A Brief Discussion on the in Vitro Diagnostic Reagent Inspection Practice of Self-examination Management Regulations for Medical Device Registration / 中国医疗器械杂志

On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.

La trazabilidad en las mediciones del laboratorio clínico: impacto en la calidad y seguridad del paciente / Traceability in clinical laboratory measurements: impact on quality and patient safety

Las mediciones confiables, trazables metrológicamente y comparables proporcionan la base racional para la evaluación de la calidad de un resultado y el fortalecimiento de las redes de laboratorios clínicos, lo cual permite mejorar la calidad de atención y la seguridad del paciente. En este documento se revisan los principios básicos que deben seguirse para garantizar la trazabilidad de las mediciones del laboratorio clínico, las ventajas de utilizar métodos trazables, el impacto de no hacerlo, y se discuten las principales limitaciones para relacionar las mediciones con los estándares de medición de referencia apropiados

Reliable, metrologically traceable, and comparable measurements provide the rationale for evaluating the quality of a result and strengthening clinical laboratory networks, thereby improving quality of care and patient safety. This document reviews the basic principles that must be followed to ensure the traceability of clinical laboratory results, the advantages of using traceable methods, the impact of not doing so, and the main limitations in relating measurements to appropriate reference standards

Discussion on Supervision and Sampling of Biochemical Test Kits / 中国医疗器械杂志

As an important part of medical devices, in vitro diagnostic reagents are important means to prevent and diagnose and protect people's health. Supervision and sampling is an important and key supervision method to ensure the in vitro diagnostic reagent products are qualified. This paper summarizes the problems encountered in recent years in vitro diagnostic quantitative testing kit supervision sampling, analyzes the causes of these problems, and puts forward corresponding suggestions, hoping to provide constructive suggestions for supervision sampling.

Potencialidades da atenção primária à saúde na consolidação do teste rápido anti-HIV: análise do discurso / The potential of primary health care in the consolidation of the of the anti-HIV rapid test: discourse analysis / Potencialidades de la atención primaria en la consolidación de la prueba rápida del VIH: análisis del discurso

Objetivo: analisar o discurso dos gerentes de saúde a respeito das potencialidades para realização do Teste Rápido anti-HIV na Atenção Primária à Saúde. Método: estudo exploratório, qualitativo, realizado em um dos cinco Distritos Sanitários da capital paraibana. A coleta de dados foi realizada em setembro de 2017. Utilizou-se o dispositivo teórico-metodológico da Análise do Discurso, de matriz francesa, por meio do conceito-análise potencialização da APS na consolidação do TR anti-HIV, divididos em dois blocos discursivos: a acessibilidade geográfica e a acessibilidade sócio-organizacional. Resultados: os discursos apontam elementos potencializadores da APS para a realização TR anti-HIV: proximidade do serviço de saúde, arranjos organizacionais, diagnóstico precoce do HIV, agilidade no resultado do teste rápido anti-HIV e tratamento imediato. Conclusão: verificou-se potencialidades na consolidação do teste rápido anti-HIV, evidenciando a Atenção Primária à Saúde como um espaço facilitador na ampliação da integralidade e o acesso aos serviços de saúde.

Objective: to analyze the discourse of health managers regarding the potentialities for conducting the HIV Rapid Test in Primary Health Care. Method: exploratory, qualitative study, conducted in one of the five Health Districts of the capital of Paraíba. Data collection was carried out in September 2017. We used the theoretical and methodological device of Discourse Analysis, of French matrix, through the concept-analysis potentialization of PHC in the consolidation of anti-HIV TR, divided into two discursive blocks: geographical accessibility and socio-organizational accessibility. Results: the speeches point out potentializing elements of PHC for the realization of anti-HIV test: proximity of the health service, organizational arrangements, early diagnosis of HIV, agility in the result of the rapid anti-HIV test and immediate treatment. Conclusion: potentialities in the consolidation of the anti-HIV rapid test were verified, evidencing Primary Health Care as a facilitating space in the expansion of integrality and access to health services.

