Performance differences among commercially available antigen rapid tests for COVID-19 in Brazil.

A rapid and accurate diagnosis is a crucial strategy for containing the coronavirus disease (COVID-19) pandemic. Considering the obstacles to upscaling the use of RT-qPCR, rapid tests based on antigen detection (Ag-RDT) have become an alternative to enhance mass testing, reducing the time for a prompt diagnosis and virus spreading. However, the performances of several commercially available Ag-RDTs have not yet been evaluated in several countries. Here, we evaluate the performance of eight Ag-RDTs available in Brazil to diagnose COVID-19. Patients admitted to tertiary hospitals with moderate or mild COVID-19 symptoms and presenting risk factors for severe disease were included. The tests were performed using a masked protocol, strictly following the manufacturer's recommendations and were compared with RT-qPCR. The overall sensitivity of the tests ranged from 9.8 to 81.1%, and specificity greater than 83% was observed for all the evaluated tests. Overall, slight or fair agreement was observed between Ag-RDTs and RT-PCR, except for the Ag-RDT COVID-19 (Acro Biotech), in which moderate agreement was observed. Lower sensitivity of Ag-RDTs was observed for patients with cycle threshold > 25, indicating that the sensitivity was directly affected by viral load, whereas the effect of the disease duration was unclear. Despite the lower sensitivity of Ag-RDTs compared with RT-qPCR, its easy fulfillment and promptness still justify its use, even at hospital admission. However, the main advantage of Ag-RDTs seems to be the possibility of increasing access to the diagnosis of COVID-19 in patients with a high viral load, allowing immediate clinical management and reduction of infectivity and community transmission.

Diagnostic performance of commercially available COVID-19 serology tests in Brazil.

Timely and accurate laboratory testing is essential for managing the global COVID-19 pandemic. Reverse transcription polymerase chain reaction remains the gold-standard for SARS-CoV-2 diagnosis, but several practical issues limit the test's use. Immunoassays have been indicated as an alternative for individual and mass testing. OBJECTIVES: To access the performance of 12 serological tests for COVID-19 diagnosis. METHODS: We conducted a blind evaluation of six lateral-flow immunoassays (LFIAs) and six enzyme-linked immunosorbent assays (ELISAs) commercially available in Brazil for detecting anti-SARS-CoV-2 antibodies. RESULTS: Considering patients with seven or more days of symptoms, the sensitivity ranged from 59.5% to 83.1% for LFIAs and from 50.7% to 92.6% for ELISAs. For both methods, the sensitivity increased with clinical severity and days of symptoms. The agreement among LFIAs performed with digital blood and serum was moderate. Specificity was, in general, higher for LFIAs than for ELISAs. Infectious diseases prevalent in the tropics, such as HIV, leishmaniasis, arboviruses, and malaria, represent conditions with the potential to cause false-positive results with these tests, which significantly compromises their specificity. CONCLUSION: The performance of immunoassays was only moderate, affected by the duration and clinical severity of the disease. Absence of discriminatory power between IgM/IgA and IgG has also been demonstrated, which prevents the use of acute-phase antibodies for decisions on social isolation.

Economic impact of localized cutaneous leishmaniasis on adult patients of a referral service in Belo Horizonte, Minas Gerais State, Brazil.

Cutaneous leishmaniasis (CL) is a disease associated with low-income populations. Thus, in assessing the burden of this disease, it is important to include its economic impact on individuals. We aimed to evaluate CL economic impact on patients treated at a referral service in the State of Minas Gerais, Brazil. This is a cross-sectional study based on the analysis of interviews and medical records from which we assembled direct medical and non-medical costs related to CL, from a societal perspective. One hundred patients were included; 50% had a monthly per capita income of up to USD 259.60 and spent on average USD 187.32 with the disease, representing an average monthly impact of 22.5% (USD 133.80). The disease imposed direct medical costs, such as: private medical appointments, medications, medical exams, dressing material, and co-participation in health insurances. Direct non-medical costs were mainly related to patients' transportation to health centers (USD 4,911.00), but also included medically-necessary care, food, and domestic and business outsourcing services. Although the Brazilian public health system guarantees access to health care, CL still represents a substantial economic impact for patients. The main action to reduce the expenses with this disease is decentralizing services for CL diagnosis and therapeutic approach, as well as increasing their efficiency.

