Draft ID: a53a71bb-2815-47e7-9592-d3722c2e9afc
Date: 24/02/2023 14:13:16
Survey on Chagas disease in EU/EEA- to
support guidelines on SoHO donor selection
and preventive measures- Blood
Fields marked with * are mandatory.
Chagas disease was identified and prioritized, by an expert meeting held by ECDC, for evaluation of risks
through SoHO. Consequently, ECDC initiated the development of evidence-based guidelines to help EU
/EEA countries to establish effective donor selection strategy and preventive measures to reduce the risk of
SoHO transmitted Trypanosoma cruzi, the parasite causing Chagas disease.
To provide relevant background information as well as providing evidence that will support some of the
statements of the guideline, we are asking the National Focal Points for blood of the ECDC SoHO network
to collect information on donor selection strategies and data on blood donors regarding Chagas disease in
EU/EEA countries. The National Focal Point is advised to consult national competent and authorities,
regional competent bodies and blood establishments if needed.
Please note that questions on hematopoietic stem cells are included in the survey for ‘Survey on Chagas
disease in EU/EEA- SoHO donor selection strategies Non-Reproductive Tissues and Cells’
ECDC DATA PRIVACY STATEMENT
Download
Privacy_statement_SRM.pdf
* When answering this questionnaire, you are aware that your answers might be made public. Your answers
will be used in the technical report and related peer-review publication that will be produced, and in other
outputs in accordance with ECDC's mandate. ECDC might need to contact the respondent for further
clarification.
I understand
Respondent general information
1
Respondent information
Personal data
First name
Surname
Email
Place of employment
Unit
Work position/ Occupation
2
* Country
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovak Republic
Slovenia
Spain
Sweden
* Name of Institute/Organization
Scope of the survey
All questions consider donors of blood and blood components for transfusion purpose.
All questions on donor deferral, donor eligibility and testing of donors should be answered considering risk
for transmission of Trypanosoma cruzi from donors through transfusion.
Definition of blood donors
3
For this survey, ‘blood donors’ includes first time donors and repeat blood donors donating whole blood or
blood components for transfusion purposes.
A first time donor has no donation history and depending on the national policy may or may not donate
blood during their first visit to the blood establishment.
For this survey, a repeat donor is considered a donor who has returned to the blood establishment and
donated blood or blood components. In countries where first time donors may donate during the first-time
visit, repeat donors donated more than once. In countries where first donors do not donate during the first
visit, repeat donors donated at least once.
Regulatory framework
Do you have specific legislation, policies, quality standards, guidelines or recommendations that aims to
reduce transmission of Trypanosoma cruzi through blood transfusion in your country?
Yes, national legislation
Yes, national policies, quality standards, guidelines or recommendations
Yes, regional legislation
Yes, regional policies, quality standards, guidelines or recommendations
No
If yes, please describe what is covered, e.g. donor deferral, testing etc.
If legislation, policies, quality standards, guidelines or recommendations apply on regional levels, please
describe if there are regional differences.
Evaluation of donor eligibility
Donor History Questionnaire
Please list all the questions included in the donor history questionnaire that directly or indirectly ask for
Chagas disease.
The questions may for example be disease related, origin and residency related, familial related, travel
related, previous blood transfusion in countries endemic for Chagas disease or question on tropical
diseases etc.
4
Deferral of donors at risk of T. cruzi infection
Please describe the criteria used for temporary or permanent deferral of donors at risk of T. cruzi infection
depending on the risk evaluation, e.g. returning from a travel to Chagas endemic country, mother born in
Chagas endemic country etc, considering and specifying the following:
Differences depending on the blood components collected
If and when the deferral is based on laboratory screening test
When applicable, length of deferral period
When applicable, threshold of duration of travel or residency
Donor eligibility
If applicable, please specify the eligibility criteria to donate blood for donors assessed being at risk of T.
cruzi infection.
Additional information
If applicable, please fill out additional information or comments that may be relevant.
Laboratory testing of blood donors for T. cruzi
5
Laboratory screening test of blood donors
Do you perform laboratory screening tests of blood donors for T. cruzi infections?
Yes, all blood donors
Yes, all first-time donors
Yes, donors at risk of having Chagas disease
No
If ‘yes, donors at risk of having Chagas disease’, please describe what criteria lead to the decision to
perform laboratory screening test of the donor.
Are you using one or a combination of two tests for laboratory screening test of the donor for T. cruzi
infection?
One test
A combination of two tests
Additional comment
Do all blood establishments or reference centres in your country use the same screening test methods and
confirmatory test methods for testing of blood donors for T. cruzi infections?
