Evaluation of a worldwide EQA scheme for complex clonality analysis of clinical lymphoproliferative cases demonstrates a learning effect.

Gene Rearrangement Genes, Immunoglobulin Genes, T-Cell Receptor Humans Laboratory Proficiency Testing Lymphoproliferative Disorders / genetics Molecular Diagnostic Techniques Observer Variation Polymerase Chain Reaction Predictive Value of Tests Quality Assurance, Health Care Quality Control Reproducibility of Results
Clonality analysis External quality assessment IG rearrangements TCR rearrangements

Journal

Virchows Archiv : an international journal of pathology
ISSN: 1432-2307
Titre abrégé: Virchows Arch
Pays: Germany
ID NLM: 9423843

Informations de publication

Date de publication:
Aug 2021
Historique:
received: 17 06 2020
accepted: 28 01 2021
revised: 18 11 2020
pubmed: 10 3 2021
medline: 10 9 2021
entrez: 9 3 2021
Statut: ppublish

Résumé

Clonality analysis of immunoglobulin (IG) or T-cell receptor (TR) gene rearrangements is routine practice to assist diagnosis of lymphoid malignancies. Participation in external quality assessment (EQA) aids laboratories in identifying systematic shortcomings. The aim of this study was to evaluate laboratories' improvement in IG/TR analysis and interpretation during five EQA rounds between 2014 and 2018. Each year, participants received a total of five cases for IG and five cases for TR testing. Paper-based cases were included for analysis of the final molecular conclusion that should be interpreted based on the integration of the individual PCR results. Wet cases were distributed for analysis of their routine protocol as well as evaluation of the final molecular conclusion. In total, 94.9% (506/533) of wet tests and 97.9% (829/847) of paper tests were correctly analyzed for IG, and 96.8% (507/524) wet tests and 93.2% (765/821) paper tests were correctly analyzed for TR. Analysis scores significantly improved when laboratories participated to more EQA rounds (p=0.001). Overall performance was significantly lower (p=0.008) for non-EuroClonality laboratories (95% for IG and 93% for TR) compared to EuroClonality laboratories (99% for IG and 97% for TR). The difference was not related to the EQA scheme year, anatomic origin of the sample, or final clinical diagnosis. This evaluation showed that repeated EQA participation helps to reduce performance differences between laboratories (EuroClonality versus non-EuroClonality) and between sample types (paper versus wet). The difficulties in interpreting oligoclonal cases highlighted the need for continued education by meetings and EQA schemes.

Identifiants

DOI: 10.1007/s00428-021-03046-0 PMID: 33686511 PMC: PMC8364525
pubmed: 33686511
doi: 10.1007/s00428-021-03046-0
pii: 10.1007/s00428-021-03046-0
pmc: PMC8364525
doi:

Types de publication

Comparative Study Evaluation Study Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

365-376

Subventions

Organisme : EuroClonality Foundation
ID : N/A

Informations de copyright

© 2021. The Author(s).

