Evidence map›Paper›PMID 25036192›Full record

ArticleLeukemia2015

A certified plasmid reference material for the standardisation of BCR-ABL1 mRNA quantification by real-time quantitative PCR.

H White, L Deprez, P Corbisier, V Hall, F Lin, S Mazoua, S Trapmann, A Aggerholm, H Andrikovics, S Akiki and 61 more

Abstract read
In one paragraph

Article in Leukemia, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed.

  1. Trial
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  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Digital PCR forHemaSphere · 2020
    Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Digital PCR in Myeloid Malignancies: Ready to Replace Quantitative PCR?International journal of molecular sciences · 2019
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

71 authors.

H White1] National Genetics Reference Laboratory (Wessex), Salisbury District Hospital, Salisbury, UK [2] Faculty of Medicine, University of Southampton, Southampton, UK.
L DeprezEuropean Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel, Belgium.
P CorbisierEuropean Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel, Belgium.
V HallNational Genetics Reference Laboratory (Wessex), Salisbury District Hospital, Salisbury, UK.
F Lin1] National Genetics Reference Laboratory (Wessex), Salisbury District Hospital, Salisbury, UK [2] Faculty of Medicine, University of Southampton, Southampton, UK.
S MazouaEuropean Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel, Belgium.
S TrapmannEuropean Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel, Belgium.
A AggerholmDepartment of Haematology, Aarhus University Hospital, Aarhus, Denmark.
H AndrikovicsHungarian National Blood Transfusion Service, Budapest, Hungary.
S AkikiRegional Genetics Laboratory, Birmingham Women's NHS Foundation Trust, Birmingham, UK.
G BarbanyDepartment of Molecular Medicine and Surgery, Clinical Genetics Karolinska Institutet, Stockholm, Sweden.
N Boeckx1] Department of Laboratory Medicine, UZ Leuven, Belgium [2] Department of Oncology, KU Leuven, Belgium.
A BenchMolecular Malignancy Laboratory and Haemato-Oncology Diagnostic Service, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
M CatherwoodHaematology Department, Belfast City Hospital, Belfast, UK.
J-M CayuelaHaematology Laboratory and EA3518, University Hospital Saint-Louis, AP-HP, University Paris Diderot, Paris, France.
S ChudleighDepartment of Molecular Haematology, Yorkhill NHS Trust, Glasgow, UK.
T ClenchMolecular Haematology, Bristol Royal Infirmary, Bristol, UK.
D ColomerHematopathology Unit, Hospital Clinic, IDIBAPS, Barcelona, Spain.
F DaraioDepartment of Clinical and Biological Science, University of Turin, Turin, Italy.
S DulucqLaboratoire Hematologie, CHU Bordeaux, Hematopoiese Leucemique et Cibles Therapeutiques, INSERM U1035, Universite Bordeaux, Bordeaux, France.
J FarrugiaCombined Laboratories, Derriford Hospital, Plymouth, UK.
L FletcherDepartment of Genetics and Molecular Pathology, SA Pathology, Adelaide, SA, Australia.
L ForoniImperial Molecular Pathology, Centre for Haematology, Imperial College London, London, UK.
R GandertonMolecular Pathology, University Hospitals Southampton NHS Foundation Trust, Southampton, UK.
G GerrardImperial Molecular Pathology, Centre for Haematology, Imperial College London, London, UK.
E GineikienėHematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santariskiu Clinics, Vilnius, Lithuania.
S HayetteLaboratory of Molecular Biology and UMR5239, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre Bénite, France.
H El HousniMedical Genetics Department, Erasme Hospital, Brussels, Belgium.
B IzzoDepartment of Clinical Medicine and Surgery, University 'Federico II' of Naples, Naples, Italy.
M JanssonDepartment of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.
P JohnelsDepartment of Clinical Genetics, University and Regional Laboratories, Lund, Sweden.
T JurcekDepartment of Internal Medicine-Hematology and Oncology, Masaryk University and University Hospital Brno, Brno, Czech Republic.
V KairistoTurku University Hospital, TYKSLAB, Laboratory of Molecular Genetics, Turku, Finland.
A KizilorsLaboratory for Molecular Haemato-Oncology, Kings College Hospital, London, UK.
D-W KimCancer Research Institute, The Catholic University of Korea, Seoul, South Korea.
T LangeAbteilung für Hämatologie und internistische Onkologie, Universität Leipzig, Leipzig, Germany.
T LionChildren's Cancer Research Institute/LabDia Labordiagnostik and Medical University, Vienna, Austria.
K M PolakovaInstitute of Hematology and Blood Transfusion, Prague, Czech Republic.
G MartinelliDepartment of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.
S McCarronCancer Molecular Diagnostics, St James's Hospital, Dublin, Ireland.
P A MerleVU Medical Centre, Department of Haematology, Amsterdam, The Netherlands.
B MilnerDepartment of Medical Genetics, NHS-Grampian, Aberdeen, UK.
G Mitterbauer-HohendannerDepartment of Laboratory Medicine, Medical University of Vienna, Vienna, Austria.
M NagarLaboratory of Hematology, Sheba Medical Center, Tel Hashomer, Israel.
G NicklessMolecular Oncology Diagnostics Unit, Guy's Hospital, London, UK.
J NomdedéuLab Hematologia, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
D A NymoenDivision of Pathology, Rikshospital, Oslo University Hospital, Oslo, Norway.
E O LeibundgutMolecular Diagnostics Laboratory, Department of Hematology, University Hospital Bern, Bern, Switzerland.
U OzbekGenetics Department, Institute of Experimental Medicine (DETAE), Istanbul University, Istanbul, Turkey.
T PajičSpecialized Haematology Laboratory, Division of Internal Medicine, Department of Haematology, University Medical Centre, Ljubljana, Slovenia.
H PfeiferDepartment of Internal Medicine, Hematology/Oncology, Goethe University, Frankfurt, Germany.
C PreudhommeLaboratoire d'hématologie, CHU Lille, Lille, France.
K RaudseppUnited Laboratories of Tartu University Hospitals, Tartu, Estonia.
G RomeoMolecular Haematology Laboratory, PathWest Laboratory Medicine, Royal Perth Hospital, Perth, WA, Australia.
T SachaHematology Department, Jagiellonian University, Krakow, Poland.
R TalmaciHematology Department, Fundeni Clinical Institute, University of Medicine and Pharmacy 'Carol Davila', Bucharest, Romania.
T TouloumenidouHematology Department and HCT Unit, G. Papanicolaou Hospital, Thessaloniki, Greece.
V H J Van der VeldenDepartment of Immunology, Erasmus MC, Rotterdam, The Netherlands.
P WaitsBristol Genetics Laboratory, Southmead Hospital, Bristol, UK.
L WangDepartment of Haematology, Royal Liverpool University Hospital, Liverpool, UK.
E WilkinsonHMDS, Leeds Institute of Oncology, St James's University Hospital, Leeds, UK.
G WilsonSheffield Diagnostic Genetics Service, Sheffield Children's NHS Foundation Trust, Sheffield, UK.
D WrenMolecular Diagnostics, The Royal Marsden NHS Foundation Trust, Sutton, UK.
R ZadroDepartment of Laboratory Diagnostics, Clinical Hospital Center, Zagreb University School of Medicine, Zagreb, Croatia.
J ZiermannDepartment of Hematology/Oncology, Jena University Hospital, Jena, Germany.
K ZoiHaematology Research Laboratory, Biomedical Research Foundation, Academy of Athens, Athens, Greece.
M C MüllerIII. Medizinische Klinik, Medizinische Fakultät Mannheim der Universität Heidelberg, Mannheim, Germany.
A HochhausDepartment of Hematology/Oncology, Jena University Hospital, Jena, Germany.
H SchimmelEuropean Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel, Belgium.
N C P Cross1] National Genetics Reference Laboratory (Wessex), Salisbury District Hospital, Salisbury, UK [2] Faculty of Medicine, University of Southampton, Southampton, UK.
H EmonsEuropean Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel, Belgium.

