Viral Hepatitis -Laboratory Networks and Capacity in Mongolia

Nicholson, S.1 , Littlejohn, M.1, Dimech, W.2, Catton, M.1

1. The Doherty Institute, WHO Collaborating Centre for Viral Hepatitis.

28th July, 2017 – The Doherty Insttitute

2. National Serology Reference Laboratory, Australia (NRL). WHO Collaborating Centre for Diagnostics and Laboratory Support

for HIV and AIDS and Other Blood-borne Infections.

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Regional Viral Hepatitis Laboratory Network – Western Pacific Region (WPR)

• WPR is the first region to begin development of a Regional Viral Hepatitis Laboratory Network.

• Laboratory networks can help provide:

Currently no such network exists for viral hepatitis at the global or regional level in World Health Organization (WHO).

Slide 2

Disease Burden

Disease Control

Strengthen Quality Assurance

Enhance Capacity Building efforts

Outbreak

and

emergency

response

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

WHO Laboratory Networks - WPR

Existing networks for vaccine-preventable diseases include measles, rubella, Japanese encephalitis, poliomyelitis, rotavirus.

Slide 3

Measles RubellaJapanese

encephalitis

Poliomyletis Rotavirus Hepatitis

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

The Hepatitis network intends to achieve a number of objectives related to:

• Supporting member states in ensuring diagnostic accuracy

• Implementing quality assurance programs for laboratories

• Ensure capacity to link laboratory and epidemiologic data

• Determine data sharing systems for testing and treatment

• Mobilize resources to enhance viral hepatitis diagnosis, treatment monitoring and surveillance.

In conjunction with WHO Western Pacific Region we are just finalizing the Terms of Reference related to achieving these objectives.

Slide 4

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

The aim of the Laboratory Network

• Is to have National Reference Laboratories (NRL’s) for viral hepatitis in focus countries: China, Mongolia, The Philippines, Viet Nam, Cambodia and Laos.

• High performing laboratories in the region would be designated as Regional Reference Laboratories (RRLs) for viral hepatitis, including labs in Australia.

Slide 5

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

WHO’s first National Workshop for Strengthening and Linking Viral Hepatitis Laboratory, Surveillance and Patient Monitoring Systems was held in Ulaanbaatar Mongolia 25-27 April this year.

The laboratory team from the

Doherty Institute included

Margaret Littlejohn and I and also

Wayne Dimech from the

Australian National Serology

Reference Laboratory.

Slide 6

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Mongolian visit - Objectives

To describe existing laboratory services in Mongolia, identify gaps and make recommendations to the WHO Mongolian Regional Office, Mongolian Ministry of Health and WHO Headquarters in Geneva.

Slide 7

Accessing laboratory diagnostics and capacity - Methods

• Pre workshop questionnaire sent to laboratories.

• 4 hour laboratory workshop with presentations and use of a self-assessment tool.

• Presentations – Mongolian representatives and WHO facilitators.

• Presentations, questionnaire, self-assessment tool all translatedinto Mongolian.

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Method 1 - Pre workshop questionnaire sent to laboratories

• The questionnaire covered hepatitis A, B, C, D and E.

• The 90 questions reviewed: the type of testing performed, participation in quality assurance programs, performance of quality control, presence of testing strategies, referral of samples and collection/reporting of surveillance data.

Slide 9

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Method 2 – Lab Capacity Self-Assessment Tool

• Designed by us before attending the workshop.

• The tool has seven sections.

• We went through each section andexplained a series of points relatingto each topic.

• Participants then rated from 1 to 4, where 1 was ‘not present/not available to 4 was ‘complete and functional.’

Slide 10

Lab Organisation

Specimen managemant

Testing & Process Ctrl

Lab Safety

Reagent & Equip

Procurement

Data Management

Quality Assurance

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Method 2 (cont.)Laboratory Session Workshop

• The workshop group reviewed each of the sections together to determine an overview of the Mongolian laboratory network capacity.

• We reviewed the Self-Assessment Tool results along with other WHO Lab facilitators from CDC Korea and WPRO. Identified gaps and made recommendations.

Slide 11

• There were representatives from public and private laboratories, hospitals and a clinic - 30 people participated in this session and 14 laboratories completed the survey.

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Slide 12

Hep B &

Hep C14

Hep A 3

Hep E1

Majority labs reported using a

documented quality management

system and performing audits.

Results – a snapshot

All 14 labs performed

HepBsAg and HepCAb tests,

but only 3 tested for Hep A

and one for Hep E and very

few tested for acute hepatitis

A, B, D or E. Limited number

of labs testing for IgM.

Most labs participated in

Quality assurance programs

for commonly performed tests

for Hep A, B and C but none

for Hep D and Hep E.Only half of the participants

reported data to the national

registry of infectious diseases.

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Challenges/Gaps identified

• Transportation of samples

• Quality assurance

• Test kit procurement

• Testing strategies & referral of samples

• Training of staff (equipment technicians & engineers, transportation, scientific and medical.)

• Sample storage

Slide 13

Challenges/Gaps presented

Our Laboratory capacity findings were presented back to all the workshop participants and WHO Mongolian Regional office, the Ministry of Health and WHO headquarters Geneva -along with recommendations that may help to overcome some of the challenges.

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Conclusion

• The laboratory pre- workshop survey and self-assessment tool were effective methods for collecting information about national laboratory hepatitis testing capacity.

• Data was easily collated, analysed and gaps could be identified relatively quickly. The self assessment tool aided group discussion amongst participants. It was an effective way to assess capacity across a broad range of participants from public labs, private labs, hospitals and clinics .

• The survey and self-assessment tool will be further refined for use in future national workshops in The Philippines, China, Vietnam, Cambodia and Laos.

Slide 15

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Future Direction

• As each country is assessed and recommendations implemented it is expected there will be improvement in the quality of hepatitis testing, which in turn will aid in hepatitis surveillance, treatment and prevention programs.

• With time there will be establishment of additional Hepatitis Reference laboratories in the WPR and globally.

• There is a lot of work to be done but we have other well established Networks to use as a guide.

Slide 16

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Measles Rubella Global Lab Network

• Our laboratory is a Western Pacific Region Measles/Rubella Regional Reference laboratory, this Measles/Rubella lab network began in 1999 and has 2 other Regional Reference Laboratories within our region.

• The Measles Rubella network is now well established within our region but also globally, consisting of over 700 laboratories worldwide.

Slide 17

Hepatitis Laboratory Network

• We are at the beginning.

• This is where we are back on the timeline where Measles/Rubella was back in the late 90’s, even though there is a lot of work to be done we have a path to follow.

Polio 1992

Meas/Rub 1999

2017Meas/Rub

Global Network2017

Hepatitis2017

Hepatitis Global Network

?Year?

The Peter Doherty Institute for Infection and Immunity A joint venture between The University of Melbourne and The Royal Melbourne Hospital

Acknowledgements

Slide 20

Linh-Vi, LEWPR regional coordinator Philipines

Joe WoodringWPR US CDC Philipines

Donghyok, KwonWHO CDC Korea

Geoff BeckettCDC US

Naara NaranbatWPR Mongolia

All Mongolian representatives and organisers

Yvan, HutinWHO HQ Geneva

Ben CowieNicole RomeroLaura Thomas

PDI

With thanks

doherty.edu.au

/DohertyInstitute

@TheDohertyInst #DohertyInstitute

@surono23 #Globalhealth #Publichealth