PQDx 0198-071-00
WHO PQDx PR
April/2016, version 2.0
Standard Treatment Guideline
The information contained in this document, be it guidelines, recommendations, diagnostic algorithms or treatment regimens, are offered in this document in the public interest. To the best of the knowledge of the guideline writing team, the information contained in these guidelines is correct. Imple...mentation of any aspect of these guidelines remains the responsibility of the implementing agency in so far as public health liability resides, or the responsibility of the individual clinician in the case of diagnosis or treatment.
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This document provides brief information answering common questions regarding COVID-19 diagnostic tests and how to prioritize them to the patients most in need.
L’expansion de la mise en œuvre des approches de suivi du traitement par la réalisation de tests de mesure de la charge virale et de tests de diagnostic chez le nourrisson sera indispensable pour garantir la qualité des soins et des traitements ainsi que le succès des programmes. Le fait de ch...oisir le réseau de diagnostic, les types d’échantillons ainsi que les interventions et les stratégies les plus appropriés dans chaque pays et pour chaque partenaire au niveau national et régional permettra de soutenir cet effort, de renforcer la collaboration et d’optimiser les investissements réalisés dans la mise en œuvre des tests en vue d’obtenir des effets manifestes.
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This guide provides an overview of the major elements that must be considered before, during and after the implementation of antigen-detecting rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2. This guide is complementary to policy guidance issued by the World Health Organization (WHO). The guide may ...appeal to a range of audiences including Ministries of Health, donors, public and private organizations/agencies acting as implementing partners and community based and civil society organizations with experience working on health, especially organizations familiar with similar testing campaigns for other disease programmes like HIV and malaria
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The purpose of this TPP is to communicate the minimum and ideal characteristics desired to meet the need for discriminating low levels of risk for transmission, i.e. targeted prevalence thresholds in the surveyed areas. An in vitro diagnostic test is needed for the detection of analyte(s) specific t...o Wuchereria bancrofti, Brugia malayi, and Brugia timori to aid in the surveillance of defined geographic areas as to whether infection and/or transmission potential has increased (recrudescence) or decreased (elimination of transmission).
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Soil-transmitted helminths are a group of intestinal worms that include Ascaris lumbricoides (giant roundworm), Trichuris trichiura (whipworm), and Ancylostoma spp. (A. duodenale, A. ceylanicum) and Necator americanus (hookworms). Despite the clear biological differences among the different species,... their transmission is characterized by the same sequence of events: (i) infected individuals excrete worm eggs through their stool in soil; (ii) under optimal conditions of moisture and temperature the excreted eggs develop into infectious stages; and (iii) finally, infection occurs through oral uptake (Ascaris, Ancylostoma and Trichuris) or skin penetration (Ancylostoma and Necator) of these infectious stages (embryonated eggs and third stage larvae) that reside in the soil and/or in the environment (referring to their common name).
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Health ministries currently lack effective tools for monitoring and evaluation of schistosomiasis control programmes. Egg detection can be used, but the cost, challenges of obtaining samples, and the need for trained personnel and equipment limit the frequency of monitoring. The purpose of this TPP ...is to guide the development of new diagnostic tools to reliably measure when prevalence is above or below a cut-off of 10% in school-aged children. Communities remaining above 10% require annual MDA, while communities below 10% can reduce MDA frequency as long as < 10% prevalence can be maintained. However, the lack of a reliable test has hindered the development of maintenance strategies. The test is also needed to track changes of prevalence > 10% to ensure that annual MDA is reducing overall prevalence.
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In 2009, WHO’s Second International Conference on Buruli Ulcer Control and Research resolved to strengthen the capacity of national laboratories to confirm cases of the disease, but advised that “efforts are still needed to develop simple diagnostic tools usable in the field as well as disabilit...y prevention methods”.
In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
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In 2007, the Sixtieth World Health Assembly adopted resolution WHA60.13 on control of leishmaniasis, urging Member States, among other actions:
to strengthen prevention, active detection and treatment of cases of both cutaneous and visceral leishmaniasis in order to decrease the disease burde...n; and
to strengthen the capacity of peripheral health centres to deliver primary and secondary care, so that they provide appropriate affordable diagnosis and treatment and act as sentinel surveillance sites.
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In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive... predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
In March 2018, they convened a global meeting with the aim of establishing an action plan to develop new diagnostic solutions for Buruli ulcer and to create a framework of collaboration to address unmet needs in diagnostics for the disease. The participants agreed to develop a target product profile (TPP) to address the need for a rapid diagnostic test for use at the primary health-care level.
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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 diagnostics, 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.
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This analysis focused on the chronic form of HAT caused by T. b. gambiense, as it contributes to the majority of disease burden. Information from the literature review,
product development landscape, and stakeholder interviews was compiled to:
- Identify use cases and understand current diagnosti...c practices and tools associated with each use case.
- Analyze progress toward robust diagnostics for HAT across different biomarkers.
- Develop recommendations for steps to improve the availability, access, and adoption of HAT diagnostic tools.
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