Pöördumine

UN City, Marmorvej 51 Tel.: +45 45 33 70 00 Email: [email protected] DK-2100 Copenhagen Ø Denmark

Fax: +45 45 33 70 01 Website: https://www.who.int/europe

WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ

WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ

Date: 12 May 2025 Dr Karmen Joller Minister of Social Affairs Ministry of Social Affairs Suur-Ameerika 1 10129 Tallinn Estonia

REGIONAL OFFICE FOR EUROPE BUREAU RÉGIONAL DE L’EUROPE

REGIONALBÜRO FÜR EUROPA ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО

Head office:

UN City, Marmorvej 51, DK-2100 Copenhagen Ø, Denmark

Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01

Email: [email protected] Website: https://www.who.int/europe

Our reference: Notre référence: Unser Zeichen: См. наш номер:

Your reference: Votre référence: Ihr Zeichen: На Ваш номер:

Dear Madam,

WHO European Regional Measles and Rubella Laboratory Network Laboratory Accreditation for 2025

As part of the annual accreditation procedure, the national measles and rubella laboratory of your country, as a member of the WHO global Measles and Rubella Laboratory Network, was reviewed by the WHO Regional Office for Europe. Based on the results of this review, I am pleased to inform you that the laboratory is fully accredited as a WHO National Measles/Rubella Laboratory for 2025. Enclosed is the accreditation review summary, including the scope of the accreditation and the recommendations of the review, for your information. Significant progress has been made in the WHO European Region in recent years towards achieving and documenting interruption of the endemic transmission of measles and rubella viruses. However, as evidenced by the occurrence of measles outbreaks, the achievement of these goals has been delayed. In addition to high vaccination coverage, it is essential that all Member States maximize efforts to implement laboratory-supported elimination-standard surveillance for the rapid detection of outbreaks and for the documentation of disease elimination, as detailed in the recently published guidance Eliminating measles and rubella in the WHO European Region. It is of the utmost importance that adequate and sustainable resources continue to be allocated to measles and rubella laboratories, enabling appropriate and prompt investigation of measles and rubella cases. Close collaboration between laboratory and epidemiological surveillance, from specimen collection to final case classification, including virus genetic characterization, is an essential requirement for elimination. Additionally, the oversight role of national measles and rubella laboratories should be strengthened, including through the establishment of national laboratory networks and/or quality assurance programmes, to ensure the reliability of the measles and rubella laboratory results provided throughout the country.

– 2 –

I would like to thank you personally for your ongoing support of the measles and rubella elimination programme and to congratulate the staff of the laboratory on the successful accreditation. Yours very truly,

Dr Hans Henri P. Kluge Regional Director Encls: Measles and Rubella National Laboratory Check-list for WHO Accreditation Copy for information to:

Ms Helen Sõber, Adviser, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, 10122 Tallinn, Estonia Ms Agne Nettan-Sepp, Head, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, 10129 Tallinn, Estonia H.E. Ms Riia Salsa-Audiffren, Ambassador Representative of the Republic of Estonia, Permanent Mission of the Republic of Estonia to the United Nations Office and other international organizations in Geneva, Chemin du Petit-Saconnex 28A, CH-1209 Genève, Switzerland H.E. Mr Andre Pung, Ambassador Extraordinary and Plenipotentiary, Embassy of the Republic of Estonia, Frederiksgade 19, 4th floor, 1265 Copenhagen K, Denmark Ms Kristina Köhler, Liaison Officer, WHO Country Office, Estonia, Paldiski Road 81, 10617 Tallinn, Estonia

1

Measles and Rubella National Laboratory or sub-National Laboratory Check-

list for WHO Accreditation

Section 1: General Review & Overall Findings

Dates of

Review:

01/01/2023 –

31/12/2023

On-site / Desk Review Accreditation for

calendar year:

2025

Name of

Laboratory:

Laboratory of Communicable Diseases

Republic of Estonia Health Board

Address: Paldiski mnt 81, 10614 Tallinn

Country ESTONIA

Phone: +372 794

3599

Email: [email protected]

[email protected]

Website: www.terviseamet.ee

Head of Institute: Brigit Lao Head of Department: Janne Pullat

Head of Measles and

Rubella Laboratory:

Oksana Joamets

Technical Supervisor: Oksana Joamets

Number of laboratories under supervision: 1

Name of

Reviewer(s):

Dr. Myriam Ben Mamou & Dovile Videbaek, WHO/Europe

Name of National Accreditation Authority (if appropriate) and current accreditation status from this

authority (e.g. ISO15189 or other, provide documentation):

Estonian Accreditation Centre, EVS-EN ISO 15189:2012.

Accreditation Certificate No M004. Accreditation is valid until 29.06.2024

(http://eak.ee/dokumendid/pdf/kasitlusala/M004.pdf)

2

Summary of Accreditation Review

Recommendations (check one):

Accredit: Laboratory meets all criteria

Measles: Rubella:

Serology Serology

Detection RT-PCR/RT-qPCR Detection RT-PCR/RT-qPCR

Sequencing Sequencing

Cell Culture Cell Culture

Measles testing not done Rubella testing not done

Provisionally accredit: Laboratory passed the most recent proficiency test, but needs to

strengthen one or more of the remaining criteria (check off relevant criteria):

Measles: Rubella:

Serology Serology

Detection RT-PCR/RT-qPCR Detection RT-PCR/RT-qPCR

Sequencing Sequencing

Cell Culture Cell Culture

Measles testing not done Rubella testing not done

Do not accredit: Laboratory did not pass the most recent proficiency test and/or did not meet

other performance indicators.

Measles: Rubella:

Serology Serology

Detection RT-PCR/RT-qPCR Detection RT-PCR/RT-qPCR

Sequencing Sequencing

Cell Culture Cell Culture

Measles testing not done Rubella testing not done

3

Main General Findings:

Findings:

1. Confirmatory test results of Sub-national Laboratories’ referred specimens are reported

within 14 days for ≥ 80% of specimens received: 100%

2. The laboratory reports monthly to WHO (≥ 80%): Completeness:

Timeliness:

100%

92%

3. IgM tests are performed on at least 50 specimens annually:

Measles:

Rubella:

253

150

4a.

Measles and Rubella IgM test results conducted for primary

diagnostics are reported by the laboratory within 4 days of

receipt, for ≥ 80% of specimens

Measles:

Rubella:

92.1%

100%

4b.

If molecular virus detection by real-time RT-PCR is performed

in addition to serology, positive test results are reported by the

laboratory within 4 days of receipt, for ≥80% of specimens

Measles:

Rubella:

100%

NA

5.

The accuracy of IgM detection is ≥ 90% (NLs sending sera to

RRL and SNLs to NLs for confirmatory testing) -

31 measles and 30 rubella samples

Measles:

Rubella:

97%

100%

6a. At least one run per month is performed for measles and rubella

detection Realtime RT-PCR

Measles:

Rubella:

Yes

NA

6b. At least one run per quarter is performed for measles and rubella

GT RT-PCR, sequencing

Measles:

Rubella:

Yes

NA

7. Score on most recent WHO Serology proficiency test is ≥ 90%:

PT panel number: 02302 Date reported: 26/01/2023

Measles:

Rubella:

100%

100%

8.

Performance on most recent WHO Molecular EQA

is passed (P) /re-test (R) (provisionally passed)/fail (F)

Panel number for measles: 23-1 Date reported: 28/12/2023

Panel number for rubella: Date reported: dd/mm/yyyy

Measles Mol detection:

Measles Sequencing:

Rubella Mol detection:

Rubella Sequencing:

Passed

Passed

NA

NA

9.

For labs that conduct virus sequencing: Virus sequencing is completed

AND reported to WHO through MeaNS or RubeNS within 2 months of

receipt of specimens, for ≥80% of the specimens appropriate for genetic

analysis

MeaNS;

RubeNS:

100% (2/2)

NA

10. Score from on-site review of laboratory operating procedures and practices is ≥ 80%:

Conclusion

• Excellent performance for serology and measles RT-PCR & sequencing

• Laboratory is commended for excellent monthly data reporting to WHO

UN City, Marmorvej 51 Tel.: +45 45 33 70 00 Email: [email protected] DK-2100 Copenhagen Ø Denmark

Fax: +45 45 33 70 01 Website: https://www.who.int/europe

WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ

WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ

Date: 12 May 2025 Dr Karmen Joller Minister of Social Affairs Ministry of Social Affairs Suur-Ameerika 1 10129 Tallinn Estonia

REGIONAL OFFICE FOR EUROPE BUREAU RÉGIONAL DE L’EUROPE

REGIONALBÜRO FÜR EUROPA ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО

Head office:

UN City, Marmorvej 51, DK-2100 Copenhagen Ø, Denmark

Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01

Email: [email protected] Website: https://www.who.int/europe

Our reference: Notre référence: Unser Zeichen: См. наш номер:

Your reference: Votre référence: Ihr Zeichen: На Ваш номер:

Dear Madam,

WHO European Regional Measles and Rubella Laboratory Network Laboratory Accreditation for 2025

As part of the annual accreditation procedure, the national measles and rubella laboratory of your country, as a member of the WHO global Measles and Rubella Laboratory Network, was reviewed by the WHO Regional Office for Europe. Based on the results of this review, I am pleased to inform you that the laboratory is fully accredited as a WHO National Measles/Rubella Laboratory for 2025. Enclosed is the accreditation review summary, including the scope of the accreditation and the recommendations of the review, for your information. Significant progress has been made in the WHO European Region in recent years towards achieving and documenting interruption of the endemic transmission of measles and rubella viruses. However, as evidenced by the occurrence of measles outbreaks, the achievement of these goals has been delayed. In addition to high vaccination coverage, it is essential that all Member States maximize efforts to implement laboratory-supported elimination-standard surveillance for the rapid detection of outbreaks and for the documentation of disease elimination, as detailed in the recently published guidance Eliminating measles and rubella in the WHO European Region. It is of the utmost importance that adequate and sustainable resources continue to be allocated to measles and rubella laboratories, enabling appropriate and prompt investigation of measles and rubella cases. Close collaboration between laboratory and epidemiological surveillance, from specimen collection to final case classification, including virus genetic characterization, is an essential requirement for elimination. Additionally, the oversight role of national measles and rubella laboratories should be strengthened, including through the establishment of national laboratory networks and/or quality assurance programmes, to ensure the reliability of the measles and rubella laboratory results provided throughout the country.

– 2 –

I would like to thank you personally for your ongoing support of the measles and rubella elimination programme and to congratulate the staff of the laboratory on the successful accreditation. Yours very truly,

Dr Hans Henri P. Kluge Regional Director Encls: Measles and Rubella National Laboratory Check-list for WHO Accreditation Copy for information to:

Ms Helen Sõber, Adviser, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, 10122 Tallinn, Estonia Ms Agne Nettan-Sepp, Head, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, 10129 Tallinn, Estonia H.E. Ms Riia Salsa-Audiffren, Ambassador Representative of the Republic of Estonia, Permanent Mission of the Republic of Estonia to the United Nations Office and other international organizations in Geneva, Chemin du Petit-Saconnex 28A, CH-1209 Genève, Switzerland H.E. Mr Andre Pung, Ambassador Extraordinary and Plenipotentiary, Embassy of the Republic of Estonia, Frederiksgade 19, 4th floor, 1265 Copenhagen K, Denmark Ms Kristina Köhler, Liaison Officer, WHO Country Office, Estonia, Paldiski Road 81, 10617 Tallinn, Estonia

1

Measles and Rubella National Laboratory or sub-National Laboratory Check-

list for WHO Accreditation

Section 1: General Review & Overall Findings

Dates of

Review:

01/01/2023 –

31/12/2023

On-site / Desk Review Accreditation for

calendar year:

2025

Name of

Laboratory:

Laboratory of Communicable Diseases

Republic of Estonia Health Board

Address: Paldiski mnt 81, 10614 Tallinn

Country ESTONIA

Phone: +372 794

3599

Email: [email protected]

[email protected]

Website: www.terviseamet.ee

Head of Institute: Brigit Lao Head of Department: Janne Pullat

Head of Measles and

Rubella Laboratory:

Oksana Joamets

Technical Supervisor: Oksana Joamets

Number of laboratories under supervision: 1

Name of

Reviewer(s):

Dr. Myriam Ben Mamou & Dovile Videbaek, WHO/Europe

Name of National Accreditation Authority (if appropriate) and current accreditation status from this

authority (e.g. ISO15189 or other, provide documentation):

Estonian Accreditation Centre, EVS-EN ISO 15189:2012.