Objectivo: analizar el discurso de los gestores sanitarios sobre las potencialidades de la realización de la prueba rápida del VIH en la Atención Primaria de Salud. Método: estudio exploratorio, cualitativo, realizado en uno de los cinco Distritos de Salud de la capital de Paraíba. La recogida de datos se realizó en septiembre de 2017. Se utilizó el dispositivo teórico-metodológico de la Análise do Discurso, de matriz francesa, mediante el concepto de análisis de la potencialidad del APS en la consolidación del TR anti-VIH, dividido en dos bloques discursivos: la accesibilidad geográfica y la accesibilidad socio-organizacional. Resultados: los discursos muestran los elementos potenciales de la APS para la realización de TR contra el VIH: la proximidad del servicio de salud, los arreglos organizativos, el diagnóstico precoz del VIH, la agilidad en el resultado de la prueba rápida contra el VIH y el tratamiento inmediato. Conclusión: se verificaron las potencialidades en la consolidación de la prueba rápida contra el VIH, evidenciando a la Atención Primaria a la Salud como un espacio facilitador en la ampliación de la integralidad y el acceso a los servicios de salud.

Avaliação do kit Filaria Deteção; IgG4 produzido com o antígeno recombinante Wb123 para diagnóstico da filariose linfática no Brasil / Evaluation of the Filaria Detection; IgG4 kit employing recombinant Wb123 antigen for diagnosis of lymphatic filariasis in Brazil / Evaluación de pruebas de anticuerpos antifiláricos IgG4, fabricado con el antígeno recombinante Wb123, para el diagnóstico de la filariasis linfática en Brasil

RESUMO O Plano Global de Eliminação da Filariose Linfática, lançado pela Organização Mundial da Saúde em 2000, propõe o uso de testes de detecção de antígeno circulante filarial como ferramenta diagnóstica para avaliação e monitoramento das ações de controle da parasitose. Entretanto, esses testes, apesar de apresentarem alta sensibilidade, não conseguem detectar com eficiência a infecção em seu estágio inicial, quando ainda não existe a presença de helmintos adultos. Considerando essa limitação, a pesquisa de anticorpos antifilariais tem sido apontada como uma alternativa, uma vez que os anticorpos produzidos contra as larvas infectantes do parasito são detectados antes da presença de antígeno circulante filarial. O objetivo deste estudo foi definir o ponto de corte e avaliar a acurácia do kit Filaria Detect™ IgG4 produzido com o antígeno recombinante Wb123 para diagnóstico da filariose linfática no Brasil. Para isso, foi realizado um estudo de avaliação de teste diagnóstico, no qual foram utilizadas 256 amostras de soro: 79 (30,9%) obtidas de indivíduos microfilarêmicos e 177 (60,1%), de indivíduos amicrofilarêmicos e que testaram negativo para os testes imunológicos Bm14 CELISA e Og4C3 ELISA. A definição do ponto de corte ideal, bem como da acurácia do kit Filaria Detect™ IgG4, foi obtida através da construção de curvas ROC, sendo a densidade óptica de 0,239 aquela na qual o teste obteve melhor desempenho, com sensibilidade de 81,0% e especificidade de 96,6%. Os resultados obtidos demonstraram que o kit Filaria Detect™ IgG4 é uma ferramenta promissora para investigação e monitoramento de áreas submetidas ao tratamento em massa para filariose linfática.

ABSTRACT The Global Programme to Eliminate Lymphatic Filariasis, launched by the World Health Organization in the year 2000, proposes the use of circulating filarial antigen tests as a diagnostic tool to assess and monitor initiatives to control filarial infection. However, despite a high sensitivity, these tests are not efficient to detect infection at early stages, before worms have reached the adult stage. Considering this limitation, anti-filarial antibody testing has been suggested as an alternative, given that the antibodies produced against the larvae are detectable before the presence of circulating filarial antigen. The objective of the present study was to determine the diagnostic cut-off and the accuracy of the Filaria Detect™ IgG4 kit employing recombinant Wb123 antigen for diagnosis of lymphatic filariasis in Brazil. For that, we performed a diagnostic evaluation study in which 256 serum samples were analyzed: 79 (30.9%) obtained from microfilaremic individuals and 177 (60.1%) from amicrofilaremic individuals who tested negative with the Bm14 CELISA and Og4C3 ELISA immunologic tests. The ideal cutoff as well as the Filaria Detect™ IgG4 kit accuracy were determined based on ROC curve analyses, with an optical density of 0.239 identified as the cutoff with the best performance, with 81.0% sensitivity and 96.6% specificity. The results show that the Filaria Detect™ IgG4 kit is a promising tool for investigation and monitoring of areas undergoing mass drug administration for lymphatic filariasis.

