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Measles and Rubella National Laboratory or sub-National Laboratory Check- list for WHO Accreditation Section 1: General Review & Overall Findings Dates of 01/01/2023 – On-site / Desk Review Accreditation for Review: 31/12/2023 calendar year: 2025 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 [email protected] 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. 100% within 14 days for ≥ 80% of specimens received: Completeness: 100% 2. The laboratory reports monthly to WHO (≥ 80%): Timeliness: 92% 3. IgM tests are performed on at least 50 specimens annually: Measles: 253 Rubella: 150 Measles and Rubella IgM test results conducted for primary 4a. diagnostics are reported by the laboratory within 4 days of Measles: 92.1% receipt, for ≥ 80% of specimens Rubella: 100% If molecular virus detection by real-time RT-PCR is performed Measles: 100% 4b. in addition to serology, positive test results are reported by the Rubella: NA laboratory within 4 days of receipt, for ≥80% of specimens The accuracy of IgM detection is ≥ 90% (NLs sending sera to Measles: 97% 5. RRL and SNLs to NLs for confirmatory testing) - Rubella: 100% 31 measles and 30 rubella samples At least one run per month is performed for measles and rubella Measles: Yes 6a. detection Realtime RT-PCR Rubella: NA At least one run per quarter is performed for measles and rubella Measles: Yes 6b. GT RT-PCR, sequencing Rubella: NA Score on most recent WHO Serology proficiency test is ≥ 90%: 7. Measles: 100% PT panel number: 02302 Date reported: 26/01/2023 Rubella: 100% 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: 23-1 Date reported: 28/12/2023 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; 100% (2/2) 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 • Excellent performance for serology and measles RT-PCR & sequencing • Laboratory is commended for excellent monthly data reporting to WHO 3 WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ REGIONAL OFFICE FOR EUROPE Date: 12 May 2025 BUREAU RÉGIONAL DE L’EUROPE REGIONALBÜRO FÜR EUROPA ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО Dr Karmen Joller Minister of Social Affairs Head office: UN City, Marmorvej 51, Ministry of Social Affairs DK-2100 Copenhagen Ø, Denmark Suur-Ameerika 1 Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01 10129 Tallinn Email: [email protected] Website: https://www.who.int/europe Estonia Our reference: Your reference: Notre référence: Votre référence: Unser Zeichen: Ihr Zeichen: См. наш номер: 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. 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 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 –2– Saatja: "WEI, Xue" <[email protected]> Saaja: "Karmen Joller - SOM" <[email protected]>, "Agne Nettan-Sepp", "Helen Sõber" Teema: 2025 Accreditation of WHO Reference Measles and Rubella Laboratories - Estonia Kuupäev: 2025-05-12 07:36 Please see the attached correspondence sent from the World Health Organization, Regional Office for Europe. One or more attachments may be included. Veuillez vous référer à la correspondance ci-jointe du Bureau régional de l'Europe de l'Organisation mondiale de la santé. Une ou plusieurs annexes peuvent être jointes. Mit der Bitte um Kenntnisnahme der beiliegenden Korrespondenz (eine oder mehrere Anlagen), Weltgesundheitsorganisation, Regionalbüro für Europa. См. прикрепленные письма от Европейского регионального бюро Всемирной организации здравоохранения (один или несколько прикрепленных файлов)