Yes
No
If no, please describe
6
Laboratory test methods
Please list the laboratory test methods (e.g., enzyme-linked immunosorbent assay, chemiluminescent immunoassay etc) that are used for screening and
for confirmatory testing for T. cruzi infection in blood donors.
Screening test method Confirmatory test method
1
2
3
4
5
6
7
Laboratory test methods for donors in the acute phase of Chagas disease
Do you test donors suspected to be in the acute phase of Chagas disease?
Yes
No
If yes, please describe what laboratory test methods from above described methods that are used for
donors in the acute phases of the disease.
Confirmatory testing
Where is the confirmatory testing for T. cruzi infection performed?
In blood establishments
In reference centres
Other
If other, please specify.
Number of blood donors in the member state
Number of blood donors screened by laboratory test for T. cruzi infection
Please state the number of blood donors screened by laboratory tests for T. cruzi infection per year in your
country.
8
Insert the total number per year or n/a if data are not available.
Total numbers of blood donors screened by laboratory test for T. cruzi (actual number)
2022
2021
2020
2019
2018
2017
9
Number of T. cruzi positive blood donors
Please state the number of blood donors who tested positive for T. cruzi infection in above screening tests.
10
Insert the total number per year or n/a if data are not available.
Total numbers of blood donors tested positive for T. cruzi (actual number)
2022
2021
2020
2019
2018
2017
11
If applicable, please fill out additional information or comments that may be relevant.
Risk factors associated with Chagas disease
For the blood donors who tested positive for T. cruzi infection, if known, please describe the risk factors
identified in the donor eligibility evaluation.
If there is at least one donor who tested positive for T. cruzi infection, can ECDC contact you to discuss the
risk profile of these donors?
Yes
No
Total number of deferred donors regarding Chagas disease
If available, please state the total number of deferred blood donors regarding Chagas disease.
12
Insert the total number per year or n/a if data are not available.
Total number of deferred donors regarding Chagas disease per year
2022
2021
2020
2019
2018
2017
13
Total number of blood donors
Please state the total number of blood donors in your country.
14
Insert the total number per year or n/a if data are not available.
Total number of blood donors per year
2022
2021
2020
2019
2018
2017
15
Additional information
Please fill out additional information or comment if needed.
Pathogen reduction/inactivation
Do you use pathogen reduction/inactivation techniques to inactivate or reduce T. cruzi in blood
components?
No
Yes
16
If yes, please describe which techniques that are used and for which blood components.
Blood component Pathogen reduction or inactivation technique
1
2
17
If applicable, please fill out additional or comments that may be relevant
Additional information
Please fill out additional information or comments that may be relevant.
Contact
Contact Form
18
Draft ID: 79c501e3-94e9-4c0f-a7d2-5f904c6b1c82
Date: 24/02/2023 14:23:43
Survey on Chagas disease in EU/EEA- to support guidelines on SoHO
donor selection and preventive measures- Reproductive cells
Fields marked with * are mandatory.
Chagas disease was identified and prioritized, by an expert meeting held by ECDC, for evaluation of risks
through SoHO. Consequently, ECDC initiated the development of evidence-based guidelines to help EU
/EEA countries to establish effective donor selection strategy and preventive measures to reduce the risk of
SoHO transmitted Trypanosoma cruzi, the parasite causing Chagas disease.
To provide relevant background information as well as providing evidence that will support some of the
statements of the guideline, we are asking the National Focal Points for medically assisted reproduction
(MAR) of the ECDC SoHO network to collect information on donor selection strategies and data on donors
of reproductive cells regarding Chagas disease in EU/EEA countries. The National Focal Point is advised
to consult national competent authorities, regional competent bodies and establishment for MAR if needed.
ECDC DATA PRIVACY STATEMENT
* When answering this questionnaire, you are aware that your answers might be made public. Your answers
will be used in the technical report and related peer-review publication that will be produced, and in other
outputs in accordance with ECDC's mandate. ECDC might need to contact the respondent for further
clarification.
I understand
Download
Privacy_statement_SRM.pdf
Contact information
1
Respondent general information
Responses
First name
Surname
Email
Place of employment
Unit
Work position/ Occupation
2
* Country
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovak Republic
Slovenia
Spain
Sweden
* Name of Institute/Organization
Scope of the survey
All questions consider donors of reproductive cells for medically assisted reproduction purposes. The
questions on partner donors do not consider donation for direct use.
All questions on donor deferral, donor eligibility and testing of donors should be answered considering risks
for transmission of Trypanosoma cruzi from donors through medically assisted reproduction.
