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1
Organisation mondiale de la Santé. (2011). Planches pour le diagnostic microscopique du paludisme.
Available in English, French, Spanish, Chinese, Russian and Arabic
https://apps.who.int/iris/handle/10665/337832
August 2020.
Essential diagnostic products areconsidered an integral part of UHC, they are an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a r
...
eview of the UHC pilot in September 2019 established that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for diagnostic products was less than 50 percent for level 2 and 3 facilities and as low as 30 percent for level 4 and 5 facilities.
more
National Essential Diagnostic List
recommended
Tuberculosis (TB) is the deadliest infectious disease in most low- and middle-income countries, claiming more than 4,000 lives each day. The unprecedented COVID-19 pandemic has seriously impacted people with pre-existing health conditions. People with TB are usually more vulnerable to other infectio
...
ns, including the novel coronavirus, due to pre-existing lung damage. They are also at higher risk of developing complications from COVID-19.
more
Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including malaria, HIV and COVID-19. Visually interpreted RDTs, more than any other class of diagnostic
...
s, fulfil WHO’s ASSURED criteria,1 enabling their use at the lowest levels of health care and in self-testing.2 Their utility is, however, compromised every time a test is incorrectly performed or interpreted or its result is not available in a timely manner for clinical decisionmaking and surveillance.
more
Taeniasis and cysticercosis caused by the parasite T. solium affect vulnerable populations,
mainly in Latin America, sub-Saharan Africa and Asia, where pigs (the intermediate host) roam
free and poor sanitation allows pigs access to human faeces.
The article investigates the diagnostic capabilities and prevalence of chronic obstructive pulmonary disease (COPD) in primary care settings in northern Brazil. It highlights that COPD is often underdiagnosed and undertreated in resource-limited reg
...
ions. The study involved 34 general practitioners and used spirometry to evaluate their diagnostic accuracy compared to clinical assessments. Findings revealed significant discrepancies between GP diagnoses and spirometry results, with many false positives and negatives. The study underscores the need for better training and the use of spirometry to improve COPD diagnosis and case-finding in primary care, emphasizing the importance of targeted strategies to enhance healthcare outcomes in developing countries.
more
Mpox Molecular Diagnostic Tests(RT-PCR)
recommended
March 2025. Access to appropriate, quality-assured diagnostics remains a challenge. There is limited information on key characteristics of available test kits, including their performance, reliability, and ability to detect relevant Mpox clades. Additionally, the lack of multiplex
...
diagnostic tools capable of distinguishing Mpox from other pathogens with similar clinical presentations further complicates case detection and response efforts.
more
Technical specifications series for submission to WHO prequalification: diagnostic assessment;TSS-3
The Global Schistosomiasis Alliance Diagnostic Workstream has developed a communications piece listing all commercially available diagnostics for schistosomiasis
The Global Schistosomiasis Alliance Diagnostic Workstream has developed a communications piece listing all commercially available diagnostics for schistosomiasis
This manual is to assist health care providers and laboratory scientists to diagnose mycobacterium ulcerans disease (Buruli ulcer). The manual aims to achieve a better understanding of the clinical presentation and its diagnosis. The methods described are tailored to various levels of care and avail
...
able resources to improve the diagnosis and surveillance of the disease.
more
This document provides an overview of malaria rapid diagnostic tests (RDTs) for Principal Recipients (PRs) of Global Fund grants, indicating their eligibility for procurement under the Global Fund's Quality Assurance Policy. The included products ha
...
ve been assessed and approved by the WHO Prequalification of Diagnostics Programme (WHO PQ), the relevant regulatory authorities of the GHTF founding members or the Global Fund Expert Review Panel for Diagnostics (ERPD). Updates are made based on new evidence and regulatory assessments.
more
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic
...
tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, including analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
more
Malaria remains a significant global health concern, with 249 million cases and 408,000 deaths reported in 2022, primarily in sub-Saharan Africa. The most vulnerable populations are children under five and pregnant women. Rapid and accurate diagnosis using microscopy or malaria rapid
...
diagnostic tests (mRDTs) is essential to ensure timely treatment, prevent severe disease and promote the rational use of antimalarial drugs. This UNICEF Technical Bulletin provides guidance on the procurement, quality assurance and selection of WHO-prequalified mRDTs, including considerations for areas with a high prevalence of pfhrp2/3 gene deletions. The bulletin also highlights UNICEF’s approach to sustainability, product verification and long-term arrangements with manufacturers, which ensure a reliable supply while supporting integrated child health management programmes. The bulletin serves as a valuable resource for countries, partners and programmes involved in the implementation of malaria case management and diagnostics.
more
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic
...
tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, including analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
more
HIV rapid diagnostic test market landscape
recommended
The analysis includes the three most commonly used HIV rapid diagnostic test
(RDT) categories: HIV-only professional use RDTs, dual HIV/syphilis professional use
RDTs, and HIV self-tests (HIVST).
On World TB Day, the World Health Organization (WHO) is urging countries to accelerate action to end tuberculosis (TB) and expand access to lifesaving services by using new innovations such as diagnostic tests that can be used near the point-of-car
...
e and tongue swabs that can help detect the disease faster reaching more people.
more
