataram que não apresentaram nenhum sintoma e 62 (35,8%) não informaram sobre presença ou não de sintomas, sendo excluídos da análise. Os sintomas mais frequentemente apresentados pelos profissionais infectados foram: cefaleia 46,5% (59/127); perda de olfato 32,3% (41/127); perda de paladar 30,7% (39/127); tosse seca 27,6% (35/127); diarreia 24,4% (31/127); dores no corpo 27,6% (35/127); outros 13,4% (17/127); dores nas pernas 11,8% (15/127); tonteira 11,8% (15/127) e febre 9,4% (12/127). Estabelecer um protocolo de vigilância com um teste fácil e rápido para as políticas de COVID-19 entre os profissionais na linha de frente e atuantes na assistência é imperativo para o controle da transmissão de SARS-CoV-2 e definir critérios epidemiológicos que orientem a tomada de decisão quanto ao isolamento de profissionais infectados sintomáticos e assintomáticos.


The seroprevalence of SARS-CoV-2 was determined from a cross-sectional epidemiological survey carried out at the Gaffrée and Guinle University Hospital in the city of Rio de Janeiro, Brazil from October to November 2020 during the COVID-19 pandemic in the population of employees who worked in that period. Sociodemographic characterization was performed in addition to the analysis of associations between the variables of interest or exposure with SARS-CoV-2 infection to establish which signs and symptoms were more prevalent. For the study, blood samples were collected and immunochromatographic assays (COVID-19 IgG/IgM ECO Test® and Medtest® Coronavirus (COVID-19) IgG/IgM) were used to detect IgG and IgM anti-SARS-CoV-2. A sample calculation obtaining 391 health professionals showed that 173 (44.2%) individuals had at least one positive result for SARS-CoV-2 infection. There was no significant difference between the median ages of patients who had SARS-CoV-2 infection (median 40 years, IIQ 34-53) and those who did not have infection (median 39 years, IIQ 32-49), P value = 0.148. There was also no difference between the sex of professionals with and without SARS-COV-2 infection (OR = 1.02; 95% CI 0.59 ­ 1.78). Of the 173 professionals who had SARS-COV-2 infection, 70 (40.5%) reported symptoms related to COVID-19, while 41 (23.7%) professionals reported that they had no symptoms and 62 (35.8%) did not report on the presence or absence of symptoms, being excluded from the analysis. The symptoms most frequently presented by the infected professionals were: headache 46.5% (59/127); loss of smell 32.3% (41/127); loss of taste 30.7% (39/127); dry cough 27.6% (35/127); diarrhea 24.4% (31/127); body pain 27.6% (35/127); another 13.4% (17/127); leg pain 11.8% (15/127); dizziness 11.8% (15/127) and fever 9.4% (12/127). Establish a surveillance protocol with an easy and quick test for COVID-19 policies among frontline and care professionals is imperative to control the transmission of SARS-CoV-2 and define epidemiological criteria that guide the decision-making regarding the isolation of symptomatic and asymptomatic infected professionals.


Subject(s)
Humans , Male , Female , Signs and Symptoms , Seroepidemiologic Studies , Health Surveys , Health Personnel , COVID-19 Testing , SARS-CoV-2 , COVID-19/diagnosis
8.
Säo Paulo med. j ; 139(2): 190-195, Mar.-Apr. 2021. tab, graf
Article in English | LILACS | ID: biblio-1181008

ABSTRACT

ABSTRACT BACKGROUND: Although it is known that the new coronavirus disease (COVID-19), which was first seen in Wuhan, China, in December 2019 and has affected the whole world, mainly targets the respiratory tract, cases of this disease with a wide clinical spectrum are emerging as information is shared. CASE REPORT: We present the case of a pregnant woman who was diagnosed with venous sinus thrombosis after she developed headache and hemiparesis. Polymerase chain reaction (PCR) positivity lasted for two weeks after COVID-19 had been diagnosed. CONCLUSIONS: In patients with suspected COVID-19, especially in the presence of causes of hypercoagu- lability and presence of atypical features, venous sinus thrombosis needs to be kept in mind in making the differential diagnosis.


