1 Clinical and Laboratory Standards Institute, "User veriflcation of precision and estimation of bias; Approved guideline—Third edition" Clinical and Laboratory Standards Institute 2014
2 Halling KC, "Test veriflcation and validation for molecular diagnostic assays" 136 : 11-13, 2012
3 "Standard: Establishment and veriflcation of performance speciflcations. 42 CFR § 493.1253, Oct. 1, 2015"
4 Jennings L, "Recommended principles and practices for validating clinical molecular pathology tests" 133 : 743-755, 2009
5 BIO-RAD, "Rare Mutation Detection Best Practices Guidelines"
6 Clinical and Laboratory Standards Institute, "Quality management for molecular genetic testing; Approved guideline" Clinical and Laboratory Standards Institute 2012
7 Hee-Jung Chung ; 허미나 ; Sumi Yoon ; Keumrock Hwang ; Hwan-Sub Lim ; Hanah Kim ; Hee-Won Moon ; Yeo-Min Yun, "Performance Evaluation of the QXDx BCR-ABL %IS Droplet Digital PCR Assay" 대한진단검사의학회 40 (40): 72-75, 2020
8 College of American Pathologists, "Molecular pathology checklist" College of American Pathologists 2021
9 Clinical and Laboratory Standards Institute, "Molecular methods for clinical genetics and oncology testing; Approved guideline—Third edition" Clinical and Laboratory Standards Institute 2012
10 Association for Molecular Pathology, "Molecular Diagnostic Assay Validation : Update to the 2009 AMP Molecular Diagnostic Assay Validation White Paper"
1 Clinical and Laboratory Standards Institute, "User veriflcation of precision and estimation of bias; Approved guideline—Third edition" Clinical and Laboratory Standards Institute 2014
2 Halling KC, "Test veriflcation and validation for molecular diagnostic assays" 136 : 11-13, 2012
3 "Standard: Establishment and veriflcation of performance speciflcations. 42 CFR § 493.1253, Oct. 1, 2015"
4 Jennings L, "Recommended principles and practices for validating clinical molecular pathology tests" 133 : 743-755, 2009
5 BIO-RAD, "Rare Mutation Detection Best Practices Guidelines"
6 Clinical and Laboratory Standards Institute, "Quality management for molecular genetic testing; Approved guideline" Clinical and Laboratory Standards Institute 2012
7 Hee-Jung Chung ; 허미나 ; Sumi Yoon ; Keumrock Hwang ; Hwan-Sub Lim ; Hanah Kim ; Hee-Won Moon ; Yeo-Min Yun, "Performance Evaluation of the QXDx BCR-ABL %IS Droplet Digital PCR Assay" 대한진단검사의학회 40 (40): 72-75, 2020
8 College of American Pathologists, "Molecular pathology checklist" College of American Pathologists 2021
9 Clinical and Laboratory Standards Institute, "Molecular methods for clinical genetics and oncology testing; Approved guideline—Third edition" Clinical and Laboratory Standards Institute 2012
10 Association for Molecular Pathology, "Molecular Diagnostic Assay Validation : Update to the 2009 AMP Molecular Diagnostic Assay Validation White Paper"
11 Shrivastava A, "Methods for the determination of limit of detection and limit of quantitation of the analytical methods" 2 : 21-25, 2011
12 Armbruster DA, "Limit of blank, limit of detection and limit of quantitation" 29 (29): S49-S52, 2008
13 Broeders S, "Guidelines for validation of qualitative real-time PCR methods" 37 : 115-126, 2014
14 Clinical and Laboratory Standards Institute, "Evaluation of linearity of quantitative measurement procedures" Clinical and Laboratory Standards Institute 2020
15 Clinical and Laboratory Standards Institute, "Evaluation of detection capability for clinical laboratory measurement procedures; Approved guideline—Second edition" Clinical and Laboratory Standards Institute 2012
16 Yuan D, "Droplet digital PCR for quantiflcation of PML-RARα in acute promyelocytic leukemia : a comprehensive comparison with real-time PCR" 411 : 895-903, 2019
17 Mazaika E, "Digital droplet PCR : CNV analysis and other applications" 82 : 7.24.1-7.24.13, 2014
18 Wolstencroft EC, "Development of a quantitative real-time polymerase chain reaction assay for the detection of the JAK2 V617F mutation" 9 : 42-46, 2007
19 Schnittger S, "Development and validation of a real-time quantiflcation assay to detect and monitor BRAFV600E mutations in hairy cell leukemia" 119 : 3151-3154, 2012
20 Jennings LJ, "Design and analytic validation of BCR-ABL1 quantitative reverse transcription polymerase chain reaction assay for monitoring minimal residual disease" 136 : 33-40, 2012
21 Clinical and Laboratory Standards Institute, "Deflning, establishing, and verifying reference intervals in the clinical laboratory; Approved guideline—3rd edition" Clinical and Laboratory Standards Institute 2010
22 Mattocks CJ, "A standardized framework for the validation and veriflcation of clinical molecular genetic tests" 18 : 1276-1288, 2010
23 Heuser M, "2021 Update on MRD in acute myeloid leukemia : a consensus document from the European LeukemiaNet MRD Working Party" 138 : 2753-2767, 2021