Building TB Diagnostic Capacity in Quality-Assured

Laboratory Systems

Dr. John Ridderhof (CDC)Chair of Global Laboratory Initiative

April 3, 2009Beijing, China

Essential Elements for Laboratory Strengthening

• Infrastructure, biosafety and utilities• Human resource development (including training and retention)• Specimen referral, supply chain management and logistics• Equipment and maintenance• Technical procedures (disease-specific)• Quality assurance• Data management

Logistics and supplies

Human Resources

(Guidelines

Technology transfer)

Infrastructure Quality Assurance

Linked referral 

systems and reporting

– Recognize and acknowledge the importance of laboratory systems in TB control and commit adequate human and financial resources.

Actions needed at the Country Level

Training MaterialTraining Material

GuidelinesGuidelinesPrograms/Programs/ReportsReports

Workshops/ConferencesWorkshops/Conferences

The US initiative in the 90The US initiative in the 90’’s to meet the challenge of MDRs to meet the challenge of MDR--TBTB““The Laboratory Makes a DifferenceThe Laboratory Makes a Difference””

National Laboratory Initiatives

– Set up a national mechanism to ensure coordination at all levels among departments responsible for laboratory services, disease-specific programmes, human resource development, and training

Actions needed at the Country Level (2)

Province Laboratories

District Laboratories

Health Centers

Ministry of Health

Global Programs

TB HIV Malaria Vaccine Prev Dis EPR

EPRVaccine Prev DisMalariaHIVTB

National Laboratory Infrastructure

National Institutes

National Reference Laboratory

Province Laboratories

District Laboratories

Health Centers

Ministry of Health

National Laboratory Infrastructure

Laboratory Division/Directorate

LaboratoryCoordinator/auditor

Quality Assurance

Training

– Ensure that health sector plans include adequately conceptualized and budgeted components for comprehensive laboratory capacity development.

Actions needed at the Country Level (3)

Planning, Constructing/Renovating Laboratories for MDRTB Diagnosis

Appropriate design and biosafety for culture and (integrated) molecular diagnostics

– Identify and remove barriers to laboratory staff career development, remuneration, staff retention, and sustainability of technical competency

Actions needed at the Country Level (4)

36% 32% 36%

77%

36%

Funding Infrastructure Equip & Sup Human Resources

EQA

Questionnaire results in 2006 among regional advisors from 75 countries:Major challenges are experienced in the area of….

Source: WHO

Laboratory Staff• laboratory’s greatest asset• critical to quality• partners in public health• qualified professionals

– Prepare a national inventory of donor and technical partner efforts in laboratory strengthening and identify synergies and opportunities for optimization of resources

Actions needed at the Country Level (5)

CROSS-CUTTING STREAMS

HIV

Immun-ization

INTEGRATED SERVICE DELIVERY

Linked Referral Services

Strengthen Laboratory Capacity

Training/Retention

Logistics and Commodities Management

Facility & Equipment Maintenance

TB

Malaria

INTEGRATED LABORATORY CAPACITY STRENGTHENING FOR DISEASES OF PUBLIC

HEALTH IMPORTANCE

Quality Assurance

Ref: GAP/CDC

– Formulate/modify policies and screening algorithms to facilitate scale-up of rapid diagnostics for MDR- and XDR-TB control

Actions needed at the Country Level (6)

WHO Guidance:Liquid culture and DST

Guidance on First and Second Line DSTLine Probe Assays for MDRTB

Country-specific Algorithms:Using LPA to replace culturefor SM (+) drug susceptible patients

SM + No result

MICROSCOPY

CULTURE

SM -

Solid Liquid

DST-FLD

No resultNegative Positive

Not MDR, res other drugs

DST-SLD

XDR No result

Solid Liquid

Not MDR, susc No result

Not XDR, res other drugs Not XDR, susc

MDR

Solid Liquid

LPA

– Engage private laboratories to improve access to TB diagnostic capacity, ensuring adequate support, training and quality assurance.

Actions needed at the Country Level (7)

•Laboratory Standards•External Quality Assessment (EQA)•Training•Accreditation•Surveillance•Referral

Making private laboratories part of the system

‘From unimaginable…to indispensable’

Strengthening TB laboratories