Xpert MTB/RIF Implementation Manual: Technical and Operational "How-To": Practical Considerations

by World Health Organization

Overview

In December 2010, WHO first recommended the use of the Xpert MTB/RIF assay. The WHO's policy statement was supported by a rapid implementation document, which provided the technical "how-to" and operational considerations for rolling out the use of the assay. An unprecedented uptake of this new technology followed the release of WHO's policy: by the end of March 2014, more than 2,300 GeneXpert instruments and more than 6 million Xpert MTB/RIF cartridges had been procured in the public sector in 104 countries eligible for concessional prices.

An Expert Group was convened by WHO in May 2013 to review the current body of evidence on use of Xpert MTB/RIF. The resulting recommendations from the Expert Group are included in the WHO Policy update, which widens the recommended use of Xpert MTB/RIF, including for the diagnosis of paediatric TB and on selected specimens for the diagnosis of extrapulmonary TB, and includes an additional recommendation on the use of Xpert MTB/RIF as the initial diagnostic test in all individuals presumed to have pulmonary TB.

The accompanying Xpert MTB/RIF implementation manual has been developed to replace the first edition and takes into consideration the current body of evidence and operational experiences available, in the context of the Policy update.

Product Details

ISBN-13:	9789241506700
Publisher:	World Health Organization
Publication date:	04/20/2015
Pages:	50
Product dimensions:	6.25(w) x 9.75(h) x 0.20(d)

About the Author

World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.

Table of Contents

1 Background vii

2 Policy Development 1

2.1 Procedure for Developing Policies 1

2.2 Initial Policy Recommendations and Follow Up 1

2.3 Policy Update 2

2.4 Summary of Who's 2013 Policy Recommendations 3

3 Evidence Base 5

3.1 Evidence Available at the End of 2010 5

3.2 Evidence Base as of February 2013 6

4 Positioning the Test and Selecting a Site 9

5 Testing and Managing Patients 10

5.1 Selecting Individuals to Be Tested 10

5.2 Test Performance 12

5.3 Interpreting Results From, Xpert MTB/Rif 14

5.4 Diagnostic Algorithms 16

5.5 Monitoring Patients During Treatment 18

5.6 Using Xpert MTB/Rif In Drug Resistance Surveys 18

5.7 Using Xpert MTB/Rif in TB Prevalence Survey 19

6 Case Definitions and Patient Registration 21

6.1 Tb Case 21

6.2 Classification Based On Type Of Drug Resistance 21

6.3 Registration of TB Cases Diagnosed Using Xpert MTB/Rif 21

7 Practical Considerations 23

7.1 Operatonal Considerations 23

7.2 Preferential Pricing and Eligible Countrifs 28

7.3 Implementation Costs 29

7.4 Public Health Impact of Xpert MTB/Rif 29

8 Monitoring and Evaluation 32

8.1 Routine Monitoring 32

8.2 Measuring the Impact 33

9 Collaboration and Coordination 35

9.1 Knowledge Sharing 35

9.2 Donors Supporting the Roll-Out of Xpert MTB/Rif 35

Annex 1 Countries Eligible for Preferential Pricing On Equipment and Consumables 37

Annex 2 Standard Operating Procedure (SOP) for Processing Extrapulmonary Specimens (CSF, Lymph Nodes And Other Tissues) For Xpert MTB/RIF Assay 39