Références

Van Dongen JJM, Wolvers-Tettero IL (1991) Analysis of immunoglobulin and T cell receptor genes, part II. Clin Chim Acta 198:93–174. https://doi.org/10.1016/0009-8981(91)90247-A
doi: 10.1016/0009-8981(91)90247-A pubmed: 1863986
Van Krieken JHJM, Langerak AW, Macintyre EA et al (2007) Improved reliability of lymphoma diagnostics via PCR-based clonality testing. Report of the BIOMED-2 Concerted Action BHM4-CT98-3936. Leukemia 21:201–206. https://doi.org/10.1038/sj.leu.2404467
doi: 10.1038/sj.leu.2404467 pubmed: 17170732
Van Dongen JJ, Langerak AW, Bruggemann M et al (2003) Design and standardization of PCR primers and protocols for detection of clonal immunoglobulin and T-cell receptor gene recombinations in suspect lymphoproliferations: report of the BIOMED-2 Concerted Action BMH4-CT98-3936. Leukemia 17:2257–2317. https://doi.org/10.1038/sj.leu.2403202
doi: 10.1038/sj.leu.2403202 pubmed: 14671650
Brüggemann M, White H, Gaulard P, Garcia-Sanz R, Gameiro P, Oeschger S, Jasani B, Ott M, Delsol G, Orfao A, Tiemann M, Herbst H, Langerak AW, Spaargaren M, Moreau E, Groenen PJTA, Sambade C, Foroni L, Carter GI, Hummel M, Bastard C, Davi F, Delfau-Larue MH, Kneba M, van Dongen JJM, Beldjord K, Molina TJ (2007) Powerful strategy for PCR-based clonality assessment in T-cell malignancies. Report of the BIOMED-2 Concerted Action BHM4-CT98-3936. Leukemia 21:215–221. https://doi.org/10.1038/sj.leu.2404481
doi: 10.1038/sj.leu.2404481 pubmed: 17170730
Evans PAS, Pott C, Groenen PJTA, Salles G, Davi F, Berger F, Garcia JF, van Krieken JHJM, Pals S, Kluin P, Schuuring E, Spaargaren M, Boone E, González D, Martinez B, Villuendas R, Gameiro P, Diss TC, Mills K, Morgan GJ, Carter GI, Milner BJ, Pearson D, Hummel M, Jung W, Ott M, Canioni D, Beldjord K, Bastard C, Delfau-Larue MH, van Dongen JJM, Molina TJ, Cabeçadas J (2007) Significantly improved PCR-based clonality testing in B-cell malignancies by use of multiple immunoglobulin gene targets. Report of the BIOMED-2 Concerted Action BHM4- CT98-3936. Leukemia 21:207–214. https://doi.org/10.1038/sj.leu.2404479
doi: 10.1038/sj.leu.2404479 pubmed: 17170731
Langerak AW, Molina TJ, Lavender FL, Pearson D, Flohr T, Sambade C, Schuuring E, al Saati T, van Dongen JJM, van Krieken JHJM (2007) PCR-based clonality testing in tissue samples with reactive lymphoproliferations: usefulness and pitfalls. A study from the BIOMED-2 Concerted Action BMH4-CT98- 3936. Leukemia 21:222–229. https://doi.org/10.1038/sj.leu.2404482
doi: 10.1038/sj.leu.2404482 pubmed: 17170729
McClure RF, Kaur P, Pagel E et al (2006) Validation of immunoglobulin gene rearrangement detection by PCR using commercially available BIOMED-2 primers. Leukemia 20:176–179. https://doi.org/10.1038/sj.leu.2404049
doi: 10.1038/sj.leu.2404049 pubmed: 16307010
Halldorsdottir AM, Zehnbauer BA, Burack WR (2007) Application of BIOMED-2 clonality assays to formalin-fixed paraffin embedded follicular lymphoma specimens: superior performance of the IGK assays compared to IGH for suboptimal specimens. Leuk Lymphoma 48:1338–1343. https://doi.org/10.1080/10428190701377022
doi: 10.1080/10428190701377022 pubmed: 17613763
Liu H, Bench AJ, Bacon CM, Payne K, Huang Y, Scott MA, Erber WN, Grant JW, du MQ (2007) A practical strategy for the routine use of BIOMED-2 PCR assays for detection of B- and T-cell clonality in diagnostic haematopathology. Br J Haematol 138:31–43. https://doi.org/10.1111/j.1365-2141.2007.06618.x
doi: 10.1111/j.1365-2141.2007.06618.x pubmed: 17555445