Economic impact of localized cutaneous leishmaniasis on adult patients of a referral service in Belo Horizonte, Minas Gerais State, Brazil / Impacto econômico da leishmaniose cutânea localizada em pacientes adultos em um serviço de referência em Belo Horizonte, Minas Gerais, Brasil / Impacto económico de la leishmaniosis cutánea localizada que afecta a pacientes adultos en un servicio de referencia en Belo Horizonte, Minas Gerais, Brasil

Cutaneous leishmaniasis (CL) is a disease associated with low-income populations. Thus, in assessing the burden of this disease, it is important to include its economic impact on individuals. We aimed to evaluate CL economic impact on patients treated at a referral service in the State of Minas Gerais, Brazil. This is a cross-sectional study based on the analysis of interviews and medical records from which we assembled direct medical and non-medical costs related to CL, from a societal perspective. One hundred patients were included; 50% had a monthly per capita income of up to USD 259.60 and spent on average USD 187.32 with the disease, representing an average monthly impact of 22.5% (USD 133.80). The disease imposed direct medical costs, such as: private medical appointments, medications, medical exams, dressing material, and co-participation in health insurances. Direct non-medical costs were mainly related to patients' transportation to health centers (USD 4,911.00), but also included medically-necessary care, food, and domestic and business outsourcing services. Although the Brazilian public health system guarantees access to health care, CL still represents a substantial economic impact for patients. The main action to reduce the expenses with this disease is decentralizing services for CL diagnosis and therapeutic approach, as well as increasing their efficiency.

A leishmaniose cutânea (LC) é uma doença associada a populações de baixa renda. Portanto, a inclusão do impacto financeiro sobre os pacientes é muito importante para avaliar a carga dessa doença. Tivemos como objetivo avaliar o impacto econômico da LC em pacientes afetados pela doença e tratados em um centro de referência para LC no Estado de Minas Gerais, Brasil. Foi um estudo transversal com base em análise de entrevistas e prontuários médicos para compilação dos gastos médicos e não médicos diretos relacionados à LC, desde uma perspectiva societal. Foram incluídos cem pacientes; 50% tinham renda mensal per capita de até USD 259,60. O gasto médio na doença foi de USD 187,32, o que representa um impacto mensal médio de 22,5% (USD 133,80). A doença impôs custos médicos diretos, como o pagamento por consultas médicas particulares, exames médicos, material para curativos e co-participação em seguro de saúde. Os custos não médicos diretos estiveram relacionados ao transporte dos pacientes até os centros de saúde, cuidados adicionais, alimentação e contratos com serviços terceirizados para atividades domésticas e laborais. O transporte dos pacientes para as consultas médicas representava a principal parcela dos gastos (USD 4.911,00). Embora o acesso à assistência à saúde seja um direito garantido pelo Sistema Único de Saúde, a LC ainda gera um impacto financeiro substancial para os pacientes. A descentralização dos serviços diagnósticos e terapêuticos para LC e o aumento de sua eficiência são as principais medidas que podem reduzir os gastos com essa doença.

La leishmaniosis cutánea (LC) es una enfermedad asociada a poblaciones con ingresos bajos. Por ello, incluir el impacto financiero para las personas es muy importante a la hora de evaluar la carga de esta enfermedad. Nuestro objetivo fue evaluar el impacto económico de la LC, de pacientes afectados por esta enfermedad, que fueron tratados por un servicio de referencia para el tratamiento de la LC en el Estado de Minas Gerais, Brasil. Este estudio transversal basado en entrevistas y análisis de registros médicos para la recopilación de gastos médicos y no-médicos directos, relacionados con la LC desde una a perspectiva social. Se incluyeron a cien pacientes; el 50% contaba con ingresos mensuales per cápita de hasta USD 259,60 y gastaban un promedio de USD 187,32 en la enfermedad, representando un impacto promedio mensual de 22,5% (USD 133,80). La enfermedad supuso costes médicos directos, como el pago de citas médicas privadas, medicamentos, exámenes médicos, material para vendajes, y coparticipación en seguros médicos. Los costes directos no-médicos estaban relacionados con el transporte de los pacientes a los centros de salud, el cuidado necesario, comida, y contratos con servicios externalizados para actividades domésticas y laborales. El transporte de los pacientes para citas médicas representó la principal razón para los gastos (USD 4.911,00). A pesar de que el acceso a los cuidados de salud es un derecho garantizado por el sistema de salud público brasileño, la LC todavía supone un impacto financiero importante para los pacientes. La descentralización de los servicios para el diagnóstico de LC, la aproximación terapéutica, y el incremento de su eficiencia, son las acciones con principal potencial para reducir los gastos financieros de esta enfermedad.