3
Definition of donors
For this survey, ‘donors’ include donors and candidate donors of reproductive cells for medically assisted
reproduction purposes. For this survey a candidate donor is a donor who has not yet passed the mandatory
pre-donation screening.
Regulatory framework
National or regional legislation, policies, quality standards, guidelines or
recommendations
Do you have specific legislation, policies, quality standards, guidelines or recommendations that aims to reduce
transmission of T. cruzi transmission through medically assisted reproduction in your country?
Yes, national legislation
Yes, national policies, quality standards, guidelines or recommendations
Yes, regional legislation
Yes, regional policies, quality standards, guidelines or recommendations
No
If yes, please describe what is covered, e.g. donor deferral, testing etc.
If the legislation, policies, quality standards, guidelines or recommendations apply on a regional level,
please describe if there are regional differences.
Evaluation of donor eligibility
Partner donors of reproductive cells (not direct use)
Do you consider potential infections of T. cruzi in the eligibility evaluation of partner donors?
Yes
No
4
If yes, please list all the questions included in the donor history questionnaire that directly or indirectly ask
for Chagas disease.
The questions may for example be disease related, origin and residency related, familial related, travel
related, previous blood transfusion in countries endemic for Chagas disease or question on tropical
diseases etc.
Non-partner donors of reproductive cells
Do you consider potential infections of T. cruzi in the eligibility evaluation of non-partner donors?
Yes
No
If no, please describe the rationale.
Deferral/exclusion of donors at risk of T. cruzi infection
Non-partner donors and partner donors (not direct use)
Please describe the criteria used for deferral/exclusion of donors at risk of T. cruzi infection depending on
the risk evaluation, e.g. returning from a travel to Chagas endemic country, mother born in Chagas
endemic country etc, considering and specifying the following:
Differences depending on partner or non-partner donors
Differences depending on the cells, i.e. sperms or oocytes
If and when the exclusion/deferral is based on laboratory screening test
When applicable, length of deferral period
When applicable, threshold of duration of travel or residency
5
Additional information
Please fill out additional information or comments if needed.
Donor eligibility after temporary deferral
Non-partner donors and partner donors (not direct use)
If applicable, please specify the eligibility criteria to donate after temporary deferral.
Laboratory testing of donors for T. cruzi
Non-partner donors and partner donors (not direct use)
Laboratory screening tests
Do you perform laboratory screening tests of donors of reproductive cells for T. cruzi infections?
Yes, all donors (partner and non-partner donors)
Yes, all non-partner donors
Yes, partner and non-partner donors at risk of having Chagas disease
Yes, only non-partner donors at risk of having Chagas disease
Other
No
If other, please specify
If 'yes, donors (partner and/or non-partner donors) at risk of having Chagas disease', please describe what
criteria lead to the decision to test donors considering and specifying the following:
6
When applicable, differences depending on partner or non-partner donors.
When applicable, differences depending on the cells, i.e. sperms or oocytes, to be donated.
Laboratory test methods
Do all establishments for MAR, reference centres or laboratories in your country use the same screening
test methods and confirmatory test methods for testing of donors of reproductive cells for T. cruzi infections?
Yes
No
Not known
If no or not known, please describe.
7
Please list the laboratory test methods, or examples of the laboratory test methods, (e.g., enzyme-linked immunosorbent assay, chemiluminescent
immunoassay etc) that are used for screening and for confirmatory testing for T. cruzi infection in donors.
Please indicate if information is not available (n/a).
Screening test method Confirmatory test method
1
2
3
4
5
6
7
8
Laboratory test methods for donors in the acute phase of Chagas disease
Do you test donors suspected to be in the acute phase of Chagas disease?
Yes
No
If yes, please describe what laboratory test methods from above described methods that are used for
donors in the acute phases of the disease.
Laboratory screening tests
Are you using one or a combination of two tests for screening of donors for T. cruzi infection?
One test
A combination of two tests
Additional comment
Confirmatory testing
Where is the confirmatory testing for T. cruzi infection performed?
In MAR establishments
In reference centres
Other
If other, please specify.
Additional comment
Please fill out additional information or comments if needed.
9
Non-partner donors that have been tested for T. cruzi
For donors that have been assessed being at risk of carrying Chagas disease, are non-partner sperm
donors retested for T. cruzi infection after the quarantine period of the sperm donation?
Yes
No
For donors that have been assessed being at risk of carrying Chagas disease, are non-partner oocyte
donors retested for T. cruzi infection after the quarantine period of the oocyte donation?
