Strengthening Regional Viral Hepatitis

Laboratory Capacity

Donghyok Kwon DVM, PhD

HIV, Hepatitis and STI Unit
Division of Communicable Diseases
WHO Western Pacific Region

NRL Asian Workshop on Quality, o4 March, 2019

World Health
Organization

1| Western Pacific Region

Contents
q Implementation of Regional Action Plan for Viral
Hepatitis in the Western Pacific (2016-2020)
q Strengthen laboratory capacity for viral hepatitis
q Report from informal consultation on viral
hepatitis laboratory services (June 2018)
q Regional Viral Hepatitis Laboratory Network
q Future plans

World Health
Organization

2| Western Pacific Region

Of the 325M people living with chronic HBV and
HCV globally, almost half are in the WPR
115 M in WPR ~14 M in WPR

~45% of the global 257 million ~20% of the global 71 million

people living with hepatitis B people living with hepatitis C

Western Pacific Region:

40% of the global burden for HBV and HCV
(highest in the world)

World Health
Organization

3| Source : WHO Global Hepatitis Report 2017 Western Pacific Region

Mortality by major communicable diseases, 2015:
Global, SEAR, WPR
SEAR has 30.5% of all global hepatitis WPR has 33.3% of all global hepatitis
related deaths related deaths
1600000

1400000

1200000

HIV/AIDS
1000000

Tuberculosis
800000

Malaria
600000

Hepatitis-
400000 related

200000

0
Global SEARO WPRO

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4| Western Pacific Region

Current services on viral hepatitis

q Lack of political commitment and investment

q Limited availability and access to testing and treatment
q Lack of data at national/subnational levels
q Limited financial resources and high cost commodities

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Organization

5| Western Pacific Region

REPORT CARD ON ELIMINATION – WPR
Targets Interventions 2020 target 2030 target WPR (2018)

1. Service Three dose hepatitis 90% 90% 93% (2017)

coverage B vaccination
Birth dose hepatitis 50% 90% 85% (2017)
B vaccination

Blood safety 95 % screened 100 % screened 98% screened (2015)

donations donations
Injection safety 0% 0% 3.2% unsafe injections (2015)
Harm reduction 200 injection sets 300 injection sets 57 injection sets
/ PWID / PWID / PWID (2015)
Testing 30% diagnosed 90% diagnosed HBV: 17%/ HCV: 21% (2016)
Treatment 5M (HBV) and 3M 80% eligible HBV: 4 million (2016)
(HCV) treated treated HCV: 254,000 (2%, 2016)
2. Impact Incidence -30% -90% HBV prevalence in children:
(About 1% HBsAg (0.1% HBsAg in 0.93% (2016)/ HCV incidence:
in children ) children) 6 per 100,000 (2015)
Mortality -10% -65% 24.1 deaths per 100,000 (2015)

World Health
Organization

6| PMTCT: Prevention of mother to child transmission (universal birth dose or other approaches) Western Pacific Region
PWID: Person who injects drugs
 HBV cascade of care, WPR 2016

Only 17 % of people living

with HBV have been
diagnosed and 20% of
those diagnosed received
treatment

20%

l Source: WHO based on modelling studies of the Center for Disease Analysis / World Health
Organization

7 | Polaris Western Pacific Region

 HCV cascade of care, WPR 2016

Only 21% of people living

21% with HCV have been
diagnosed and 9% of
those diagnosed received
treatment

9%

l Source: WHO, based on modelling studies of the Center for Disease Analysis / World Health
Organization
|
8 Polaris Western Pacific Region
 National Reference Laboratories
for Viral Hepatitis: 6

World Health
Organization

9| Western Pacific Region

Strengthening lab capacity for viral hepatitis
q Hepatitis programme review in countries (2017~2018)
§ Philippines (Aug, Sep 2017, Jan 2019), Mongolia (Sep 2017, Oct 2018),
Cambodia (Oct 2017), Kiribati (Feb 2018), Malaysia (Mar, Oct 2018), Papua
New Guinea (May 2018), Lao PDR (June 2018)

q Training workshop on Hepatitis B and C screening, diagnosis and

treatment (2017, 2018)
§ Organized by TREAT Asia/amfAR, supported by WPRO, SEARO, WHO CCs
Kanazawa University (Japan) and Sanjay Gandhi Institute (India)
§ Participants: 2017 (30 clinicians 9 countries) 2018 (46 HCPs from 16
countries in the Asia Pacific and WHO country office staff)
§ Training modules:
1) Introduction of viral hepatitis 2) Transmission and prevention of hepatitis
B and C 3) Testing and serological markers 4) Assessing liver fibrosis 5)
Clinical management of hepatitis B and C infection and 6) WHO M&E
framework for viral hepatitis and patient monitoring
World Health
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10 | Western Pacific Region

q Survey on lab capacity for HIV, hepatitis and STI in selected
countries (2018)
§ National systems to support testing/ Laboratory capacity
§ Selected countries (10)
§ HCV and HBV: fewer systems were in place in comparison to HIV, Syphilis
§ Systems were not in place in at least half of labs on
• Licensing of labs, registration
• Qualification of test kits, test kit stock outs
• Quality management; accreditation; licensing of lab workers
§ Limited capacity and quality of laboratory services for viral hepatitis
§ Survey result will be posted on the WPRO website in April 2019

q Informal consultation on laboratory capacity strengthening on

viral hepatitis in the WPR (Jun 2018)