Subject(s)
Humans , Female , Pregnancy , Venous Thrombosis/diagnosis , SARS-CoV-2/isolation & purification , SARS-CoV-2/genetics , COVID-19/complications , Headache/etiology , Paresis/etiology , Sinus Thrombosis, Intracranial/diagnostic imaging , China , Polymerase Chain Reaction , Thrombophilia , COVID-19 Testing , COVID-19/diagnosis
9.
Säo Paulo med. j ; 139(2): 186-189, Mar.-Apr. 2021. tab, graf
Article in English | LILACS | ID: biblio-1181004

ABSTRACT

ABSTRACT CONTEXT: Various skin manifestations have been reported in coronavirus disease. It may be difficult to determine the etiology of these lesions in view of the increased frequency of handwashing during the pandemic, along with occurrences of irritant contact dermatitis and allergic contact dermatitis due to disinfectant use; usage of herbal medicine and supplements to strengthen the immune system; and urticarial or maculopapular drug eruptions due to COVID-19 treatment. The variety of associated skin manifestations seen with COVID-19 makes it challenging to identify virus-specific skin manifestations. Petechiae, purpura, acrocyanosis and necrotic and non-necrotic purpura, which can be considered as manifestations of vascular involvement on the skin, have been reported. CASE REPORT: Here, we report a case of eruptive cherry angiomas, which was thought to have developed due to COVID-19, with a papulovesicular rash on distal extremities that progressed over time to reticular purpura. CONCLUSION: The case presented had a papulovesicular rash at the onset, which evolved to retiform purpura, and eruptive cherry angiomas were observed. It should be kept in mind that dermatological signs may vary in patients with COVID-19.


Subject(s)
Humans , Male , Female , Middle Aged , Purpura/virology , Skin/virology , Skin Diseases, Viral/virology , Exanthema/virology , COVID-19/complications , COVID-19/virology , Hemangioma/virology , Skin/drug effects , Skin/pathology , Treatment Outcome , Skin Diseases, Viral/diagnosis , Skin Diseases, Viral/therapy , COVID-19 Testing , SARS-CoV-2 , COVID-19/drug therapy , COVID-19/therapy
10.
Washington; Organización Panamericana de la Salud; Mar. 17, 2021. 89 p. tab.
Non-conventional in Spanish | LILACS | ID: biblio-1253360

ABSTRACT

En este documento se presenta orientación provisional sobre las mejores prácticas para evaluar la efectividad de las vacunas contra la COVID-19 usando el diseño de estudio observacional. Se examinan las consideraciones esenciales del diseño, el análisis y la interpretación de las evaluaciones de la efectividad de las vacunas contra la COVID-19, dado que se pueden obtener resultados sesgados aun en entornos en los que la exhaustividad y la calidad de los datos son altas. Esta orientación se dirige principalmente a las evaluaciones realizadas en los países de ingresos bajos o medianos, pero la mayoría de los conceptos también son aplicables en entornos de ingresos altos.


Since its emergence in December 2019, SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has taken a tremendous toll globally; by 28 February 2021, there have been over 110 million cases and 2.5 million deaths worldwide from COVID-19 (1). Although most COVID-19 deaths occur among older adults and persons with chronic comorbid medical conditions, deaths have occurred in persons of all ages. Moreover, the pandemic has caused widespread morbidity and necessitated control measures that have devastated economies worldwide. In response to the pandemic, the global efforts to develop multiple vaccines to protect against COVID-19 disease have been unrivalled in the history of public health. By the end of 2020, three COVID-19 vaccines have received Emergency Use Approval/Listing (EUA/EUL) by maturity level 4 regulatory authorities, based on reaching predefined criteria for safety and efficacy, and at least several dozen more are in clinical trials.