RESUMEN En el programa mundial de eliminación de la filariasis linfática, puesto en marcha por la Organización Mundial de la Salud en el año 2000, se propone el uso de pruebas de detección del antígeno filárico circulante como instrumento de diagnóstico para la evaluación y el seguimiento de las medidas de control de la parasitosis. Sin embargo, esas pruebas, a pesar de tener un alto grado de sensibilidad, no permiten detectar con eficiencia la infección en su fase inicial, cuando todavía no existen helmintos adultos. En vista de esa limitación, se ha señalado como una opción el estudio de anticuerpos antifiláricos, puesto que los anticuerpos producidos contra las larvas infectantes del parásito se detectan antes de la existencia de antígeno filárico circulante. El objetivo de este estudio fue definir el punto de corte y evaluar la exactitud del estuche Detect™ para pruebas de anticuerpos antifiláricos IgG4, fabricado con el antígeno recombinante Wb123, para el diagnóstico de la filariasis linfática en Brasil. Para ello, se realizó un estudio de evaluación de la prueba diagnóstica, en el cual se utilizaron 256 muestras de suero, a saber, 79 (30,9%) obtenidas de personas microfilarémicas y 177 (60,1%) de personas amicrofilarémicas, que arrojaron resultados seronegativos en las pruebas inmunológicas CELISA Bm14 y ELISA Og4C3. La definición del punto de corte ideal y de la exactitud del estuche Detect™ se obtuvo con la construcción de curvas de la característica operativa del receptor (ROC); una densidad óptica de 0,239 marcó el mejor nivel de desempeño de la prueba, con una sensibilidad de 81,0% y una especificidad de 96,6%. Los resultados obtenidos demostraron que el estuche Detect™ es un instrumento prometedor para la investigación y el seguimiento de las regiones donde se realiza un tratamiento masivo de la filariasis linfática.

Research on Application of Intelligent Tracing System for IVD Reagents Based on Blockchain Technology / 中国医疗器械杂志

In recent years, the IVD industry has developed rapidly based on the increasing market demand, and plays an important role in disease prevention, clinical diagnosis, health monitoring and guiding treatment. Therefore, followed quality and safety issues are highly concerned. The unique advantages of blockchain technology, decentralization, distrust and non-tampering, can write into trusted node data in every link covering production, circulation and usage of IVD reagents, and establish a distributed ledger with full backup, which makes the anti-conterfeiting and traceability for IVD reagents possible. We discuss whole process intelligent tracing system for IVD reagents based on blockchain technology. Through the strong mechanism of pre-supervision and post-punishment, the source of reagents can be traced, quality and responsibility can be investigated, and the medical inspection quality and diagnostic safety can be guarded.

Changes and Related Reflections on the European Union's in Vitro Diagnostic Medical Device Classification Supervision System / 中国医疗器械杂志

By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.

Brief Introduction about New Regulation of EU on IVDR / 中国医疗器械杂志

There are five-year transitional period for manufacturers after the issue of regulation(EU) 2017/746 on

Complete screening of exons 2, 3, and 4 of kras and nras genes reveals a higher number of clinically relevant mutations than food and drug administration quantitative polymerase chain reaction-based commercial kits