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11 | Western Pacific Region

Report - Informal Consultation on the Quality
Improvement of Laboratory Services for Viral
Hepatitis in the WPR, 26-27 June 2018, Manila
§ Participants
§ Temporary Advisers: 9 from 7 institutes
- CDC, Korea Red Cross, NCCL, NRL, PPTC, SPC, VIDRL
§ Secretariats: 2 (HQ, SEARO), 3 (WCO Philippines), 6 WPRO

§ Objectives of the meeting

§ to review and discuss the current status and issues on viral
hepatitis laboratory services in the Western Pacific Region
§ to develop recommendations for improving the quality of
laboratory services for viral hepatitis

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Organization

12 | Western Pacific Region

Programmes
§ Overview of WHO strategic direction in elimination viral hepatitis

§ The status of viral hepatitis laboratory capacities in the Region

§ Survey on lab capacity in selected countries and PICs
§ Overview of viral hepatitis lab services in SEARO

§ Ensuring laboratory quality management

§ Strengthening quality of lab services
§ Quality assurance of blood transfusion

§ Quality diagnostics for viral hepatitis

§ WHO PQ of diagnostics/ Quality assurance systems for diagnostics in China

§ Collaboration for improvement of viral hepatitis lab services

§ Roles of WP Regional viral hepatitis lab partnership for capacity building
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13 | Western Pacific Region

 § Poster Walk session: where we are and what to do
§ SPC, NRL, VIDRL, PPTC, NCCL, Korea Red Cross, US CDC

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14 | Western Pacific Region

 § Laboratory capacity mapping (HIV, HBC, HCV and Syphilis)

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15 | Western Pacific Region

 § Lab Quality Management Mapping (Participation in EQAS)

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16 | Western Pacific Region

Recommendations – for Member States

§ Consider developing national strategic plans on strengthening laboratory

services for both clinical and public health (surveillance) purposes

§ Establish and support development of in-country quality assurance systems

§ Identify key national laboratories that can facilitate EQA in country

§ Use EQA as an opportunity to improve services by providing feedback and

refresher courses to laboratories

§ Learn from the experiences of HIV testing services

§ Adapt and implement WHO testing guidelines for viral hepatitis B and C

§ Ensure the availability of human resources for quality management

§ Quality improvement of laboratories including EQA should involve private

laboratories within the country
World Health
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17 | Western Pacific Region

Recommendations – for WHO and Partners

§ Support countries in advocating for high-level commitment for quality

laboratory services and sustained domestic funding

§ Enhance cooperation within and across countries and with collaborating

partners by establishing networks using existing systems

§ Establish communications among regional laboratories, WHO and WHO

collaborating centres and strengthen dissemination of information

§ Enhance integration and collaboration across programmes including

sharing of resources

§ Support countries in their expansion of hepatitis testing services by

disseminating WHO recommendations, advocating for development and
registration of quality diagnostic assays

World Health
Organization

18 | Western Pacific Region

Recommendations – for WHO and Partners

§ Consider creation of dedicated posts for laboratory experts in WHO

regional/country offices to advocate for the importance of laboratory
services and provide technical support

§ Seek donors and identify opportunities for external funding for laboratory
strengthening in collaboration with countries and partners

§ Develop collaborative research with countries to address public health

issues related to laboratory services

§ Establish an informal technical working group for hepatitis testing. The

priority is to initiate discussion on the terms of reference of the group
with key partners then expand and link with other existing networks
supporting laboratory services in the Region

§ Meeting report: http://iris.wpro.who.int/handle/10665.1/14230

World Health
Organization

19 | Western Pacific Region

Regional viral hepatitis laboratory network
q Review & assess viral hepatitis lab capacity in countries
§ Viral hepatitis programme review (country mission)
§ Survey
q Mapping lab capacity of technical assistance provider
§ WHO CCs: NRL, VIDRL, CDC, Shanghai Blood Centre, PPTC, SPC, Health
Sciences Authority , Korea Red Blood, and so on
§ Partner institutions
q Establish functional & horizontal network
§ Informal technical working group (TWG) on hepatitis testing
§ WHO CCs, National Reference Laboratories (or equivalent labs)
q Coordinate tailored country support by matching and
connecting technical assistance providers and member states
in need
World Health
Organization

20 | Western Pacific Region

Future plans
q Support Workshop on ensuring universal access to prenatal
screening for HIV, syphilis and hepatitis B: 18-19 June, China
§ Nominate two participants (8 countries)
§ one from the MOH laboratory programme
§ one from the MOH PMTCT/MCH programme

q Publish laboratory survey report on WPRO website

q Establish informal Technical Working Group (WTG) for

hepatitis testing
§ Develop Terms of Reference of TWG
§ Launch in the 2nd quarter

World Health
Organization

21 | Western Pacific Region

q Support countries to (with partners: WHOCCs & RRL)
§ Designate National Reference Laboratory for viral hepatitis
§ Establish domestic EQAS Programme
§ Train laboratory staff
§ Develop national testing & diagnostic algorithms and guidelines
§ Establish laboratory services for screening blood donations

§ Ensure the quality of laboratory services for viral hepatitis

including facilitating the registration of quality-assured
diagnostics
§ Establish laboratory networks in country

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Organization

22 | Western Pacific Region

Acknowledgement
q WHO CCs: NRL (Wayne Dimech), VIDRL (Suellen
Nicholson, Kathy Jackson), Shanghai Blood Center (Wang
Xun), Korea Red Cross, PPTC, SPC
q National Reference Laboratories in countries
q WHO CO staff
q WPR HSI unit (Naoko Ishikawa, Po-Lin Chan, Linh-Vi Le)

World Health
Organization

23 | Western Pacific Region