iCMLf Forum 2014 - Xiao-Jun Huang - China Standardization Project

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Information about iCMLf Forum 2014 - Xiao-Jun Huang - China Standardization Project
Science-Technology

Published on March 10, 2014

Author: jangeissler

Source: authorstream.com

“China Standardization Project of BCR-ABL detection in CML”: An efficient way for multi-centers to simultaneously derive and validate CFs: “China Standardization Project of BCR-ABL detection in CML ”: An efficient way for multi-centers to simultaneously derive and validate CFs Ya -Zhen Qin and Xiao-Jun Huang Peking University People's Hospital, Peking University Institute of Hematology, Beijing, China Introduction to my institution (PUIH) : Introduction to my institution (PUIH) Newly diagnosed CML per year :~100 Total number of CML patients treated by TKI:~800 Number of hematologists : ~ 40 Real-time PCR, FISH, cytogenetics: clinical routine Qualitative PCR of BCR/ABL: established in 1989 Real-time PCR of BCR/ABL: since 2004 Clinical access to TKI: imatinib, nilotinib, dasatinib Aim of the Project: Aim of the Project To test the accuracy and stability of BCR-ABL detection of the participated laboratories and help to improve the performance of those not well done To derive and validate laboratory specific CFs of the participants Great variation existed in the BCR-ABL results from different laboratories: Great variation existed in the BCR-ABL results from different laboratories Same samples detected in 10 labs in May 2010 Variation caused by: different detection methods problems in protocol China Standardization Project of BCR-ABL detection in CML : China Standardization Project of BCR-ABL detection in CML Initiated in 2010 Participants A regional reference lab: Peking University People’s Hospital (PKUPH) The 1 st batch : 9 labs from hospitals (Participated in 2010) The 2 nd batch : 13 labs from hospitals and a commercial lab (Participated in 2013) PowerPoint Presentation: Locations of the participants Beijing 1st batch of labs reference lab 2nd batch of labs PowerPoint Presentation: A sample exchange between Adelaide international reference laboratory (IMVS) and PKUPH in 2012 PKUPH: regional reference lab Distributing samples for comparing and deriving CFs: Distributing samples for comparing and deriving CFs Preparing and distributing samples by PKUPH Performing BCR-ABL detection according to the laboratory’s own protocols Analyzing results and calculating CF by PKUPH Preparation of distributing samples by PKUPH: Preparation of distributing samples by PKUPH Fresh nucleated cells from newly diagnosed BCR-ABL (+) CML patients were 10-fold serial diluted by cells from BCR-ABL (-) patients TRIzol was added and mixed with cells, each tube with about 8 million cells Twelve samples (4 dilutions, 3 samples per dilution) were frozen shipped to the participants Summary of the five comparisons of the 1st batch laboratories: Summary of the five comparisons of the 1 st batch laboratories Samples May 2010 Samples August 2010 Samples April 2011 Samples July 2011 Samples September 2012 Accuracy of BCR-ABL detection is greatly improved Deriving CF Qin YZ. et al. Chinese J of Hematology 2013; 34: 104-108 Usual validation method in the world: Usual validation method in the world Participating laboratory sends 20-30 samples to reference laboratory, they simultaneously test these samples and CF is validated Validation is a laborious work for a reference laboratory We performed validation by simultaneously distributing same prepared samples to the participants Validating CF of the 1st batch of labs in 2013: Validating CF of the 1st batch of labs in 2013 Preparing validation samples by PKUPH 22 times dilutions of fresh BCR-ABL (+) nucleated cells by BCR-ABL (-) cells. 10 parallel samples per dilution The dilutions covered 3-log BCR-ABL levels range, with the highest level lower than 10% IS 10 sets of same samples were prepared, and each set contained 22 samples with different BCR-ABL levels The samples were distributed and were simultaneously tested by PKUPH and the other 9 laboratories over 2-3 months Summary of the validation results: Summary of the validation results Lab number CF Bias (fold) Lower limit (fold) Upper limit (fold) Conclusion 1 0.62 1.00 -2.9 2.9 √ 2 0.41 1.29 -3.36 3.88 √ 3 0.55 1.26 -5.84 6.24 √ 4 0.74 1.31 -4.64 5.11 √ 5 0.95 1.36 -2.63 3.16 √ 6 0.52 1.24 -2.79 3.18 √ 7 0.37 2.32 -1.81 2.95 8 0.11 4.47 -88.4 90 9* 0.27 - - - *Because 30% of validation samples could not be detected BCR-ABL by this lab, validation was not performed. 1st comparison results of the 2nd batch participants: 1 st comparison results of the 2 nd batch participants Comparison and validation are ongoing…: Comparison and validation are ongoing… Recalculation and validation of CFs for the 3 labs in the 1 st batch which failed validation Deriving and validating CFs for the 2nd batch participants Revalidation once a year Summary: Summary The approach we derive and validate CF is practical and efficient when a number of centers need to be performed simultaneously Our simultaneously distributing same prepared samples method might be the way to regularly test the stability of BCR-ABL detection of multi-centers Acknowledgements: Acknowledgements Labs involved in the Project Adelaide reference laboratory (IMVS) Susan Branford Linda Fletcher Novartis China PowerPoint Presentation: 北京大学血液病研究所 INSTITUTE OF HEMATOLOGY

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