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July 2018 This fourth edition of the Unitaid/WHO market and technology landscape: HIV rapid diagnostic tests for self-testing report summarizes the current HIV testing gap; the challenges facing efforts to scale up; and the potential role HIV se ... more
Copenhagen, Denmark, 24–25 August 2017
Polymerase Chain Reaction (‎PCR)‎ has significantly helped in early diagnosis and commencement of specific interventions for diseases control. It also plays a critical role in understanding the disease epidemiology and unraveling the transmission dynamics of the disease. This manual intends to p ... more
The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. Th ... more
Information Note Advice for countries using or planning to introduce dual HIV/syphilis RDT in antenatal services and other testing sites. WHO/RHR/17.01
This document provides brief information answering common questions regarding COVID-19 diagnostic tests and how to prioritize them to the patients most in need.
In 2019, an estimated 10 million individuals fell ill with tuberculosis (TB) and 3 million of them were not reported to have beendiagnosed and notified. The gap is proportionately even wider for drug-resistant TB. Of the estimated 465 000 patients with rifampicin-resistant and multi-drug resistant T ... more
Au total, 18 laboratoires de 13 pays ont participé aux quatre cycles d'AQE : 10 laboratoires de huit pays africains endémiques, dont quatre ont participé aux quatre cycles et trois à trois cycles. Les résultats globaux ont montré que la performance médiane de ces laboratoires s'est amélioré ... more
This Tuberculosis guide has been developed jointly by Médecins Sans Frontières and Partners In Health. It aims at providing useful information to the clinicians and health staff for the comprehensive management of tuberculosis. Forms of susceptible and resistant tuberculosis, tuberculosis in child ... more
This document provides guidelines and tools for monitoring the quality of outsourced viral load test results in India, defining processes and procedures as well as quality indicators and a monitoring checklist for assuring quality of services. Annexes include reporting forms and checklists for monit ... more
PLoS ONE 13(8): e0202499. https://doi.org/10.1371/journal.pone.0202499 This was a school-based cross-sectional study conducted in 2015 among 305 school children aged 7–16 years from two primary schools located in Ilemela and Magu Districts, north-western Tanzania. Single stool and urine samples w ... more
July 2018
Ethiopia Antimicrobial Resistance Surveillance Plan
Second Edition AIDS Medicines and diagnostics services July 2015
9 March 2022, Timely and accurate diagnostic testing for SARS-CoV-2 is an essential part of a comprehensive COVID-19 response strategy. Ag-RDTs can be performed by individuals in which they collect their own specimen, perform a simple rapid test and interpret their test result themselves at a time a ... more
Many critical questions remain about the effectiveness of COVID-19 vaccines in real-world settings. These questions can only be answered in post-introduction vaccine effectiveness studies.This guidance document outlines an approach to leverage existing surveillance systems for Severe Acute Respirato ... more
Hendra virus (HeV) continues to pose a serious public health concern as spillover events occur sporadically. Terminally ill horses can exhibit a range of clinical signs including frothy nasal discharge, ataxia or forebrain signs. Early signs, if detected, can include depression, inappetence, colic o ... more
This document provides detailed guidance on laboratory testing for suspected diphtheria cases during significant outbreaks or in low-resource settings. It aims to supplement and build on other existing WHO guidance documents on surveillance standard ... more
Tests zur Detektion einer Infektion mit SARS-CoV-2 (neuartiges Coronavirus) sowie zum Nachweis von Antikörpern gehören zu den sog. In-vitro-Diagnostika (IVD). Das erstmalige Inverkehrbringen von In-vitro-Diagnostika auf dem deutschen Markt ist nac ... more
WHO has launched an online course on tobacco product regulation in response to the need for clear, practical advice on building laboratory testing capacity. This course is based on the Tobacco Product Regulation: Building ... more
Any individual that meets the suspected case definition of monkeypox should be offered testing in appropriately equipped laboratories by staff trained in the relevant technical and safety procedures. Confirmation of monkeypox virus infection is based on nucleic acid amplification testing (NAAT), usi ... more
100 méthodes d'essai pour 100 principes pharmaceutiques actifs Pour les projets Minilab existants qui souhaitent remplacer les anciens manuels ou les initiatives qui veulent lancer de nouveaux projets, la nouvelle "Minilab Edition 2020" peut être obtenue au prix préférentiel de 50 € auprès d ... more
deux méthodes d'essai sur les comprimés et les injections de dexaméthasone
This guide includes information relevant for tuberculosis (TB) program and laboratory managers, as well as Ministry of Health officials across disease programs interested in establishing integrated solutions for specimen referral. Though TB-focused ... more