Patel KP, Pan Q, Wang Y, Maitta RW, du J, Xue X, Lin J, Ratech H (2010) Comparison of BIOMED-2 versus laboratory-developed polymerase chain reaction assays for detecting T-cell receptor-gamma gene rearrangements. J Mol Diagn 12:226–237. https://doi.org/10.2353/jmoldx.2010.090042
doi: 10.2353/jmoldx.2010.090042 pubmed: 20181819 pmcid: 2871730
Sandberg Y, van Gastel-Mol EJ, Verhaaf B, Lam KH, van Dongen JJ, Langerak AW (2005) BIOMED-2 multiplex immunoglobulin/T-cell receptor polymerase chain reaction protocols can reliably replace Southern blot analysis in routine clonality diagnostics. J Mol Diagn 7(4):495–503. https://doi.org/10.1016/S1525-1578(10)60580-6
doi: 10.1016/S1525-1578(10)60580-6 pubmed: 16237219 pmcid: 1888492
Droese J, Langerak AW, Groenen PJ, Brüggemann M, Neumann P, Wolvers-Tettero IL, van Altena MC, Kneba M, van Dongen JJ (2004) Validation of BIOMED-2 multiplex PCR tubes for detection of TCRB gene rearrangements in T-cell malignancies. Leukemia 18(9):1531–1538. https://doi.org/10.1038/sj.leu.2403428
doi: 10.1038/sj.leu.2403428 pubmed: 15284865
Langerak AW, Groenen PJ, Brüggemann M et al (2012) EuroClonality/BIOMED-2 guidelines for interpretation and reporting of Ig/TCR clonality testing in suspected lymphoproliferations. Leukemia 26(10):2159–2171. https://doi.org/10.1038/leu.2012.246
doi: 10.1038/leu.2012.246 pubmed: 22918122 pmcid: 3469789
Cree IA, Deans Z, Ligtenberg MJ, for the European Society of Pathology Task Force on Quality Assurance in Molecular Pathology; Royal College of Pathologists et al (2014) Guidance for laboratories performing molecular pathology for cancer patients. J Clin Pathol 67(11):923–931. https://doi.org/10.1136/jclinpath-2014-202404
doi: 10.1136/jclinpath-2014-202404 pubmed: 25012948
International Organization for Standardization (2012) ISO 15189:2012 Medical laboratories - particular requirements for quality and competence. ISO, Geneva
Harris S, Bruggemann M, Groenen PJTA, Schuuring E, Langerak AW, Hodges E (2012) Clonality analysis in lymphoproliferative disease using the BIOMED-2 multiplex PCR protocols; experience from the EuroClonality group EQA scheme. J Hematop 5:91–98. https://doi.org/10.1007/s12308-012-0144-x
doi: 10.1007/s12308-012-0144-x
Miller JE, Wilson SS, Jaye DL, Kronenberg M (1999) An automated semiquantitative B and T cell clonality assay. Mol Diagn 4:101–117. https://doi.org/10.1016/s1084-8592(99)80035-6
doi: 10.1016/s1084-8592(99)80035-6 pubmed: 10462626
Greiner TC, Rubocki RJ (2002) Effectiveness of capillary electrophoresis using fluorescent-labeled primers in detecting T-cell receptor gamma gene rearrangements. J Mol Diagn 4:137–143. https://doi.org/10.1016/s1525-1578(10)60694-0
doi: 10.1016/s1525-1578(10)60694-0 pubmed: 12169674 pmcid: 1906981
Kuo FC, Hall D, Longtine JA (2007) A novel method for interpretation of T-cell receptor gamma gene rearrangement assay by capillary gel electrophoresis based on normal distribution. J Mol Diagn 9:12–19. https://doi.org/10.2353/jmoldx.2007.060032
doi: 10.2353/jmoldx.2007.060032 pubmed: 17251331 pmcid: 1867425
United Kingdom External Quality Assessment Services (2019) http://www.ukneqasli.co.uk/eqa-pt-programmes/molecular-genetics-programmes/igh-tcr-clonality-status-accredited . Accessed 22 October 2019
College of American Pathologists (2019) https://documents.cap.org/documents/2019-surveys-catalog.pdf . Accessed 22 October 2019
Wetenschappelijk Instituut Volksgezondheid/Institut scientifique de la Santé publique (2019) https://www.wiv-isp.be/QML/Informatiebrochure_EKE.pdf . Accessed 22 October 2019