Abstract Background: The presence of clinically relevant mutations in KRAS and NRAS genes determines the response of anti-epidermal growth factor receptor antibody therapy for metastatic colorectal cancer (mCRC). The only quantitative polymerase chain reaction (qPCR)-based diagnostic tests approved by the Food and Drug Administration (FDA) screen merely for mutations in codons 12 and 13 of KRAS. Objective: The objective of the study was to study the frequency of clinically relevant mutations in KRAS and NRAS genes that are not included in FDA-approved qPCR tests. Methods: Formalin-fixed paraffin-embedded tumor specimens from 1113 mCRC Mexican patients from different health institutions across the country were analyzed by Sanger sequencing for KRAS mutations in exons 2, 3, and 4. Furthermore, 83 were analyzed in exons 2, 3, and 4 of NRAS. Results: From the specimens tested for KRAS, 33.69% harbored a mutation. From these, 71.77% were in codon 12 and 27.69% in codon 13 (both located in exon 2). Codons 59 (exon 3) and 146 (exon 4) accounted for the remaining 0.54%. From the 83 specimens, in which NRAS was analyzed, three mutations were found in codon 12 (3.61%). Approximately 6% of RAS mutated specimens would have been falsely reported as RAS wild type if an FDA-approved qPCR diagnostic test had been used. Conclusions: While these kits based on qPCR can be very practical and highly sensitive, their mutation coverage ignores mutations from poorly genetically characterized populations.

Cost minimization analysis of an in-house molecular test for cytomegalovirus in relation to a commercial molecular system

ABSTRACT Introduction: Cytomegalovirus may cause severe disease in immunocompromised patients. Nowadays, quantitative polymerase chain reaction is the gold-standard for both diagnosis and monitoring of cytomegalovirus infection. Most of these assays use cytomegalovirus automated molecular kits which are expensive and therefore not an option for small laboratories, particularly in the developing world. Objective: This study aimed to optimize and validate an in-house cytomegalovirus quantitative polymerase chain reaction test calibrated using the World Health Organization Standards, and to perform a cost-minimization analysis, in comparison to a commercial cytomegalovirus quantitative polymerase chain reaction test. Study design: The methodology consisted of determining: optimization, analytical sensitivity, analytical specificity, precision, curve variability analysis, and inter-laboratorial reproducibility. Patients (n = 30) with known results for cytomegalovirus tested with m2000 RealTime System (Abbott Laboratories, BR) were tested with the in-house assay, as well as patients infected with other human herpes virus, in addition to BK virus. A cost-minimization analysis was performed, from a perspective of the laboratory, assuming diagnostic equivalence of the methodologies applied in the study. Results: The in-house assay had a limit of detection and quantification of 60.3 IU/mL, with no cross-reactivity with the other viral agents tested. Moreover, the test was precise and had a R 2 of 0.954 when compared with the m2000 equipment. The cost analysis showed that the assay was economically advantageous costing a median value of 37.8% and 82.2% in comparison to the molecular test in use at the hospital and the m2000 equipment, respectively. Conclusions: These results demonstrated that in-house quantitative polymerase chain reaction testing is an attractive alternative in comparison to automated molecular platforms, being considerably less expensive and as efficacious as the commercial methods.

HIV prevalence in recently incarcerated adult males in the Federal District, Brasilia, Brazil

Abstract INTRODUCTION: This study intends to describe a HIV intake screening strategy in recently incarcerated adults in Distrito Federal, Brasilia, Brazil. METHODS: We tested 455 recently incarcerated adults in Distrito Federal in 2016 using rapid tests (RT) applied to oral samples (OS). RESULTS: The estimated frequency of positive tests was 0.88% (95% confidence interval [CI] 0.34% to 2.24%). CONCLUSIONS: The present findings reveal the potential significance of detecting new HIV infection cases in a vulnerable population using point-of-care rapid diagnostic tests.

Comparative performance of four malaria rapid diagnostic tests, Vikia Malaria Pf/Pan, Meriline-Meriscreen Pf/Pv/Pan, Right Sign Malaria Pf/Pan, and Right Sign Malaria Pf, among febrile patients in Gabon

Abstract INTRODUCTION: Rapid diagnostic tests (RDTs) are selected based on their performances. Here, we compared the diagnostic performance of different malaria RDTs. METHODS: Febrile patients were tested for malaria using Vikia Malaria Pf/Pan, Meriline-Meriscreen Pf/Pv/Pan, Right Sign Malaria Pf/Pan, and Right Sign Malaria Pf RDTs at Melen Regional Hospital in Gabon. RESULTS: In total, 120 of 274 tested children (43.8%) had malaria. The sensitivity was > 95% for all RDTs, while the specificity was > 85% for two tests. One test generated invalid tests (8%). CONCLUSIONS: Based on their performances, all tests except one may be recommended for malaria diagnosis.