How cutaneous leishmaniasis and treatment impacts in the patients' lives: A cross-sectional study.

BACKGROUND: Until now, few studies have evaluated the effect of cutaneous leishmaniasis (CL) on patients' quality of life, and none have used a specific instrument to measure this effect. The objective of this study was to identify factors that may be associated with the high impact of CL and to assess patients' satisfaction with treatment and health services by utilizing a disease-specific questionnaire. METHODOLOGY: Between December 2015 and May 2017, 100 patients with localized cutaneous leishmaniasis were interviewed at a leishmaniasis referral center in Brazil. Data were collected by two questionnaires. One questionnaire compiled the sociodemographic, economic, and clinical information related to the disease. The second questionnaire was the Cutaneous Leishmaniasis Impact Questionnaire (CLIQ), which consisted of two subscales that measured 1) the general impact of CL and 2) patients' perceptions of treatment and health services. The median scores from each of these two subscales were used to dichotomize the dependent variables. Risk factors for the high impact of CL and for low patient satisfaction with treatment and health services were analyzed with a logistic regression analysis. RESULTS: The chance of higher impact of CL was increased in patients with the presence of comorbidities (OR: 3.9; CI 1.25-12.36), in those with absences from work (OR: 12.0; CI 3.78-42.55), in those who relied on public transportation by a municipal bus (OR: 5.8; CI 1.27-26.77), and in those who had illness-related expenses greater than U$137 (OR: 3.5; CI 1.17-10.24). The chance of patient dissatisfaction with treatment and health services increased with higher education (OR: 5.0; CI 1.19-21.03) and with illness-related expenses exceeding U$137 (OR: 4.64; CI 1.49-14.48). Once the sample was non-probabilistic, findings are not representative of CL patients in general. CONCLUSIONS: CL and its treatment have a negative impact on patients' quality of life. Considering these effects during public health planning may help patients to confront the disease.

Development and initial validation of a cutaneous leishmaniasis impact questionnaire.

BACKGROUND: The impact of cutaneous leishmaniasis (CL) on the quality of life of patients has been neglected in research studies worldwide. The few reported studies have used non-specific questionnaires for the disease, which represents a limitation since generic instruments may not address specific aspects of the disease, compromising the evaluation of its real impact. The aim of this paper is to describe the development and the initial validation of an instrument for evaluating the impact of CL, named the Cutaneous Leishmaniasis Impact Questionnaire. METHODOLOGY: The formulation and validation of the instrument consisted of the following steps: (1) literature review; (2) conceptual framework construction and initial item generation; (3) tool analysis by health professionals (experts); (4) tool evaluation performed by the patients; and (5) a pilot study with 100 patients with localized CL, evaluated at a reference ambulatory facility in Belo Horizonte, in the state of Minas Gerais, Brazil. The structure of the proposed instrument was analyzed using hierarchical cluster analysis (ICLUST). RESULTS: Twenty-seven items were initially proposed by the researchers to compose the questionnaire. Content validity (evaluates if the instrument fully assesses the construct of interest) was evaluated by the panel of experts, while face validity (evaluates how potential participants interpret the items) was evaluated by the target population. In this step, some items were excluded, reformulated and/or included. After evaluating a factorial structure of the items in accordance with the cluster analysis, we assembled a questionnaire with 25 items (alpha = 0.86), with high reliability and homogeneity, which address the following: 1) the general impact of the disease (alpha = 0.91, beta = 0.67) and 2) the evaluation of the perception about the treatment and health services (alpha = 0.72, beta = 0.51). CONCLUSIONS: The Cutaneous Leishmaniasis Impact Questionnaire, developed with contributions from patients and experts, was confirmed, in this first validation, as a useful and reliable instrument.

Mucosal leishmaniasis: the experience of a Brazilian referral center.

