Quality assurance for point-of-care testing in Mozambique's National Health Service

Medical care in Mozambique is mostly provided through the national health service of the Ministry of Health. All primary healthcare and HIV-related services are provided free of charge. There are over 1500 public sector health facilities in Mozambique and most of these are primary healthcare centres. Although all hospitals have a laboratory, only a quarter of the health centres have a formal laboratory. In this context, point-of-care (POC) testing and syndromic management of diseases play an important role in the health system. Both communicable and non-communicable diseases are prevalent in the Mozambican population. Mozambique has a population of 28 million and is among the nine countries with the highest HIV prevalence in the world.1 HIV prevalence in the country among people aged 15­49 years is 11.5%, ranging from 3.7% in the Niassa province in the north to 25.1% in the Gaza province in the south.2,3 HIV prevalence is higher among women (13.1%) than among men (9.2%), and higher in urban areas (15.9%) compared with rural areas (9.2%).2,3 Among children aged between 0 and 11 years, HIV prevalence is 1.4%, and 2.3% in those younger than one year.2,3 It is estimated that 102 new infections in children occur daily in Mozambique (Ministry of Health, unpublished data). Demographic impact studies show that an estimated 1.6 million Mozambicans were living with HIV in 2009.

Avaliação da utilização das tecnologias simplificadas de contagem de linfócitos T-CD4+ no serviço nacional de saúde de Moçambique

A contagem dos Linfócitos TCD4+ no sangue periférico continua a ser um importante marcador para monitorar a progressão da doença e eficácia da terapia anti-retroviral (ART), apesar da introdução recentemente da testagem de carga viral, por ser um indicador mais sensível que a contagem de CD4; e continua a ser uma aposta para monitoramento por parte do Governo Moçambicano. Uma das formas de melhorar o acesso ao monitoramento da infecção aos pacientes vivendo com VIH-SIDA (PVHS), foi a introdução das tecnologias simplificadas de diagnóstico de CD4, os analisadores PIMATM Alere. A presente pesquisa pretende estudar a utilização dos analisadores PIMA em Moçambique. O objetivo foi avaliar a utilização das Tecnologias Simplificadas de Contagem de Células Sanguíneas Linfócitos TCD4 PIMATM, nas condições reais do Serviço Nacional de Saúde (SNS) de Moçambique. O estudo realizou-se entre Outubro e Dezembro de 2016, abrangeu todas as unidades sanitárias que fazem a contagem dos Linfócitos TCD4, usando o analisador automático PIMA. Baseou-se em pesquisa documental e visita a algumas unidades sanitárias nas Províncias de Niassa, Maputo e Cidade de Maputo (para observação direta e analise de processos clínicos dos PVHS para a determinação do tempo de inicio do TARV após o diagnósticos de VIH). Na pesquisa documental, usou-se a base de dados da Alere, que está conectado a todos os instrumentos de contagem de Linfócitos CD4 instalados nas unidades sanitárias do país, para descarregar a informação de testagem ao longo dos anos 2014, 2015 e 2016...

Peripheral blood TCD4 + lymphocytes count remains an important marker for monitor-ing disease progression and antiretroviral therapy (ART) effectiveness, despite the recent intro-duction of viral load testing, as it is a more sensitive indicator than the CD4 count; And remains a gamble for monitoring by the Mozambican Government. One of the ways to improve access to infection monitoring for patients living with VIH/AIDS (PLWHA) was the introduction of simplified CD4 diagnostic technologies, PIMATM Alere analyzers. The present research intends to study the use of PIMA analyzers in Mozambique. To evaluate the use of Simplified TCD4 PIMATM Hemodynamic Blood Cell Count Technologies under the real conditions of the Na-tional Health Service (NHS) of Mozambique. The study was carried out between October and December 2016, and covered all health units that count TCD4 lymphocytes using PIMA equip-ment. Documentary research and visits to some health units were carried out in the provinces of Niassa, Maputo and Maputo City (for direct observation and analysis of PLWHA clinical processes for the determination of time to start ART after VIH diagnosis). In documentary re-search, the Alere database was used, which is connected to all the CD4 lymphocyte count in-struments installed in the country's health units, to download the test information over the years 2014, 2015 and 2016...

