DEVELOPMENT OF INTERNATIONAL SCALE SECONDARY STANDARDS FOR BCR-ABL1 TRANSCRIPT QUANTITATIVE ASSAY
(Abstract release date: 05/19/16)
EHA Library. Day G. 06/09/16; 134736; PB1836
Dr. Gwo-Jen Day
Contributions
Contributions
Abstract
Abstract: PB1836
Type: Publication Only
Background
Presence of fusion gene BCR-ABL1 is indicative of chronic myelogenous leukemia. Quantitative assay of BCR-ABL1 transcript in patient blood can measure response to therapy. Harmonization of BCR-ABL1 transcript assay results among laboratories is needed in order to standardize clinical reporting. In 2009 the World Health Organization (WHO) developed a panel of four BCR-ABL1 primary standards to calibrate secondary standards and to establish an international scale (IS) for reporting assay results as a ratio of fusion transcript to control gene transcript (%IS). Reliable secondary standards are essential for monitoring performance of BCR-ABL1 quantitative assays.
Aims
This study creates a panel of BCR-ABL1 secondary standards, based on the WHO primary standards, for use with Xpert BCR-ABL Monitor assay (Cepheid).
Methods
Maine Molecular Quality Controls, Inc. (MMQCI) manufactured a panel of four secondary standards consisting of BCR-ABL1 b3a2 fusion transcript and ABL1 control gene transcript in a proprietary stabilizing matrix. Transcript ratios were calibrated to yield the same %IS results as the four WHO primary standards: approximately 0.01%IS, 0.1%IS, 1%IS, and 10%IS. Three lots of MMQCI panels were tested on one lot of Xpert BCR-ABL Monitor contemporaneous with testing WHO primary standards.
Results
Three unique lots of MMQCI secondary standards panels yielded quantitative results in good agreement with one another and with the WHO primary standards panel at each of the four %IS levels. MMQCI secondary standards panels demonstrated linearity across the range of %IS levels, comparable to linearity of WHO primary standards.
Conclusion
MMQCI’s BCR-ABL1 secondary standards panel shows potential for verifying performance of Xpert BCR-ABL Monitor, thereby contributing to harmonization of minimal residual disease (MRD) measurements to the International Scale. This approach to creating standards secondary to WHO primary standards serves as a model for creation of secondary standards for Xpert BCR-ABL Ultra (Cepheid).
Session topic: E-poster
Keyword(s): BCR-ABL, Monitor, Quantitative RT-PCR, Standardization
Type: Publication Only
Background
Presence of fusion gene BCR-ABL1 is indicative of chronic myelogenous leukemia. Quantitative assay of BCR-ABL1 transcript in patient blood can measure response to therapy. Harmonization of BCR-ABL1 transcript assay results among laboratories is needed in order to standardize clinical reporting. In 2009 the World Health Organization (WHO) developed a panel of four BCR-ABL1 primary standards to calibrate secondary standards and to establish an international scale (IS) for reporting assay results as a ratio of fusion transcript to control gene transcript (%IS). Reliable secondary standards are essential for monitoring performance of BCR-ABL1 quantitative assays.
Aims
This study creates a panel of BCR-ABL1 secondary standards, based on the WHO primary standards, for use with Xpert BCR-ABL Monitor assay (Cepheid).
Methods
Maine Molecular Quality Controls, Inc. (MMQCI) manufactured a panel of four secondary standards consisting of BCR-ABL1 b3a2 fusion transcript and ABL1 control gene transcript in a proprietary stabilizing matrix. Transcript ratios were calibrated to yield the same %IS results as the four WHO primary standards: approximately 0.01%IS, 0.1%IS, 1%IS, and 10%IS. Three lots of MMQCI panels were tested on one lot of Xpert BCR-ABL Monitor contemporaneous with testing WHO primary standards.
Results
Three unique lots of MMQCI secondary standards panels yielded quantitative results in good agreement with one another and with the WHO primary standards panel at each of the four %IS levels. MMQCI secondary standards panels demonstrated linearity across the range of %IS levels, comparable to linearity of WHO primary standards.
Conclusion
MMQCI’s BCR-ABL1 secondary standards panel shows potential for verifying performance of Xpert BCR-ABL Monitor, thereby contributing to harmonization of minimal residual disease (MRD) measurements to the International Scale. This approach to creating standards secondary to WHO primary standards serves as a model for creation of secondary standards for Xpert BCR-ABL Ultra (Cepheid).