Subject(s)
Humans , Immunization Programs/organization & administration , Vaccination Coverage/statistics & numerical data , COVID-19 Vaccines/immunology , COVID-19 Testing/methods , SARS-CoV-2/immunology , COVID-19/immunology , Data Collection , Adaptive Immunity/immunology , SARS-CoV-2/isolation & purification , SARS-CoV-2/genetics , COVID-19/genetics , COVID-19/virology
11.
Actual. SIDA. infectol ; 29(105): 34-41, 2021 mar. fig, tab
Article in Spanish | LILACS, BINACIS | ID: biblio-1348955

ABSTRACT

Introducción: En COVID-19 grave, identificar pacientes con mayor riesgo de ventilación mecánica (VM) ayuda a optimizar el manejo. Materiales y métodos: Análisis retrospectivo de características clínico-epidemiológicas de pacientes con COVID-19 ingresados a UTI entre marzo/septiembre 2020. Se utilizó estadística descriptiva, análisis univariado (p significativa <0.05) y multivariado (variables significativas en el univariado).Resultados: Ingresaron 114 pacientes, 91 (79,8%) hombres, edad promedio 54,6 ±14,8 años. 66 (57,9%) eran obesos, 44 (38,6%) ≥ 60 años, 38 (33,3%) hipertensos (33,3%) y 28 (24,6%) diabéticos. 39 (23%) tenían ferritina elevada, 62 (76,5%) linfopenia y 33 (41,3%) LDH aumentada. Mortalidad global 34%. 72 pacientes (63,1%) requirieron VM. Los predictores independientes de requerimiento de VM en el análisis multivariado fueron sexo masculino, edad ≥60 años, diabetes, linfopenia y ferritina y LDH aumentadas. Conclusiones: En pacientes con COVID-19 grave, los predictores independientes de necesidad de VM fueron sexo masculino, edad ≥ 60 años, diabetes, niveles elevados de ferritina y LDH y linfopenia


Introduction: In severe COVID-19, identifying patients with a higher risk of mechanical ventilation (MV) helps to optimize management.Materials and methods: Retrospective analysis of clinical-epidemiological characteristics of patients with COVID-19 admitted to ICU between March / September 2020. Descriptive statistics, univariate and multivariate analysis were used. Results: 114 patients were admitted, 91 (79.8%) were men, mean age 54.6 ± 14.8 years. 66 (57.9%) were obese, 44 (38.6%) ≥60 years, 38 (33.3%) were hypertensive (33.3%) and 28 (24.6 %) diabetics. 39 (23%) had elevated ferritin, 62 (76.5%) had lymphopenia, and 33 (41.3%) had increased LDH. Overall mortality 34%. 72 patients (63.1%) required MV. The independent predictors of MV requirement in the multivariate analysis were male sex, age ≥60 years, diabetes, lymphopenia, and increased ferritin and LDH.Conclusions: In patients with severe COVID-19, the independent predictors of the need for MV were male sex, age ≥ 60 years, diabetes, elevated levels of ferritin and LDH, and lymphopenia


Subject(s)
Humans , Middle Aged , Aged , Aged, 80 and over , Oxygen Inhalation Therapy , Respiration, Artificial , Multivariate Analysis , Retrospective Studies , Risk Assessment , COVID-19 Testing , COVID-19/therapy , Intensive Care Units
12.
ABCS health sci ; 46: e021302, 09 fev. 2021. tab, ilus
Article in English | LILACS | ID: biblio-1281240

ABSTRACT

INTRODUCTION: The spread of SARS-CoV-2 has caused a global public health crisis (pandemic). One of the most important measures to control the transmission chain of the new coronavirus is to identify those infected through laboratory testing. OBJECTIVE: Synthesize the recommendations for the specimen collection for detection and diagnosis of COVID-19. METHODS: This is an integrative review, considering the publications of the following databases: PubMed and Google Academic from January 2020. RESULTS: 468 publications were identified, 20 of which were considered eligible. The publications recommend that technical training for specimen collection and careful observation of infection prevention protocols are fundamental. This manuscript highlights the steps for specimen collection as materials for collection, storage, transportation, individual protection, and laboratory analysis of samples. Currently, the Reverse Transcription - Polymerase Chain Reaction test is the recommended and gold standard method of identifying COVID-19 cases. Serological tests play an important role in research and surveillance. CONCLUSION: In summary, the documents ensure that the RT-PCR is the gold standard for SARS-CoV-2 detection and recommend standardization of collection and conditioning methods to avoid errors related to the collection and false negative results.


