SOP- Quality Assurance of Malaria Diagnostic Tests
Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to provide quality data which can be used for health research and patient treatment. As the use of laboratory... tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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This is an update of a seven-year TB and Leprosy national strategic plan (TBL-NSP), which extends from 2013 to 2020. The update focuses on the plan covering from 2017-20 and is based on the 2017 external mid-term programme review key findings and recommendations; the global and national End TB strat...e-gies and targets; stakeholders consultation and recent revision of the national TB guidelines.
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National Tuberculosis Programme
The National Strategic Plan (NSP) for Tuberculosis (TB) 2016-2020 builds on the past experiences for the National Tuberculosis Programme and its partners. This NSP provides a roadmap for delivering quality TB prevention and care service to the entire population, ...as an integral part of the country's move toward Universal Health Coverage. Between 1990 and 2015, Myanmar reduced the prevalence of TB by 50%, meeting the targets set by the Millennium Development Goals. Going forward, the country aims to further accelerate the rate decline.
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This guide includes information relevant for tuberculosis (TB) program and laboratory managers, as well as Ministry of Health officials across disease programs interested in establishing integrated solutions for specimen referral. Though TB-focused in name, it offers integration-oriented assessment,... design, and monitoring guidance related to improving coordination and efficiency, and is relevant for other programs as well. Country case studies include viral load and early infant diagnosis (EID) in Uganda and EID in Ethiopia.
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Myanmar is one of the world’s 22 high tuberculosis (TB) burden countries, and supporting TB control in Myanmar is a global priority. This report reflects the findings, discussions, conclusions and recommendations of the fourth international review mission of the Myanmar National TB Programme (NTP)..., which brought together international and national partners to review progress in TB control and to offer guidance on future TB control directions and efforts.
A high-quality national disease prevalence survey completed in 2010 demonstrated a TB disease burden two to three times higher than anticipated on the basis of previous surveys. In 2011 about 200 000 adults and children will have developed TB, including 20 000 HIV infected and 9000 suffering from MDR-TB, both of which will require additional care and costly treatment. TB remains among the top killers of adults, and more women die of TB than from maternal causes.
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Transforming the Quality of Health Care in Ethiopia
The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerat...ions, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
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ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to pr...ovide general technical guidance to African Union Members States on the rollout, establishment, implementation, monitoring, and evaluation of SARS-CoV-2 Ag RDT interventions so as to effectively and efficiently detect, control and minimise errors in the performance of COVID-19 laboratory testing processes. It describes the core components for quality assurance, resources mobilisation and advocacy for scale up, monitoring, evaluation, learning and accountability for SARS-CoV-2 implementation.
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A Situational Assessment and Five-YearAction Plan for the Africa CDC Strengthening Regional Public Health Institutions and Capacity for Surveillance and Response Program
All personnel performing SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDT) need to understand how to safely perform testing, ensure quality testing and interpret results. This course is developed to provide theoretical knowledge on SARS-CoV-2 Ag-RDT testing. The learning package consists of 10 modu...les, which include recorded presentations and videos.
Availble in different languages
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Validation of elimination of mother-to-child transmission, or vertical transmission, of HIV, syphilis and hepatitis B virus (HBV), is an attestation that a country has successfully met standard criteria for elimination, or for being at 1 of the 3 levels of achievement on the ‘Path to Elimination... while delivering quality services for women, girls and their children, through the life-course, respecting human rights and ensuring gender equality and community engagement.
This document, the third version, adds on EMTCT of hepatitis B virus (HBV), bringing together a package of interventions and metrics to support integrated management and monitoring of vertical transmission across a wide range of epidemiological and programmatic contexts.
This document, the third version, adds on EMTCT of hepatitis B virus (HBV), bringing together a package of interventions and metrics to support integrated management and monitoring of vertical transmission across a wide range of epidemiological and programmatic contexts.
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The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid diagnostic tests (RDTs) targeting the M...UL_3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
Biorisk Management
Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
Biological Waste management
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This country cooperation strategy (CCS) outlines how the World Health Organization (WHO) will work with the Lao People’s Democratic Republic over the next five years (2024–2028), supporting the implementation of the five-year health sector development plans and the Health Sector Reform Strategy ...2021–2030 to attain the Sustainable Development Goals (SDGs) by 2030.
The Lao People’s Democratic Republic experienced substantial economic growth in the 30 years prior to the coronavirus disease (COVID-19) pandemic, contributing to reduced poverty and significant progress toward the SDGs. However, the COVID-19 pandemic brought this development to a halt. It was anticipated that the COVID-19 recovery and the tremendous population growth in recent years would provide opportunities for a shift toward more sustainable and inclusive development in the years ahead. In 2023, however, the contrary was the case. Rural residents, including many ethnic minorities, continued to face marginalization because of limited access to education, health care and economic opportunities.
Despite the challenges of COVID-19 and other disease outbreaks, the country has made significant improvements in health. Nonetheless, progress has been uneven and not everyone has benefited from these achievements. In the mountainous region, many people lack access to quality health care because of the unequal distribution of well-trained health-care workers. Preventable deaths due to poor-quality health care for children and newborns, infants and mothers remain a concern, as do communicable diseases such as sexually transmitted infections and tuberculosis. The increasing burden of noncommunicable diseases and the health impact of worsening climate change further heighten the need for strengthened and resilient health systems, which are at risk due to an underfunded health sector and weak economy.
This CCS aims to address remaining and future challenges as well as health needs while creating an impact that is sustainable. It identifies three strategic priorities and nine deliverables (Table 1) to support the attainment of the national vision of Health for all by all, as articulated in the 9th Health Sector Development Plan 2021–2025. It contributes to the country’s goals to achieve universal health coverage, graduate from least developed country status by 2026 and attain SDGs by 2030.
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