GLI Guidance and Tools

This guide describes the various phases to create and strengthen specimen referral systems, essential components involved in referral, as well as other considerations for TB programme and laboratory managers, Ministry of Health officials, and other stakeholders across disease programmes. In addition to describing transport mechanisms and equipment required to move specimens in a safe manner, this guide also provides information on logistics, results reporting, data management, monitoring and evaluation, and standard operating procedures that will facilitate and improve specimen referral systems.

This guide provides practical guidance to develop an actionable implementation plan to smoothly transition to use of Xpert MTB/RIF Ultra cartridges, ensuring uninterrupted service and avoiding cartridge wastage. Topics covered in the guide include adapting national guidelines and diagnostic algorithms; managing existing cartridge supply, forecasting, procurement and distribution; planning site-level computer software upgrades and trainings of laboratory personnel and clinicians; ensuring coordination among donors and partners supporting Xpert implementation in countries; and monitoring impact of the roll-out of Xpert MTB/RIF Ultra.

This guide provides practical guidance on implementation of WHO recommendations and international best practices for TB laboratory strengthening. It is an updated version of the GLI Guide for Providing Technical Support to TB Laboratories, providing the latest practical guidance on use of newly recommended diagnostics in model algorithms, as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostics connectivity, biosafety, data management, human resources, strategic planning and other topics. Providers of technical assistance may also use the guide as a reference for available resources and tools.

This Framework, developed as a collaboration between the WHO Global TB Programme and the GLI core group, comprises 12 core indicators that measure countries’ capacity to detect TB accurately and rapidly using new diagnostics, provide universal DST, and ensure the quality of testing. The Framework serves as a guide for all countries developing plans for laboratory strengthening during 2016-2025, and also provides methods for calculating country-specific targets for the numbers of tests and facilities needed for each of the main diagnostic technologies.

Guidelines for sputum smear microscopy have been published by WHO and The Union, but in the decade since publication, many developments have occurred and a revised and updated text replacing both was considered timely. The GLI Handbook is a practical guide for the laboratory technician; it draws on the ideas outlines above and references best practice documents released by WHO and the GLI. The Handbook uses simple text and clear illustrations to assist laboratory staff in understanding the important issues involved in conducting sputum smear microscopy for the diagnosis of TB.

Although there are many international guidelines and technical materials for procedures and EQA, there is little or no external validation to assure that countries are adequately managing the microscopy networks. This accreditation tool is based on the many WHO-approved guidelines that provide technical direction, recommendations and specific forms to document and monitor performance of microscopy networks. The tool is composed of eleven standards with each a corresponding measure defining the minimum allowable performance to achieve accreditation.

Diagnostic manufacturers are increasingly expressing the need to be informed about the type of TB diagnostics they should invest in, as well as the potential market size for these products. The development of target product profiles (TPPs) is therefore an important step to align the needs of end-users with the specifications and targets that product developers should meet in terms of the performance and operational characteristics of such tests. Consensus on the minimal and optimal specifications of four different types of TB diagnostic tests has been reached following a meeting convened by WHO on behalf of GLI and the New Diagnostics Working Group.

This document describes standardized procedures related to sputum collection, handling, analyses, and reporting, with a focus on testing that has the greatest impact on microbiology endpoints for MDR-TB clinical trials (sputum culture conversion in liquid and solid media).

Laboratories performing AFB smear microscopy as well as Xpert MTB/RIF require adequate ventilation to minimize the occupational risk of infection. However, this is difficult to achieve in many settings where facilities have limited airflow, and where commercially produced biosafety cabinets are not affordable or appropriate. This guide provides specifications for the manufacture of a ventilated workstation that has been validated.