-
Something wrong with this record ?
Assessment of droplet digital polymerase chain reaction for measuring BCR-ABL1 in chronic myeloid leukaemia in an international interlaboratory study
S. Scott, A. Cartwright, S. Francis, L. Whitby, AP. Sanzone, A. Mulder, S. Galimberti, S. Dulucq, C. Mauté, C. Lauricella, M. Salmon, S. Rose, J. Willoughby, N. Boeckx, N. Pallisgaard, J. Maier, EO. Leibundgut, H. Zizkova, L. Ling Goh, C. Duong,...
Language English Country Great Britain
Document type Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
PubMed
34114218
DOI
10.1111/bjh.17521
Knihovny.cz E-resources
- MeSH
- Fusion Proteins, bcr-abl blood MeSH
- K562 Cells chemistry MeSH
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive blood MeSH
- HL-60 Cells chemistry MeSH
- Laboratories, Clinical MeSH
- Humans MeSH
- Linear Models MeSH
- Biomarkers, Tumor blood MeSH
- Reverse Transcriptase Polymerase Chain Reaction methods MeSH
- Reagent Kits, Diagnostic MeSH
- Reproducibility of Results MeSH
- Laboratory Proficiency Testing * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Comparative Study MeSH
- Geographicals
- Asia MeSH
- Europe MeSH
- North America MeSH
Measurement of BCR activator of RhoGEF and GTPase -ABL proto-oncogene 1, non-receptor tyrosine kinase (BCR-ABL1) mRNA levels by reverse transcription quantitative polymerase chain reaction (RTqPCR) has been critical to treatment protocols and clinical trials in chronic myeloid leukaemia; however, interlaboratory variation remains a significant issue. Reverse transcriptase droplet digital PCR (RTddPCR) has shown potential to improve testing but a large-scale interlaboratory study is required to definitively establish this. In the present study, 10 BCR-ABL1-positive samples with levels ranging from molecular response (MR)1·0 -MR5·0 were tested by 23 laboratories using RTddPCR with the QXDX BCR-ABL %IS kit. A subset of participants tested the samples using RTqPCR. All 23 participants using RTddPCR detected BCR-ABL1 in all samples to MR4·0 . Detection rates for deep-response samples were 95·7% at MR4·5 , 78·3% at MR4·7 and 87·0% at MR5·0 . Interlaboratory coefficient of variation was indirectly proportional to BCR-ABL1 level ranging from 29·3% to 69·0%. Linearity ranged from 0·9330 to 1·000 (average 0·9936). When results were compared for the 11 participants who performed both RTddPCR and RTqPCR, RTddPCR showed a similar limit of detection to RTqPCR with reduced interlaboratory variation and better assay linearity. The ability to detect deep responses with RTddPCR, matched with an improved linearity and reduced interlaboratory variation will allow improved patient management, and is of particular importance for future clinical trials focussed on achieving and maintaining treatment-free remission.
Advanced Therapies National Institute for Biological Standards and Control Potters Bar UK
Clinical Research Division Fred Hutchinson Cancer Research Center Seattle WA USA
Department of Clinical and Experimental Medicine University of Pisa Pisa Italy
Department of Genomics Strand Life Sciences Bangalore India
Department of Haematology Inselspital Bern University Hospital Bern Switzerland
Department of Haematology Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK
Department of Laboratory Medicine ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Department of Laboratory Medicine University Hospitals Leuven Leuven Belgium
Department of Molecular Genetics Institute of Hematology and Blood Transfusion Praha Czech Republic
Department of Oncology KU Leuven Leuven Belgium