Yes
No
Additional information
Please fill out additional information or comments if needed.
MAR activity
Non-partner and partner donors (not direct use)
If the donor is found infected with T. cruzi, for which type of donors could donation of reproductive cells
proceed?
Partner donors and non-partner donors (general policy)
Partner donors only (general policy)
Specific situations only
None
Please describe the rationales and specify if there are differences regarding specific donors and/or cells.
If reproductive cells are used from a donor infected with T. cruzi, are there protocols for the follow-up of the
recipient?
Yes
10
No
If yes, please describe.
Number of donors of reproductive cells
11
Number of donors of reproductive cells screened by laboratory test for T. cruzi infection
If available, please state the number of donors of reproductive cells screened by laboratory tests for T. cruzi infection per year in your country.
Insert the total number per year or n/a if data are not available.
Non-partner donors screened by laboratory tests for T. Non-partner donors including candidate donors screened
Partner donors screened by laboratory tests for T. cruzi
cruzi by laboratory tests for T. cruzi
2022
2021
2020
2019
2018
2017
12
Number of T. cruzi positive donors of reproductive cells
If available, please state the number of donors of reproductive cells who tested positive for T. cruzi infection in above screening tests.
Insert the total number per year or n/a if data are not available.
Non-partner donors including candidate donors
Non-partner donors who tested positive for T. cruzi Partner donors who tested positive for T. cruzi
who tested positive for T. cruzi
2022
2021
2020
2019
2018
2017
13
For the donors who tested positive for T. cruzi infection, if known, please describe the risk factors identified
in the donor eligibility evaluation.
If there is at least one donor who tested positive for T. cruzi infection, can ECDC contact you to discuss the
risk profile of these donors?
Yes
No
14
Total number of deferred/excluded non-partner donors of reproductive cells due to Chagas disease
If available, please state the total number of excluded/deferred donors of reproductive cells including candidate donors due to Chagas disease, i.e. donors
living with Chagas disease and donors at risk of Chagas disease in your country.
Insert the total number per year or n/a if data are not available.
Total number of deferred/excluded non-partner donors
Total number of deferred/excluded non-partner donors Total number of deferred/excluded partner donors due to
including candidate donors due to Chagas disease, i.e.
due to Chagas disease, i.e. donors living with Chagas Chagas disease, i.e. donors living with Chagas disease
donors living with Chagas disease and donors at risk of
disease and donors at risk of Chagas disease. and donors at risk of Chagas disease.
Chagas disease.
2022
2021
2020
2019
2018
2017
15
Total number of donors of reproductive cells
Please state the number of donors of reproductive cells in your country.
Insert the total number per year or n/a if data are not available.
Non-partner donors Non partner donors including candidate donors Partner donors
2022
2021
2020
2019
2018
2017
16
Additional information
Please fill out additional information or comments if needed.
Additional information
Please fill out additional information or comments that may be relevant.
Contact
Contact Form
17
Draft ID: b91ef684-45e0-4760-b427-4abed6d3de91
Date: 24/02/2023 14:09:11
Survey on Chagas disease in EU/EEA- to
support guidelines on SoHO donor selection
and preventive measures- Organs
Fields marked with * are mandatory.
Chagas disease was identified and prioritized, by an expert meeting held by ECDC, for evaluation of risks
through SoHO. Consequently, ECDC initiated the development of evidence-based guidelines to help EU
/EEA countries to establish effective donor selection strategy and preventive measures to reduce the risk of
SoHO transmitted Trypanosoma cruzi, the parasite causing Chagas disease.
To provide relevant background information as well as providing evidence that will support some of the
statements of the guideline, we are asking the National Focal Points for organs of the ECDC SoHO network
to collect information on donor selection strategies and data on organ donors regarding Chagas disease in
EU/EEA countries. The National Focal Point is advised to consult national competent authorities, regional
competent bodies and organ procurement organisations if needed.
ECDC DATA PRIVACY STATEMENT
* When answering this questionnaire, you are aware that your answers might be made public. Your answers
will be used in the technical report and related peer-review publication that will be produced, and in other
outputs in accordance with ECDC's mandate. ECDC might need to contact the respondent for further
clarification.
I understand
Download
Privacy_statement_SRM.pdf
Respondent general information
1
Email
Responses
First name
Surname
Work position/ Occupation
Place of employment
Unit
Work position/ Occupation
2
* Country
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovak Republic
Slovenia
Spain
Sweden
* Name of Institute/Organization
Scope of the survey
All questions consider living or deceased potential donors of organs for transplantation purposes.
