Laboratory Tools, Guidelines and Manuals
from Challenge TB, TB CARE I, TB CAP and partners
Challenge TB Tools
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GxAlert Implementation Strategy 2016 (Zipped Package)
A guide to the implementation of GxAlert or other connectivity devices that are capable of linking diagnostic results to patient records. GxAlert allows for fast feedback of laboratory results to patients, referring clinicians, treatment centers, MoH staff and the country’s existing health information systems.
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Guide for providing technical support
to TB laboratories in low- and middle-income countriesThis guide is intended to familiarize those who are providing technical assistance to TB laboratories in low- and middle-income countries with WHO recommendations and international best practices. It may be used as a training resource for new TB laboratory consultants or as refresher training for established consultants prior to a technical assistance assignment. The manual is intended to provide a comprehensive overview of topics to be considered before and during an assignment.
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Guidance for countries on the specifications for managing TB laboratory equipment and supplies
This document provides guidance to governments, NTPs, donors and others responsible for the procurement, logistics and management of laboratory equipment and other commodities used in TB laboratory services. Such services include reliable TB microscopy and culture, and drug susceptibility testing. The document will be useful in developing systems for the efficient and timely procurement of quality laboratory equipment and supplies, and the ongoing management of all TB-related laboratory commodities.
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ISO 15189 Quality Management System Implementation
Look Before You Leap – Best Practice Guidance DocumentThis guidance document is designed to provide public TB laboratories with best practices when embarking on implementing a quality management system and seeking ISO 15189 accreditation.
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TB Microscopy Network Accreditation
This guidance document is constructed as a tool to allow both countries and consultants to objectively evaluate performance against a set of standards that represent existing WHO guidance and to develop the foundation for a network accreditation program based on WHO-approved guidelines and standards.
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A Practical Handbook for National TB Laboratory Strategic Plan Development (Updated)
This package contains the handbook, a facilitators manual, participants manual and dynamic budget excel sheets (6Mb)
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WHO TB Laboratory Biosafety Manual
This manual encourages countries to accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of pathogenic micro-organisms in laboratories within their geographical borders.
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TB Laboratory Assessment Tool (English Version)
This WHO manual encourages countries to accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of pathogenic microorganisms in laboratories within their geographical borders. This is the third edition which adds new chapters on risk assessment, safe use of recombinant DNA technology and transport of infectious materials.
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Manuel de sécurité biologique pour les laboratoires de la tuberculose
Le présent manuel indique quelles sont les mesures de sécurité biologique minimum qui doivent être prises aux différents niveaux des laboratoires chargés d’effectuer le diagnostic de la tuberculose afin de réduire de risque de contracter l’infection sur le lieu de travail.
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Laboratoire de Tuberculose Formulaire D’evaluation (Français/French)
Le diagnostique et le suivi du traitement par l’examen microscopique de frottis réalisés sur des crachats est la pierre de voute de la stratégie DOTS. La couverture de population plus nombreuse par le DOTS requiert le renforcement des structures de laboratoire et de leur capacité à fournir de services fiables et de haute qualité. Ce document couvre l’ensemble des informations minimales requises pour mener à bien une évaluation utile d’un réseau de laboratoire.
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Rapid Implementation of Xpert MTB-RIF Diagnostic Test
Rapid Implementation of the Xpert MTB/RIF diagnostic test – Technical and Operational ‘How-to’ Practical considerations.
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Intensified implementation of GeneXpert MTB/RIF in 3 Countries
Nigeria, Indonesia and Kazakhstan were selected as initial TB CARE I countries for rapid implementation of Xpert MTB/RIF. They receive intensified technical support from March 2011 to March 2013. A final report was written describing the overall process of Xpert MTB/RIF implementation, challenges, lessons learnt and way forward for each individual country, as well as for TB CARE I in general.
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Laboratory Assessment Form
Laboratory Assessment Form (English)
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Laboratoire de Tuberculose Formulaire d’evaluation (Français/French)
Laboratoire de Tuberculose Formulaire d’evaluation (Français/French)
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The Roadmap to Successful Xpert Implementation – 37 Steps
This Roadmap shows how in 37 Steps GeneXpert can be implemented successfully.
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External Quality Assurance Package (22Mb)
This package provides standard materials for External Quality Assurance (EQA) training which allows countries to implement the guidelines correctly and efficiently. The package covers all main areas of AFB-microscopy EQA (rechecking, panels and supervision; newer developments (i.e. fluorescence; review of different AFB-microscopy techniques; complementary to EQA guide, AFB-microscopy training package). The package also facilitates training by providing various modules, presentations and exercises.
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Logistics Supply Management Tool (1.8Mb)
The Logistics Management Tool is used for the procurement, logistics and management of laboratory equipment and other supplies that are required for TB microscopy, and TB culture and DST (C/DST). It provides guidance to countries and development partners on specifications and mechanisms for the efficient and timely procurement of quality laboratory equipment and supplies and the ongoing management of all TB-related laboratory commodities. The tool consists of equipment specifications, recommendations on BSC installation, guidelines on laboratory commodity management, inventory control and algorithms, and spreadsheets for calculating quantities and costs of consumables. It was developed for the NTPs, NGOs, and agencies for tenders of laboratory equipment in low- and middle-income countries in order to implement or expand C/DST. Others responsible for the procurement, logistics and management of laboratory equipment and other supplies required for TB microscopy and TB culture and DST can also use this management tool.
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Management Information System English and French (14Mb)
A management Information System (MIS) ensures standardized recording and reporting in laboratories. The system provides tools for reporting and monitoring of AFB-smears and supplies. It also promotes correct analysis, rechecking EQA important parameters, and culture internal quality control. It improves the efficiency of culture/DST bench records versus databases, it ensures correct data entry and easy and regular analyses as well as patient follow-up culture/DST. The MIS is provided both as printable hard copies and generic electronic software (dbase – Epi Info).
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Roadmap for Laboratory Strengthening
The purpose of the Roadmap for Laboratory Strengthening is to guide the development or updating of National Laboratory Strategic plans to incorporate the specific requirements for providing the laboratory services needed for TB diagnosis, treatment and control.
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GeneXpert Implementation Guideline Ethiopia
This guideline describes and facilitate processes for the smooth introduction of the GeneXpert MTB/RIF Assay system into the National TB diagnostic network in order to improve TB and MDR-TB case detection in presumptive MDR-TB patients and in difficult to diagnose groups of patients such as children and HIV infected presumptive TB cases.