Qualitätssicherungs-Initiative Pathologie (2019) https://quip.eu/wp-content/uploads/2019/07/004_QuIP-Programm_25072019.pdf . Accessed 22 October 2019
The Royal College of Pathologists of Australasia Quality Assurance Programs (2019) https://rcpaqap.com.au/products/molecular . Accessed 22 October 2019
van Krieken JH, Normanno N, Blackhall F, Boone E, Botti G, Carneiro F, Celik I, Ciardiello F, Cree IA, Deans ZC, Edsjö A, Groenen PJTA, Kamarainen O, Kreipe HH, Ligtenberg MJL, Marchetti A, Murray S, Opdam FJM, Patterson SD, Patton S, Pinto C, Rouleau E, Schuuring E, Sterck S, Taron M, Tejpar S, Timens W, Thunnissen E, van de Ven PM, Siebers AG, Dequeker E (2013) Guideline on the requirements of external quality assessment programs in molecular pathology. Virchows Arch 462(1):27–37. https://doi.org/10.1007/s00428-012-1354-4
doi: 10.1007/s00428-012-1354-4 pubmed: 23250354
Thunnissen E, Bovée JV, Bruinsma H et al (2011) EGFR and KRAS quality assurance schemes in pathology: generating normative data for molecular predictive marker analysis in targeted therapy. J Clin Pathol 64:884–892. https://doi.org/10.1136/jclinpath-2011-200163
doi: 10.1136/jclinpath-2011-200163 pubmed: 21947301
Keppens C, Tack V, ’t Hart N et al (2018) A stitch in time saves nine: external quality assessment rounds demonstrate improved quality of biomarker analysis in lung cancer. Oncotarget 9(29):20524–20538. https://doi.org/10.18632/oncotarget.24980
doi: 10.18632/oncotarget.24980 pubmed: 29755669 pmcid: 5945546
Keppens C, Dufraing K, Van Krieken HJ et al (2019) European follow-up of incorrect biomarker results for colorectal cancer demonstrates the importance of quality improvement projects. Virchows Arch 475(1):25–37. https://doi.org/10.1007/s00428-019-02525-9
doi: 10.1007/s00428-019-02525-9 pubmed: 30719547 pmcid: 6611891
EuroClonality (2019) http://euroclonality.org . Accessed 22 October 2019
International Organization for Standardization (2010) ISO 17043:2010 Conformity assessment - general requirements for proficiency testing. ISO, Geneva
Website of the Biomedical Quality Assurance Research Unit, Clonality schemes (2019) http://kras.eqascheme.org/info/public/static/euroclonality.xhtml . Accessed 22 October 2019
Hattie J, Timperley H (2007) The power of feedback. Rev Educ Res 77(1):81–112. https://doi.org/10.3102/003465430298487
doi: 10.3102/003465430298487
Hicks PJ, Margolis MJ, Carraccio CL, Clauser BE, Donnelly H, Fromme HB, Gifford KA, Poynter SE, Schumacher DJ, Schwartz A, the PMAC Module 1 Study Group (2018) A novel workplace-based assessment for competency-based decisions and learner feedback. Med Teach 40(11):1143–1150. https://doi.org/10.1080/0142159X.2018.1461204
doi: 10.1080/0142159X.2018.1461204 pubmed: 29688108
Flentje M, Böhmelt D, Sieg L, Eismann H (2019) Instructors for on-the-job training of advanced paramedics – definition of competencies and development of a quality management tool for a “High Responsibility Organization”. GMS J Med Educ 36(1):Doc8. https://doi.org/10.3205/zma001216
doi: 10.3205/zma001216 pubmed: 30828608 pmcid: 6390088
Dufraing K, Lierman E, Vankeerberghen A, Franke S, Dequeker E (2020) External quality assessment schemes for molecular diagnostic labs in Belgium - can we improve it? Accred Qual Assur 25:39–49. https://doi.org/10.1007/s00769-019-01410-x
doi: 10.1007/s00769-019-01410-x
Tembuyser L, Dequeker EM (2016) Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic laboratories and external quality assessment providers. Virchows Arch 468(1):31–41. https://doi.org/10.1007/s00428-015-1839-z
doi: 10.1007/s00428-015-1839-z pubmed: 26306715