Training Package on XPERT MTB/RIF

USAID; WHO; FIND; et al. global laboratory initiative (2017) C_WHO
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 ... more

Module de formation sur XPERT MTB/RIF

USAID; WHO; FIND; et al. global laboratory initiative (2017) C_WHO
October 2018
Quick reference guide
User manual.
orientations provisoires, 25 juin 2021. Des tests de diagnostic rapides et précis sont un outil essentiel pour prévenir et contrôler la propagation du COVID-19. Ce document décrit les recommandations relatives aux stratégies nationales de dépi ... more
Interium guidance, 25 June 2021Timely and accurate diagnostic testing is an essential tool in preventing and controlling the spread of COVID-19. This document describes recommendations for national testing strategies and the use of PCR and rapid antigen te ... more
Laboratory monitoring & evaluation tool Xpert Pre-installation Checklist Accessed December 2017
User Guide. This Laboratory Assessment Tool (LAT) is specifically designed to assess capacities of existing laboratories which have implemented or aim to implement SARS-CoV-2 testing. It addresses both core capacities of a ... more
ASLM strives to keep laboratory networks in Africa connected and informed of diagnostic tools, techniques, procedures and advancements related to COVID-19 testing with interactive training and information sessions using the Extended Community Health ... more
Research to develop point-of-care tests is in progress. Treatment of Buruli ulcer comprises 8 weeks of combined antibiotics (rifampicin and clarithromycin). Complementary therapies such as wound care, skin graft and prevention of disability are need ... more

Tobacco product regulation

World Health Organization; Together lets beat Tobacco (2018) C_WHO
Building laboratory testing capacity
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 ... more
Laboratory Safety Handbook. Global edition Las pruebas de cultivo y sensibilidad a fármacos son necesarias especialmente para los pacientes con riesgo de tuberculosis resistente a los medicamentos y para vigilar su respuesta al tratamiento. Si b ... more
La détection directe des protéines virales du SRAS-CoV-2 (antigènes) dans les écouvillons nasaux et autres sécrétions respiratoires à l'aide de tests immunologiques à flux latéral (également appelés ... more

Diagnostic de l’ulcère de Buruli au laboratoire

Portaels, F. Organisation Mondiale de la Santé (2014) C_WHO
Manuel destiné au personnel de santé. Le présent manuel est un guide spécialisé sur les techniques et les méthodes de laboratoire à utiliser pour le diagnostic de l’ulcère de Buruli, une maladie provoquée par Mycobacterium ulcerans. Destiné aux techniciens et aux scientifi ques de labora ... more