Analysis of Class II Common Problems in the Registration of / 中国医疗器械杂志

From the perspective of technical review, this paper made statistics on the supplement contents of

Diagnostic efficacy of three test kits for SARS-CoV-2 nucleic acid detection / 浙江大学学报·医学版

OBJECTIVE@#To compare the diagnostic efficacy among three RT-PCR test kits for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid detection.@*METHODS@#The throat swab samples from 40 hospitalized patients clinically diagnosed as coronavirus disease 2019 (COVID-19) and 16 hospitalized non-COVID-19 patients were recruited. The SARS-CoV-2 nucleic acid was detected in throat swab samples with RT-PCR test kits from Sansure Biotech ("Sansure" for short), Jiangsu Bioperfectus Technologies ("Bioperfectus" for short) and BGI Genomics ("BGI" for short). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and Kappa value were analyzed. The viral nucleic acid was extracted from the throat swab samples by one-step cleavage and magnetic bead methods, and the efficacy of two extraction methods was also compared. The results of magnetic bead method for nucleic acid extraction by two different extractors (Sansure Natch CS S12C Fully Automated Nucleic Acid Extraction System vs. Tianlong NP968-C Nucleic Acid Extractor) were also compared.@*RESULTS@#The sensitivity, specificity, PPV, NPV and kappa value were 95.00%, 87.50%, 95.00%, 87.50%and 0.825 for Sansure kit; 90.00%, 87.50%, 94.74%, 77.78%and 0.747 for the Bioperfectus kit, and 82.50%, 81.25%, 91.67%, 65.00%and 0.593 for the BGI kit, respectively. The positive, negative and total coincident rates and kappa value of viral nucleic acid detection results using the samples extracted by one-step cleavage and magnetic bead methods were 95.24%, 100.00%, 96.43%and 0.909, respectively, but the one-step cleavage method took only 25 min, while the magnetic bead method required 180 min. The positive, negative and total coincident rates and kappa value of viral nucleic acid detection results using the samples extracted by the two different nucleic acid extractors were 85.00%, 100.00%, 89.29% and 0.764, respectively.@*CONCLUSIONS@#The detection efficacy for SARS-CoV-2 nucleic acid by the Sansure kit is relatively higher and the one-step cleavage method has advantages of convenient operation and less time consuming.

Analysis of Quality Management of in Vitro Diagnostic Reagent Clinical Trials / 中国医疗器械杂志

Clinical trial is an important step of in vitro diagnostic reagents research and development. Based on the Guiding Principles and the key points of inspect on the spot, combined with the actual work experience, the article focuses on the prominent problems in the whole process of in vitro diagnostic reagent clinical trials. It is helpful to improve the level of hospital drug clinical trial centre and the quality of in vitro diagnostic reagent clinical trials by analyzing the issues.

Evaluation of equine corneal endothelium after exposure to 0. 05% brilliant blue - an in vitro study / Avaliação do endotélio corneano de equinos após contato com o corante azul brilhante 0, 05% - estudo in vitro

The aim of this study was to evaluate the immediate effects of 0.05% brilliant blue on corneal endothelium of horses. Thirty-eight corneas of 19 horses, male or female, of different ages were studied. Corneas were randomly divided into two groups. Group 1: Corneal endothelium was covered with 0.3mL of brilliant blue 0.05% for 60 seconds followed by rinsing with a balanced salt solution. Group 2: Corneal endothelium was covered with BSS for 60 seconds. The corneas were excised with an 8mm trephine and prepared to analyze posterior endothelial surface using a light microscope (24 corneas) and a scanning electron microscope (14 corneas). The equine posterior corneal endothelium surface observed by optical microscopy and scanning electron microscopy revealed a continuous layer of polygonal cells of uniform size and shape in both the control and treatment groups. Due to non-normal residuals at ANOVA mean comparison, a generalized linear model was utilized at 5% level of significance. The chi-square test stated that treatment and control group were not different statistically. The 0.05% brilliant blue did not cause damage to equine corneal endothelium.(AU)

