Research progress in quality control materials used for clinical molecular pathological testing

doi:10.3877/cma.j.issn.2095-5820.2018.02.004

Abstract

Abstract:

Molecular pathological testing is important to the individualized treatment of cancer, and the accuracy and reliability of the testing results is closely related to the patient curative effect. In order to ensure the quality of the testing, it is necessary to use specific quality control materials for strictly monitoring the testing process. This paper reviews the types, advantages and limitations of commonly used quality control materials for molecular pathological testing so as to provide help for the selection of related quality control products in the laboratory and to provide more accurate and reliable results for the clinic.

Key words: Molecular pathology, Quality control materials, Quality assurance

Xueliang Wang, Yanqun Xiao, Hualiang Wang. Research progress in quality control materials used for clinical molecular pathological testing[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2018, 06(02): 80-83.

/ / Recommend

Add to citation manager EndNote|Ris|BibTeX

URL: https://zhlcsysgldzzz.cma-cmc.com.cn/EN/10.3877/cma.j.issn.2095-5820.2018.02.004

https://zhlcsysgldzzz.cma-cmc.com.cn/EN/Y2018/V06/I02/80

References 20

1	Ludwig JA, Weinstein JN. Biomarkers in cancer staging, prognosis and treatment selection [J]. Nat Rev Cancer, 2005,5(11):845-856.
2	Bellon E, Ligtenberg MJ, Tejpar S, et al. External quality assessment for KRAS testing is needed: setup of a European program and report of the first joined regional quality assessment rounds [J]. Oncologist, 2011,16(4):467-478.
3	Deans ZC, Bilbe N, O′Sullivan B, et al. Improvement in the quality of molecular analysis of EGFR in non-small-cell lung cancer detected by three rounds of external quality assessment [J]. J Clin Pathol, 2013, 66(4):319-325.
4	Emile JF, Tisserand J, Bergougnoux L, et al. Improvement of the quality of BRAF testing in melanomas with nationwide external quality assessment, for the BRAF EQA group [J]. BMC Cancer, 2013, 13:472.
5	Normanno N, Fenizia F, Castiglione F, et al. External quality assessment for EGFR mutations in Italy: improvements in performances over the time [J]. ESMO Open, 2017,2(2):e000160.
6	Normanno N, Pinto C, Castiglione F, et al. The Italian external quality assessment for RAS testing in colorectal carcinoma identifies methods-related inter-laboratory differences [J]. J Transl Med, 2015, 13:287.
7	Boleij A, Tops BB, Rombout PD, et al. RAS testing in metastatic colorectal cancer: excellent reproducibility amongst 17 Dutch pathology centers [J]. Oncotarget, 2015,6(17):15681-15689.
8	Zhang R, Ding J, Han Y, et al. The reliable assurance of detecting somatic mutations in cancer-related genes by next-generation sequencing: the results of external quality assessment in China [J]. Oncotarget, 2016,7(36):58500-58515.
9	Zhang R, Peng R, Li Z, et al. Synthetic Circulating Cell-free DNA as Quality Control Materials for Somatic Mutation Detection in Liquid Biopsy for Cancer [J]. Clin Chem, 2017,63(9):1465-1475.
10	Xiao Y, Gao X, Maragh S, et al. Cell lines as candidate reference materials for quality control of ERBB2 amplification and expression assays in breast cancer [J]. Clin Chem, 2009,55(7):1307-1315.
11	Dijkstra JR, Opdam FJ, Boonyaratanakornkit J, et al. Implementation of formalin-fixed, paraffin-embedded cell line pellets as high-quality process controls in quality assessment programs for KRAS mutation analysis [J]. J Mol Diagn, 2012,14(3):187-191.
12	Zhang R, Han Y, Huang J, et al. Results of first proficiency test for KRAS testing with formalin-fixed, paraffin-embedded cell lines in China [J]. Clin Chem Lab Med, 2014,52(12):1851-1857.
13	Patton S, Normanno N, Blackhall F, et al. Assessing standardization of molecular testing for non-small-cell lung cancer: results of a worldwide external quality assessment (EQA) scheme for EGFR mutation testing [J]. Br J Cancer, 2014,111(2):413-420.
14	Dumur CI, Almenara JA, Powers CN, et al. Quality control material for the detection of somatic mutations in fixed clinical specimens by next-generation sequencing [J]. Diagn Pathol, 2015,10:169.
15	Li Y, Zhang R, Han Y, et al. Comparison of the types of candidate reference samples for quality control of human epidermal growth factor receptor 2 status detection [J]. Diagn Pathol, 2016,11(1):85.
16	Li Y, Zhang R, Peng R, et al. Reliability Assurance of Detection of EML4-ALK Rearrangement in Non-Small Cell Lung Cancer: The Results of Proficiency Testing in China [J]. J Thorac Oncol, 2016, 11(6):924-929.
17	Jia S, Zhang R, Lin G, et al. A novel cell line generated using the CRISPR/Cas9 technology as universal quality control material for KRAS G12V mutation testing [J]. J Clin Lab Anal, 2018 [Epub ahead of print]
18	Peng R, Zhang R, Lin G, et al. CRISPR/Cas9 Technology-Based Xenograft Tumors as Candidate Reference Materials for Multiple EML4-ALK Rearrangements Testing [J]. J Mol Diagn, 2017,19(5): 766-775.
19	Zook JM, Catoe D, McDaniel J, et al. Extensive sequencing of seven human genomes to characterize benchmark reference materials [J]. Sci Data, 2016,3:160025.
20	Cornish A, Guda C. A Comparison of Variant Calling Pipelines Using Genome in a Bottle as a Reference [J]. Biomed Res Int, 2015, 2015:456479.

[1]	Xiaoqin Zeng, Shaoxia He, Qing Xiao, Min Ming, Guifang Gong, Quanwen He, Hongen Liu. Rapid Assessment Procedure Study on Service Satisfaction of the Free Pre-pregnancy Eugenic Health Check in Guangzhou [J]. Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition), 2014, 10(06): 748-752.
[2]	Jincheng Pan, Shuangjian Jiang, Chengqiang Mo, Yu Chen. Clinical characteristics and prognosis of primary prostate sarcoma in adults [J]. Chinese Journal of Endourology(Electronic Edition), 2020, 14(06): 456-459.
[3]	Jinchun Lu. Current situation and countermeasures of semen analysis in andrology laboratories of China [J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2017, 05(02): 65-70.
[4]	Dan Guo, Anqi Wang, Jian Sun, Yingchun Xu. Quality assurance and quality control of biospecimen [J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2017, 05(01): 36-45.
[5]	Huiwen Tan, Limei Yin, Chuan Zuo, Diou Cheng, Rui Zeng, Xun Yao. Practice and thinking on the teaching management and quality assurance system construction of diagnostics and internal medicine for international students in China [J]. Chinese Journal of Diagnostics(Electronic Edition), 2021, 09(02): 92-94.

Please choose a citation manager

Content to export