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WHO and INstand Collaboration on Molecular EQA for Measles and Rubella

Learn about the collaboration between WHO and INstand to improve molecular EQA for measles and rubella. Explore the process and results of the first molecular PT exercise in Europe.

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WHO and INstand Collaboration on Molecular EQA for Measles and Rubella

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  1. New Collaboration between WHO and INSTAND e.V. on Molecular EQA for Measles and Rubella Process and results of 1st molecular PT exercise in EUR Oliver Donoso Mantke1and Heinz Zeichhardt1,2,3 1INSTAND e.V. - Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e.V., Düsseldorf 2ProfessorofVirology (retired) Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Institut für Virologie, Berlin 3Institut für Qualitätssicherung in der Virusdiagnostik - IQVD, Berlin at GBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin Vanessa Lindig3 andHans-Peter Grunert4 3Institut für Qualitätssicherung in der Virusdiagnostik - IQVD, Berlin at GBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin 4GBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin in cooperationwith Sabine Santibanezand Annette Mankertz Nationales Referenzzentrum für Masern, Mumps und Röteln am Robert Koch-Institut, Berlin FG 12 Masern, Mumps, Röteln und Viren bei Abwehrschwäche

  2. International 14 Organistions / Scientific Societies National 28 Organistions / Scientific Societies

  3. INSTAND EQASchemes

  4. INSTAND Target Value Laboratories (in total: 36;6 for MeV+RubV) O. Adams Universitätsklinikum Düsseldorf A. BaillotNiedersächsischesLandesgesundheitsamt, Hannover S. Becker / M. EickmannPhilippsUniversität Marburg, Nat. Konsiliarlab. Filoviren C.-T. Bock / S. Niendorf / A. Mas-Marques Robert Koch-Institut, Berlin; Nat. Konsiliarlab. Noroviren; Nat. Konsiliarlab. Rotaviren S. Diedrich Robert Koch-Institut, Berlin; NRZ Poliomyelitis und Enteroviren RegionalesReferenzlabor der WHO/EURO für Poliomyelitis U. Dittmer / S. Ross / M. RoggendorfUniversitätsklinik Essen; NRZ HCV; Nat. Konsiliarlab. Tollwut G. DoblerInstitut für Mikrobiologie der Bundeswehr, München; Nat. Konsiliarlab. FSME Ch. Drosten / A.-M. Eis-HübingerUniversität Bonn; Nat. KonsiliarlaborfürCoronaviren J. Eberle / L. Gürtler Ludwig-Maximillians-UniversitätMünchen, Max-von-PettenkoferInstitut G. Enders / M. Enders Labor Enders, Stuttgart J. FuhrmannMVZ Labor 28 GmbH, Berlin A. Gessner / B. Schmidt / J. Wenzel Universität Regensburg; Nat. Konsiliarlab. HAV und HEV S. Günther / J. Schmidt-Chanasit / P. Emmerich Bernhard-Nocht-Institut, Hamburg; NRZ trop. Infektionserreger, WHO CC G. Harms-ZwingenbergerInstitutfürTropenmedizin, Berlin H.H. Hirsch Universität Basel, Dept. Biomedizin D. Huzly / M. Panning Universitätsklinikum Freiburg G. Jahn / K. HamprechtUniversitätsklinikumTübingen; Nat. Konsiliarlab. CMV A. Karl / K. Frank / K. GubbeDRK-BlutspendedienstOst, Plauen V. Kempf / H. Rabenau / A. Berger / M. StürmerUniversitätsklinikum Frankfurt; NRZRetroviren D. Krüger / J. Hofmann Charité Universitätsmedizin Berlin, CCM; Nat. Konsiliarlab.Hantaviren; Labor Berlin – Charité Vivantes GmbH C. Kücherer Robert Koch-Institut, Berlin U.G. Liebert Universität Leipzig A. Mankertz / S. Santibanez Robert Koch-Institut, Berlin; NRZMasern, Mumps und Röteln T. Mertens / D. Michel Universitätsklinikum Ulm; Nat. Konsiliarlab.CMV S. ModrowUniversität Regensburg; Nat. Konsiliarlab. Parvoviren S. Nick / H. Scheiblauer Paul-Ehrlich-Institut, Langen; PrüflaborfürIVD M. Nübling / M. Chudy / S.A. Baylis / J. Kreß Paul-Ehrlich-Institut, Langen, WHO CC H. Pfister / U. Wieland / S. Silling / R. Kaiser Uniklinik Köln; NRZPapillom- und Polyomaviren B. WeißbrichUniversitätWürzburg A. Sauerbrei / P. WutzlerUniversitätsklinikum Jena; Nat. Konsiliarlab. HSV und VZV T. Schulz / A. Heim MedizinischeHochschule Hannover; Nat. Konsiliarlab. Adenoviren T. Schulz / W. Puppe / C. Schmitt MedizinischeHochschule Hannover; Nat. Konsiliarlab. EBV, HHV 6, 7, 8 B. Schweiger Robert Koch-Institut, Berlin; NRZ Influenza; Nat. Konsiliarlab. RSV, Parainfluenzaviren, HMPV S. Smola, N. Müller-Lantzsch, J. RisslandUniversitätsklinikum des Saarlandes K. Überla / K. KornUniversitätsklinikum Erlangen J. Ziebuhr, D. Glebe / C. Schüttler / W. GerlichUniversitätGießen; NRZHBV und HDV