Objetivou-se avaliar os efeitos imediatos de uma solução de 0,05% de azul brilhante sobre o endotélio da córnea de equinos. Trinta e oito córneas de 19 cavalos, machos ou fêmeas, de diferentes idades foram estudadas. As córneas foram divididas aleatoriamente em dois grupos. Grupo 1: O endotélio corneano foi perfundido com 0,3mL de azul brilhante 0,05% durante 60 segundos seguido por irrigação com uma solução salina balanceada. Grupo 2: O endotélio corneano foi perfundido com BSS durante 60 segundos. As córneas foram posteriormente excisadas com trépano de 8mm e preparadas para análise endotelial utilizando um microscópio óptico (24 córneas) e um microscópio eletrônico de varredura (14 córneas). A análise da superfície posterior do endotélio da córnea equina observada por microscopia óptica e microscopia eletrônica de varredura revelou uma camada contínua de células poligonais de tamanho e forma uniformes tanto no grupo controle quanto no grupo tratamento. Devido aos resíduos não normais na comparação da média de ANOVA, utilizou-se um modelo linear generalizado com nível de significância de 5%. Evidenciou-se com o teste qui-quadrado que não houve diferença estatística entre o grupo controle e o grupo tratamento. O azul brilhante de 0,05% não causou dano ao endotélio corneano de equinos.(AU)

Transferencia de intervalos de referencia en Valencia-Venezuela / Transference of reference intervals in Valencia-Venezuela / Transferência de intervalos de referência em Valência-Venezuela

El objetivo de la presente investigación consistió en revisar si los valores de referencia producidos por la industria de diagnóstico in vitro eran transferibles a una determinada población. Para este estudio fueron analizadas muestras de suero de una población de 23 individuos. El análisis de las muestras estudiadas fue realizado mediante el método de colorimetría usando equipos Rx Daytona. Los analitos determinados para el estudio fueron glucemia, colesterol, triglicéridos por método enzimático y creatinina por método cinético, empleando el kit de reactivos de la misma casa comercial del instrumento. Para la evaluación y análisis estadístico de los datos fue empleado el logaritmo de decisión propuesto por Ventimiglia y Fink en 2002. Como resultado se obtuvieron porcentajes de transferibilidad de 100% para la totalidad de los analitos. De acuerdo con los resultados obtenidos, se dieron por verificados y se aceptó la transferibilidad de los intervalos de referencia comerciales para la población en estudio.

The aim of this investigation was to review if the reference values produced by the in vitro diagnostic industry were transferable to a specific population; for the study, serum samples from a population of 23 individuals were analyzed.The analysis of the samples was carried out using the colorimetric method with Rx Daytona equipment. The analytes determined for the study were glycemia, cholesterol, triglycerides by enzymatic method and creatinine by kinetic method, using the reagent kit from the same commercial brand of said equipment. The statistical analysis was done applying the decision logarithm proposed by Ventimiglia F and Fink N (2002). As a result, percentages of 100% of transferability were found on all the analytes. According to the results obtained, the transferability of the commercial reference intervals for the population under study was accepted.

O objetivo da presente investigação foi revisar se os valores de referência produzidos pela indústria de diagnóstico in vitro eram transferíveis para uma população específica. Para esse estudo amostras de soro foram analisadas de uma população de 23 indivíduos. A análise das amostras estudadas foi realizada utilizando o método de colorimetria, utilizando equipamentos Rx Daytona. Os analitos determinados para o estudo foram glicemia, colesterol, triglicerídeos pelo método enzimático e creatinina pelo método cinético, utilizando o kit de reagentes da mesma casa comercial do instrumento. Para a avaliação e análise estatística dos dados foi utilizado o logaritmo de decisão proposto por Ventimiglia F e Fink N 2002. Como resultados, percentuais de transferibilidade de 100% foram obtidos para todos os analitos. De acordo com os resultados obtidos, foram tidos como verificados e se aceita a transferibilidade dos intervalos de referência comerciais para a população em estudo.

