{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T15:04:52Z","timestamp":1770822292636,"version":"3.50.1"},"reference-count":60,"publisher":"Archives of Pathology and Laboratory Medicine","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2012,1]]},"abstract":"\n Context<\/jats:italic>\n .\u2014Monitoring minimal residual disease by quantitative reverse transcription polymerase chain reaction has proven clinically useful, but as yet there are no Food and Drug Administration\u2013approved tests. Guidelines have been published that provide important information on validation of such tests; however, no practical examples have previously been published.\n <\/jats:p>\n \n Objective<\/jats:italic>\n .\u2014To provide an example of the design and validation of a quantitative reverse transcription polymerase chain reaction test.\n <\/jats:p>\n \n Design<\/jats:italic>\n .\u2014To describe the approach used by an individual laboratory for development and validation of a laboratory-developed quantitative reverse transcription polymerase chain reaction test for\n BCR-ABL1<\/jats:italic>\n fusion transcripts.\n <\/jats:p>\n \n Results<\/jats:italic>\n .\u2014Elements of design and analytic validation of a laboratory-developed quantitative molecular test are discussed using quantitative detection of\n BCR-ABL1<\/jats:italic>\n fusion transcripts as an example.\n <\/jats:p>\n \n Conclusions<\/jats:italic>\n .\u2014Validation of laboratory-developed quantitative molecular tests requires careful planning and execution to adequately address all required analytic performance parameters. How these are addressed depends on the potential for technical errors and confidence required for a given test result. We demonstrate how one laboratory validated and clinically implemented a quantitative\n BCR-ABL1<\/jats:italic>\n assay that can be used for the management of patients with chronic myelogenous leukemia.\n <\/jats:p>","DOI":"10.5858\/arpa.2011-0136-oa","type":"journal-article","created":{"date-parts":[[2011,12,30]],"date-time":"2011-12-30T12:38:43Z","timestamp":1325248723000},"page":"33-40","source":"Crossref","is-referenced-by-count":22,"title":["Design and Analytic Validation of BCR-ABL1 Quantitative Reverse Transcription Polymerase Chain Reaction Assay for Monitoring Minimal Residual Disease"],"prefix":"10.5858","volume":"136","author":[{"given":"Lawrence J","family":"Jennings","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frederick A","family":"Smith","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin C","family":"Halling","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diane L","family":"Persons","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suzanne","family":"Kamel-Reid","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"_","family":"_","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"3906","reference":[{"issue":"3","key":"i1543-2165-136-1-33-b01","series-title":"J Clin Oncol","first-page":"377","article-title":"Prognostic value of minimal residual disease quantification before allogeneic stem-cell transplantation in relapsed childhood acute lymphoblastic leukemia: the ALL-REZ BFM Study Group","volume":"27","author":"Bader\n P,","year":"2009","unstructured":"Bader\n P, \n \n Kreyenberg\n H, \n \n Henze\n GH\n , et al. \n Prognostic value of minimal residual disease quantification before allogeneic stem-cell transplantation in relapsed childhood acute lymphoblastic leukemia: the ALL-REZ BFM Study Group. J Clin Oncol. 2009;27(3):377\u2013384."},{"issue":"12","key":"i1543-2165-136-1-33-b02","series-title":"Blood","first-page":"5477","article-title":"Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study","volume":"111","author":"Borowitz\n MJ,","year":"2008","unstructured":"Borowitz\n MJ, \n \n Devidas\n M, \n \n Hunger\n SP\n , et al. \n Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study. Blood. 