Resources

Policies & Supporting documents

• Policy framework for implementing new TB diagnostics

IGRAs

• Policy statement
• Expert Group Meeting report
• Factsheet
• Related press release

Commercial Serodiagnosis

• Policy statement
• Expert Group Meeting report
• Factsheet
• Related press release

Xpert MTB/RIF

• Policy statement
• Rapid Implementation document
• Checklist
• Factsheet
• Related press release

Microscopy

• Policy statement on same day diagnosis by microscopy
• Policy statement on Fluorescence LED microscopy
• Expert Group Meeting report
• Definition of sputum smear positive TB case
• Reduction of number of smears for the diagnosis of PTB
 

Culture and DST

• Policy statement on non-commercial culture and DST
• SOPs on non-commercial culture and DST methods
• Expert Group Meeting report
• Policy Guidance on DST for SL drugs (in revision)
• Background information on the use of liquid medium for culture and DST

Molecular Line Probe Assay (LPA)

• Policy statement
• WHO Expert Group report: Molecular line probe assays for rapid screening of patients at risk of MDR-TB

Microscopy Training Package

• Acid-Fast Direct Smear Microscopy Training Package

Culture Training Package

• Select the below link, right click, copy and paste into a web browser to download
  http://www.tbcare1.org/publications/toolbox/tools/complab/Lab_Tools.zip

Factsheet and briefing notes (Initiatives and Projects)

Factsheets

• MDR-TB
• TB Diagnostics
• Xpert MTB/RIF Test
• Serodiagnostic tests
• TB Interferon Gamma Release Assay (IGRAs)

Briefing Notes: Initiatives and Projects

• TB Xpert project
• EXPAND-TB project
• Global Laboratory Initiative (GLI)

Training Packages

• Training Package Culture October 2012
• Training Package DST October 2012
• Training Package LPA October 2012

GLI Laboratory Toolbox

GLI (under WHO guidance) has developed a 'Laboratory toolbox' to standardize laboratory methods.

I. Contents

1. A Roadmap for Laboratory Strengthening
   Roadmap for Laboratory Strengthening
   
   
2. Standard Operating Procedures
   Introduction guidance
   List of SOPs
   
   Module 1: Master SOP for writing quality management documents
   
   Safety
   Module 2: Procedure in case of spill of specimens in an AFB microscopy laboratory
   Module 3: Procedure in case of spill of infectious material within the biological safety cabinets
   Module 4: Emergency procedure in case of major biohazard incident outside the biological safety cabinet
   Module 5: Fumigation of a biological safety cabinet
   Module 6: Emergency procedure in case of fire
   Module 7: Use of personal protective equipment in an AFB microscopy laboratory
   Module 8: Use of personal protective equipment for culture and drug susceptibility testing
   Module 9: Use of disinfectants
   
   Use and maintenance of equipment
   Module 10: Use and maintenance of class I and class II biological safety cabinets
   Module 11: Use and maintenance of an autoclave
   Module 12: Use and maintenance of an electromagnetic balance
   Module 13: Use and maintenance of a centrifuge
   Module 14: Use and maintenance of a freezer
   Module 15: Use and maintenance of a refrigerator
   Module 16: Use and maintenance of an incubator
   Module 17: Use and maintenance of an inspissator
   Module 18: Maintenance of a light microscope
   Module 19: Maintenance of a fluorescence microscope
   Module 20: Use and maintenance of a pH meter
   Module 21: Use and maintenance of a water distiller
   
   Preparation of reagents
   Module 22: Preparation of reagents for microscopy
   Module 23: Preparation of reagents for culture and drug-susceptibility testing
   Module 24: Preparation of plain egg-based media
   Module 25: Preparation of Löwenstein-Jensen drug-containing media
   
   Procedures
   Module 26: Ziehl-Neelsen staining
   Module 27: Auramine staining
   Module 28: Rechecking acid-fast bacilli smears for external quality assessment
   Module 29: Sample conditions and transport for culture procedure
   Module 30: Specimen processing for culture
   Module 31: Drug susceptibility testing, proportion method
   Module 32: Identification of Mycobacterium tuberculosis
   Module 33: Niacin test
   Module 34: Catalase test
   Module 35: Nitrate reduction test
   Module 36: Growth on PNB medium
   Module 37: Maintenance of mycobacterial strains
   
   
3. Logistics Supply Management Tool
   AFBsuppliesProcurementVs2
   CU&DSTsupplies
   Guidance for countries on the specifications for managing TB laboratory equipments and supplies
   UserGuide_AFBlabSupplies
   UserGuide_SuppliesCU&DSTworkbook
   
   
4. External Quality Assurance Package
   AFB microscopy
   EQA Overview & Planning
   Facilitator Guide
   Optional Modules
   Panel Tests
   Rechecking
   Supervision
   
   
5. Management Information System
   Culture & DST
   French Versions
   Microscopy & EQA
   
   
6. Culture and DST Package
   Participant Manual
   Trainer's Manual

II. Databases for Culture & DST

The entire GLI Laboratory Toolbox is a zip file which is 75MB in size and can be downloaded from here:
http://www.tbcare1.org/publications/toolbox/tools/complab/Lab_Tools.zip
(Select the above link, right click, copy and paste into a web browser to download)

Others

• Ventilated Workstation Manual for AFB Smear Microscopy
• Briefing note: TB diagnostics and laboratory and laboratory strengthening
• Laboratory Services in Tuberculosis Control; (WHO/TB/98.258):
  http://www.who.int/entity/tb/publications/who_tb_98_258/en/index.html
  - Part I Organization and Management
  - Part II Microscopy
  - Part III Culture
• The Public Health Service National Tuberculosis Reference Laboratory and the National Laboratory Network. International Union Against Tuberculosis and Lung Disease, 1998:
  http://www.uphs.upenn.edu/bugdrug/antibiotic_manual/iuatld_natTBreflabmanual.pdf
• Laboratory Biosafety Manual, Third Edition
• TB Laboratory Biosafety Manual
• New technologies for tuberculosis control: a framework for their adoption, introduction and implementation
• Stop TB planning matrix and frameworks tool, laboratory annexes
• Planning and budgeting for TB control activities
• WHO user manual part 1: Planning and budgeting tool for tuberculosis control
• WHO user manual part 2: Planning and budgeting tool for tuberculosis control
• Laboratory Quality Management System Training Toolkit (English, French, Russian)
• The WHO/CDC/CLSI Laboratory Quality Management Handbook is available in PDF in English at http://www.who.int/ihr/publications/lqms/en/index.html. Hard copies of the handbook can be ordered at the WHO book shop at http://apps.who.int/bookorders/anglais/detart1.jsp?codlan=1&codcol=15&codcch=828. Translations in French and Russian are on-going.
• The WHO Laboratory Assessment Tool and its annexes (English, French, Russian, and Spanish)
• Procedure for mycobacteria culture using LJ medium from sputum (direct)

Related links

KIT Information Portal Laboratory Quality Strengthening

TB diagnostics and laboratory strengthening

http://www.finddiagnostics.org/programs/tb/find-negotiated-prices/

Evidence-Based Tuberculosis Diagnosis: a comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics

Retooling Task Force on TB diagnostics pipeline

Global Laboratory Initiative Tuberculosis Network

The Tubeculosis Coalition for Technical Assistance (TB/CTA)

Partner's and laboratory resource's links

UNITAID
FIND
KNCV
CDC
USAID
PEPFAR
KIT
ASLM
IRD
Fondation Mérieux