National Workshops for Strengthening and Linking Viral Hepatitis Laboratory, Surveillance and Patient Monitoring Systems.
Background
Hepatitis B and C infection remains a significant issue throughout the world, with 71 million people infected with hepatitis C virus (HCV) [1] and 310 million people infected with hepatitis B virus (HBV) [2]. The disease caused 1.34 million deaths in 2015, a number comparable to annual deaths caused by tuberculosis and higher than those caused by HIV. While mortality from HIV, tuberculosis, and malaria is now declining, mortality caused by viral hepatitis is on the rise. The world has only recently expressed its alarm about the burden of viral hepatitis. The response is still at an early phase in most countries, which limits the reliability and scope of available data. Hepatitis B can be prevented by vaccination, and effective treatment reduces the progression of liver disease. The development of new antiviral therapies can now successfully cure Hepatitis C. Despite this, up to one-third of individuals infected with chronic HBV and HCV go on to develop cirrhosis of the liver or other complications of chronic infection.
The Western Pacific Region (WPR) is disproportionately affected by hepatitis B and C, and also faces challenges associated with limited resources and capacity. Compared with other geographical regions, the WPR has the highest number of viral hepatitis-related deaths per year, accounting for approximately 39% of global mortality due to hepatitis, of which 94% is attributable to chronic hepatitis B and C infections. Within the WPR, the highest percentage of hepatitis-related mortality is attributed to liver cancer (67%), followed by cirrhosis (27%), and acute hepatitis (6%) [3].
In 2015, Member States in the Region approved the Regional Action Plan for Viral Hepatitis in the Western Pacific 2016-2020 [4]. The Regional Action Plan and subsequently the Global Health Sector Strategy on Viral Hepatitis 2016-2021 [5] identified strengthening of national laboratory systems as a priority action needed for quality hepatitis diagnosis, treatment and monitoring of disease burden. Additionally, laboratory capacity is crucial to assess the burden of hepatitis in general and at-risk populations.
Correct management of viral hepatitis requires a significant focus on testing, particularly at the subnational and provincial levels where potentially poor quality rapid tests are widely used, many of which have unknown sensitivity and specificity. These potentially poorly performing viral hepatitis rapid tests are being used for blood and antenatal screening, particularly for detection of HBV infection. Without regulation of test kits, national algorithms and quality assurance programs in place, national laboratories and authorities remain unaware of the compendium of and quality of laboratory testing being used to diagnose and treat HBV and HCV in provincial and subnational laboratories.
Prevention, treatment and surveillance programmes are all underpinned by laboratory testing so gaps in laboratory capacity should be accessed and strengthened where necessary. Most WPR Member States have health information systems and preventive and care services for viral hepatitis. However previous assessments suggested that capacity for viral hepatitis B and C serology testing was generally poor and quality assurance systems were inadequate, particularly among countries where the viral hepatitis burden is high (Cambodia, China, Mongolia, the Philippines and Viet Nam) [6]. The laboratories need support to establish national external quality assessment schemes (EQAS) for hepatitis testing, to use approved test kits and to implement uniform quality management systems (QMS) and standards in their countries.
Objectives
In order to assist Member States to achieve the laboratory and surveillance milestones outlined in the Regional Action Plan, WPRO, in collaboration with local, regional and global experts, aimed to organise national integrated surveillance and laboratory workshops in high burden countries. The first of these national workshops was delivered in Ulaanbaatar, Mongolia on 25-27 April which has a significant burden of disease The workshop was attended by 90 public and private laboratory staff and managers, clinicians, and epidemiologists and was led by 11 facilitators from WHO, WHO Collaborating Centres (for Viral Hepatitis, and for Diagnostics and Laboratory Support for HIV and AIDS and Other Blood-borne Infections), US and Korean CDCs as well as from the Mongolian National Centre for Communicable Diseases, and the Mongolian Ministry of Health.
Several important gaps were identified during the workshop in laboratory capacity, including sample storage and transportation, provision of quality assessment schemes, training, and test kit procurement. Recommended actions were developed during the workshop, with input from all levels of public laboratories, the private sector and importantly from the Ministry of Health. An unexpected, but important outcome was the receptiveness of the Mongolian laboratory personnel to the presentations on good laboratory practices (from an Australian viewpoint), which introduced them to some aspects of QMS practices they were not aware of.
WPRO (and their collaborators) have committed to organise national workshops in 5 further high burden countries in the coming 12 months (China, Philippines, Laos, Vietnam and Cambodia). As each country is assessed and actions implemented, it is expected that an improvement in the quality of hepatitis testing will occur, supporting hepatitis prevention, treatment and surveillance programmes in the region.
The integrated laboratory and surveillance workshops are the first steps towards the successful establishment of a Regional Network of Hepatitis Reference Laboratories. The aim of this Network of laboratories is to provide quality assurance and quality management programmes to increase and monitor quality of testing in the region, provide advice to implementing partners, surveillance data to monitor intervention and the ability to rapidly respond to outbreaks and emergencies. Establishing a Viral Hepatitis Laboratory Network will also facilitate enhanced surveillance activities by providing guidance and support for seroprevalence surveys and data management systems to collect WHO recommended viral hepatitis diagnosis and treatment monitoring indicators. Currently, no such network exists at the global or regional level within the WHO. WPRO will be the first region to develop a Regional Hepatitis Reference Laboratory Network.
References
[1] The Polaris Observatory HCV Collaborators (2016). Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. The Lancet Gastroenterology & Hepatology. Available at http://dx.doi.org/10.1016/S2468-1253(16)30181-9
[2] Updated estimates to be published in 2017, submitted to Lancet.
[3] Stanaway, Jeffrey D et al. (2016). The global burden of viral hepatitis from 1990 to 2013: findings from the Global Burden of Disease Study 2013. The Lancet, Volume 388, Issue 10049: 1081-1088.
[4] World Health Organization Western Pacific Regional Office (2016). Regional Action Plan for Viral Hepatitis in the Western Pacific. Available at http://www.wpro.who.int/hepatitis/resource/features/regional_action_plan/en/.
[5] World Health Organization. (2016). Global health sector strategy on viral hepatitis 2016-2021. Available at http://www.who.int/hepatitis/strategy2016-2021/ghss-hep/en/
[6] World Health Organization (2015). Improving the quality of and access to HIV, syphilis and hepatitis B and C testing: laboratory gap analysis in selected countries of the Western Pacific Region. Available at http://www.wpro.who.int/hiv/documents/topics/testing/quality_of_access_to_HIV_Syphilis_Hepa_testing/en/.