"Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to eng...age in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents"--Page 7.
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Mpox is an emerging zoonotic disease caused by the mpox virus, a member of the Orthopoxvirus genus closely related to the variola virus that causes smallpox. Mpox was first discovered in 1958 when outbreaks of a pox-like disease occurred in monkeys kept for research. The first human case was recorde...d in 1970 in the Democratic Republic of the Congo (DRC) during a period of intensified effort to eliminate smallpox and since then the infection has been reported in a number of African countries. Mpox can spread in humans through close contact, usually skin-to-skin contact, including sexual contact, with an infected person or animal, as well as with materials contaminated with the virus such as clothing, beddings and towels, and respiratory droplets in prolonged face to face contact. People remain infectious from the onset of symptoms until all the lesions have scabbed and healed. The virus may spread from infected animals through handling infected meat or through bites or scratches. Diagnosis is confirmed by polymerase chain reaction (PCR) testing of material from a lesion for the virus’s DNA. Two separate clades of the mpox virus are currently circulating in Africa: Clade I, which includes subclades Ia and Ib, and Clade II, comprising subclades IIa and IIb. Clade Ia and Clade Ib have been associated with ongoing human-to-human transmission and are presently responsible for outbreaks in the Democratic Republic of the Congo (DRC), while Clade Ib is also contributing to outbreaks in Burundi and other countries.
In 2022‒2023 mpox caused a global outbreak in over 110 countries, most of which had no previous history of the disease, primarily driven by human-to-human transmission of clade II through sexual contact. In just over a year, over 90,000 cases and 150 deaths were reported to the WHO. For the second time since 2022, mpox has been declared a global health emergency as the virus spreads rapidly across the African continent. On 13 Aug 2024, Africa CDC declared the ongoing mpox outbreak a Public Health Emergency of Continental Security (PHECS), marking the first such declaration by the agency since its inception in 2017.7 This declaration empowered the Africa CDC to lead and coordinate responses to the mpox outbreak across affected African countries. On August 14, 2024, the WHO declared the resurgence of mpox a Public Health Emergency of International Concern (PHEIC) emphasizing the need for coordinated international response.
As of August 2024, Mpox has expanded beyond its traditional endemic regions, with new cases reported in countries including Sweden, Thailand, the Philippines, and Pakistan. Sweden has confirmed its first case of Clade 1 variant, which has been rapidly spreading in Africa, particularly in DRC. The emergence of this new variant raises concerns about its potential for higher lethality and transmission rates outside Africa.
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The SAARC Member States have more than an estimated 2.0 million TB cases accounting for close to one-third of the total cases of TB in the world. India alone had almost one-fifth of the global disease burden due to TB. India, Pakistan and Bangladesh followed by Afghanistan are the major contributors... of disease burden of TB in the SAARC Region. They are countries that have a dubious distinction of being on the list of 22 TB High Disease Countries in the world.
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Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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Accessed 15th of October 2015
HIV testing programmes need to ensure that all clients who test for HIV are provided with correct diagnoses. The accuracy of HIV testing is critical to prevent misdiagnosis, as the consequences of giving an incorrect test result can be serious for clients, HIV testing services, HIV programmes and pu...blic health.
With the evolution of global HIV epidemiology, HIV testing approaches must also evolve to maintain accuracy and efficiency in population-level diagnosis. Reports suggest that misdiagnosis of HIV status may occur when suboptimal testing algorithms and out-of-date testing strategies are used. As a result of changing epidemiology and declining HIV positivity in testing, WHO recommends all countries use a standard three-test strategy to ensure a PPV of at least 99%, minimizing false-positive misdiagnosis. The WHO-recommended HIV testing strategy, along with quality assurance measures such as retesting to verify a positive diagnosis prior to initiation of HIV treatment, is cost-effective as it prevents misdiagnosis and unnecessary initiation of costly lifelong treatment.
This implementation guide provides practical advice on switching to a three-test strategy and instituting other measures that can help national HIV programmes deliver high-quality, accurate HIV testing services and ensure that misdiagnosis is minimized.
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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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Zambia has recognised the Public Health threat of antimicrobial resistance and its impact on morbidity and mortality, as well as the subsequent economic consequences. The country has recorded microorganisms which have developed resistance to antimicrobial drugs. Notable among these are; Multidrug Re...sistant Mycobacterium Tuberculosis (MDR), Human Immunodeficiency virus resistant to antiretroviral drugs, Plasmodium resistance to antimalarial drugs, and fungal species showing indications of resistance to antifungal drugs. Emergence of “Superbugs” such as Methicillin Resistant Staphylococcus aureus (MRSA), Extended Spectrum beta-lactam (ESBL) producing Klebsiella pneumoniae and Vancomycin Resistant Enterococci (VRE) have also been reported.
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Meeting Report
27–30 June 2017 Manila, Philippines
Public Report
PQMC 0001-001-04 WHO PQMC Public Report November/2016, version 8.0
This report highlights key achievements registered by the Ministry of Health, affiliated institutions, implementing agencies both at central and decentralized levels in 2013-2014. Generally, the Health Sector accomplishments and programs routine data for 2013-2014 confirm that Rwanda maintains its p...rogress towards the realization of health-related MDGs and national health targets as well.
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