INTRODUÇÃO: A disseminação do SARS-CoV-2 ocasionou uma crise na saúde pública mundial (pandemia). Uma das mais importantes medidas de controle da cadeia de transmissão do novo coronavírus consiste em identificar os infectados por meio de teste laboratorial. OBJETIVO: Sintetizar as recomendações para a coleta de amostras para detecção e diagnóstico da COVID-19. MÉTODO: Trata-se de uma revisão integrativa, considerando as publicações do Google Acadêmico e Pubmed a partir de janeiro de 2020. RESULTADOS: Foram identificadas 468 publicações, das quais 20 foram consideradas elegíveis. As publicações recomendam que a capacitação técnica para a coleta das amostras e a observação criteriosa de protocolos de prevenção de infecção são fundamentais. Destacam-se nesse artigo as etapas para a coleta de amostras como materiais para coleta, armazenamento, transporte, proteção individual e análise laboratorial das amostras. Atualmente, o teste de Reverse Transcription - Polymerase Chain Reaction é o método recomendado e padrão-ouro para a identificação dos casos de COVID-19. Os testes sorológicos desempenham um papel importante na pesquisa e vigilância. CONCLUSÃO: Em síntese, os documentos asseguram que o RT-PCR é o teste padrão-ouro para detecção do SARS-CoV-2 e recomenda a padronização dos métodos de coleta e acondicionamento, a fim de evitar erros relacionados com a coleta e resultados falso-negativos.


Subject(s)
Specimen Handling , COVID-19 Testing , COVID-19/diagnosis , Pandemics
13.
Article in Chinese | WPRIM | ID: wpr-880476

ABSTRACT

Since the outbreak of COVID-19, the accurate and rapid clinical diagnosis technology of SARS-CoV-2 has played a crucial role in the prevention and control of epidemic situation. This study aims to analyze and discuss the key points for quality control of 2019 novel coronavirus testing kits, while incorporating the actual testing process, the distribution of testing kits and interpretation of relevant policies and regulations.


Subject(s)
COVID-19 , COVID-19 Testing , Humans , Quality Control , SARS-CoV-2
14.
Braz. arch. biol. technol ; 64(spe): e21200147, 2021. tab, graf
Article in English | LILACS | ID: biblio-1285565

ABSTRACT

Abstract With the COVID-19 pandemic, many diagnostic tests (molecular or immunological) were rapidly standardised, given the urgency of the situation, many are still in the process of being validated. The main objective of this study was to review the aspects of the diagnostic kits approved in Brazil and their application in the different federative units to gather epidemiological information. In order to achieve these objectives, a survey was carried out on the data available at the regulatory agency (ANVISA) and in the literature. The main countries that have registered products in Brazil are China (51.4%), Brazil (16.6%), South Korea (9.2%), USA (8.8%) and Germany (3.6%). The methodologies of these products are based on the detection of nucleic-acid (15.8%), antigen (13%) and antibody (71.2%). In the immunological tests, it was verified that the sensitivity ranged from 55 to 100% and the specificity from 80 to 100%. The percentage of cases in the samples tested in Brazil is elevated in almost all federative units since eight states showed 40% of positive cases in tested samples, while 18 states displayed between 20 and 40%. In conclusion, this review showed that Brazil is dependent on external technology to respond to pandemics, epidemics and endemics disease and needs to improve its biotechnological scheme to solve further diseases outbreaks.