2008;111(12):5477\u20135485."},{"issue":"31","key":"i1543-2165-136-1-33-b03","series-title":"J Clin Oncol","first-page":"5195","article-title":"Real-time quantitative polymerase chain reaction detection of minimal residual disease by standardized WT1 assay to enhance risk stratification in acute myeloid leukemia: a European LeukemiaNet study","volume":"27","author":"Cilloni\n D,","year":"2009","unstructured":"Cilloni\n D, \n \n Renneville\n A, \n \n Hermitte\n F\n , et al. \n Real-time quantitative polymerase chain reaction detection of minimal residual disease by standardized WT1 assay to enhance risk stratification in acute myeloid leukemia: a European LeukemiaNet study. J Clin Oncol. 2009;27(31):5195\u20135201."},{"issue":"15","key":"i1543-2165-136-1-33-b04","series-title":"N Engl J Med","first-page":"1423","article-title":"Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia","volume":"349","author":"Hughes\n TP,","year":"2003","unstructured":"Hughes\n TP, \n \n Kaeda\n J, \n \n Branford\n S\n , et al. \n Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia. N Engl J Med. 2003;349(15):1423\u20131432."},{"issue":"23","key":"i1543-2165-136-1-33-b05","series-title":"N Engl J Med","first-page":"2408","article-title":"Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia","volume":"355","author":"Druker\n BJ,","year":"2006","unstructured":"Druker\n BJ, \n \n Guilhot\n F, \n \n O'Brien\n SG\n , et al. \n Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N Engl J Med. 2006;355(23):2408\u20132417."},{"issue":"5","key":"i1543-2165-136-1-33-b06","series-title":"Arch Pathol Lab Med","first-page":"743","article-title":"Recommended principles and practices for validating clinical molecular pathology tests","volume":"133","author":"Jennings\n L,","year":"2009","unstructured":"Jennings\n L, \n \n Van Deerlin\n VM, \n \n Gulley\n ML\n \n . Recommended principles and practices for validating clinical molecular pathology tests. Arch Pathol Lab Med. 2009;133(5):743\u2013755."},{"issue":"1","key":"i1543-2165-136-1-33-b07","series-title":"Blood","first-page":"28","article-title":"Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results","volume":"108","author":"Hughes\n T,","year":"2006","unstructured":"Hughes\n T, \n \n Deininger\n M, \n \n Hochhaus\n A\n , et al. \n Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results. Blood. 2006;108(1):28\u201337."},{"issue":"8","key":"i1543-2165-136-1-33-b08","series-title":"Am J Hematol","first-page":"517","article-title":"Technical aspects and clinical applications of measuring BCR-ABL1 transcripts number in chronic myeloid leukemia","volume":"84","author":"Foroni\n L,","year":"2009","unstructured":"Foroni\n L, \n \n Gerrard\n G, \n \n Nna\n E\n , et al. \n Technical aspects and clinical applications of measuring BCR-ABL1 transcripts number in chronic myeloid leukemia. Am J Hematol. 2009;84(8):517\u2013522."},{"issue":"4","key":"i1543-2165-136-1-33-b09","series-title":"J Mol Diagn","first-page":"421","article-title":"Inter-laboratory comparison of chronic myeloid leukemia minimal residual disease monitoring: summary and recommendations","volume":"9","author":"Zhang\n T,","year":"2007","unstructured":"Zhang\n T, \n \n Grenier\n S, \n \n Nwachukwu\n B, \n \n Wei\n C, \n \n Lipton\n JH, \n \n Kamel-Reid\n S\n \n . Inter-laboratory comparison of chronic myeloid leukemia minimal residual disease monitoring: summary and recommendations. J Mol Diagn. 2007;9(4):421\u2013430."