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 in name, it offers integration-oriented assessment,... design, and monitoring guidance related to improving coordination and efficiency, and is relevant for other programs as well. Country case studies include viral load and early infant diagnosis (EID) in Uganda and EID in Ethiopia.
more
Prequalification of Male Circumcision Devices
PQMC_007 v1 16 December 2011
The GTFCC Laboratory Support for Public Health Surveillance document provides guidelines on using DNA-based molecular techniques for identifying and monitoring Vibrio cholerae strains in cholera outbreaks. It highlights the importance of genetic sequencing for tracking transmission, detecting new va...riants, and improving outbreak response. The report explains methods like PCR testing, whole genome sequencing (WGS), and multiple loci VNTR analysis (MLVA), detailing their advantages and applications. It also outlines best practices for sample collection, storage, and transportation, emphasizing collaboration between national and international laboratories to enhance cholera surveillance and control efforts.
more
The speed of developing diagnostics for SARS-CoV-2, the causative agent of coronavirus disease 2019 (COVID-19), has been quite remarkable. Diagnostics have focused on nucleic acid amplification testing (NAAT) to identify infected individuals in acute-phase disease for timely implementation of mitiga...tion strategies and case management. More and more immunodiagnostics, mostly rapid diagnostic tests, are being made available as an alternative to NAATs. This type of test can be used out-of-laboratory conditions at large scale.
more
The WHO BioHub Biosafety & Biosecurity: criteria and operational modalities sets out the requirements to which laboratories wishing to receive biological materials as part of this international exchange system should abide, to ensure safe and secure operations. These provisions are in accordance wit...h the recommendations of the WHO Laboratory Biosafety Manual 4th edition (LBM4), adopting an evidence- and risk-based approach to enable scalable and adaptable biosafety provisions and actions, proportionate to the assessed risk
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
Health Systems for Outcomes Publication | This report summarizes the findings of a qualitative study on health workers’ performance and career in Rwanda to identify bottlenecks, strengths and shortcomings for human resources in the health sector, as perceived by both health workers and users of he...alth services.
more
Capability and Performance
The microbiology laboratory database software.
WHONET is a desktop Windows application for the management and analysis of microbiology laboratory data with a particular focus on antimicrobial resistance surveillance. WHONET, available in 28 languages, supports local, national, regional, and global ...surveillance efforts in over 2,300 hospital, public health, animal health, and food laboratories in over 130 countries worldwide.
more
Limited coverage of laboratory services and long turnaround times from real-time reverse transcription-polymerase chain reaction (rRT-PCR) for the detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been insufficient to meet the demands in many African countries in response... to the COVID-19 pandemic. Rapid antigen diagnostic tests (AgRDTs) are potentially useful as they can inform healthcare workers and individuals of their infection status at point-of-care testing
more
Building laboratory testing capacity
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the current low disease prevalence, the positive predicti...ve value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care. Confirmation of Tbg infection requires microscopic examination of body fluids necessitating specific training. The best performing methods are laborious and reach 85–95% diagnostic sensitivity when performed by skilled personnel.
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the current low disease prevalence, the positive predicti...ve value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care.
more
This document aims to provide interim guidance for microbiology and virology experts, other laboratory professionals, laboratory managers, infectious disease programme managers, public health professionals and other stakeholders that provide primary, confirmatory or advanced testing for SARS-CoV-2, ...including genomic sequencing, or are involved in making decisions on establishing or scaling up capability and capacity to detect and characterize circulating SARS-CoV-2 variants.
more
This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.