Subject(s)
Humans , SARS Virus/isolation & purification , COVID-19/diagnosis , Immunologic Tests/instrumentation , Brazil/epidemiology , Enzyme-Linked Immunosorbent Assay/instrumentation , Chromatography, Affinity/instrumentation , COVID-19 Testing/instrumentation , COVID-19 Nucleic Acid Testing/methods
15.
Cad. Saúde Pública (Online) ; 37(3): e00277420, 2021.
Article in English | LILACS | ID: biblio-1285823

ABSTRACT

Abstract: Since the first recorded case of COVID-19 on February 26, 2020, Brazil has seen an exponential growth in the number of cases and deaths. The national testing approach has been insufficient to correctly use this tool in the support of containing the epidemic in the country. In this communication, we discuss efforts and challenges to scale-up COVID-19 testing at the Brazilian Unified National Health System (SUS). This communication presents the initial results of the research project created to investigate the political, industrial, technological, and regulatory aspects that may affect the diagnostic and testing capacity for COVID-19 in Brazil. The paper draws on the review of academic literature, media publication, and collection of public data on tests purchase and regulation. It enlists initiatives to enhance PCR testing, national production and development of technologies, as well as regulatory measures to fast-track new tests. Our analysis indicates some points of reflection. Firstly, the lack of a consistent national strategy to fight COVID-19 exarcebated supply problems of diagnostic components. If the country was eventually able to circumvent this situation, it still faces a more structural dependency on the importation of diagnostic components. Secondly, the discontinued funding and distribution of tests may have implied health policy fragmentation and the growing importance of local governments and non-state actors to fighting the epidemics within SUS. Finally, initiatives established since the second semester of 2020 have expanded the testing capacity at SUS. However, it has not been sufficient to control the progress of the epidemic in the country.


Resumo: Desde que o primeiro caso de COVID-19 no Brasil foi notificado, em 26 de fevereiro de 2020, o país assiste a um crescimento exponencial no número de casos e mortes. A estratégia nacional de testagem tem sido insuficiente para usar essa ferramenta corretamente no apoio à contenção da epidemia no país. O artigo discute os esforços e desafios para escalonar a testagem para COVID-19 no Sistema Único de Saúde (SUS). O texto apresenta os resultados iniciais de um projeto de pesquisa sobre os aspectos políticos, industriais, tecnológicos e regulatórios que podem afetar a capacidade diagnóstica e de testagem para COVID-19 no Brasil. O estudo se apoia em revisão da literatura cientifica, artigos publicados na mídia e coleta de dados públicos sobre a compra e regulamentação de testes. O texto faz referência a iniciativas para ampliar a testagem de PCR, a produção nacional e o desenvolvimento de tecnologias, além de medidas regulatórias fast-track para novos testes. Nossa análise sugere alguns pontos para reflexão. Primeiro, a falta de uma estratégia nacional consistente para combater a COVID-19 agravou os problemas de fornecimento de reagentes de diagnostico num primeiro momento. Esta situação foi posteriormente resolvida, embora coloque novamente em pauta a dependência estrutural do país na importação de insumos de saúde estratégicos. Em segundo lugar, financiamento e a distribuição de testes, que ocorreram de forma descontinuada, podem indicar a fragmentação da política sanitária, assim como o papel de governos estaduais, municipais e atores não estatais no combate à epidemia no âmbito do SUS. Por último, iniciativas estabelecidas no segundo semestre de 2020 contribuíram para ampliar a capacidade de testagem molecular no SUS. Contudo, essa capacidade não foi suficiente para controlar a epidemia no Brasil.