INTRODUCTION: Pentavalent antimonials (Sbv) are the most commonly used drugs for the treatment of mucosal leishmaniasis (ML), despite their high toxicity and only moderate efficacy. The aim of this study was to report therapeutic responses with different available options for ML. METHODS: This study was based on a review of clinical records of 35 patients (24 men and 11 women) treated between 2009 and 2015. RESULTS: The median age of patients was 63 years, and the median duration of the disease was 24 months. Seventeen patients received Sbv, while nine patients were treated with liposomal amphotericin B (AmB), and another nine patients were treated with fluconazole. Patients treated with AmB received a total median accumulated dose of 2550mg. The mean duration of azole use was 120 days, and the daily dose ranged from 450 to 900mg. At the three-month follow-up visit, the cure rate was 35%, 67%, and 22% for Sbv, AmB, and azole groups, respectively. At the six-month follow-up visit, the cure rates for Sbv, AmB, and azole groups were 71%, 78%, and 33%, respectively. CONCLUSIONS: There is a scarcity of effective ML treatment alternatives, and based on our observations, fluconazole is not a valid treatment option.

Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial.

BACKGROUND: Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES: The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS: It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS: A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).

Mucosal leishmaniasis: the experience of a Brazilian referral center

Abstract INTRODUCTION Pentavalent antimonials (Sbv) are the most commonly used drugs for the treatment of mucosal leishmaniasis (ML), despite their high toxicity and only moderate efficacy. The aim of this study was to report therapeutic responses with different available options for ML. METHODS This study was based on a review of clinical records of 35 patients (24 men and 11 women) treated between 2009 and 2015. RESULTS The median age of patients was 63 years, and the median duration of the disease was 24 months. Seventeen patients received Sbv, while nine patients were treated with liposomal amphotericin B (AmB), and another nine patients were treated with fluconazole. Patients treated with AmB received a total median accumulated dose of 2550mg. The mean duration of azole use was 120 days, and the daily dose ranged from 450 to 900mg. At the three-month follow-up visit, the cure rate was 35%, 67%, and 22% for Sbv, AmB, and azole groups, respectively. At the six-month follow-up visit, the cure rates for Sbv, AmB, and azole groups were 71%, 78%, and 33%, respectively. CONCLUSIONS There is a scarcity of effective ML treatment alternatives, and based on our observations, fluconazole is not a valid treatment option.

Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial

BACKGROUND Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).

Improvement of direct agglutination test (DAT) for laboratory diagnosis of visceral leishmaniasis in Brazil.

We previously standardized the direct agglutination test (DAT) to detect anti-Leishmania chagasi promastigote antibodies (DAT-LPC) with good sensitivity and specificity for diagnosing visceral leishmaniasis (VL). In this paper, we present a technical upgrade by introducing some modifications into the antigen preparation. This antigen was evaluated in DAT (DAT-Mod) using 61 sera samples from VL patients and 96 samples from patients with other diseases. The DAT-Mod presented a cut-off of 1:100, satisfactory reproducibility (VC <5.8), sensitivity of 93.4%, specificity of 96.9%, and diagnostic efficiency of 95.5%. The improvement in antigen preparation reduced inter-batch variations and resulted in a high test performance.

Comparative evaluation of direct agglutination test, rK39 and soluble antigen ELISA and IFAT for the diagnosis of visceral leishmaniasis.

Five serological tests for the diagnosis of visceral leishmaniasis (VL) were compared: a direct agglutination test (DAT) based on freeze-dried antigen (DAT-fd); a locally produced DAT (DAT-LPC); an IgG ELISA against rK39 (ELISA-rK39); an IgG ELISA for Leishmania chagasi (ELISA-L. chagasi); and an IgG IFAT against L. chagasi. Serum samples from 88 patients with VL, 20 non-infected individuals and 85 patients with others infectious diseases were evaluated. The sensitivity rates were: DAT-fd, 96.6%; DAT-LPC, 95.5%; ELISA-rK39, 88.6%; ELISA-L. chagasi, 89.8%; and IFAT, 92.0% (P>0.05). The specificity for the control groups varied from 53.3% to 100%. DAT-fd had the highest efficiency (97.4%), followed by DAT-LPC (91.7%) and ELISA-rK39 (90.7%). Our data suggest that DAT-fd, DAT-LPC and ELISA-rK39 are useful tests for the diagnosis of VL and could replace IFAT as the routine diagnostic test in Brazil.

