Establishment of genomic RNA reference materials for BCR-ABL1 P210 measurement
Quantitation of BCR - ABL 1 with the quantitative reverse transcriptase polymerase chain reaction (RT-PCR) is very important in monitoring chronic myeloid leukemia (CML), which relies on an RNA reference material. A genomic RNA reference material (RM) containing the BCR - ABL 1 P210 fusion mutation...
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| Veröffentlicht in: | Analytical and bioanalytical chemistry 2024-11, Vol.416 (26), p.5733-5742 |
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| container_title | Analytical and bioanalytical chemistry |
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| creator | Yang, Yi Wang, Xia Niu, Chunyan Zhou, Shujun Gao, Huafang Jin, Xiaohua Wang, Shangjun Du, Meihong Cheng, Xiaoyan Zhu, Lingxiang Dong, Lianhua |
| description | Quantitation of
BCR
-
ABL
1 with the quantitative reverse transcriptase polymerase chain reaction (RT-PCR) is very important in monitoring chronic myeloid leukemia (CML), which relies on an RNA reference material. A genomic RNA reference material (RM) containing the
BCR
-
ABL
1 P210 fusion mutation was developed, and an absolute quantitative method based on one-step reverse transcription digital PCR (RT-dPCR) was established for characterizing the RM. The proposed dPCR method demonstrates high accuracy and excellent analytical sensitivity, as shown by the linear relationship (0.94 |
| doi_str_mv | 10.1007/s00216-024-05492-6 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3102469855</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3118936008</sourcerecordid><originalsourceid>FETCH-LOGICAL-c256t-3cc44377cacb2c0b7d252bb3afa3717087dcd901ec12f086454edb6b45d6fa243</originalsourceid><addsrcrecordid>eNp9kLtOwzAUQC0EgvL4AQZkiYUlcP1MMrZVeUgVoApmy3FuIFWTFDsZ-HsMLSAxMNmSzz22DyGnDC4ZQHoVADjTCXCZgJI5T_QOGTHNsoRrBbs_e8kPyGEISwCmMqb3yYHIuWKS6xG5n4XeFqs6vDbY9rSr6Au2XVM7urgfU48Vemwd0sb26Gu7CrTqPJ1MF8l4Mmf0kTOgDdowePwUHJO9KkJ4sl2PyPP17Gl6m8wfbu6m43niuNJ9IpyTUqSps67gDoq05IoXhbCVFSlLIUtLV-bA0DFeQaalklgWupCq1JXlUhyRi4137bu3AUNvmjo4XK1si90QjGCxis4zpSJ6_gdddoNv4-sixbJcaIAsUnxDOd-FEP9t1r5urH83DMxnbbOpbaLXfNU2Og6dbdVD0WD5M_KdNwJiA4R41L6g_737H-0HfyiH3w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3118936008</pqid></control><display><type>article</type><title>Establishment of genomic RNA reference materials for BCR-ABL1 P210 measurement</title><source>SpringerLink Journals - AutoHoldings</source><creator>Yang, Yi ; Wang, Xia ; Niu, Chunyan ; Zhou, Shujun ; Gao, Huafang ; Jin, Xiaohua ; Wang, Shangjun ; Du, Meihong ; Cheng, Xiaoyan ; Zhu, Lingxiang ; Dong, Lianhua</creator><creatorcontrib>Yang, Yi ; Wang, Xia ; Niu, Chunyan ; Zhou, Shujun ; Gao, Huafang ; Jin, Xiaohua ; Wang, Shangjun ; Du, Meihong ; Cheng, Xiaoyan ; Zhu, Lingxiang ; Dong, Lianhua</creatorcontrib><description>Quantitation of
BCR
-
ABL
1 with the quantitative reverse transcriptase polymerase chain reaction (RT-PCR) is very important in monitoring chronic myeloid leukemia (CML), which relies on an RNA reference material. A genomic RNA reference material (RM) containing the
BCR
-
ABL
1 P210 fusion mutation was developed, and an absolute quantitative method based on one-step reverse transcription digital PCR (RT-dPCR) was established for characterizing the RM. The proposed dPCR method demonstrates high accuracy and excellent analytical sensitivity, as shown by the linear relationship (0.94 < slope < 1.04, R
2
≧0.99) between the measured and nominal values of b2a2, b3a2, and
ABL
1-ref within the dynamic range (10
4
–10
1
copies/reaction). Homogeneity and stability assessment based on dPCR indicated that the RM was homogeneous and stable for 24 months at −80 °C. The RM was used to evaluate inter-laboratory reproducibility in eight different laboratories, demonstrating that participating laboratories could consistently produce copy concentrations of b3a2 and
ABL
1-ref, as well as the
BCR
-
ABL
1/
ABL
1 ratio (CV < 2.0%). This work suggests that the RM can be employed in establishing metrological traceability for detecting mutations in the
BCR
-
ABL
1 fusion gene, as well as in quality control for testing laboratories.