Resumen: Desde que se registró el primer caso de COVID-19 el 26 de febrero de 2020, Brasil ha visto un crecimiento exponencial en el número de casos y muertes. La estrategia nacional para preconizar el test de diagnóstico ha sido insuficiente en el uso correcto de esta herramienta, con el fin de ayudar a contener la epidemia en el país. Se presentó los esfuerzos y los desafíos para ampliar la realización de pruebas de COVID-19 en el Sistema Único de Salud brasileño (SUS). Este artículo presenta los resultados iniciales del proyecto de investigación sobre los aspectos políticos, industriales, tecnológicos y regulatorios que pueden afectar la capacidad de diagnóstico para la COVID-19 en Brasil. El grupo de investigación realizó una revisión de la literatura académica, medios de comunicación y recogida de datos públicos respecto a la adquisición de tests y su regulación. Se haz referencia a iniciativas para promover la realización de pruebas de PCR, la producción nacional y el desarrollo de tecnologías, así como las medidas regulatorias fast-track para nuevas pruebas. Nuestro análisis indica algunos puntos de reflexión. Primero, la falta de una estrategia nacional consistente para luchar contra la COVID-19 que exacerbó los problemas de sumistro de los componentes de diagnóstico en un primer momento. Se solucionó posteriormente esta situación, aunque se coloque nuevamente en pauta la dependencia estructural del país en la importación de insumos de salud estratégicos. Segundo, la financiación y la distribución de tests de forma descontinuada pueden indicar la fragmentación de la política de salud, así como los gobiernos estaduales, municipales, y atores no estatales asumiendo un rol preponderante en acciones de combate a la epidemia en el SUS. En último, las iniciativas establecidas en el segundo semestre del 2020 contribuyeron para ampliar la capacidad de realización de tests moleculares en el SUS. Sin embargo, esa capacidad no fue suficiente para controlar la epidemia en Brasil.


Subject(s)
Humans , COVID-19 , Brazil , COVID-19 Testing , SARS-CoV-2 , Government Programs
16.
Cad. Saúde Pública (Online) ; 37(1): e00238420, 2021. tab, graf
Article in Portuguese | LILACS | ID: biblio-1153664

ABSTRACT

A ausência de testagens em massa para o diagnóstico da COVID-19 gera a necessidade de conhecer a dimensão da doença por meio da sua sintomatologia clínica. O objetivo foi investigar o perfil de sintomas relacionados à COVID-19 e aspectos relacionados. Foi analisada a amostra de participantes da Pesquisa Nacional por Amostra de Domicílios (PNAD-COVID19) realizada em maio de 2020. Foi realizada análise de classes latentes (ACL) com covariáveis sociodemográficas sobre 11 sintomas relatados por 346.181 indivíduos. Foram utilizados testes de Rao-Scott e análise de resíduos padronizados para mensurar a associação com o padrão de utilização dos serviços de saúde. Análise espacial de varredura foi realizada para identificar as áreas de risco para os casos de COVID-19. A ACL mostrou seis classes de sintomatologia, segundo o padrão de respostas dos indivíduos analisados: (1) todos os sintomas; (2) prevalência alta dos sintomas; (3) predominância de febre; (4) predominância de tosse/dor de garganta; (5) leves sintomas com predominância de dor de cabeça e (6) ausência de sintomas. Pessoas do sexo feminino, cor parda, provenientes das regiões Norte e Nordeste e em todas as três faixas etárias mais velhas apresentaram maior associação com a classe com todos os sintomas (classe 1). A maioria da procura por serviços também foi realizada por esse grupo de indivíduos, porém com distintos perfis de uso. A análise espacial mostrou sobreposição dessa classe com áreas de maior risco de casos de COVID-19. Os achados sustentam a importância da investigação dos sintomas, servindo para a identificação epidemiológica de possíveis casos em um cenário com baixa taxa de testagem populacional.


La ausencia de pruebas masivas para el diagnóstico de la COVID-19 genera la necesidad de conocer la dimensión de la enfermedad mediante su sintomatología clínica. El objetivo fue investigar el perfil de síntomas relacionados con la COVID-19 y sus aspectos relacionados. Se analizó la muestra de participantes de la Encuesta Nacional por Muestra de Domicilios (PNAD-COVID19), realizada en mayo de 2020. Se efectuó el análisis de clases latentes (ACL) con covariables sociodemográficas sobre 11 síntomas mencionados por 346.181 individuos. Se utilizaron pruebas de Rao-Scott y análisis de residuos estandarizados para medir la asociación con el patrón de utilización de los servicios de salud. Se efectuó un análisis espacial de barrido para identificar las áreas de riesgo con casos de COVID-19. La ACL mostró seis clases de sintomatología, según el patrón de respuestas de los individuos analizados: (1) todos los síntomas; (2) prevalencia alta de los síntomas; (3) predominancia de fiebre; (4) predominancia de tos/dolor de garganta; (5) leves síntomas con predominancia de dolor de cabeza y; (6) ausencia de síntomas. Personas del sexo femenino, mestizos/mulatos, provenientes de las regiones Norte y Nordeste y en las tres franjas etarias más viejas presentaron una mayor asociación con la clase de todos los síntomas (clase 1). La mayoría de búsquedas de servicios también se realizó por parte de este grupo de individuos, aunque con distintos perfiles de uso. El análisis espacial mostró sobreposición de esta clase con áreas de mayor riesgo de casos de COVID-19. Estos hallazgos sostienen la importancia de la investigación de los síntomas, sirviendo para la identificación epidemiológica de posibles casos en un escenario con baja tasa de pruebas entre la población.