  5. INSTAND EQA Schemes (68 Schemes)in Virus Immunology and Genome Detection 2016 Zeichhardt – SoGAT Graz – 28.05.2015

  6. Accreditation issues1- Rolling out 2015 molecular PT for the European region • Invite NRLs performing molecular testing in routine to enrol in Instand molecular PT (Nov 2015 round) • NRLs to pay for the fees, WHO to support labs in need • Instand to expand protocols to get full set of results • Continue collaboration to harmonize Instand and CDC molec PT in coming rounds 7

  7. PCR/NAT - Measles Virus Collaboration – WHO EURO and INSTAND (991) Nov 2015 Summary oforganizationaldata: No. of laboratories invited for participation: 37 (call of participation beginning Sep 2015) No. of laboratories registered for participation: 34 (as of 7 Oct 2015) Bulk shipment of sample panels to RRLs: 18.11.2015 No. of laboratories reporting results: 34 (from 33 countries) (as of 27 May 2016) Response rate: 100%

  8. PCR/NAT - Measles Virus Collaboration – WHO EURO and INSTAND (991) Nov 2015 Sample properties (asdiscussed in Aug 2015): $Infectiousvirusesarechemicallyinactivated on the sample FTA disk.

  9. PCR/NAT - Measles Virus Collaboration – WHO EURO and INSTAND (991) Nov 2015 Summary of qualitative resultsandtypingresults: & The success rates for all 4 samples in test categories 20 and 40, respectively, refer to the number of participating laboratories. Laboratories having reported results obtained by several methods are recorded only once. § One participant (Participant No. 1191), who was registered for genotyping, did not report results in test category 40. This was evaluated as "false" result in test category 40. # One participant (Participant No. 49690), who was registered for genotyping, was not able to report results in test category 40 due to weak PCR signals. This was evaluated as "false" result in test category 40.

  10. PCR/NAT - Measles Virus Collaboration – WHO EURO and INSTAND (991) Nov 2015 Link toresultsfromregular INSTAND EQA scheme (386): && The success rates for all 4 samples in test categories 20 and 40, respectively, refer to the number of participating laboratories. Laboratories having reported results obtained by several methods are recorded only once.

  11. PCR/NAT - Measles Virus Collaboration – WHO EURO and INSTAND (991) Nov 2015 • New testcategory • forsequencequality: • Success rate for all samples • referstothenumberofparticipatinglaboratories • (in 1stround/Nov 2015 not evaluated • w/o consequencesforcertificate) • 21/28 = 75.0% • Results: seedetailsby S. Santibanez (RKI)

  12. Evaluation ofsequencequality – Measles • - Panel containedthree MV-positive samples • -Sequencedataprovidedby27 countries/ 28labs (forallsamples) • - All samplescorrectlysequencedby20 countries/ 21labs • -Deviationsfromthereferencesequence in: • - one sample 3 countries • - twosamples 1country • - threesamples 3 countries Mismatch at oneormore pos. Single „N“ at oneormore pos. Single ntmissinginside Incompleteends Single additional ntinside The N-450 correctlysequenced Deviation(s) • Sample 991003: B3-H • - 24 countries/ 25 labs • 3 countries • Sample 991001: D8-FM • - 20 countries/ 21 labs • 7 countries • Sample 991004: D4-M • - 23 countries/ 24 labs • 4 countries