All questions on donor exclusion, donor eligibility and testing of donors should be answered considering risk
for transmission of Trypanosoma cruzi from donors through organ transplantation.
Definition deceased potential donors
3
In this survey, deceased potential organ donors should be understood to cover both donation after brain
death and donation after circulatory death, definition of potential donor is according to Beatriz Domínguez-
Gil et al. Transplant International 2011.
Regulatory framework
Do you have specific legislation, policies, quality standards, guidelines or recommendations that aims to
reduce transmission of T. cruzi through transplantation of organs in your country?
Yes, national legislation
Yes, national policies, quality standards, guidelines or recommendations
Yes, regional legislation
Yes, regional policies, quality standards, guidelines or recommendations
No
If yes, please describe what is covered, e.g. donor deferral, testing etc.
If the legislation, policies, quality standards, guidelines or recommendations apply on a regional level,
please describe if there are regional differences.
Evaluation of donor eligibility
Living donors
Do you consider potential infections of T. cruzi in the eligibility evaluation of living organ donors?
Yes
No
If yes, please list all the questions included in the donor history questionnaire that directly or indirectly ask
for Chagas disease.
The questions may for example be disease related, origin and residency related, familial related, travel
related, previous blood transfusion in countries endemic for Chagas disease or question on tropical
diseases etc.
4
Deceased potential donors
Do you consider potential infections of T. cruzi in the eligibility evaluation of deceased potential donors?
Yes
No
If yes, please list all the questions included in the donor history questionnaire (heteroanamnesis) that
directly or indirectly ask for Chagas disease?
The questions may for example be disease related, origin and residency related, familial related, travel
related, previous blood transfusion in countries endemic for Chagas disease or question on tropical
diseases etc.
Deferral/exclusion of donors at risk of T. cruzi infection
All organ donors- living and deceased potential donors
Please describe the criteria used for deferral/exclusion of donors at risk of T. cruzi infection depending on the
risk evaluation, e.g. returning from a travel to Chagas endemic country, mother born in Chagas endemic country
etc, considering and specifying the following:
• Differences depending on the organ to be donated
• Differences depending on living or deceased donors
• If and when the exclusion/deferral is based on laboratory screening test
• When applicable, length of deferral period
• When applicable, threshold of duration of travel or residency
5
Additional information
Please fill out additional information or comments if needed.
Donor eligibility after temporary deferral
Living organ donors
If applicable, please specify the eligibility criteria to donate after temporary deferral regarding Chagas
disease.
Laboratory testing of donors for T. cruzi
All organ donors- living and deceased potential donors
Laboratory screening tests
Do you perform laboratory screening tests of organ donors for T. cruzi infection?
Yes, all donors
Yes, donors at risk of having Chagas disease
No
If ‘yes, donors at risk of having Chagas disease’, please describe what criteria lead to the decision to test
donors considering and specifying the following:
When applicable, differences depending on organ to be donated.
When applicable, differences depending on living or deceased donors.
6
Are you using one or a combination of one or two tests for laboratory screening test of donors for T. cruzi?
One test
A combination of two tests
Additional comment if needed.
Laboratory test methods
Do all organ procurement organisations, reference centres or laboratories in your country use the same
screening test methods and confirmatory test methods for testing of donors for T. cruzi infections?
Yes
No
Not known
If no or not known, please describe.
Please list the laboratory test methods, or examples of the laboratory test methods, (e.g., enzyme-linked
immunosorbent assay, chemiluminescent immunoassay etc) that are used for screening and for
confirmatory testing for T. cruzi infection in organ donors.
7
Please indicate if information is not available (n/a)
Screening test method Confirmatory test method
1
2
3
4
5
6
7
8
Laboratory tests methods for post-mortem samples
If applicable, please list the test methods from above-described methods, used for post-mortem samples
from deceased donors.
Laboratory test methods for donors in the acute phase of Chagas disease
Do you test donors suspected to be in the acute phase of Chagas disease?
Yes
No
If yes, please describe what laboratory test methods that are used for donors in the acute phases of the
disease.
Confirmatory testing
Where is the confirmatory testing for T. cruzi infection performed?
In procurement organisations
In reference centres
Other
If other, please specify.
Additional information
Please add additional information or comments if needed.
9
Organ transplantation activity
All donors- living and deceased organ donors
If the donor is found infected with T. cruzi, for which organs could donation proceed?
All organs (general policy)
All organs from living donors (general policy)
All organs from deceased donors (general policy)
Specific organs from living donors
Specific organs from deceased donors
No organs
Please describe the rationales.