Avaliação da utilização das tecnologias simplificadas de contagem de linfócitos T-CD4+ no serviço nacional de saúde de Moçambique / Evaluation of the use of simplified T-CD4 + lymphocyte counting technologies in the national health service of Mozambique

A contagem dos Linfócitos TCD4+ no sangue periférico continua a ser um importante marcador para monitorar a progressão da doença e eficácia da terapia anti-retroviral (ART), apesar da introdução recentemente da testagem de carga viral, por ser um indicador mais sensível que a contagem de CD4; e continua a ser uma aposta para monitoramento por parte do Governo Moçambicano. Uma das formas de melhorar o acesso ao monitoramento da infecção aos pacientes vivendo com VIH-SIDA (PVHS), foi a introdução das tecnologias simplificadas de diagnóstico de CD4, os analisadores PIMATM Alere. A presente pesquisa pretende estudar a utilização dos analisadores PIMA em Moçambique. O objetivo foi avaliar a utilização das Tecnologias Simplificadas de Contagem de Células Sanguíneas Linfócitos TCD4 PIMATM, nas condições reais do Serviço Nacional de Saúde (SNS) de Moçambique. O estudo realizou-se entre Outubro e Dezembro de 2016, abrangeu todas as unidades sanitárias que fazem a contagem dos Linfócitos TCD4, usando o analisador automático PIMA. Baseou-se em pesquisa documental e visita a algumas unidades sanitárias nas Províncias de Niassa, Maputo e Cidade de Maputo (para observação direta e analise de processos clínicos dos PVHS para a determinação do tempo de inicio do TARV após o diagnósticos de VIH). Na pesquisa documental, usou-se a base de dados da Alere, que está conectado a todos os instrumentos de contagem de Linfócitos CD4 instalados nas unidades sanitárias do país, para descarregar a informação de testagem ao longo dos anos 2014, 2015 e 2016…

Peripheral blood TCD4 + lymphocytes count remains an important marker for monitor ing disease progression and antiretroviral therapy (ART) effectiveness, despite the recent intro duction of viral load testing, as it is a more sensitive indicator than the CD4 count; And remains a gamble for monitoring by the Mozambican Government. One of the ways to improve access to infection monitoring for patients living with VIH/AIDS (PLWHA) was the introduction of simplified CD4 diagnostic technologies, PIMATM Alere analyzers. The present research intends to study the use of PIMA analyzers in Mozambique. To evaluate the use of Simplified TCD4 PIMATM Hemodynamic Blood Cell Count Technologies under the real conditions of the Na tional Health Service (NHS) of Mozambique. The study was carried out between October and December 2016, and covered all health units that count TCD4 lymphocytes using PIMA equip ment. Documentary research and visits to some health units were carried out in the provinces of Niassa, Maputo and Maputo City (for direct observation and analysis of PLWHA clinical processes for the determination of time to start ART after VIH diagnosis). In documentary re search, the Alere database was used, which is connected to all the CD4 lymphocyte count in struments installed in the country's health units, to download the test information over the years 2014, 2015 and 2016. The results show that a number of 254 analyzers transmitted to the data base about 4519 records, which were analyzed in relation; the probability of survival, which was 50% in 6 months; The median use of each instrument was 80 tests per month; the median of waste in the order of 5%; In a total of 1349 SNS laboratories technicians, only 29% of them have been trained to operate with the PIMAs; A total of 146 clinical trials of 5 health units were analyzed, of which 68 were in agreement with the study. 50% of the patients started ART after 24 hours of diagnosis and up to 80% of the patients had already started ART in 15 days. This stud was concluded that the use of PIMA analyzers under the actual conditions of the National Health Service of Mozambique is not totally adequate. However, these analyzers reduced the time of initiation of antiretroviral therapy for PLWHA, to 24 hours after VIH diagnosis, and improved treatment accessibility.