"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.
more
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.
more
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.
more
Accessed 15th of October 2015
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
more
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.
more
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.
more
Meeting Report
27–30 June 2017 Manila, Philippines
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.
more
The review’s objectives are to review progress in TB control with emphasis on DOTS strategy implementation, summarize the experience, lessons learnt and methods of work and to make recommendations for international donors, technical agencies and the Ministry of Health.
Public Report
PQMC 0001-001-04 WHO PQMC Public Report November/2016, version 8.0
The Mapping Antimicrobial Resistance and Antimicrobial Use Partnership (MAAP) project has conducted a multi-year, multi-country study that provides stark insights on the under-reported depth of the antimicrobial resistance (AMR) crisis across Africa and lays out urgent policy recommendations to addr...ess the emergency.
MAAP reviewed 819,584 AMR records from 2016-2019, from 205 laboratories across Burkina Faso, Cameroon, Eswatini, Gabon, Ghana, Kenya, Malawi, Nigeria, Senegal, Sierra Leone, Tanzania, Uganda, Zambia, and Zimbabwe. MAAP also reviewed data from 327 hospital and community pharmacies and 16 national-level AMC datasets.
more