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WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ Date: 25 November 2021 REGIONAL OFFICE FOR EUROPE BUREAU RÉGIONAL DE L’EUROPE Mr Tanel Kiik REGIONALBÜRO FÜR EUROPA Minister of Health and Labour ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО Ministry of Social Affairs Head office: Suur-Ameerika 1 UN City, Marmorvej 51, DK-2100 Copenhagen Ø, Denmark 10129 Tallinn Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01 Estonia Email: [email protected] Website: http://www.euro.who.int Our reference: Your reference: Notre référence: Votre référence: Unser Zeichen: Ihr Zeichen: См. наш номер: На Ваш номер: Dear Sir, As part of the annual accreditation procedure, the National Measles/Rubella Laboratory of your country was reviewed during the second and third quarters of 2021 by the WHO Regional Office for Europe. Based on the results of this review, I am pleased to inform you that the National Laboratory is fully accredited as a WHO Measles/Rubella National Laboratory for 2022. Enclosed are the scope of the accreditation and the recommendations of the review for your information. Since the beginning of the COVID-19 pandemic, the WHO European Region has experienced a drastic and unprecedented decrease in the number of measles cases reported by the Member States. The risk of measles resurgence in the Region is real. It is crucial to sustain high quality measles and rubella surveillance including rapid and quality epidemiological and laboratory investigation and use of available molecular tools for case confirmation and outbreak characterization. The implementation of the European Immunization Agenda 2030 (EIA2030), adopted by the 71 st Regional Committee for Europe in September 2021, will provide us the framework to enhance comprehensive surveillance of vaccine-preventable diseases including measles and rubella elimination and strengthen immunization delivery and monitoring systems thereby contributing to primary health care and universal health coverage. I take this opportunity to thank you personally for your ongoing support to measles and rubella elimination and congratulate the staff of the National Measles/Rubella Laboratory on the successful accreditation. Yours very truly, Dr Hans Henri P. Kluge Regional Director UN City, Marmorvej 51 Tel.: +45 45 33 70 00 Email: [email protected] DK-2100 Copenhagen Ø Fax: +45 45 33 70 01 Website: http://www.euro.who.int Denmark Copy for information to: Ms Elen Ohov, Adviser, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, 10122 Tallinn, Estonia Ms Triin Uusberg, Head, European and International Coordination Department, Ministry of Social Affairs, Suur-Ameerika 1, 10129 Tallinn, Estonia H.E. Ms Katrin Saarsalu-Layachi, Ambassador Extraordinary and Plenipotentiary, Permanent Representative, 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 William Mart Laanemäe, 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 –2– Measles and Rubella National Laboratory or sub-National Laboratory Check- list for WHO Accreditation Section 1: General Review & Overall Findings Dates of 01/01/2020 – On-site / Desk Review Accreditation for Review: 31/12/2020 calendar year: 2022 Name of Health Board Laboratory of Communicable Diseases Laboratory: Address: Paldiski mnt 81, 10614 Tallinn Country ESTONIA Phone: +372 7943638 Email: [email protected] Website: www.terviseamet.ee Head of Institute: Üllar Lanno Head of Department: Janne Pullat (since April 2021) Head of Measles and Janne Pullat Rubella Laboratory: Technical Supervisor: Liidia Dotsenko (until 12 Nov 2021) 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) 1  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 2  Main General Findings: Findings: Confirmatory test results of Sub-national Laboratories’ referred specimens are reported 1. NA within 14 days for ≥ 80% of specimens received: Completeness: 75% 2. The laboratory reports monthly to WHO: Timeliness: 67% 3. IgM tests are performed on at least 50 specimens annually: Measles: 95 Rubella: 93 Measles and Rubella IgM test results conducted for primary 4. diagnostics are reported by the laboratory within 4 days of Measles: 100% receipt, for ≥ 80% of specimens Rubella: 100% The accuracy of IgM detection is ≥ 90% (NLs sending sera to Measles: 100% 5. RRL and SNLs to NLs for confirmatory testing) - Rubella: 100% 35 measles and 6 rubella samples Molecular tests are performed on at least 2 specimens per quarter, for Measles: No 6. measles and rubella (RT-PCR, GT) Rubella: NA Score on most recent WHO Serology proficiency test is ≥ 90%: 7. Measles: 98.6% PT panel number: 02003 Date reported: 16/12/2020 Rubella: 96.1% Performance on most recent WHO Molecular EQA Measles Mol detection: Passed is passed (P) /re-test (R) (provisionally passed)/fail (F) Measles Sequencing: Passed 8. Panel number for measles: 20-1 Date reported: 02/02/2021 Rubella Mol detection: NA Panel number for rubella: Date reported: dd/mm/yyyy Rubella Sequencing: NA For labs that conduct virus sequencing: Virus sequencing is completed AND reported to WHO through MeaNS or RubeNS within 2 months of MeaNS; NA (no seq.) 9. receipt of specimens, for ≥80% of the specimens appropriate for genetic RubeNS: NA analysis 10. Score from on-site review of laboratory operating procedures and practices is ≥ 80%: Conclusion • Good performance for serology and measles RT-PCR & sequencing 3 Saatja: ABDUSALYAMOVA, Malika <[email protected]> Saadetud: 30.11.2021 20:21 Adressaat: Tanel Kiik <[email protected]>; Triin Uusberg <[email protected]>; Elen Ohov <[email protected]> Koopia: Elen Ohov <[email protected]>; Triin Uusberg <[email protected]>; SM Info <[email protected]>; <[email protected]>; <[email protected]>; <[email protected]>; <[email protected]>; KÖHLER, Kristina <[email protected]>; BEN MAMOU, Myriam Corinne <[email protected]>; VIDEBAEK, Dovile <[email protected]> Teema: 2022 Accreditation of WHO Reference Measles and Rubella Laboratories. Please see the attached correspondence sent from the World Health Organization, Regional Office for Europe. 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