RESUMEN
This study aimed to investigate the factors related to the individual and the health system that contribute to delayed diagnosis of leprosy in an endemic area in the Northeastern Brazil. This is a cross-sectional study of 120 individuals with leprosy. Demographic and clinical data and information on the factors related to the individual and the health system that contribute to delayed diagnosis of leprosy were obtained. Delayed diagnosis in months was estimated for each participant by interviews. A multivariate Poisson's regression analysis was performed between the outcome and the independent variables. The median delay in the diagnosis of leprosy was 10.5 (4.0-24.0) months. Approximately 12.6% of participants had grade 2 disability (G2D) at the time of diagnosis. In the multivariate Poisson regression analysis, males, older age, low schooling level, residing in urban areas, multibacellar or tuberculoid leprosy, not seeking healthcare immediately after symptom onset, suspected leprosy, excessive referrals, and the need for three or more consultations to confirm the diagnosis were associated with longer diagnostic delay. This study found a significant delay in the diagnosis of leprosy in Arapiraca, Northeastern Brazil, which may explain the continuously high rate of G2D among new cases. Factors related to the individual and the health system were associated with longer diagnostic delay. Interventions to raise awareness of the disease among the general population and strengthen primary health care are urgently needed.
Asunto(s)
Diagnóstico Tardío , Lepra , Masculino , Humanos , Estudios Transversales , Brasil/epidemiología , Lepra/diagnóstico , Lepra/epidemiología , EscolaridadRESUMEN
Abstract: This study aimed to investigate the factors related to the individual and the health system that contribute to delayed diagnosis of leprosy in an endemic area in the Northeastern Brazil. This is a cross-sectional study of 120 individuals with leprosy. Demographic and clinical data and information on the factors related to the individual and the health system that contribute to delayed diagnosis of leprosy were obtained. Delayed diagnosis in months was estimated for each participant by interviews. A multivariate Poisson's regression analysis was performed between the outcome and the independent variables. The median delay in the diagnosis of leprosy was 10.5 (4.0-24.0) months. Approximately 12.6% of participants had grade 2 disability (G2D) at the time of diagnosis. In the multivariate Poisson regression analysis, males, older age, low schooling level, residing in urban areas, multibacellar or tuberculoid leprosy, not seeking healthcare immediately after symptom onset, suspected leprosy, excessive referrals, and the need for three or more consultations to confirm the diagnosis were associated with longer diagnostic delay. This study found a significant delay in the diagnosis of leprosy in Arapiraca, Northeastern Brazil, which may explain the continuously high rate of G2D among new cases. Factors related to the individual and the health system were associated with longer diagnostic delay. Interventions to raise awareness of the disease among the general population and strengthen primary health care are urgently needed.
Resumo: Neste estudo objetivou-se investigar os fatores relacionados ao indivíduo e ao sistema de saúde que contribuem para o atraso no diagnóstico da hanseníase em uma área endêmica no Nordeste do Brasil. Trata-se de um estudo transversal que incluiu 120 pacientes com hanseníase. Foram obtidos dados demográficos, clínicos e informações sobre fatores relacionados ao indivíduo e ao sistema de saúde que contribuem para o atraso no diagnóstico da hanseníase. O atraso do diagnóstico em meses foi estimado para cada participante por meio de entrevistas. Foi realizada uma análise multivariada por regressão de Poisson entre o resultado e as variáveis independentes. A mediana de atraso no diagnóstico da hanseníase foi de 10,5 (4,0-24,0) meses. Aproximadamente 12,6% dos participantes apresentavam grau de incapacidade física 2 (GIF 2) no momento do diagnóstico. Na análise multivariada por regressão de Poisson, homens, idosos, baixa escolaridade, residir em área urbana, hanseníase multibacilar, hanseníase tuberculóide, não procurar atendimento imediatamente após perceber os primeiros sintomas, suspeita de hanseníase, encaminhamentos excessivos e três ou mais consultas necessárias para confirmação diagnóstica associaram-se ao maior atraso diagnóstico. Este estudo encontrou um atraso significativo no diagnóstico da hanseníase em Arapiraca, Nordeste do Brasil, o que pode explicar a taxa continuamente alta de GIF 2 entre os casos novos. Fatores relacionados ao indivíduo e ao sistema de saúde foram associados ao maior atraso no diagnóstico. Intervenções para aumentar a conscientização sobre a doença entre a população geral e fortalecer a atenção primária à saúde são urgentemente necessárias.
Resumen: El objetivo de este estudio fue investigar los factores relacionados con el individuo y el sistema de salud que contribuyen al diagnóstico tardío de la lepra en un área endémica del Nordeste de Brasil. Se trata de un estudio transversal que incluyó a 120 pacientes con lepra. Se obtuvieron datos demográficos, clínicos e informaciones sobre los factores relacionados con el individuo y el sistema de salud que contribuyen al diagnóstico tardío de la lepra. Se estimó el retraso del diagnóstico en meses para cada participante a través de entrevistas. Se realizó un análisis multivariante por regresión de Poisson entre el resultado y las variables independientes. La mediana de retraso en el diagnóstico de lepra fue de 10,5 (4,0-24,0) meses. Aproximadamente el 12,6% de los participantes tenían grado de discapacidad física 2 (GIF 2) en el momento del diagnóstico. En el análisis multivariante por regresión de Poisson se encontró que los hombres, ancianos, la baja escolaridad, vivir en área urbana, la lepra multibacilar, la lepra tuberculoide, no buscar atención médica inmediatamente tras notar los primeros síntomas, la sospecha de lepra, las derivaciones excesivas y la necesidad de tres o más consultas para confirmar el diagnóstico se asociaron con un mayor retraso del diagnóstico. Este estudio encontró un retraso significativo en el diagnóstico de la lepra en Arapiraca, Nordeste de Brasil, lo que puede explicar la tasa continuamente alta de GIF 2 entre los nuevos casos. Factores relacionados con el individuo y el sistema de salud se asociaron con el mayor retraso del diagnóstico. Intervenciones para aumentar la concienciación sobre la enfermedad entre la población general y fortalecer la atención primaria de salud son urgentemente necesarias.