The lack of mass testing for COVID-19 diagnosis creates the need to determine the magnitude of the disease based on its clinical symptoms. The study aimed to analyze the profile of COVID-19 symptoms and related aspects in Brazil. The author analyzed the sample of participants from the Brazilian National Household Sample Survey (PNAD-COVID19) conducted in May 2020. Latent class analysis (LCA) was performed with sociodemographic covariables and 11 symptoms reported by 346,181 individuals. Rao-Scott test and standardized residual analysis were used to measure the association with the pattern of health services use. Spatial scan analysis was performed to identify areas at risk of COVID-19 cases. LCA showed six classes of symptoms based on the pattern of answers by participants: (1) all the symptoms; (2) high prevalence of symptoms; (3) predominance of fever; (4) predominance of cough/sore throat; (5) mild symptoms with predominance of headache; and (6) absence of symptoms. Female sex, brown skin color, the North and Northeast regions of Brazil, and all three older age brackets showed stronger association with the class with all the symptoms (class 1). Most use of health services was also by this group of individuals, but with different profiles of use. Spatial analysis showed juxtaposition of this class with areas at greater risk of COVID-19. These finding underline the importance of investigating symptoms for the epidemiological identification of possible cases in a scenario with low population testing rates.


Subject(s)
Humans , Male , Aged , COVID-19 , Brazil/epidemiology , Latent Class Analysis , COVID-19 Testing , SARS-CoV-2
17.
Mem. Inst. Oswaldo Cruz ; 116: e210018, 2021. tab, graf
Article in English | LILACS | ID: biblio-1287340

ABSTRACT

BACKGROUND Coronavirus disease 2019 (COVID-19) is highly infectious causing millions of deaths worldwide. Nasopharyngeal swabs are the primary sample of choice for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), thus, to decrease the exposure to potentially infected samples through the collection is a key point to reduce the risk of infection in healthcare workers. OBJECTIVES This study aimed to evaluate the sensitivity and viral load of saliva specimens by days of symptoms onset comparing to nasopharyngeal swabs in subjects with mild symptoms. METHODS Saliva and nasopharyngeal swabs samples were collected from São Paulo Hospital workers presenting mild symptoms, such as fever, cough, sore throat, rhinorrhea, myalgia, headaches, anosmia, ageusia, and fatigue. To understand the positivity and viral load, reverse transcription-polymerase chain reaction (RT-PCR) was performed. FINDINGS Saliva specimens presented a sensitivity of 98.6% compared to nasopharyngeal swabs. Overall, saliva showed lower viral load compared to nasopharyngeal swabs, regarding days of symptoms onset on diagnosis, the first four days had significant changes in viral load and no significant difference was reported in the days five to nine. MAIN CONCLUSIONS Although RT-PCR of saliva has presented a lower viral load compared to nasopharyngeal swabs, saliva specimens are a potential and reliable candidate for COVID-19 diagnosis through RT-PCR.