Diagnostics Catalog August 2018

Global Drug Facility World Health Organization WHO, Stop TB (2018) C_WHO
Stop TB`s GDF provides a wide range of diagnostic equipment and laboratory supplies in its Diagnostics Catalog
WHO recommends replacing western blotting and line immunoassays with simpler tests in HIV testing services. These simpler tests include rapid diagnostic t ... more
‎‎Orientations provisoires, 28 janvier 2021 Dans cette version mise à jour des orientations sur la sécurité biologique en laboratoire en rapport avec le SARS-CoV-2, le virus responsable de la maladie à coronavirus 2019 (COVID-19), les points suivants ont été ajoutés : aspects de ... more
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 describ ... more
Protocol for the use of rapid tests for the detection of antibodies against SARS - COV-2/COVID-19
Technical specifications for selection of essential in vitro diagnostic tests for SARS-COV-2, 14 June 2021
TECHNICAL SPECIFICATIONS FOR TEST SELECTION ESSENTIAL IN VITRO DIAGNOSTIC TESTS FOR SARS-COV-2
This document aims to provide interim guidance for microbiology and virology experts, other laboratory professionals, laboratory managers, infectious disease programme managers, public health profes ... more
This document provides countries with recommendations for structuring a public health entomology laboratory network. The document will help countries to identify their areas of need and determine how the entomology network can be strengthened, espec ... 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 ... more
Practical guide for doctors, nurses,laboratory technicians, medical auxiliaries,water and sanitation specialists and logisticians
ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to pr ... more
ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to pr ... more
This manual is designed primarily to assist managers of national malaria programmes and national reference laboratory responsible for quality assurance of malaria microscopy control. The information is also applicable to non-governmental organizatio ... more
The recommendations in these guidelines promote the use of simple, non-invasive diagnostic tests to assess the stage of liver disease and eligibility for treatment; prioritize treatment for those with most advanced liver disease and at greatest risk ... more
The overall objective of this implementation plan is to define the strategy for implementation of the Xpert MTB/RIF test for rapid detection of TB and rifampicin (RIF) resistance in Tanzania, within the context of the National Tuberculosis and Leprosy Programme (NTLP) strategic plan and other nation ... more
Operational Guidelines for the national and district health workers & planners. These new approaches include use of selective chemotherapy, Rapid Diagnostic Tests (RDTs), Zinc for treatment of cholera in children and complementary use of OCV
School of Public Health, Fudan University, Key Laboratory of Public Health Safety, Ministry of Education, Shanghai, China PLOS ONE | www.plosone.org 1, May 2013 | Volume 8 | Issue 5 | e64915
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 ... more
This publication aims to provide updated guidance on the specific use of yellow fever laboratory assays in the context of surveillance to be used across the Global Yellow Fever Laboratory Network fo ... more
This resource consists of technical guidelines for District Medical Officers, counselors and laboratory technicians for second-line antiretroviral therapy drugs, operational guidelines for pilot roll-out in two centres and ... more
Prepared as an outcome of ICMR Expert Group on Immunophenotyping of Hematolymphoid Neoplasms | Coordinated by Division of Non Communicable Diseases | This document addresses on various issue related to good quality practices in laboratory work up of ... more
The present DHR-ICMR guidelines comprehensively address the various concerns regarding the clinical assessment, treatment, and laboratory diagnosis of rickettsial diseases in India and the world. It is hoped that physicians, health care workers, the ... more
Self-care interventions are evidence-based, quality drugs, devices, diagnostics and/or digital products which can be provided fully or partially outside of formal health services and can be used with or without the direct supervision of health care personnel. Where HPV ... more
Most of the global burden of sepsis occurs in low- and middle-income countries (LMICs), but the prevalence and etiology of sepsis in LMICs are not well understood. In particular, the lack of laboratory infrastructure in many LMICs has historically p ... more
The main objective of this self learning programme is to understand the purpose of biostatistics through realistic cases and to acquire basic biostatistics skills that can be applied to your work. The target audiences of this training are medical and biomedical students, ... more
The major areas of focus for the plan will be:
- Social mobilization and community empowerment (health promotion & education for disease prevention);
- Promotion of access to safe water, good sanitation and hygiene;
- Surveillance and labor ... more