RESUMEN
The COVID-19 pandemic has given rise to numerous commercially available antigen rapid diagnostic tests (Ag-RDTs). To generate and to share accurate and independent data with the global community requires multisite prospective diagnostic evaluations of Ag-RDTs. This report describes the clinical evaluation of the OnSite COVID-19 rapid test (CTK Biotech, CA, USA) in Brazil and the United Kingdom. A total of 496 paired nasopharyngeal (NP) swabs were collected from symptomatic health care workers at Hospital das Clínicas in São Paulo, Brazil, and 211 NP swabs were collected from symptomatic participants at a COVID-19 drive-through testing site in Liverpool, United Kingdom. Swabs were analyzed by Ag-RDT, and results were compared to quantitative reverse transcriptase PCR (RT-qPCR). The clinical sensitivity of the OnSite COVID-19 rapid test in Brazil was 90.3% (95% confidence interval [CI], 75.1 to 96.7%) and in the United Kingdom was 75.3% (95% CI, 64.6 to 83.6%). The clinical specificity in Brazil was 99.4% (95% CI, 98.1 to 99.8%) and in the United Kingdom was 95.5% (95% CI, 90.6 to 97.9%). Concurrently, analytical evaluation of the Ag-RDT was assessed using direct culture supernatant of SARS-CoV-2 strains from wild-type (WT), Alpha, Delta, Gamma, and Omicron lineages. This study provides comparative performance of an Ag-RDT across two different settings, geographical areas, and populations. Overall, the OnSite Ag-RDT demonstrated a lower clinical sensitivity than claimed by the manufacturer. The sensitivity and specificity from the Brazil study fulfilled the performance criteria determined by the World Health Organization, but the performance obtained from the UK study failed to do. Further evaluation of Ag-RDTs should include harmonized protocols between laboratories to facilitate comparison between settings. IMPORTANCE Evaluating rapid diagnostic tests in diverse populations is essential to improving diagnostic responses as it gives an indication of the accuracy in real-world scenarios. In the case of rapid diagnostic testing within this pandemic, lateral flow tests that meet the minimum requirements for sensitivity and specificity can play a key role in increasing testing capacity, allowing timely clinical management of those infected, and protecting health care systems. This is particularly valuable in settings where access to the test gold standard is often restricted.
Asunto(s)
COVID-19 , Humanos , Brasil , COVID-19/diagnóstico , Pandemias , Estudios Prospectivos , SARS-CoV-2 , Reino Unido , Biotecnología , Prueba de COVID-19RESUMEN
The COVID-19 pandemic has led to the commercialization of many antigen-based rapid diagnostic tests (Ag-RDTs), requiring independent evaluations. This report describes the clinical evaluation of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom. The collected samples (446 nasal swabs from Brazil and 246 nasopharyngeal samples from the UK) were analyzed by the Ag-RDT and compared to reverse transcription-quantitative PCR (RT-qPCR). Analytical evaluation of the Ag-RDT was performed using direct culture supernatants of SARS-CoV-2 strains from the wild-type (B.1), Alpha (B.1.1.7), Delta (B.1.617.2), Gamma (P.1), and Omicron (B.1.1.529) lineages. An overall sensitivity and specificity of 88.2% (95% confidence interval [CI], 81.3 to 93.3) and 100.0% (95% CI, 99.1 to 100.0), respectively, were obtained for the Brazilian and UK cohorts. The analytical limit of detection was determined as 1.0 × 103 PFU/mL (Alpha), 2.5 × 102 PFU/mL (Delta), 2.5 × 103 PFU/mL (Gamma), and 1.0 × 103 PFU/mL (Omicron), giving a viral copy equivalent of approximately 2.1 × 104 copies/mL, 9.0 × 105 copies/mL, 1.7 × 106 copies/mL, and 1.8 × 105 copies/mL for the Ag-RDT, respectively. Overall, while a higher sensitivity was claimed by the manufacturers than that found in this study, this evaluation finds that the Ag-RDT meets the WHO minimum performance requirements for sensitivity and specificity of COVID-19 Ag-RDTs. This study illustrates the comparative performance of the Hotgen Ag-RDT across two global settings and considers the different approaches in evaluation methods. IMPORTANCE Since the beginning of the SARS-CoV-2 pandemic, we have witnessed growing numbers of antigen rapid diagnostic tests (Ag-RDTs) being brought to market. In the United Kingdom, this was somewhat controlled indirectly as the government offered free tests from a small number of companies. However, as this has now ceased, individuals are responsible for their own acquisition of test kits. Similarly in Brazil, as of January 2022, pharmacies and other health care retailers are permitted to sell Ag-RDTs directly to the community. Many of these Ag-RDTs have not been externally evaluated, and results are not readily available to the public. Thus, there is now a need for a transparent evaluation of Ag-RDTs with both analytical and clinical evaluation. We present an independent review of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom.