New strategy to improve quality control of Montenegro skin test at the production level

Guedes, Deborah Carbonera; Minozzo, João Carlos; Pasquali, Aline Kuhn Sbruzzi; Faulds, Craig B.; Soccol, Carlos Ricardo; Soccol, Vanete Thomaz

doi:10.1590/0037-8682-0131-2017

Cited by 8 publications

(5 citation statements)

References 17 publications

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“…Additionally, lyophilization (freeze drying) extends the shelf life of tuberculin [49] and increases the heat stability of the bacille Calmette-Guérin (BCG) vaccine for tuberculosis [50], but lyophilization has not been explored as an option for leishmanin. Studies could be performed in experimental animal models such as guinea pigs [51] to compare the stability and immunogenicity of liquid or lyophilized soluble leishmanin stored at various temperatures over assorted time periods.…”

Section: Production and Storage Of Leishmaninmentioning

confidence: 99%

A review of the leishmanin skin test: A neglected test for a neglected disease

et al. 2021

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The leishmanin skin test (LST) has been used for decades to detect exposure and immunity to the parasite Leishmania, the causative agent of the neglected tropical disease leishmaniasis. In the LST, Leishmania antigen (leishmanin) is intradermally injected into the forearm. In an individual who has been previously infected, a delayed-type hypersensitivity (DTH) reaction results in a measurable induration at the site of the injection, indicating that previous exposure to Leishmania has resulted in the development of cell-mediated immunity. LST positivity is associated with long-lasting protective immunity against reinfection, most notably as reported for visceral leishmaniasis (VL). Despite efforts over the past few decades, leishmanin antigen is no longer produced under good manufacturing practice (GMP) conditions anywhere in the world. Consequently, the use of the LST in epidemiological studies has declined in favor of serological and molecular tests. In this review, we provide a historical overview of the LST and justification for the reintroduction of leishmanin. A GMP-grade leishmanin can be used to detect immunity in vivo by the LST and can be investigated for use in an interferon-γ release assay (IGRA), which may serve as an in vitro version of the LST. The LST will be a valuable tool for surveillance and epidemiological studies in support of the VL elimination programs and as a surrogate marker of immunity in vaccine clinical trials. Methods A review of the literature was conducted using PubMed as the primary database, with MeSH terms “leishmanin skin test” OR “Montenegro test” OR “Montenegro skin test.” Articles written in English that describe the history or standardization of leishmanin, the use of leishmanin in an IGRA, or the use of the LST in epidemiological studies or vaccine trials were prioritized in our appraisal of the literature.

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Section: Production and Storage Of Leishmaninmentioning

confidence: 99%

A review of the leishmanin skin test: A neglected test for a neglected disease

et al. 2021

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“…Esta prueba suele ser positiva a partir de un mes de adquirida la infección. La fabricación de los antígenos para cada una de las especies presenta algunas dificultades en su fabricación, en su validación y en su control de calidad; por lo que se está proponiendo la utilización de moléculas de nueva generación como los péptidos sintéticos 20,37,[63][64][65][66] .…”