8 January 2021 Sequencing enabled the world to rapidly identify SARS-CoV-2 and develop diagnostic tests and other tools for outbreak management. Continued genome sequencing supports the monitoring of the disease’s spread and evolution of the viru ... more
These guidelines provide new and updated recommendations on the use of point-of-care testing in children under 18 months of age and point-of-care tests to monitor treatment in people living with HIV; the treatment monitoring algorithm; and timing of ... more
This policy guideIine is intended for use by healthcare professionals invoIved in the management of Covid-19 in South Africa. The document provides guidance on diagnostic tests available, on antigen test performance and accessibility. 1t focuses on ... more
Über SARS-CoV-2-Testsysteme informieren das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und das Paul-Ehrlich-Institut. Die Informationen ergänzen sich, den rechtlichen Rahmen bietet u.a. die Coronavirus-Testverordnung-TestV. Das BfArM bietet eine Liste von Antigen- ... more
On September 10, 2022, the Ministry of Health (MOH) announced a cholera outbreak in Aleppo governorate with 15 laboratory confirmed cases reported between August 25 and September 9, 2022. Activities under this plan seek to address the immediate need ... more
The 6th edition of the essential medicine list has been developed based on the 5th edition list of essential medicines, the National Standard Treatment Guidelines and Protocols 2013, list of laboratory commodities and List of Consumables used in pub ... more
This Rapid Advice Guideline updates the Interim Guidance on the “Assessment of infants with microcephaly in the context of Zika virus” published in February 2016 (WHO/ZIKV/MOC/16.3). The recommendations provides guidance on the screening, clinical assessment, neuroimaging, ... more
Accessed: 02.05.2020 These consolidated guidelines provide recommendations for comprehensive prevention and case management strategies in Kenya Scope of the Guidelines: Infection prevention and control Patient triage Emergency Medical Services Case management ... more
This report investigates the impact of potential misclassification of samples on HIV prevalence estimates for 23 surveys conducted from 2010-2014. In addition to visual inspection of laboratory results, we examined how accounting for potential miscl ... more
PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control ... more
The USAID | DELIVER PROJECT, Task Order 4, developed this guide for quantifying health commodities; it will assist technical advisors, program managers, warehouse managers, procurement officers, and service providers in (1) estimating the total commodity needs and costs for successful implementation ... more
As of October 2017, the global database comprised almost 30 000 records, including results from bioassays to measure phenotypic resistance, and biochemical and molecular tests for resistance mechanisms. The current report presents an overview of dat ... more
Q3: Can febrile seizures (simple or complex) be managed at first or second level care by non-specialist health care providers in low and middle income country settings? What is the role of diagnostic tests in the management of febrile seizures by no ... more
The following protocol has been designed to investigate the extent of infection, as determined by seropositivity in the general population, in any country in which COVID-19 virus infection has been reported. Each country may need to tailor some aspects of this protocol to align with public health, ... more
WHO has a unique combination of technical public health and scientific expertise, and a global operational footprint, with field offices in more than 150 countries. In 2020, this global, technical, and operational reach meant WHO was able to support countries around the world in every aspect of COVI ... more
These guidelines provide new and updated recommendations on the use of point-of-care testing in children under 18 months of age and point-of-care tests to monitor treatment in people living with HIV; the treatment monitoring algorithm; and timing of ... more
The Strategy provides a high-level unifying framework to leverage existing capacities, address barriers and strengthen the use of genomic surveillance in the detection, monitoring and response to public health threats. Genomic surveillance is part of the broader surveillance and ... more
Clinical guideline, Methods, Evidence and Recommendations In this guideline the following is covered: information needs of people with chronic hep titis B and their carers; where children, young people and adults with chronic hepatitis B a- should be assessed; assessment of liver disease, includi ... more

Fever Diagnostic Technology Landscape

UNITAID World Health Organisation (WHO) (2018) C_WHO
1st edition. Unitaid’s report describes a slate of new devices that can more efficiently identify dangerously ill children so that they can be treated immediately. These tools make it easier to recognize danger signs, and support integrated approaches to reducing childhood deaths from the three ... more