},{"issue":"12","key":"i1543-2165-136-1-33-b10","series-title":"Leukemia","first-page":"2318","article-title":"Standardization and quality control studies of \u2018real-time\u2019 quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual disease detection in leukemia\u2014a Europe Against Cancer program","volume":"17","author":"Gabert\n J,","year":"2003","unstructured":"Gabert\n J, \n \n Beillard\n E, \n \n van der Velden\n VH\n , et al. \n Standardization and quality control studies of \u2018real-time\u2019 quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual disease detection in leukemia\u2014a Europe Against Cancer program. Leukemia. 2003;17(12):2318\u20132357."},{"issue":"3","key":"i1543-2165-136-1-33-b11","series-title":"J Mol Diagn","first-page":"385","article-title":"beta-Glucuronidase is an optimal normalization control gene for molecular monitoring of chronic myelogenous leukemia","volume":"8","author":"Lee\n JW,","year":"2006","unstructured":"Lee\n JW, \n \n Chen\n Q, \n \n Knowles\n DM, \n \n Cesarman\n E, \n \n Wang\n YL\n \n . beta-Glucuronidase is an optimal normalization control gene for molecular monitoring of chronic myelogenous leukemia. J Mol Diagn. 2006;8(3):385\u2013389."},{"issue":"12","key":"i1543-2165-136-1-33-b12","series-title":"Leukemia","first-page":"2474","article-title":"Evaluation of candidate control genes for diagnosis and residual disease detection in leukemic patients using \u2018real-time\u2019 quantitative reverse-transcriptase polymerase chain reaction (RQ-PCR)\u2014a Europe against cancer program","volume":"17","author":"Beillard\n E,","year":"2003","unstructured":"Beillard\n E, \n \n Pallisgaard\n N, \n \n van der Velden\n VH\n , et al. \n Evaluation of candidate control genes for diagnosis and residual disease detection in leukemic patients using \u2018real-time\u2019 quantitative reverse-transcriptase polymerase chain reaction (RQ-PCR)\u2014a Europe against cancer program. Leukemia. 2003;17(12):2474\u20132486."},{"issue":"4","key":"i1543-2165-136-1-33-b13","series-title":"Leuk Res","first-page":"483","article-title":"The effect of total-ABL, GUS and B2M control genes on BCR-ABL monitoring by real-time RT-PCR","volume":"31","author":"Rulcova\n J,","year":"2007","unstructured":"Rulcova\n J, \n \n Zmekova\n V, \n \n Zemanova\n Z, \n \n Klamova\n H, \n \n Moravcova\n J\n \n . The effect of total-ABL, GUS and B2M control genes on BCR-ABL monitoring by real-time RT-PCR. Leuk Res. 2007;31(4):483\u2013491."},{"issue":"1","key":"i1543-2165-136-1-33-b14","series-title":"Blood","first-page":"276","article-title":"Detection of BCR-ABL mutations in patients with CML treated with imatinib is virtually always accompanied by clinical resistance, and mutations in the ATP phosphate-binding loop (P-loop) are associated with a poor prognosis","volume":"102","author":"Branford\n S,","year":"2003","unstructured":"Branford\n S, \n \n Rudzki\n Z, \n \n Walsh\n S\n , et al. \n Detection of BCR-ABL mutations in patients with CML treated with imatinib is virtually always accompanied by clinical resistance, and mutations in the ATP phosphate-binding loop (P-loop) are associated with a poor prognosis. Blood. 2003;102(1):276\u2013283."},{"issue":"5","key":"i1543-2165-136-1-33-b15","series-title":"Int J Oncol","first-page":"1099","article-title":"Quantitative real-time RT-PCR monitoring of BCR-ABL in chronic myelogenous leukemia shows lack of agreement in blood and bone marrow samples","volume":"28","author":"Stock\n W,","year":"2006","unstructured":"Stock\n W, \n \n Yu\n D, \n \n Karrison\n T\n , et al. \n Quantitative real-time RT-PCR monitoring of BCR-ABL in chronic myelogenous leukemia shows lack of agreement in blood and bone marrow samples. Int J Oncol. 2006;28(5):1099\u20131103."},{"issue":"11","key":"i1543-2165-136-1-33-b16","series-title":"Leukemia","first-page":"1925","article-title":"Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia","volume":"20","author":"Branford\n S,","year":"2006","unstructured":"Branford\n S, \n \n Cross\n NC, \n \n Hochhaus\n A\n , et al. \n Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia. Leukemia. 