If donation could proceed for specific organs and/or donor type, please specify the specific organs as well
as the donor type for which donation could proceed.
If organs are transplanted from a donor infected with T. cruzi, are there protocols for the follow-up of the
recipient?
Yes
No
If yes, please describe.
Number of organ donors
10
Number of organ donors screened by laboratory test for T. cruzi infection
If available, please state the number of organ donors screened by laboratory test for T. cruzi infection per year in your country.
Insert the total number per year or n/a if data are not available.
Numbers of deceased potential organ donors screened by laboratory tests
Numbers of living organ donors screened by laboratory tests for T. cruzi
for T. cruzi
2022
2021
2020
2019
2018
2017
11
Number of T. cruzi positive organ donors
If available, please state the number of organ donors who tested positive for T. cruzi infection in above screening tests.
Insert the total number per year or n/a if data are not available.
Numbers of living organ donors tested positive for T. cruzi Numbers of deceased potential organ donors tested positive for T. cruzi
2022
2021
2020
2019
2018
2017
12
Risk factors associated with Chagas disease
For the donors who tested positive for T. cruzi infection, if known, please describe the risk factors identified
in the donor eligibility evaluation.
If there is at least one donor who tested positive for T. cruzi infection, can ECDC contact you to discuss the
risk profile of these donors?
Yes
No
Additional comment if needed.
13
Total number of deferred donors of tissues and cells due to Chagas disease
If available, please state the total number of deferred/excluded donors due to Chagas disease, i.e. donors living with Chagas disease and donors at risk of
Chagas disease per year.
Insert the total number or n/a if data are not available.
Total number of deferred/excluded decease potential donors due to Chagas
Total number of deferred/excluded living donors due to Chagas disease, i.e.
disease, i.e. donors living with Chagas disease and donors at risk of Chagas
donors living with Chagas disease and donors at risk of Chagas disease.
disease.
2022
2021
2020
2019
2018
2017
14
Total number of organ donors
Please state the total number of organ donors in your country.
Insert the total number per year or n/a if data are not available.
Total number of living organ donors per year Total number of deceased potential organ donors per year
2022
2021
2020
2019
2018
2017
15
Numbers of T. cruzi infected recipients
Numbers of T. cruzi infected recipients
16
Please state the number of cases of recipients infected with T. cruzi through transplantation of organs from a T. cruzi infected donor in your country.
Insert the total number per year or n/a if data are not available.
Total numbers per year
2022
2021
2020
2019
2018
2017
17
Additional information
Please fill out additional information or comments that may be relevant.
Contact
Contact Form
18
Draft ID: 643d0c77-e570-4985-b5d5-65e7ed81df41
Date: 24/02/2023 14:17:59
Survey on Chagas disease in EU/EEA- to
support guidelines on SoHO donor selection
and preventive measures- Non-Reproductive
Tissues and Cells
Fields marked with * are mandatory.
Chagas disease was identified and prioritized, by an expert meeting held by ECDC, for evaluation of risks
through SoHO. Consequently, ECDC initiated the development of evidence-based guidelines to help EU
/EEA countries to establish effective donor selection strategy and preventive measures to reduce the risk of
SoHO transmitted Trypanosoma cruzi, the parasite causing Chagas disease.
To provide relevant background information as well as providing evidence that will support some of the
statements of the guideline, we are asking the National Focal Points for non-reproductive tissues and
cells of the ECDC SoHO network to collect information on donor selection strategies and data on donors
regarding Chagas disease in EU/EEA countries. The National Focal Point is advised to consult national
competent authorities, regional competent bodies and tissues and cells establishments if needed.
ECDC DATA PRIVACY STATEMENT
* When answering this questionnaire, you are aware that your answers might be made public. Your answers
will be used in the technical report and related peer-review publication that will be produced, and in other
outputs in accordance with ECDC's mandate. ECDC might need to contact the respondent for further
clarification.
I understand
Download
Privacy_statement_SRM.pdf
Respondent general information
1
Email
Responses
First name
Surname
Email
Place of employment
Unit
Work position/ Occupation
2
* Country
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovak Republic
Slovenia
Spain
Sweden
* Name of Institute/Organization
Scope of the survey
All questions consider donors of non-reproductive tissues and cells of allogenic donations.
All questions on donor deferral, donor eligibility and testing of donors should be answered considering risk
for transmission of Trypanosoma cruzi from donors to recipients through non-reproductive tissues and cells.
3
National or regional laws, policies, or recommendations
Do you have specific legislation, policies, quality standards, guidelines or recommendations that aims to
reduce transmission of T. cruzi through transplantation/application of tissues and cells in your country?