Section: Launclassified

Leishmaniasis: conceptos actuales y revisión de literatura

Marín-Sánchez

2021

UCV-SCIENTIA BIOMÉDICA

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El presente artículo se elaboró en base a una revisión documentada sobre las Leishmaniasis, grupo de enfermedades causadas por diferentes especies de protozoarios intracelulares del género Leishmania transmitidos por insecto infectados de los géneros Phlebotomus y Lutzomyia; son consideradas enfermedades reemergentes, descuidadas u olvidadas, endémicas en casi 100 países, asociadas a pobreza, malnutrición, migraciones, malas condiciones de vivienda, deficiencias de saneamiento, falta de acceso a los servicios médicos, elevados costos y toxicidad de los medicamentos, debilidad del sistema inmunitario, cambio climático, etc.; se estima que cada año existen 1,2 millones de casos anuales (con 20,000 a 30,000 defunciones) y 350 millones de personas están en riesgo de adquirir la infección. Se describe la variedad de formas clínicas de leishmaniasis con énfasis en las formas visceral, cutánea, mucocutánea y difusa, cuyo conocimiento es importante para establecer un diagnóstico correcto que considere la epidemiología, el cuadro clínico sugestivo y los exámenes auxiliares de laboratorio. Para su tratamiento, los antimoniales pentavalentes como estibogluconato de sodio (Pentostan®) y antimoniato de meglumine (Glucantime®) son las drogas de primera línea, a pesar de su toxicidad y aparición de resistencia; como segunda línea se tiene anfotericina B, miltefosina, pentamidina, aminosidina, ketaconazol, itraconazol, etc., que no son suficientes y conllevan a la búsqueda de nuevas alternativas especialmente de origen vegetal. La vigilancia, control y prevención de las leishmaniasis merece un abordaje integrado que incluye huésped, parásito y vector, acorde con los escenarios de cada país y localidad, utilizando todas las herramientas y tecnología disponibles. A pesar de todo lo avanzado, la lucha para reducir la morbimortalidad por leishmaniasis continúa, siendo un desafío que debemos afrontar.

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“…Molecular methods applied for the detection of Leishmania genetic material of was used in dogs (1 publication), and in humans (1 publication). From these publications we recorded a very high overall positivity of 93% (CI 95%; [86][87][88][89][90][91][92][93][94][95][96]. Additional data are required to further explore the suitability of this fluid for DNA detection and leishmaniasis diagnosis.…”

Section: Nasal Secretionmentioning

confidence: 99%

Noninvasive Biological Samples to Detect and Diagnose Infections due to Trypanosomatidae Parasites: A Systematic Review and Meta-Analysis

Sereno¹,

Akhoundi²,

Sayehmri³

et al. 2020

Preprint

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Unicellular eukaryotes of the Trypanosomatidae family include human and animal pathogens that belong to the Trypanosoma and Leishmania genera. Diagnosis of the diseases they caused requires the sampling of body fluids (blood, lymph, peritoneal fluid, cerebrospinal fluid, etc.) or organ biopsies (bone marrow, spleen, etc.), which are mostly obtained through invasive methods. Body fluids or appendages can be alternatives to these invasive biopsies but appropriateness remains poorly studied. To further address this question, we perform a systematic review on clues evidencing the presence of parasites, genetic material, antibodies, and antigens in body secretions, appendages, or the organs or proximal tissues that produce these materials. Paper selection was based on searches in PubMed, Web of Science, WorldWideScience, SciELO, Embase, Google. The information of each selected article (n=333) was classified into different sections and data were extracted from 77 papers. The presence of Trypanosomatidae parasites has been tracked in most of organs or proximal tissues that produce body secretions or appendages, in naturally or experimentally infected hosts. The meta-analysis highlights the paucity of studies on Human African Trypanosomiasis and a the absence on animal Trypanosomiasis. Among the collected data high heterogeneity in terms of the I2 statistic (100%) is recorded. A high positivity is recorded for antibody and genetic material detection in urine of patients and dogs suffering leishmaniasis, and of antigen for leishmaniasis and Chagas disease. Data on conjunctival swab can be analyzed with molecular methods solely for dogs suffering canine visceral leishmaniasis. Saliva and hair/bristle showed a pretty good positivity that support their potential to be used for leishmaniasis diagnosis. In conclusion, our study pinpoints significant gaps that need to be filled in order to properly address the interest of body secretion and hair or bristle for the diagnosis of infections caused by Leishmania and by other Trypanosomatidae parasites.

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New strategy to improve quality control of Montenegro skin test at the production level

Cited by 8 publications

References 17 publications

A review of the leishmanin skin test: A neglected test for a neglected disease

A review of the leishmanin skin test: A neglected test for a neglected disease

Leishmaniasis: conceptos actuales y revisión de literatura

Noninvasive Biological Samples to Detect and Diagnose Infections due to Trypanosomatidae Parasites: A Systematic Review and Meta-Analysis

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