Validação do teste imunocromatográfico rápido IT-LEISH® para o diagnóstico da leishmaniose visceral humana / Validation of the rapid immunochromatographic test IT-LEISH® for the diagnosis of human visceral leishmaniasis

O teste imunocromatográfico rápido IT-LEISH® (DiaMed IT-LEISH®) foi validado para o diagnóstico da leishmaniose visceral (LV) em quatro áreas endêmicas do Brasil. O desempenho do IT-LEISH® foi comparado ao da reação de imunofluorescência indireta; e ao da reação imunoenzimática, usando-se antígeno solúvel de Leishmania chagasi e recombinante K39 (rK39). O estudo incluiu 332 pacientes com quadro clínico sugestivo de LV: 213 casos de LV confirmados parasitologicamente; e 119 não-casos, com confirmação de outra etiologia. O teste IT-LEISH® apresentou sensibilidade de 93 por cento e especificidade de 97 por cento. As técnicas RIFI (imunofluorescência indireta), ELISA L. chagasi e ELISA rK39 apresentaram sensibilidade de 88 por cento, 92 por cento e 97 por cento e especificidades de 81 por cento, 77 por cento e 84 por cento, respectivamente. Os resultados confirmam a validade do teste IT-LEISH® para o diagnóstico da LV no Brasil...

Leishmania (Viannia) subgenus kDNA amplification for the diagnosis of mucosal leishmaniasis.

The utility of 2 polymerase chain reaction (PCR)-based assays amplifying genus or Viannia subgenus Leishmania minicircle kDNA for the diagnostics of ML was assessed. The Viannia subgenus product was yielded after PCR from isolates of L. (Viannia) braziliensis, L. (Viannia) colombiensis, and L. (Viannia) guyanensis, whereas no product was obtained with the non-Viannia-pertaining species: L. (Leishmania) amazonensis, L. (Leishmania) donovani, and L. (Leishmania) chagasi. With both assays, 11 of 13 (86.4%) patients with confirmed ML could be identified, whereas only 2 (16.7%) of these patients were positive by microscopy. All amplified genus-specific products gave a positive signal by hybridization with a Leishmania (Viannia) subgenus-specific radioactive probe. The Viannia subgenus-specific kDNA PCR represents a sensitive and specific tool for the diagnosis of ML, remarkably improving the sensitivity of parasitological methods and offering an alternative for the radioactive-dependent assays for subgenus characterization.

Diagnóstico laboratorial das formas mucosa e muco-cutânea da leishmaniose tegumentar americana / Laboratory diagnosis of mucous membrane forms the skin and muco-cutaneous leishmaniasis

Neste estudo, avaliamos a eficiência dos métodos mais comumente utilizados na rotina do diagnóstico da leishmaniose mucosa (LM) e muco-cutânea (LMC). O grupo de (LM) foi composto por 19 pacientes, sendo 13 (68,4 por cento) homens e 6 (31,6 por cento) mulheres. A média de idade foi de 56,9 com mediana de 58 anos (min=29 e máx=95). O tempo médio da lesão foi de 65 meses. O grupo de (LMC) foi composto por 17 pacientes, sendo 12 (70,6 por cento) homens e 5 (29,4 por cento) mulheres. A idade média do grupo LMC foi de 46,7 com mediana de 49 (min=18 e máx=79), com tempo médio de lesão de 148 meses. Foram realizadas hemoculturas antes do diagnóstico, aos 30, 90 e 180 dias após o tratamento, sendo os resultados sempre negativos. As culturas de fragmento de mucosa também foram negativas. A impressão por aposição do fragmento de biópsia foi positivo em um paciente do grupo LM e um grupo LMC. A intradermo reação de Montenegro foi realizada em 36 pacientes, conferindo sensibilidade de 95,2 por cento sendo de 100 por cento para o grupo de LM e 83,3 por cento do grupo LMC. A sensibilidade da PCR de fragmento de biópsia foi de 84,6 por cento e 100 por cento para os grupos de LM e LMC, respectivamente. A especificidade da PRC foi de 93,3 por cento. Antes do tratamento, detectou-se por PRC parasitário ou DNA do parasito circulante em um paciente do grupo LM. Após o tratamento, a PRC foi positiva em dois pacientes do grupo LM (aos 90 dias e, aos 180 dias) e um paciente do grupo LMC (aos 30 dias). A pesquisa de anticorpos foi avaliada através dos testes ELISA (IgA, IgG, total, IgG1, IgG2, IgG3 e IgG4) e RIFI (IgG total) utilizando antígenos de L.braziliensis e de L.amazonensis. Não foram detectados anticorpos IgA, IgG2 e IgG4. A sensibilidade da RIFI variou entre 100 por cento (Lb)e 89,5 por cento (La). A especificidade foi avaliada em pacientes portadores de Doença de Chagas, Malária, Sífilis e indivíduos não-infectados de área endêmica, sendo encontrada especificidade entre 65 por cento e 100 por cento. No ELISA, a sensibilidade variou de 64 por cento a 100 por cento e a especificidade de 40 por cento a 100 por cento. No acompanhamento pós-tratamento, não foi observada queda dos níveis de anticorpos pela técnica de RIFI. Pelo ELISA, observou-se queda dos anticorpos IgG totais anti-L braziliensis a partir de 90 dias pós-tratamento para o grupo LM (sendo a IgG3 a principal responsável pela queda) a aos 180 dias pós-tratamento para o grupo LMC. Para IgG1, a queda dos níveis de anticorpos só foi observada aos 180 dias pós-tratamento para o grupo LM nos dois antígenos estudados. A queda dos níveis de IgG3 só aconteceu utilizando a L. braziliensis, no grupo LM, a partir dos 90 dias pós-tratamento.