Funding

Department of Health
6 · The paper itself

Abstract

Serial quantification of BCR-ABL1 mRNA is an important therapeutic indicator in chronic myeloid leukaemia, but there is a substantial variation in results reported by different laboratories. To improve comparability, an internationally accepted plasmid certified reference material (CRM) was developed according to ISO Guide 34:2009. Fragments of BCR-ABL1 (e14a2 mRNA fusion), BCR and GUSB transcripts were amplified and cloned into pUC18 to yield plasmid pIRMM0099. Six different linearised plasmid solutions were produced with the following copy number concentrations, assigned by digital PCR, and expanded uncertainties: 1.08±0.13 × 10(6), 1.08±0.11 × 10(5), 1.03±0.10 × 10(4), 1.02±0.09 × 10(3), 1.04±0.10 × 10(2) and 10.0±1.5 copies/μl. The certification of the material for the number of specific DNA fragments per plasmid, copy number concentration of the plasmid solutions and the assessment of inter-unit heterogeneity and stability were performed according to ISO Guide 35:2006. Two suitability studies performed by 63 BCR-ABL1 testing laboratories demonstrated that this set of 6 plasmid CRMs can help to standardise a number of measured transcripts of e14a2 BCR-ABL1 and three control genes (ABL1, BCR and GUSB). The set of six plasmid CRMs is distributed worldwide by the Institute for Reference Materials and Measurements (Belgium) and its authorised distributors (https://ec.europa.eu/jrc/en/reference-materials/catalogue/; CRM code ERM-AD623a-f).

Indexed as

CalibrationCloning, MolecularDNAEscherichia coli ProteinsFusion Proteins, bcr-ablGene DosageHumansMembrane Transport ProteinsPlasmidsProto-Oncogene Proteins c-bcrReal-Time Polymerase Chain ReactionReference StandardsRNA, MessengerBCR-ABL1 fusion protein, humanBCR protein, humanDNAEscherichia coli ProteinsFusion Proteins, bcr-ablGusB protein, E coliMembrane Transport ProteinsProto-Oncogene Proteins c-bcrRNA, Messenger

Identifiers

PMID25036192
PMCPMC4320294

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.