A technical guide for sputum smear microscopy, initiated by the International Union against Tuberculosis, is designed to be an easy to use reference standard for the collection, storage and transport of sputum specimens and for the examination of sputum smears by direct microscopy. This edition incl...udes updates addressing bio-safety and quality assurance aspects of sputum smear microscopy.
more
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 MUL..._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.
more
Control of pollution from antibiotic manufacturing is a key part of safeguarding the longevity of antibiotics for all. Pollution contributes to antibiotic resistance and potentially undermines the effectiveness of medicines. High levels of antibiotics in water bodies downstream of manufacturing site...s have been widely documented. Currently, antibiotic pollution from manufacturing is largely unregulated and quality assurance criteria typically do not address environmental emissions.
more
This policy document is to guide the Traditional, Complimentary and Alternative Medicine practices in Rwanda. The various elements examined under the policy include, legislation and regulatory control, registration, manufacture, procurement and supply management, rational use, quality assurance, co-...ordination, monitoring and evaluation of Traditional, Complementary and Alternative Medicine practices.
more
Accessed: 02.05.2020
These interim IPC recommendations for health settings have been developed through the contributions of many individuals and institutions, such as the Centers for Disease Control-Kenya; ITECH; US Agency for International Development (USAID) Medicines, Technologies, and Pharmaceu...tical Services (MTaPS) Program; and WHO that are committed to ensuring that the transmission of COVID-19 to HCWs and the public within the health care setting is limited. The Ministry of Health (MOH) through the Directorate of Health Standards Quality Assurance and Regulations wishes to thank all the contributing authors led by the sub-committee on case management and IPC for the COVID-19 response for their expertise and time given to writing these guidelines.
more
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 document, "Sustainable Management of Radiotherapy Facilities and Equipment," by WHO and IAEA, provides guidelines for managing radiotherapy equipment and facilities to ensure effective and safe cancer treatment. It covers essential aspects like preventive and corrective maintenance, funding, inf...rastructure, and staffing requirements for sustainable operation. The document aims to support radiotherapy departments, especially in low-resource settings, by outlining strategies for equipment procurement, maintenance, and replacement, emphasizing safety, quality assurance, and optimal patient care.
more
The National pharmaceutical policy aligns itself to the Government vision for development of the health sector, as defined in Vision 2020, the Millennium Development Goals and the Economic Development for Poverty Reduction Strategy and the National Health Policy. The pharmacy policy addresses, among... other challenges, the establishment of functional National Medicines Regulatory Authority that will implement all the regulatory functions, lack of local manufacturing facilities, lack of pricing policy of health commodities and technologies in private sector. This policy is based on the following key priorities: the Quality assurance, accessibility and the rational use of medicines, other health commodities and technologies.
more
Spirometry is required as part of the comprehensive evaluation of both adult and paediatric individuals with suspected or confirmed respiratory diseases and occupational assessments. It is used in the categorisation of impairment, grading of severity, assessment of potential progression and response... to interventions. Guidelines for spirometry in South Africa are required to improve the quality, standardisation and usefulness in local respiratory practice. The broad principles of spirometry have remained largely unchanged from previous versions of the South African Spirometry Guidelines; however, minor adjustments have been incorporated from more comprehensive international guidelines, including adoption of the Global Lung Function Initiative 2012 (GLI 2012) spirometry reference equations for the South African population.
All equipment should have proof of validation regarding resolution and consistency of the system. Daily calibration must be performed, and equipment quality control processes adhered to. It is important to have standard operating procedures to ensure consistency and quality and, additionally, strict infection control as highlighted during the COVID-19 pandemic.
Adequate spirometry relies on a competent, trained operator, accurate equipment, standardised operating procedures, quality control and patient co-operation. All manoeuvres must be performed strictly according to guidelines, and strict quality assurance methods should be in place, including acceptability criteria (for any given effort) and repeatability (between efforts).
more
The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to need (e.g. basic users, supervisors, clinicians). Topics covered include: Over...view of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
more
Комплект учебных материалов по Xpert MTB/RIF
The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to nee...d (e.g. basic users, supervisors, clinicians). Topics covered include: Overview of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
more
The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to need (e.g. basic users, supervisors, clinicians). Topics covered include: Over...view of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
more
n October 2019, WHO convened the first meeting of the Buruli ulcer laboratory network (BU-LABNET) in Yaoundé, Cameroon, bringing together 11 laboratories from nine countries at the Pasteur Centre of Cameroon (CPC), the network’s Coordinating Centre. The network was formally established at th...is meeting (1) and its members were those present. The objective of BU LABNET is to improve diagnosis of Buruli ulcer based on polymerase chain reaction (PCR) using standardized testing protocols, involving external quality assurance programmes and sharing knowledge among member laboratories.
more
The WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS) was launched in 2015 to foster AMR surveillance and inform strategies to contain AMR. The system started with surveillance of AMR in bacteria causing common human infections and has expanded its scope to include surveillance... of antimicrobial consumption (AMC), invasive fungal infections, and a One Health surveillance model relevant to human health. To meet future challenges, it is in continuous evolution to enhance the quality and representativeness of data to inform the AMR burden accurately. As of the end of 2022, 127 countries, territories and areas participate in GLASS.
The fifth GLASS report, produced in collaboration with Member States, summarizes 2020 data on AMR rates in common bacteria from countries, territories, and areas. The report brings new features, including analyses of population testing coverage or AMR trends. For the first time, the report presents 2020 data on AMC at the national level. A new interactive dashboard allow users to explore AMR and AMC global data, country profiles and download the data.
This report marks the end of the early implementation phase of GLASS. In addition to presenting data collected through the latest data call, this report provides a summary of five years of national AMR surveillance data contributed to GLASS from its initiation, presents AMR findings in the context of progress of country participation in GLASS and in global AMR surveillance coverage and laboratory quality assurance systems at (sub)national level.
Patterns of antimicrobial consumption are presented by country with a particular focus on antibacterials. The report also presents the antimicrobial consumption according to the WHO AWaRe antibiotic classification, for penicillins and cephalosporines. From a One Health perspective, the report presents antimicrobial consumption data in the human sector expressed in tons to allow a comparison with antimicrobial consumption from other sectors (not included in this report).
more
This codebook outlines the set of TUFF procedures that have been developed, tested, refined, and implemented by AidData staff and affiliated faculty at the College of William & Mary. We initially employed these methods to achieve a specific objective: documenting the known universe of officially fin...anced Chinese projects in Africa (Strange et al. 2013, 2017). We have since then employed these methods to track Chinese official finance to five major world regions: Africa, the Middle East, Asia and the Pacific, Latin America and the Caribbean, and Central and Eastern Europe (Dreher et al. 2017). Additionally, other social scientists have adapted and applied the TUFF methodology to identify grants and loans from Gulf Cooperation Council (GCC) members (Minor et al. 2014), under-reported humanitarian assistance flows from traditional and non-traditional sources (Ghose 2017), foreign direct investment from Western and non-Western sources (Bunte et al. 2017), and pre-2000 foreign aid flows from China (Morgan and Zheng 2017). However, this codebook focuses specifically on TUFF data collection and quality assurance procedures to track Chinese official finance between 2000 and 2014.
more
The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
more
This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...nd rapid diagnostic providers.
more