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Rita de Sousa Surveillance and diagnostic of Hepatitis E in Portugal National Institute of Health Dr. Ricardo Jorge Portugal 1st ECDC Hepatitis E virus expert group meeting Stockholm, 9-10 December 2015 quinta-feira, 21 de Janeiro de 16

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Rita de Sousa

Surveillance and diagnostic of Hepatitis E in Portugal

National Institute of Health Dr. Ricardo JorgePortugal

1st ECDC Hepatitis E virus expert group meetingStockholm, 9-10 December 2015

quinta-feira, 21 de Janeiro de 16

1_ National surveillance system for HEV infection in Portugal

2_ Case definition

3_Lab diagnostic methods for detection and confirmation HEV

infection

4_Studies on HEV in Portuguese population and animals

reservoirs.

Topics

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Surveillance system of HEV in Portugal

_Hepatitis E is a obligatory notifiable disease since 2014

(Ministerial order nº 5681-A-2014, 29/April)

_Directorate General of Health _National Institute of Health

National Surveillance _National reference Laboratory

Regional Administrations of Health

Ministry of Health

Report the case

Physician

Report the lab result

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Surveillance system of HEV in Portugal_Data source

• Directorate-General of Health (www.dgs.pt)

National Epidemiological surveillance System (SINAVE)- Online registration of all the obligatory notifiable diseases (since 1st January 2015).

_Type of data reported

• Data is reported (through SINAVE) by physicians from all over the country (mainland and Islands)

• Compulsory online notification for obligatory notifiable diseases.

• Passive surveillance

• Case-based report (daily reporting)

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Case definition of HEV

_Clinical Criteria

Any person with a onset of symptoms compatible with acute viral hepatitis (e.g. fatigue, abdominal pain, loss of appetite, intermittent nausea and vomiting)ANDAt least one of the following three:a) Feverb) Jaundicec) Elevated serum aminotransferase levels

At least one of the following two:a) Detection of hepatitis A virus nucleic acid in plasma or stoolb) Hepatitis A virus specific antibody response

_Laboratory Criteria

At least one of the following five:a) Human to human transmissionb) Exposure to a common source of one or more casesc) Exposure to contaminated food/drinking waterd) Environmental exposurec) Recent travel to endemic region in less than 3 months

a) Possible case NAb) Probable caseAny person meeting the clinical criteria and with an epidemiological link c) Confirmed caseAny person meeting the clinical and the laboratory criteria

_Epidemiological Criteria

_Case Classification

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Laboratory diagnosis of HEV infection at National Institute of Health

_Detecting an immune response in the host:

a) Serology : detection of immunoglobulins of classe M(IgM) and G (IgG).

Performed by enzyme immunoassay (ELISA), Commercial Kit :

Until 2013 performing tests with MP Biomedicals (Genelabs)

Since 2014 using Euroimmune HEV IgG and IgM

b) Type specimens: Plasma and serum

_Detection of nucleic acids of the virus in human specimens:

a) Molecular detection of HEV virus RNA by Real-time RT-PCR, and typing by conventional PCR and sequencing (In-house protocol)

b) Type of specimens: plasma, sera and stool

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<=2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

% o

f pos

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pat

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of s

ampl

es te

sted

Year

IgM+/IgG+ Nº samples tested % of postive samples

Serological diagnosis of HEV at the National Institute of Health, 2006 - 2015

Textoquinta-feira, 21 de Janeiro de 16

!Year!

!IgM+/IgG,!

!IgM+/IgG+!

!IgM,/IgG+!

Not!detectable!an5bodies!

Total!tested!samples!

≤2006 0 1 2 78 81

2007 1 3 2 10 16

2008 4 3 2 14 23

2009 1 4 4 18 27

2010 4 2 3 17 26

2011 1 7 7 53 68

2012 1 3 5 47 56

2013 5 7 2 62 76

2014 7 8 6 92 113

2015* 1 2 5 38 46

Total 25 40 38 429 532

Laboratory diagnostic of HEV infection at the National Institute of Health, 2000 - 2015

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Year of the study Type of screened population (n)

Seroprevalence References

2015 Swine slaughterhouse workers (72) 14,9% (IgG) Teixeira et al, 2015

2015 Nationwide serosurvey Portuguese Population (1, 656) 9% (IgG) Pereira et al., 2015

2013pet veterinarians (373)

general population (120)

9,9% (IgG)

13% (IgG)Mesquita et al., 2014

1996

Blood donors (50)

Chronic liver disease patients (103)

4% (IgG)

6,8% (IgG)Macedo et al., 1998

1996 Blood donors (1,473) 2.5% (IgG) Queiros et al., 1997

Studies on HEV in Portuguese population

Serosurveys

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Serosurveys

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Year of the study Reported human cases

Anti-HEV immunoglobulins

(IgM/IgG)HEV-RNA detection

(genotype)References

2009 and 20112 cases acute

infection(kidney transplant)

Positive (IgM and IgG) positive (genotype 3c) Breda et al.,2014

2012 1 case acute infection

Positive (IgM and IgG) positive (genotype 3a) Santos et al., 2013

2012 1 case acute infection Positive IgM positive Vieira et al., 2013

2010 1 case acute infection

Positive (IgM and IgG) Not performed Duque et al., 2012

Studies on HEV in Portuguese population

Case Reports

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Case Reports

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Studies on HEV in Animal population

Serosurvey

Year of the Study: 2010 - 2011

Regions of Portugal : North and Center

Overal, 44 (22%) out of 200 pig faeces tested for the presence of HEV RNA

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*EEA (European Economic Area Grants) - Public Health Initiatives

- Population-based cross sectional study

- Blood donors from different regions of Portugal

- Evaluation of the risk of porcine-derived pharmaceutical products as potential sources of HEV infection (Faculty of Pharmacy, University of Porto (PI, Alexandre MJ)*

Project : HEPeCONTROL - Hepatitis E virus epidemiology, safety and control

Ongoing and future studies on HEV

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_ Av. Padre Cruz | 1649-016 Lisbon, PortugalTel: (+351) 217519200 | 2175226447 | 265 912 222Fax: (+351) 265 912 155E-mail: [email protected]

Thank for your attention

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