Department of Pathology Division of Haematology Queen Mary Hospital Hong Kong Hong Kong
Department of Pathology The University of Hong Kong Hong Kong Hong Kong
Department of Surgical Pathology Zealand University Hospital Roskilde Denmark
Department of Transfusion Medicine University Hospital Leipzig Leipzig Germany
Digital Biology Group Bio Rad Pleasanton CA USA
Genetics and Molecular Biology National Institute of Hematology and Blood Transfusion Hanoi Vietnam
Haematology Laboratory Hôpital Saint Louis Paris France
Laboratory of Hematology University Hospital Centre Bordeaux Pessac France
Pathology Hong Kong Sanatorium and Hospital Hong Kong Hong Kong
Personalized Medicine Service Tan Tock Seng Hospital Singapore Singapore
University of Bordeaux INSERM U1218 Bordeaux France
University of Southampton School of Medicine Southampton UK
Wessex Regional Genetics Laboratory Salisbury District Hospital Salisbury UK
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc22004120
- 003
- CZ-PrNML
- 005
- 20220228091958.0
- 007
- ta
- 008
- 220113s2021 xxk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1111/bjh.17521 $2 doi
- 035 __
- $a (PubMed)34114218
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxk
- 100 1_
- $a Scott, Stuart $u Sheffield Teaching Hospital NHS Foundation Trust, UK National External Quality Assessment Services (NEQAS) for Leucocyte Immunophenotyping, Sheffield, UK $u Faculty of Medicine Dentistry and Health, Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK
- 245 10
- $a Assessment of droplet digital polymerase chain reaction for measuring BCR-ABL1 in chronic myeloid leukaemia in an international interlaboratory study / $c S. Scott, A. Cartwright, S. Francis, L. Whitby, AP. Sanzone, A. Mulder, S. Galimberti, S. Dulucq, C. Mauté, C. Lauricella, M. Salmon, S. Rose, J. Willoughby, N. Boeckx, N. Pallisgaard, J. Maier, EO. Leibundgut, H. Zizkova, L. Ling Goh, C. Duong, WF. Tang, E. Ma, Y. Shivakumar, L. Beppu, P. Bhagavatula, A. Chantry
- 520 9_
- $a Measurement of BCR activator of RhoGEF and GTPase -ABL proto-oncogene 1, non-receptor tyrosine kinase (BCR-ABL1) mRNA levels by reverse transcription quantitative polymerase chain reaction (RTqPCR) has been critical to treatment protocols and clinical trials in chronic myeloid leukaemia; however, interlaboratory variation remains a significant issue. Reverse transcriptase droplet digital PCR (RTddPCR) has shown potential to improve testing but a large-scale interlaboratory study is required to definitively establish this. In the present study, 10 BCR-ABL1-positive samples with levels ranging from molecular response (MR)1·0 -MR5·0 were tested by 23 laboratories using RTddPCR with the QXDX BCR-ABL %IS kit. A subset of participants tested the samples using RTqPCR. All 23 participants using RTddPCR detected BCR-ABL1 in all samples to MR4·0 . Detection rates for deep-response samples were 95·7% at MR4·5 , 78·3% at MR4·7 and 87·0% at MR5·0 . Interlaboratory coefficient of variation was indirectly proportional to BCR-ABL1 level ranging from 29·3% to 69·0%. Linearity ranged from 0·9330 to 1·000 (average 0·9936). When results were compared for the 11 participants who performed both RTddPCR and RTqPCR, RTddPCR showed a similar limit of detection to RTqPCR with reduced interlaboratory variation and better assay linearity. The ability to detect deep responses with RTddPCR, matched with an improved linearity and reduced interlaboratory variation will allow improved patient management, and is of particular importance for future clinical trials focussed on achieving and maintaining treatment-free remission.