2006;20(11):1925\u20131930."},{"issue":"4","key":"i1543-2165-136-1-33-b17","series-title":"Haemostasis","first-page":"271","article-title":"Standardization of the prothrombin time in oral anticoagulant control","volume":"15","author":"van den Besselaar\n AM","year":"1985","unstructured":"van den Besselaar\n AM\n \n . Standardization of the prothrombin time in oral anticoagulant control. 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Protocols for Determination of Limits of Detection and Limits of Quantitation: Approved Guideline. Wayne, PA: NCCLS; 2004. CLSI document EP17-A."},{"key":"i1543-2165-136-1-33-b23","series-title":"Statistique\u2014vocabulaire et symboles: Partie 1, Probabilite et termes statistique generaux [Statistics\u2014Vocabulary and Symbols: Part 1, Probability and General Statistical Terms]. 2nd ed","year":"2006","unstructured":"Statistique\u2014vocabulaire et symboles: Partie 1, Probabilite et termes statistique generaux [Statistics\u2014Vocabulary and Symbols: Part 1, Probability and General Statistical Terms]. 2nd ed. Geneva, Switzerland: ISO; 2006."},{"key":"i1543-2165-136-1-33-b24","series-title":"Preliminary Evaluation of Quantitative Clinical Laboratory Methods: Approved Guideline. 2nd ed","author":"Krouwer\n JS","year":"2002","unstructured":"Krouwer\n JS\n \n . Preliminary Evaluation of Quantitative Clinical Laboratory Methods: Approved Guideline. 2nd ed. Wayne, PA: NCCLS; 2002. 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Blood. 2008;112(8):3330\u20133338."},{"issue":"8","key":"i1543-2165-136-1-33-b28","series-title":"Blood","first-page":"3118","article-title":"Detection of major bcr-abl gene expression at a very low level in blood cells of some healthy individuals","volume":"86","author":"Biernaux\n C,","year":"1995","unstructured":"Biernaux\n C, \n \n Loos\n M, \n \n Sels\n A, \n \n Huez\n G, \n \n Stryckmans\n P\n \n . Detection of major bcr-abl gene expression at a very low level in blood cells of some healthy individuals. Blood. 1995;86(8):3118\u20133122."},{"issue":"9","key":"i1543-2165-136-1-33-b29","series-title":"Nucleic Acids Res","first-page":"e45","article-title":"A new mathematical model for relative quantification in real-time RT-PCR","volume":"29","author":"Pfaffl\n MW","year":"2001","unstructured":"Pfaffl\n MW\n \n . A new mathematical model for relative quantification in real-time RT-PCR. Nucleic Acids Res. 2001;29(9):e45."},{"issue":"6","key":"i1543-2165-136-1-33-b30","series-title":"Blood","first-page":"1809","article-title":"Evolving concepts in the management of chronic myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet","volume":"108","author":"Baccarani\n M,","year":"2006","unstructured":"Baccarani\n M, \n \n Saglio\n G, \n \n Goldman\n J\n , et al. \n Evolving concepts in the management of chronic myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet. 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J Clin Oncol. 2009;27(3):377\u2013384."},{"issue":"12","key":"i1543-2165-136-1-33-b02","series-title":"Blood","first-page":"5477","article-title":"Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study","volume":"111","author":"Borowitz\n MJ,","year":"2008","unstructured":"Borowitz\n MJ, \n \n Devidas\n M, \n \n Hunger\n SP\n , et al. \n Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study. 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J Clin Oncol. 2009;27(31):5195\u20135201."},{"issue":"15","key":"i1543-2165-136-1-33-b04","series-title":"N Engl J Med","first-page":"1423","article-title":"Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia","volume":"349","author":"Hughes\n TP,","year":"2003","unstructured":"Hughes\n TP, \n \n Kaeda\n J, \n \n Branford\n S\n , et al. \n Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia. 