Session topic: E-poster
Keyword(s): BCR-ABL, Monitor, Quantitative RT-PCR, Standardization
Abstract: PB1836
Type: Publication Only
Background
Presence of fusion gene BCR-ABL1 is indicative of chronic myelogenous leukemia. Quantitative assay of BCR-ABL1 transcript in patient blood can measure response to therapy. Harmonization of BCR-ABL1 transcript assay results among laboratories is needed in order to standardize clinical reporting. In 2009 the World Health Organization (WHO) developed a panel of four BCR-ABL1 primary standards to calibrate secondary standards and to establish an international scale (IS) for reporting assay results as a ratio of fusion transcript to control gene transcript (%IS). Reliable secondary standards are essential for monitoring performance of BCR-ABL1 quantitative assays.
Aims
This study creates a panel of BCR-ABL1 secondary standards, based on the WHO primary standards, for use with Xpert BCR-ABL Monitor assay (Cepheid).
Methods
Maine Molecular Quality Controls, Inc. (MMQCI) manufactured a panel of four secondary standards consisting of BCR-ABL1 b3a2 fusion transcript and ABL1 control gene transcript in a proprietary stabilizing matrix. Transcript ratios were calibrated to yield the same %IS results as the four WHO primary standards: approximately 0.01%IS, 0.1%IS, 1%IS, and 10%IS. Three lots of MMQCI panels were tested on one lot of Xpert BCR-ABL Monitor contemporaneous with testing WHO primary standards.
Results
Three unique lots of MMQCI secondary standards panels yielded quantitative results in good agreement with one another and with the WHO primary standards panel at each of the four %IS levels. MMQCI secondary standards panels demonstrated linearity across the range of %IS levels, comparable to linearity of WHO primary standards.
Conclusion
MMQCI’s BCR-ABL1 secondary standards panel shows potential for verifying performance of Xpert BCR-ABL Monitor, thereby contributing to harmonization of minimal residual disease (MRD) measurements to the International Scale. This approach to creating standards secondary to WHO primary standards serves as a model for creation of secondary standards for Xpert BCR-ABL Ultra (Cepheid).
Session topic: E-poster
Keyword(s): BCR-ABL, Monitor, Quantitative RT-PCR, Standardization
Type: Publication Only
Background
Presence of fusion gene BCR-ABL1 is indicative of chronic myelogenous leukemia. Quantitative assay of BCR-ABL1 transcript in patient blood can measure response to therapy. Harmonization of BCR-ABL1 transcript assay results among laboratories is needed in order to standardize clinical reporting. In 2009 the World Health Organization (WHO) developed a panel of four BCR-ABL1 primary standards to calibrate secondary standards and to establish an international scale (IS) for reporting assay results as a ratio of fusion transcript to control gene transcript (%IS). Reliable secondary standards are essential for monitoring performance of BCR-ABL1 quantitative assays.
Aims
This study creates a panel of BCR-ABL1 secondary standards, based on the WHO primary standards, for use with Xpert BCR-ABL Monitor assay (Cepheid).
Methods
Maine Molecular Quality Controls, Inc. (MMQCI) manufactured a panel of four secondary standards consisting of BCR-ABL1 b3a2 fusion transcript and ABL1 control gene transcript in a proprietary stabilizing matrix. Transcript ratios were calibrated to yield the same %IS results as the four WHO primary standards: approximately 0.01%IS, 0.1%IS, 1%IS, and 10%IS. Three lots of MMQCI panels were tested on one lot of Xpert BCR-ABL Monitor contemporaneous with testing WHO primary standards.
Results
Three unique lots of MMQCI secondary standards panels yielded quantitative results in good agreement with one another and with the WHO primary standards panel at each of the four %IS levels. MMQCI secondary standards panels demonstrated linearity across the range of %IS levels, comparable to linearity of WHO primary standards.
Conclusion
MMQCI’s BCR-ABL1 secondary standards panel shows potential for verifying performance of Xpert BCR-ABL Monitor, thereby contributing to harmonization of minimal residual disease (MRD) measurements to the International Scale. This approach to creating standards secondary to WHO primary standards serves as a model for creation of secondary standards for Xpert BCR-ABL Ultra (Cepheid).
Session topic: E-poster
Keyword(s): BCR-ABL, Monitor, Quantitative RT-PCR, Standardization
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