Accreditation Certificate No M004. Accreditation is valid until 29.06.2024

(http://eak.ee/dokumendid/pdf/kasitlusala/M004.pdf)

2

Summary of Accreditation Review

Recommendations (check one):

Accredit: Laboratory meets all criteria

Measles: Rubella:

Serology Serology

Detection RT-PCR/RT-qPCR Detection RT-PCR/RT-qPCR

Sequencing Sequencing

Cell Culture Cell Culture

Measles testing not done Rubella testing not done

Provisionally accredit: Laboratory passed the most recent proficiency test, but needs to

strengthen one or more of the remaining criteria (check off relevant criteria):

Measles: Rubella:

Serology Serology

Detection RT-PCR/RT-qPCR Detection RT-PCR/RT-qPCR

Sequencing Sequencing

Cell Culture Cell Culture

Measles testing not done Rubella testing not done

Do not accredit: Laboratory did not pass the most recent proficiency test and/or did not meet

other performance indicators.

Measles: Rubella:

Serology Serology

Detection RT-PCR/RT-qPCR Detection RT-PCR/RT-qPCR

Sequencing Sequencing

Cell Culture Cell Culture

Measles testing not done Rubella testing not done

3

Main General Findings:

Findings:

1. Confirmatory test results of Sub-national Laboratories’ referred specimens are reported

within 14 days for ≥ 80% of specimens received: 100%

2. The laboratory reports monthly to WHO (≥ 80%): Completeness:

Timeliness:

100%

92%

3. IgM tests are performed on at least 50 specimens annually:

Measles:

Rubella:

253

150

4a.

Measles and Rubella IgM test results conducted for primary

diagnostics are reported by the laboratory within 4 days of

receipt, for ≥ 80% of specimens

Measles:

Rubella:

92.1%

100%

4b.

If molecular virus detection by real-time RT-PCR is performed

in addition to serology, positive test results are reported by the

laboratory within 4 days of receipt, for ≥80% of specimens

Measles:

Rubella:

100%

NA

5.

The accuracy of IgM detection is ≥ 90% (NLs sending sera to

RRL and SNLs to NLs for confirmatory testing) -

31 measles and 30 rubella samples

Measles:

Rubella:

97%

100%

6a. At least one run per month is performed for measles and rubella

detection Realtime RT-PCR

Measles:

Rubella:

Yes

NA

6b. At least one run per quarter is performed for measles and rubella

GT RT-PCR, sequencing

Measles:

Rubella:

Yes

NA

7. Score on most recent WHO Serology proficiency test is ≥ 90%:

PT panel number: 02302 Date reported: 26/01/2023

Measles:

Rubella:

100%

100%

8.

Performance on most recent WHO Molecular EQA

is passed (P) /re-test (R) (provisionally passed)/fail (F)

Panel number for measles: 23-1 Date reported: 28/12/2023

Panel number for rubella: Date reported: dd/mm/yyyy

Measles Mol detection:

Measles Sequencing:

Rubella Mol detection:

Rubella Sequencing:

Passed

Passed

NA

NA

9.

For labs that conduct virus sequencing: Virus sequencing is completed

AND reported to WHO through MeaNS or RubeNS within 2 months of

receipt of specimens, for ≥80% of the specimens appropriate for genetic

analysis

MeaNS;

RubeNS:

100% (2/2)

NA

10. Score from on-site review of laboratory operating procedures and practices is ≥ 80%:

Conclusion

• Excellent performance for serology and measles RT-PCR & sequencing

• Laboratory is commended for excellent monthly data reporting to WHO