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WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ Date: 2 January 2024 REGIONAL OFFICE FOR EUROPE BUREAU RÉGIONAL DE L’EUROPE REGIONALBÜRO FÜR EUROPA Ms Riina Sikkut ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО Minister of Health Head office: Ministry of Social Affairs UN City, Marmorvej 51, Suur-Ameerika 1 DK-2100 Copenhagen Ø, Denmark Tallinn 10129 Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01 Email: [email protected] Estonia Website: https://www.who.int/europe Dear Madam, WHO European Regional Measles and Rubella Laboratory Network Laboratory Accreditation for 2024 As part of the annual accreditation procedure, the National Measles/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 2024. Enclosed is the accreditation review summary including the scope of the accreditation and the recommendations of the review for your information. Measles continues to pose a relentlessly increasing threat worldwide, with an alarming rise in sizable measles outbreaks in the WHO European Region recently. (See the following article: A 30-fold rise of measles cases in 2023 in the WHO European Region warrants urgent action.) More than ever, it is critical that measles and rubella laboratories are adequately supported to play their essential roles of providing timely case investigation and confirmation and of ensuring, through national oversight and quality assurance programmes, the reliability of measles/rubella results provided by other laboratories. Additionally, strengthening collaboration between laboratories and epidemiological surveillance is key to complying with elimination-standard surveillance and to determining the molecular epidemiology of sporadic cases and chains of transmission, as required to support the verification of disease elimination. 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 UN City, Marmorvej 51 Tel.: +45 45 33 70 00 Email: [email protected] DK-2100 Copenhagen Ø Fax: +45 45 33 70 01 Website: https://www.who.int/europe Denmark Encls: Accreditation Review Summary Copy for information to: Ms Elen Ohov, Adviser, European Union Affairs and International Co-operation Department, Ministry of Social Affairs Suur-Ameerika 1, Tallinn 10122, Estonia Ms Triin Uusberg, Head, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, Tallinn 10129, 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 Genève CH-1209, Switzerland H.E. Mr William Mart Laanemäe, Ambassador Extraordinary and Plenipotentiary, Embassy of the Republic of Estonia, Frederiksgade 19, 4th floor, Copenhagen K 1265, Denmark Ms Kristina Köhler, Liaison Officer, WHO Country Office, Estonia, Paldiski Road 81, Tallinn 10617, Estonia –2– Measles and Rubella National Laboratory or sub-National Laboratory Check- list for WHO Accreditation Section 1: General Review & Overall Findings Dates of 01/01/2022 – On-site / Desk Review Accreditation for Review: 31/12/2022 calendar year: 2024 Name of Laboratory of Communicable Diseases Laboratory: Republic of Estonia Health Board Address: Paldiski mnt 81, 10614 Tallinn Country ESTONIA Phone: +372 794 Email: [email protected] Website: www.terviseamet.ee 3599 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) 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: 100% 2. The laboratory reports monthly to WHO (≥ 80%): Timeliness: 83% 3. IgM tests are performed on at least 50 specimens annually: Measles: 201 Rubella: 180 Measles and Rubella IgM test results conducted for primary 4. diagnostics are reported by the laboratory within 4 days of Measles: 97.5% receipt, for ≥ 80% of specimens Rubella: 97.8% The accuracy of IgM detection is ≥ 90% (NLs sending sera to Measles: 100% 5. RRL and SNLs to NLs for confirmatory testing) - Rubella: 100% 16 measles and 6 rubella samples Measles Mol detection: Yes Molecular tests are performed on at least 2 specimens per Measles Sequencing: No 6. quarter, for measles and rubella (RT-PCR, GT) Rubella Mol detection: NA Rubella Sequencing: NA Score on most recent WHO Serology proficiency test is ≥ 90%: 7. Measles: 100% PT panel number: 02203 Date reported: 26/01/2023 Rubella: 97.5%* Performance on most recent WHO Molecular EQA Measles Mol detection: Passed is passed (P) /re-test (R) (provisionally passed)/fail (F) Measles Sequencing: Retest Passed 8. Panel number for measles: 22-2 Date reported: 11/04/2023 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 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%: *Rubella in-house control not available Conclusion • Good performance for serology and measles RT-PCR & sequencing 3 Saatja: ABDUSALYAMOVA, Malika <[email protected]> Saadetud: 02.01.2024 17:06 Adressaat: <"Riina Sikkut">; <"Triin Uusberg">; <"Elen Ohov"> Koopia: <"Elen Ohov">; <"Triin Uusberg">; <"SM Info">; <[email protected]>; Kaisa.Mitt-Alvarez <[email protected]>; <[email protected]>; <[email protected]>; KÖHLER, Kristina <[email protected]>; BEN MAMOU, Myriam Corinne <[email protected]>; VIDEBAEK, Dovile <[email protected]> Teema: 2024 Accreditation of WHO Reference Measles and Rubella Laboratories Please see the attached correspondence sent from the World Health Organization, Regional Office for Europe. One or more attachments may be included.Veuillez vous r¨¦f¨¦rer ¨¤ la correspondance ci-jointe du Bureau r¨¦gional de l'Europe de l'Organisation mondiale de la sant¨¦. 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