Yes, national legislation
Yes, national policies, quality standards, guidelines or recommendations
Yes, regional legislation
Yes, regional policies, quality standards, guidelines or recommendations
No
If yes, please describe what is covered, e.g., donor deferral, testing etc.
If legislation, policies, quality standards, guidelines or recommendations apply on regional levels, please
describe if there are regional differences.
Evaluation of donor eligibility
Living donors of non-reproductive tissues and cells
Do you consider potential infections of T. cruzi in the eligibility evaluation of living donors of tissues and
cells?
Yes
No
If yes, please list all the questions included in the donor history questionnaire that directly or indirectly ask
for Chagas disease.
The questions may for example be disease related, origin and residency related, familial related, travel
related, previous blood transfusion in countries endemic for Chagas disease or question on tropical
diseases etc.
4
Are the questions in the donor history questionnaire regarding Chagas disease the same for all living
donors of tissues and living donors of cells?
Yes
No
If no, please describe.
Deceased donors of non-reproductive tissues
Do you consider potential infections of T. cruzi in the eligibility evaluation of deceased donors of tissues?
Yes
No
If yes, please list all the questions included in the donor history questionnaire (heteroanamnesis) that
directly or indirectly ask for Chagas disease?
The questions may for example be disease related, origin and residency related, familial related, travel
related, previous blood transfusion in countries endemic for Chagas disease or question on tropical
diseases etc.
Deferral/exclusion of donors at risk of T. cruzi infection
All donors of non-reproductive tissues and cells- living and deceased donors
Please describe the criteria used for deferral/exclusion of donors at risk of T. cruzi infection depending on
the risk evaluation, e.g. returning from a travel to Chagas endemic country, mother born in Chagas
endemic country etc, considering and specifying the following:
Differences depending on the tissues and cells
Differences depending on living or deceased donors
If and when the exclusion/deferral is based on laboratory screening test
When applicable, length of deferral period
When applicable, threshold of duration of travel or residency
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Donor eligibility after temporary deferral
Living donors of non-reproductive tissues and cells
If applicable, please specify the eligibility criteria to donate after temporary deferral.
Laboratory testing of donors for T. cruzi
All donors of non-reproductive tissues and cells- living and deceased donors
Laboratory screening tests
Do you perform laboratory screening tests of donors of tissues and cells for T. cruzi infection?
Yes, all donors
Yes, donors at risk of having Chagas disease
No
If ‘yes, donors at risk of having Chagas disease’, please describe what criteria lead to the decision to test donors
considering and specifying the following:
When applicable, differences depending on the tissues or cells to be donated.
When applicable, differences depending on living or deceased donors.
Are you using one or a combination of one or two tests for laboratory screening test of donors for T. cruzi?
One test
A combination or two tests
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Additional comment
Laboratory test methods
Do all tissues and cells establishments, reference centres or laboratories in your country use the same
screening test methods and confirmatory test methods for testing of donors for T. cruzi infections?
Yes
No
Not known
If no or not known, please describe.
Please list the laboratory test methods, or examples of the laboratory test methods, (e.g., enzyme-linked
immunosorbent assay, chemiluminescent immunoassay etc) that are used for screening and for
confirmatory testing for T. cruzi infection in tissue and cells donors.
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Please indicate if information is not available (n/a)
Screening test method Confirmatory test methods
1
2
3
4
5
6
7
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Laboratory tests methods for post-mortem samples
If applicable, please list the test methods from above described methods, used for post-mortem samples
from deceased donors.
Laboratory test methods for donors in the acute phase of Chagas disease
Do you test donors suspected to be in the acute phase of Chagas disease?
Yes
No
If yes, please describe what laboratory test methods that are used for donors in the acute phases of the
disease.
Confirmatory testing
Where is the confirmatory testing for T. cruzi infection performed?
In establishments
In reference centres
Other
If other, please specify.
Additional information
Please fill out additional information or comments that may be relevant.
Transplantation/application of non-reproductive tissues and cells
All donors of non-reproductive tissues and cells- living and deceased donors
If the donor is found infected with T. cruzi, for which tissues or cells could donation proceed?
All tissues and cells (general policy)
All tissues (general policy)
Specific tissue(s)
All cells (general policy)
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Specific cells
No tissues and cells
Please describe the rationales.
If donation could proceed for specific tissues and cells and/or donor type, please specify the specific
tissues and/or cells as well as the donor type for which donation could proceed.
If tissues or cells are transplanted/used from a donor infected with T. cruzi, are there protocols for the follow-
up of the recipient?