  13. PCR/NAT - Measles Virus Collaboration – WHO EURO and INSTAND (991) Nov 2015 Summary ofappliedmethodsandreported ct-values: Red= weak PCR signalsBlue= problems in seq. quality

  14. PCR/NAT - Rubella Virus Collaboration – WHO EURO and INSTAND (992) Nov 2015 Summary oforganizationaldata: No. of laboratories invited for participation: 37 (call of participation beginning Sep 2015) No. of laboratories registered for participation: 30 (as of 7 Oct 2015) Bulk shipment of sample panels to RRLs: 18.11.2015 No. of laboratories reporting results: 30 (from 28 countries) (as of 10 Mar 2016) Response rate: 100%

  15. PCR/NAT - Rubella Virus Collaboration – WHO EURO and INSTAND (992) Nov 2015 Sample properties (asdiscussed in Aug 2015): $Infectiousvirusesarechemicallyinactivated on the sample FTA disk. * The positive samples 992002 and 992004 areidentical.

  16. PCR/NAT - Rubella Virus Collaboration – WHO EURO and INSTAND (992) Nov 2015 Summary of qualitative resultsandtypingresults: && The success rates for all 4 samples in test categories 20 and 40, respectively, refer to the number of participating laboratories. Laboratories having reported results obtained by several methods are recorded only once. § One participant (Participant No. 1191), who was registered for genotyping, did not report results in test category 40. This was evaluated as "false" result in test category 40. # Four participants (Participant No. 32637, 49638, 49690 and 49711), who were registered for genotyping, were not able to report results in test category 40 due to weak PCR signals. These were evaluated as "false" results in test category 40.

  17. PCR/NAT - Rubella Virus Collaboration – WHO EURO and INSTAND (992) Nov 2015 Link toresultsfromregular INSTAND EQA scheme (389): && The success rates for all 4 samples in test categories 20 and 40, respectively, refer to the number of participating laboratories. Laboratories having reported results obtained by several methods are recorded only once.

  18. PCR/NAT - Rubella Virus Collaboration – WHO EURO and INSTAND (992) Nov 2015 • New testcategory • forsequencequality: • Success rate for all samples • referstothenumberofparticipatinglaboratories • (in 1stround/Nov 2015 not evaluated • w/o consequencesforcertificate) • 13/19 = 68.4% • Results: seedetailsby S. Santibanez (RKI)

  19. Evaluation ofsequencequality – Rubella Gap, stretchof „N“ Mismatch at oneormore pos. Incompleteends • Andothers: • singlentmissing • singleadd. ntinside • - single „N“ The 739 ntwindowof E1 correctlysequenced Deviation(s) Sample 992004: 2B - 13 countries/ 14 labs - 2 countries - 3 countries withoutresult • Sample 992002: 2B • - 13 countries/ 14 labs • 4 countries • 1 countrywithoutresult • - Panel containedthreeRV-positive samples • -Sequencedataprovidedby18 countries/ 19labs: • - 15 countries/ 16labsforall samples • - 2 countries fortwosamples • - 1countryforone sample • - All samplescorrectlysequencedby12 countries/ 13labs • -Deviationsfromthereferencesequence in: • - one sample 3 countries • - twosamples 1country • - threesamples 2 countries • Sample 992001: 1G • - 13 countries/ 14 labs • 5 countries

  20. PCR/NAT – Rubella Virus Collaboration – WHO EURO and INSTAND (992) Nov 2015 Summary ofappliedmethodsandreported ct-values: Red= weak PCR signalsBlue= problems in seq. quality

  21. Conclusions Link of WHO and INSTAND measles & rubella molecular EQA schemes was successful Sample shipment via WHO EURO and RRLs was smooth (in most cases) Participants were successful in general (success rates 62.5 - 100%) Non-reporters contributed to high failure rate For future EQA schemes *agreed at 11th Meeting of the Measles/Rubella RRLs WHO EUR – Berlin, 15.03.2016: Inclusion of sequence quality for assessment Evaluation criteria: 100% correct results in all test categories for all panel members for labs genotyping: correct genotype and zero nucleotide error Coordination of sample selection between WHO, CDC and INSTAND Harmonization of next rounds between regional and global EQA schemes (instruction sheet, check-list of required information, evaluation criteria) Online-reporting of EQA results incl. sequence submission to MeaNS/RubeNS (cooperation of PHE with WHO, CDC and INSTAND) Classification of mEQA samples as non-infectious by INSTAND

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