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This report’s central premise is that diagnostics and therapeutics, and associated test to treat strategies, are fundamental components of the pandemic response, both for COVID-19 and for future health threats. Two years into the COVID-19 pandemic
...
, this report reflects on the main challenges and key solutions on the road to equitable access to diagnostics and therapeutics.
This report draws from experience gained through the Access to COVID-19 Tools (ACT) Accelerator Diagnostics and Therapeutics pillars, and includes the perspectives of collaborating stakeholders (countries, civil society representatives and the private sector). Building on these findings, this report proposes sixteen recommended actions to address what have been identified as key structural challenges and specifies a potential owner for each action.
more
WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: MP Diagnostics HIV Blot 2.2, Number: PQDx 0198-071-00)
World Health Organization
(2016)
C_WHO
PQDx 0198-071-00
WHO PQDx PR
April/2016, version 2.0
Toolkit
HIV Treatment and Care
Policy framework.
Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the vari
...
ous dimensions of access to HCV diagnostics and pharmaceutical products, including product pricing, the regulatory environment and patent status, which together shape the national hepatitis response in different settings. It highlights key areas for action by ministries of health and other government decision-makers, pharmaceutical manufacturers and technical partners.
more
The WHO standard: Universal access to rapid tuberculosis diagnostics sets benchmarks to achieve universal access to WHO-recommended rapid diagnostics (WRDs), increase bacteriologically confirmed tub
...
erculosis and drug resistance detection, and reduce the time to diagnosis. WHO-recommended rapid diagnostics are highly accurate, cost-effective, reduce the time to treatment initiation, and impact patient-important outcomes.
more
The updated List of Essential Diagnostics contains 46 general tests that can be used for routine patient care as well as for the detection and diagnosis of a wide array of disease conditions, and 69 tests intended for the detection, diagnosis and mo
...
nitoring of specific diseases.
The List is divided into two sections depending on the user and setting: one for community settings, which includes self-testing; and a second one for clinical laboratories, which can be general and specialized facilities.
more
6 July 2021. The “WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection 2021 update” is the latest document replacing the one issued in 2020. Three new nucleic acid amplification test (NA
...
AT) classes are endorsed by WHO and included in the latest consolidated guideline
more
This document describes the key areas that national governments should consider for the introduction and scale-up of point-of-care (POC) diagnostics within national programmes, as new innovative POC technologies are being introduced into the market.
...
The next steps taken to include these new innovations within the broader context of national diagnostic networks of conventional laboratories could influence the achievement of the 2030 Fast Track targets for ending the AIDS epidemic.
POC diagnostics, when strategically introduced and integrated into national diagnostic networks, may help catalyse changes that improve the way diagnostics and clinical services are delivered. This document distils this understanding based on programmatic and market experiences of introducing POC diagnostics through catalytic investments in POC HIV technologies across numerous countries in sub-Saharan Africa. more
POC diagnostics, when strategically introduced and integrated into national diagnostic networks, may help catalyse changes that improve the way diagnostics and clinical services are delivered. This document distils this understanding based on programmatic and market experiences of introducing POC diagnostics through catalytic investments in POC HIV technologies across numerous countries in sub-Saharan Africa. more
6 July 2021. Three new nucleic acid amplification test (NAAT) classes are endorsed by WHO and included.
The latest operational handbook includes the new classes recommended by WHO. It aims at facilitating the implementation of the WHO recommendations by the Member States, technical partners, and ot
...
hers involved in managing patients with TB and DR-TB. The operational handbook provides practical information on existing and new tests recommended by WHO, step-by-step advice on implementing and scale-up testing to achieve local and national impact and lastly, model diagnostic algorithms, which are updated to incorporate the latest recommendations. An overview of budgetary considerations and information sheets on each of the newly recommended tests is provided.
more
HIV/AIDS Diagnostics Technology Landscape - 5th edition
Unitaid; World Health Organization
(2015)
C_WHO
October 2015
FIND and Standard Diagnostics (SD) have developed a lateral flow rapid diagnostic test (RDT) to screen for
T.b. gambiense HAT that is cheap and easy to use. The tests are packed individually and are stable at 40°C for
up to 25 months; they are pe
...
rformed on fresh blood obtained from a finger prick, and no instrument or electricity is required. The RDT detects host antibodies to infection in populations that are at risk, or in suspect individuals. Positive cases are subjected to further confirmatory methods to identify HAT patients.
more
Semi-annual Update
GDF is the largest global provider of quality-assured tuberculosis (TB)
medicines, diagnostics, and laboratory supplies to the public sector.
Since 2001, GDF has facilitated access to high-quality TB care in over 130
countries, providing treatmen
...
ts to over 30 million people with TB and procuring
and delivering more than $200 million worth of diagnostic equipment
more
Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however, inaccuracies associa
...
ted with current serological tests makes it difficult to fully assess the need for and impact of eradication campaigns using these tools. Under the recommendation of the WHO Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases(NTDs), a working group was assembled and tasked with agreeing on priority use cases for developing target product profiles (TPPs) for new diagnostics tools.
more
Interim Guidance, 12 July 2021; This tool was developed to assess present and surge capacities for the treatment of COVID-19 in health facilities. It allows health facilities to assess the availability and status of stockout of critical COVID-19 medicines, equipment and supplies on site and to ident
...
ify areas that need further attention to enable the facility to respond effectively to the pandemic. The tool encompasses key components that are essential to managing COVID-19 in a hospital setting, including:
health workforce (numbers, absences, COVID-19 infections, staff vaccinated for COVID-19 health workforce management, training and support);
medicines and medical supplies for management of COVID-19;
IPC capacities (protocols, safety measures, guidelines) and the availability of personal protective equipment (PPE) for staff;
diagnostic testing, imaging and patient monitoring devices and supplies
medical equipment for management of COVID-19, including O2 administration;
COVID-19 vaccine readiness ;
beds and space capacity.
more