Yes
No
If yes, please describe.
Number of donors of non-reproductive tissues and cells
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Number of donors of non-reproductive tissues and cells screened by laboratory test for T. cruzi infection
If available, please state the number of donors of tissues and cells screened by laboratory test for T. cruzi infection per year in your country.
Insert the total number per year or n/a if data are not available.
Living donors of tissues and cells screened by laboratory Haematopoietic stem cells donors screened by laboratory tests for T.
Deceased donors of tissues screened by laboratory tests for T. cruzi
tests for T. cruzi cruzi
2022
2021
2020
2019
2018
2017
11
Number of T. cruzi positive donors of non-reproductive tissues and cells
If available, please state the number of donors of tissues and cells who tested positive for T. cruzi infection in above screening tests.
Insert the total number per year or n/a if data are not available.
Living donors of tissues and cells who tested positive for T.
Deceased donors of tissues who tested positive for T. cruzi Hematopoietic stem cells donors who tested positive for T. cruzi
cruzi
2022
2021
2020
2019
2018
2017
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Please specify the source of data.
Risk factors associated with Chagas disease
For the donors who tested positive for T. cruzi infection, if known, please describe the risk factors identified
in the donor eligibility evaluation.
If there is at least one donor who tested positive for T. cruzi infection, can ECDC contact you to discuss the
risk profile of these donors?
Yes
No
Total number of deferred donors of non-reproductive tissues and cells due to Chagas disease
13
If available, please state the total number of deferred/excluded donors due to Chagas disease, i.e. donors living with Chagas disease and donors at risk of
Chagas disease.
Insert the total number or n/a if data are not available
Total number of deferred/excluded living donors due to Chagas disease per Total number of deferred/excluded deceased donors due to Chagas disease
year, i.e. donors living with Chagas disease and donors at risk of Chagas per year, i.e. donors living with Chagas disease and donors at risk of Chagas
disease. disease.
2022
2021
2020
2019
2018
2017
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Total number of donors of non-reproductive tissues and cells
Please state the total number of donors of tissue and cells in your country.
Insert the total number per year or n/a if data are not available.
Living donors of tissues and cells Deceased donors of tissues Hematopoietic stem cells donors
2022
2021
2020
2019
2018
2017
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Additional information
Please fill out additional information or comments that may be relevant.
Contact
Contact Form
16
Saatja: <
[email protected]>
Saadetud: 24.02.2023 17:32
Adressaat: <
[email protected]>; SOHO <
[email protected]>
Koopia: <
[email protected]>; <
[email protected]>;
<
[email protected]>
Teema: Question on survey on Chagas disease for information to CA
Manused: SoHO Chagas survey Blood.pdf; SoHO Chagas survey MAR.pdf; SoHO Chagas
survey Organs.pdf; SoHO Chagas survey Tissues and Cells.pdf
Dear colleagues,
Please find below a message sent on behalf of the ECDC SoHO team.
For further information, please do not hesitate to contact ECDC directly at
[email protected]
We wish you a pleasant weekend,
The ECDC and Commission SoHO teams.
Dear Competent Authorities,
ECDC is developing evidence-based guidelines for Chagas disease on SoHO donor selection and
preventive measures in EU/EEA countries.
To provide relevant background information as well as providing evidence that will support some of the
statements of the guideline, we are asking the National Focal Points (NFPs) of the ECDC SoHO network,
to collect information on donor selection strategies and data on donors regarding Chagas disease in
EU/EEA countries through a survey (EU-survey). The input from the survey will be given to an expert
panel together with evidence from systematic reviews.
(Please note that this project is separate from the ECDC microbial safety guidelines project related to the
proposed BTC regulation that has been described earlier.)
The survey covers question on donor screening and deferral and numbers of donors and is divided in four
questionnaire for each SoHO field; blood, tissues and cells, organs and medically assisted reproduction
(MAR).
ECDC has advised the NFPs to contact and consult National Competent Authorities if data is needed
and we would kindly ask you to help the NFPs with data if they will contact you and ask for help.
It is important for us to receive the information and we are very grateful for your help.
The survey will be open until Friday 7 April.
The NFPs have received the link to the survey (EU-survey) by email. For your information and to facilitate
the exchange of information between NCS and NFP, we have attached the questionnaires in Word
documents.
Please note that the replies to the survey to ECDC should be sent through EU-survey through the link
provided to the NFPs for the ECDC SoHO network and the attached documents is for your information
only.
Please do not hesitate to contact us at
[email protected] if you have any questions.
Kind regards,
The ECDC SoHO team