Auteurs

Cleo Keppens (C)

Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Kapucijnenvoer 35 block d, 1st floor, box 7001, 3000, Leuven, Belgium.
ORCID: 0000-0002-4498-8386

Elke Boone (E)

AZ Delta vzw - Laboratorium Moleculaire Diagnostiek, Deltalaan 1, 8800, Roeselare, Belgium.

Paula Gameiro (P)

Laboratory of Hemato-Oncology, Portuguese Institute of Oncology of Lisbon, Rua Prof Lima Basto, 1099-023, Lisboa, Portugal.
ORCID: 0000-0002-3761-7050

Véronique Tack (V)

Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Kapucijnenvoer 35 block d, 1st floor, box 7001, 3000, Leuven, Belgium.
ORCID: 0000-0001-8464-9541

Elisabeth Moreau (E)

AZ Delta vzw - Laboratorium Moleculaire Diagnostiek, Deltalaan 1, 8800, Roeselare, Belgium.

Elizabeth Hodges (E)

Precision Medicine Centre, Queen's University Belfast, Health Science Building, 97 Lisburn Road, Belfast, BT9 7AE, UK.

Paul Evans (P)

HMDS, Leeds Institute of Oncology, St. James University Hospital, Level 3 Bexley Wing Leeds, Leeds, LS9 7TF, UK.
ORCID: 0000-0002-7915-0946

Monika Brüggemann (M)

Department of Hematology, University Hospital Schleswig-Holstein, Langer Segen 8-10, 24105, Kiel, Germany.

Ian Carter (I)

Molecular Diagnostics, Histopathology, Nottingham University Hospitals NHS Trust, City Campus, Hucknall Rd., Nottingham, NG5 1PB, UK.

Dido Lenze (D)

Institut für Pathologie, Molekularpathologie, Charité -Universitätsmedizin Berlin, Chariteplatz 1, 10117, Berlin, Germany.

Maria Eugenia Sarasquete (ME)

Laboratorio Biología Molecular, Servicio de Hematología, Hospital Universitario de Salamanca, Paseo de San Vicente, 58-182, 37007, Salamanca, Spain.
ORCID: 0000-0001-7335-3657

Markus Möbs (M)

Institut für Pathologie, Molekularpathologie, Charité -Universitätsmedizin Berlin, Chariteplatz 1, 10117, Berlin, Germany.
ORCID: 0000-0002-1502-3032

Hongxiang Liu (H)

Molecular Malignancy Laboratory, Haematopathology and Oncology Diagnostic Service (HODS), Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Box 234, Hills Road, Cambridge, CB2 0QQ, UK.

Elisabeth M C Dequeker (EMC)

Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Kapucijnenvoer 35 block d, 1st floor, box 7001, 3000, Leuven, Belgium.

Patricia J T A Groenen (PJTA)

Department of Pathology, Radboud University Medical Centre Nijmegen, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands. patricia.groenen@radboudumc.nl.
ORCID: 0000-0003-4314-228X

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Classifications MeSH

questionsmedicales.fr › Phénomènes génétiques › Réarrangement des gènes › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Phénomènes du système immunitaire › Phénomènes immunogénétiques › Gènes d'immunoglobuline › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Phénomènes génétiques › Structures génétiques › Génome › Composants de génome › Gènes › Gènes du récepteur des cellules T › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Administration des services de santé › Évaluation de la compétence des laboratoires › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Maladies du système immunitaire › Syndromes immunoprolifératifs › Syndromes lymphoprolifératifs › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Techniques de diagnostic moléculaire › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Facteurs épidémiologiques › Biais (épidémiologie) › Biais de l'observateur › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Techniques d'amplification d'acides nucléiques › Réaction de polymérisation en chaîne › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Valeur prédictive des tests › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Assurance de la qualité des soins de santé › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Technologie, industrie et agriculture › Technologie › Contrôle de qualité › Evaluation of a worldwide EQA scheme for...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Reproductibilité des résultats › Evaluation of a worldwide EQA scheme for...