Use of Mini-FLOTAC and Fill-FLOTAC for rapidly diagnosing parasitic infections in zoo mammals / Utilização do Mini-FLOTAC e Fill-FLOTAC no diagnóstico rápido de infecções parasitárias de mamíferos em zoológicos

Abstract Animals reared in restricted environments are highly susceptible to gastrointestinal infection by helminths and protozoa and therefore zoos are characterized as being parasite-rich environments. Successful implementation of control programs of these parasites in zoo environment depends upon precise and rapid diagnosing of gastrointestinal infections. The aim of this study was to demonstrate the role of the Mini-FLOTAC technique in combination with Fill-FLOTAC for rapidly diagnosing parasitic infections in zoo mammals. Fecal samples were collected from 70 animals in four different zoos located in central and southern Italy. All the samples were analyzed using Mini-FLOTAC in combination with Fill-FLOTAC. Out of the 70 pooled samples examined, 80% (24/30) were positive for at least one parasite. Among the gastrointestinal nematodes, Strongyles were the most frequent (40%), followed by Trichuris spp. (23.3%), Parascaris spp. (13.3%) and Capillaria spp. (3.3%). Among the protozoa, Blastocystis spp., Giardia spp. and Eimeria spp. were detected in 6.6%, 3.3% and 3.3%, respectively. These results show that Mini-FLOTAC in combination with Fill-FLOTAC can be used, not only for rapidly diagnosing parasitic infections in zoo mammals, but also for monitoring control programs in which large numbers of fecal samples need to be examined rapidly and reliably.

Resumo Animais criados em ambiente restritos são altamente suscetíveis a infecção gastrointestinal por helmintos e protozoários, constituindo os zoológicos em ambientes com alta contaminação por parasitos. O sucesso da implementação de programas de controle contra estes parasitos em zoológicos depende do rápido diagnóstico das infecções por parasitas gastrointestinais. O objetivo deste estudo foi demonstrar o papel da técnica do Mini-FLOTAC em combinação com o Fill-FLOTAC no diagnóstico rápido das infecções parasitárias em mamíferos em zoológicos. Amostras de fezes foram coletadas de 70 animais de quatro diferentes zoológicos no centro e sudoeste da Itália. Todas as amostras foram analisadas pela técnica do Mini-FLOTAC em combinação com o Fill-FLOTAC. Do total de 70 pools de fezes examinadas, 80% (24/30) foram positivas para pelo menos um parasito. Entre os nematoides gastrointestinais a maior frequência foi observada para estrongilídeos (40%), seguida por Trichuris spp. (23,3%), Parascaris spp. (13,3%) e Capillaria spp. (3,3%). Entre os protozoários Blastocystis spp., Giardia spp. e Eimeria spp. foram detectados em 6,6%, 3,3% e 3,3%, respectivamente. Estes resultados demonstram que a técnica do Mini-FLOTAC em combinação com o Fill-FLOTAC pode ser utilizada não somente para o diagnóstico rápido das infecções parasitárias em mamíferos em zoológicos, mas também no monitoramento de programas de controle onde grande número de amostras fecais devem ser examinadas de forma rápida e confiável.

Challenges and successes of distributing birth kits with misoprostol to reduce maternal mortality in rural Tanzania

The Saving Mothers Project was conducted from September 2015 to March 2017 in Bunda and Tarime Districts, Mara Region, Tanzania. The purpose of this project was to train community health workers (CHWs) to use mobile phones applications to register and educate pregnant women about safe deliveries and encourage them to access skilled health care providers for antenatal care and delivery, and to provide nurses and CHWs with clean birth kits with misoprostol to distribute to women. The birth kits were for use in case women could not access the health facility, or if the health facility was lacking supplies at the time of delivery. The overall goal of the study was to reduce the maternal mortality rate by increasing women's access to health services where possible, and to clean supplies when a non-facility birth was unavoidable. This paper reports on a mixed methods evaluation of the project including a survey of over two thousand four hundred women, and focus groups with women, community health workers, and nurses participating in the project. The results of the survey and focus groups demonstrate a high degree of satisfaction with the birth kits and misoprostol and an increase in facility birth rates where the project was implemented. Differences between the two districts illustrate that policy maker support is key to successful implementation