- 650 _2
- $a nádorové biomarkery $x krev $7 D014408
- 650 _2
- $a bcr-abl fúzní proteiny $x krev $7 D016044
- 650 _2
- $a HL-60 buňky $x chemie $7 D018922
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a buňky K562 $x chemie $7 D020014
- 650 _7
- $a klinické laboratoře $7 D000090464 $2 czmesh
- 650 12
- $a testování odbornosti laboratoří $7 D059021
- 650 _2
- $a chronická myeloidní leukemie $x krev $7 D015464
- 650 _2
- $a lineární modely $7 D016014
- 650 _2
- $a reagenční diagnostické soupravy $7 D011933
- 650 _2
- $a reprodukovatelnost výsledků $7 D015203
- 650 _2
- $a polymerázová řetězová reakce s reverzní transkripcí $x metody $7 D020133
- 651 _2
- $a Asie $7 D001208
- 651 _2
- $a Evropa $7 D005060
- 651 _2
- $a Severní Amerika $7 D009656
- 655 _2
- $a srovnávací studie $7 D003160
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Cartwright, Ashley $u Sheffield Teaching Hospital NHS Foundation Trust, UK National External Quality Assessment Services (NEQAS) for Leucocyte Immunophenotyping, Sheffield, UK
- 700 1_
- $a Francis, Sebastian $u Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
- 700 1_
- $a Whitby, Liam $u Sheffield Teaching Hospital NHS Foundation Trust, UK National External Quality Assessment Services (NEQAS) for Leucocyte Immunophenotyping, Sheffield, UK
- 700 1_
- $a Sanzone, A Pia $u Advanced Therapies, National Institute for Biological Standards and Control, Potters Bar, UK
- 700 1_
- $a Mulder, André $u Department of Laboratory Medicine, University Medical Center Groningen, University of Groningen, Groningen, Netherlands
- 700 1_
- $a Galimberti, Sara $u Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
- 700 1_
- $a Dulucq, Stephanie $u Laboratory of Hematology, University Hospital Centre Bordeaux, Pessac, France $u University of Bordeaux, INSERM, U1218, Bordeaux, France
- 700 1_
- $a Mauté, Carole $u Haematology Laboratory, Hôpital Saint-Louis, Paris, France
- 700 1_
- $a Lauricella, Calogero $u Department of Laboratory Medicine, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
- 700 1_
- $a Salmon, Matthew $u Wessex Regional Genetics Laboratory, Salisbury District Hospital, Salisbury, UK $u University of Southampton, School of Medicine, Southampton, UK
- 700 1_
- $a Rose, Susan $u West Midlands Regional Genetics Laboratory, Birmingham Women's and Children's Hospitals NHS Foundation Trust, Birmingham, UK
- 700 1_
- $a Willoughby, Josh $u Sheffield Diagnostic Genetics Service, Sheffield Children's Hospital NHS Foundation Trust, Sheffield, UK
- 700 1_
- $a Boeckx, Nancy $u Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium $u Department of Oncology, KU Leuven, Leuven, Belgium
- 700 1_
- $a Pallisgaard, Niels $u Department of Surgical Pathology, Zealand University Hospital, Roskilde, Denmark
- 700 1_
- $a Maier, Jacqueline $u Department of Transfusion Medicine, University Hospital Leipzig, Leipzig, Germany
- 700 1_
- $a Leibundgut, Elisabeth O $u Department of Haematology, Inselspital, Bern University Hospital, Bern, Switzerland
- 700 1_
- $a Zizkova, Hana $u Department of Molecular Genetics, Institute of Hematology and Blood Transfusion, Praha, Czech Republic
- 700 1_
- $a Ling Goh, Liuh $u Personalized Medicine Service, Tan Tock Seng Hospital, Singapore, Singapore
- 700 1_
- $a Duong, Chinh $u Genetics and Molecular Biology, National Institute of Hematology and Blood Transfusion, Hanoi, Vietnam $u Department of Hematology and Blood Transfusion, University of Medicine and Pharmacy, Vietnam National University, Hanoi, Vietnam
- 700 1_
- $a Tang, Wing F $u Department of Pathology, Division of Haematology, Queen Mary Hospital, Hong Kong, Hong Kong
- 700 1_
- $a Ma, Edmond $u Department of Pathology, The University of Hong Kong, Hong Kong, Hong Kong $u Pathology, Hong Kong Sanatorium and Hospital, Hong Kong, Hong Kong
- 700 1_
- $a Shivakumar, Yogesh $u Department of Genomics, Strand Life Sciences, Bangalore, India
- 700 1_
- $a Beppu, Lan $u Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
- 700 1_
- $a Bhagavatula, Prasanthi $u Digital Biology Group, Bio-Rad, Pleasanton, CA, USA
- 700 1_
- $a Chantry, Andrew $u Faculty of Medicine Dentistry and Health, Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK $u Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
- 773 0_
- $w MED00009374 $t British journal of haematology $x 1365-2141 $g Roč. 194, č. 1 (2021), s. 53-60
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/34114218 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y p $z 0
- 990 __
- $a 20220113 $b ABA008
- 991 __
- $a 20220228091957 $b ABA008
- 999 __
- $a ok $b bmc $g 1751550 $s 1155269
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2021 $b 194 $c 1 $d 53-60 $e 20210610 $i 1365-2141 $m British journal of haematology $n Br J Haematol $x MED00009374
- LZP __
- $a Pubmed-20220113