Diagnóstico laboratorial das formas mucosa e muco-cutânea da leishmaniose tegumentar americana

Neste estudo, avaliamos a eficiência dos métodos mais comumente utilizados na rotina do diagnóstico da leishmaniose mucosa (LM) e muco-cutânea (LMC). O grupo de (LM) foi composto por 19 pacientes, sendo 13(68,4 por cento)homens e 6(31,6 por cento)mulheres. A média de idade foi de 56,9 com mediana de 58 anos (min=29 e máx=95). O tempo médio da lesão foi de 65 meses. O grupo de (LMC) foi composto por 17 pacientes, sendo 12(70,6 por cento) homens e 5(29,4 por cento) mulheres. A idade média do grupo LMC foi de 46,7 com mediana de 49(min=18 e máx=79), com tempo médio de lesão de 148 meses. Foram realizadas hemoculturas antes do diagnóstico, aos 30, 90 e 180 dias após o tratamento, sendo os resultados sempre negativos. As culturas de fragmento de mucosa também foram negativas. A impressão por aposição do fragmento de biópsia foi positivo em um paciente do grupo LM e um grupo LMC. A intradermo reação de Montenegro foi realizada em 36 pacientes, conferindo sensibilidade de 95,2 por cento sendo de 100 por cento para o grupo de LM e 83,3 por cento do grupo LMC. A sensibilidade da PCR de fragmento de biópsia foi de 84,6 por cento e 100 por cento para os grupos de LM e LMC, respectivamente. A especificidade da PRC foi de 93,3 por cento. Antes do tratamento, detectou-se por PRC parasitário ou DNA do parasito circulante em um paciente do grupo LM. Após o tratamento, a PRC foi positiva em dois pacientes do grupo LM(aos 90 dias e, aos 180 dias) e um paciente do grupo LMC(aos 30 dias). A pesquisa de anticorpos foi avaliada através dos testes ELISA (IgA, IgG, total, IgG1, IgG2, IgG3 e IgG4) e RIFI(IgG total) utilizando antígenos de L.braziliensis e de L.amazonensis. Não foram detectados anticorpos IgA, IgG2 e IgG4. A sensibilidade da RIFI variou entre 100 por cento(Lb)e 89,5 por cento(La).

A especificidade foi avaliada em pacientes portadores de Doença de Chagas, Malária, Sífilis e indivíduos não-infectados de área endêmica, sendo encontrada especificidade entre 65 por cento e 100 por cento. No ELISA, a sensibilidade variou de 64 por cento a 100 por cento e a especificidade de 40 por cento a 100 por cento. No acompanhamento pós-tratamento, não foi observada queda dos níveis de anticorpos pela técnica de RIFI. Pelo ELISA, observou-se queda dos anticorpos IgG totais anti-L braziliensis a partir de 90 dias pós-tratamento para o grupo LM(sendo a IgG3 a principal responsável pela queda) a aos 180 dias pós-tratamento para o grupo LMC. Para IgG1, a queda dos níveis de anticorpos só foi observada aos 180 dias pós-tratamento para o grupo LM nos dois antígenos estudados. A queda dos níveis de IgG3 só aconteceu utilizando a L.braziliensis, no grupo LM, a partir dos 90 dias pós-tratamento.