Practical Guide to Implementing a Quality Assurance System for Xpert MTB/RIF Testing

The Practical Guide to Implementing a Quality Assurance System for Xpert MTB/RIF testing and Quick Guide to Quality Assurance of Xpert MTB/RIF testing were based on a pre-publication version of the guide, developed and piloted by the Foundation for Innovative New Diagnostics (FIND) and the U.S. Centers for Disease Control and Prevention (CDC), with funding from the United States President’s Emergency Plan for AIDS Relief (PEPFAR).

This guide provides practical guidance and tools to establish and implement a quality assurance (QA) system for the Xpert MTB/RIF test across the diagnostic network. It is intended to inform Ministry of Health officials, National TB Programme officials, National TB Reference Laboratory personnel, and other key stakeholders on the how to implement activities to assure the quality of Xpert MTB/RIF results, including the planning and design of a QA system which facilitate the provision of uninterrupted diagnostic and testing services. As well, strategies and approaches for the monitoring of TB diagnostic networks, ensuring that data are evaluated and used to inform decision-making.

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Supporting documents/forms/checklists, including:

• Xpert MTB/RIF Quality Assurance Situational Analysis Checklist
• Maintenance log template
• Indicator report forms
• Competency assessment for GeneXpert users
• Assessment Checklist for Testing Sites (ACTS) checklist and User’s Guide
• Xpert MTB/RIF SOP
• Proficiency testing programme - guidelines and SOPs
• New lot testing SOP

To download all files in one zipped folder, click here.