Subject(s)
Humans , RNA, Viral , COVID-19 , Saliva , Nasopharynx , Viral Load , COVID-19 Testing , SARS-CoV-2
18.
Mem. Inst. Oswaldo Cruz ; 116: e210085, 2021. graf
Article in English | LILACS | ID: biblio-1287339

ABSTRACT

BACKGROUND The high demand for adequate material for the gold standard reverse transcription real-time polymerase chain reaction (RT-qPCR)-based diagnosis imposed by the Coronavirus disease 2019 (COVID-19) pandemic, combined with the inherent contamination risks for healthcare workers during nasopharyngeal swab (NP) sample collection and the discomfort it causes patients, brought the need to identify alternative specimens suitable for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). OBJECTIVES The aim of this work was to compare saliva and gingival fluid swabs to NP swabs as specimens for RT-qPCR-based SARS-CoV-2 diagnosis. METHODS We compared gingival fluid swabs (n = 158) and saliva (n = 207) to the rayon-tipped NP swabs obtained from mild-symptomatic and asymptomatic subjects as specimens for RT-qPCR for SARS-CoV-2 detection. FINDINGS When compared to NP swabs, gingival fluid swabs had a concordance rate of 15.4% among positive samples, zero among inconclusive, and 100% among negative ones. For saliva samples, the concordance rate was 67.6% among positive samples, 42.9% among inconclusive, and 96.8% among negative ones. However, the concordance rate between saliva and NP swabs was higher (96.9%) within samples with lower cycle threshold (Ct) values (Ct > 10 ≤ 25). MAIN CONCLUSIONS Our data suggests that whereas gingival fluid swabs are not substitutes for NP swabs, saliva might be considered whenever NP swabs are not available or recommended.


Subject(s)
Humans , COVID-19 Testing , COVID-19 , Saliva , Specimen Handling , Nasopharynx , Real-Time Polymerase Chain Reaction , SARS-CoV-2
19.
Afr. j. lab. med. (Online) ; 10(1): 1-6, 2021.
Article in English | AIM | ID: biblio-1353359

ABSTRACT

Background: As a novel and deadly acute respiratory syndrome, which later became known as coronavirus disease 2019 (COVID-19), spread beyond China in late January 2020, there were no laboratories in Africa that could test for the disease. However, in early March, just over a month later, 42 African countries had developed the expertise and resources to perform COVID-19 testing. Our goal was to document this public health success story, learn from it, and use it to inform future public health action. Intervention: Three groups were primarily responsible for establishing COVID-19 testing capacity in Africa. The first group comprised early test manufacturers who reacted with incredible speed and ingenuity early in the pandemic, such as the German company TIB MolBiol that developed a molecular test for COVID-19 before the SARS-CoV-2 genome sequence was available. The second group included private and public donors such as the Jack Ma Foundation, and the last were the coordinators of the rollout, such as the World Health Organization and the Africa Centres for Disease Control and Prevention (CDC). Lessons learnt: The first lesson was that speed is critical, especially during a crisis. It was also demonstrated that being a predictable and transparent trusted institution opens doors and improves effectiveness. Africa CDC, which was only three years old, was able to secure significant resources from external partners and rapidly build substantial testing capacity within Africa because it is a trusted institution. Recommendations: Low- and middle-income countries must build local trusted institutions to better prepare for public health challenges


Subject(s)
Humans , Male , Female , Public Health Laboratory Services , COVID-19 Testing , COVID-19 , Africa , Diagnosis
20.
Article in English | WPRIM | ID: wpr-879311

ABSTRACT

In the era of coronavirus disease 2019 (COVID-19) pandemic, imported COVID-19 cases pose great challenges to many countries. Chest CT examination is considered to be complementary to nucleic acid test for COVID-19 detection and diagnosis. We report the first community infected COVID-19 patient by an imported case in Beijing, which manifested as nodular lesions on chest CT imaging at the early stage. Deep Learning (DL)-based diagnostic systems quantitatively monitored the progress of pulmonary lesions in 6 days and timely made alert for suspected pneumonia, so that prompt medical isolation was taken. The patient was confirmed as COVID-19 case after nucleic acid test, for which the community transmission was prevented timely. The roles of DL-assisted diagnosis in helping radiologists screening suspected COVID cases were discussed.


Subject(s)
Adult , Beijing , COVID-19/diagnostic imaging , COVID-19 Testing/methods , Community-Acquired Infections/diagnostic imaging , Deep Learning , Humans , Lung/diagnostic imaging , Male , Tomography, X-Ray Computed/methods
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