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Blood. 2006;108(1):28\u201337."},{"issue":"8","key":"i1543-2165-136-1-33-b08","series-title":"Am J Hematol","first-page":"517","article-title":"Technical aspects and clinical applications of measuring BCR-ABL1 transcripts number in chronic myeloid leukemia","volume":"84","author":"Foroni\n L,","year":"2009","unstructured":"Foroni\n L, \n \n Gerrard\n G, \n \n Nna\n E\n , et al. \n Technical aspects and clinical applications of measuring BCR-ABL1 transcripts number in chronic myeloid leukemia. Am J Hematol. 2009;84(8):517\u2013522."},{"issue":"4","key":"i1543-2165-136-1-33-b09","series-title":"J Mol Diagn","first-page":"421","article-title":"Inter-laboratory comparison of chronic myeloid leukemia minimal residual disease monitoring: summary and recommendations","volume":"9","author":"Zhang\n T,","year":"2007","unstructured":"Zhang\n T, \n \n Grenier\n S, \n \n Nwachukwu\n B, \n \n Wei\n C, \n \n Lipton\n JH, \n \n Kamel-Reid\n S\n \n . Inter-laboratory comparison of chronic myeloid leukemia minimal residual disease monitoring: summary and recommendations. J Mol Diagn. 2007;9(4):421\u2013430."},{"issue":"12","key":"i1543-2165-136-1-33-b10","series-title":"Leukemia","first-page":"2318","article-title":"Standardization and quality control studies of \u2018real-time\u2019 quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual disease detection in leukemia\u2014a Europe Against Cancer program","volume":"17","author":"Gabert\n J,","year":"2003","unstructured":"Gabert\n J, \n \n Beillard\n E, \n \n van der Velden\n VH\n , et al. \n Standardization and quality control studies of \u2018real-time\u2019 quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual disease detection in leukemia\u2014a Europe Against Cancer program. Leukemia. 2003;17(12):2318\u20132357."},{"issue":"3","key":"i1543-2165-136-1-33-b11","series-title":"J Mol Diagn","first-page":"385","article-title":"beta-Glucuronidase is an optimal normalization control gene for molecular monitoring of chronic myelogenous leukemia","volume":"8","author":"Lee\n JW,","year":"2006","unstructured":"Lee\n JW, \n \n Chen\n Q, \n \n Knowles\n DM, \n \n Cesarman\n E, \n \n Wang\n YL\n \n . beta-Glucuronidase is an optimal normalization control gene for molecular monitoring of chronic myelogenous leukemia. J Mol Diagn. 2006;8(3):385\u2013389."},{"issue":"12","key":"i1543-2165-136-1-33-b12","series-title":"Leukemia","first-page":"2474","article-title":"Evaluation of candidate control genes for diagnosis and residual disease detection in leukemic patients using \u2018real-time\u2019 quantitative reverse-transcriptase polymerase chain reaction (RQ-PCR)\u2014a Europe against cancer program","volume":"17","author":"Beillard\n E,","year":"2003","unstructured":"Beillard\n E, \n \n Pallisgaard\n N, \n \n van der Velden\n VH\n , et al. \n Evaluation of candidate control genes for diagnosis and residual disease detection in leukemic patients using \u2018real-time\u2019 quantitative reverse-transcriptase polymerase chain reaction (RQ-PCR)\u2014a Europe against cancer program. Leukemia. 2003;17(12):2474\u20132486."},{"issue":"4","key":"i1543-2165-136-1-33-b13","series-title":"Leuk Res","first-page":"483","article-title":"The effect of total-ABL, GUS and B2M control genes on BCR-ABL monitoring by real-time RT-PCR","volume":"31","author":"Rulcova\n J,","year":"2007","unstructured":"Rulcova\n J, \n \n Zmekova\n V, \n \n Zemanova\n Z, \n \n Klamova\n H, \n \n Moravcova\n J\n \n . The effect of total-ABL, GUS and B2M control genes on BCR-ABL monitoring by real-time RT-PCR. 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