Graphical Abstract</description><identifier>ISSN: 1618-2642</identifier><identifier>ISSN: 1618-2650</identifier><identifier>EISSN: 1618-2650</identifier><identifier>DOI: 10.1007/s00216-024-05492-6</identifier><identifier>PMID: 39251426</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Analytical Chemistry ; Biochemistry ; Characterization and Evaluation of Materials ; Chemistry ; Chemistry and Materials Science ; Chronic myeloid leukemia ; Food Science ; Fusion protein ; Gene fusion ; Genomics ; Homogeneity ; Laboratories ; Laboratory Medicine ; Leukemia ; Monitoring/Environmental Analysis ; Mutation ; Myeloid leukemia ; Polymerase chain reaction ; Quality control ; Quantitative analysis ; Reference materials ; Research Paper ; Reverse transcription ; Ribonucleic acid ; RNA ; RNA-directed DNA polymerase ; Testing laboratories</subject><ispartof>Analytical and bioanalytical chemistry, 2024-11, Vol.416 (26), p.5733-5742</ispartof><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2024. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c256t-3cc44377cacb2c0b7d252bb3afa3717087dcd901ec12f086454edb6b45d6fa243</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00216-024-05492-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00216-024-05492-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39251426$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yang, Yi</creatorcontrib><creatorcontrib>Wang, Xia</creatorcontrib><creatorcontrib>Niu, Chunyan</creatorcontrib><creatorcontrib>Zhou, Shujun</creatorcontrib><creatorcontrib>Gao, Huafang</creatorcontrib><creatorcontrib>Jin, Xiaohua</creatorcontrib><creatorcontrib>Wang, Shangjun</creatorcontrib><creatorcontrib>Du, Meihong</creatorcontrib><creatorcontrib>Cheng, Xiaoyan</creatorcontrib><creatorcontrib>Zhu, Lingxiang</creatorcontrib><creatorcontrib>Dong, Lianhua</creatorcontrib><title>Establishment of genomic RNA reference materials for BCR-ABL1 P210 measurement</title><title>Analytical and bioanalytical chemistry</title><addtitle>Anal Bioanal Chem</addtitle><addtitle>Anal Bioanal Chem</addtitle><description>Quantitation of
BCR
-
ABL
1 with the quantitative reverse transcriptase polymerase chain reaction (RT-PCR) is very important in monitoring chronic myeloid leukemia (CML), which relies on an RNA reference material. A genomic RNA reference material (RM) containing the
BCR
-
ABL
1 P210 fusion mutation was developed, and an absolute quantitative method based on one-step reverse transcription digital PCR (RT-dPCR) was established for characterizing the RM. The proposed dPCR method demonstrates high accuracy and excellent analytical sensitivity, as shown by the linear relationship (0.94 < slope < 1.04, R
2
≧0.99) between the measured and nominal values of b2a2, b3a2, and
ABL
1-ref within the dynamic range (10
4
–10
1
copies/reaction). Homogeneity and stability assessment based on dPCR indicated that the RM was homogeneous and stable for 24 months at −80 °C. The RM was used to evaluate inter-laboratory reproducibility in eight different laboratories, demonstrating that participating laboratories could consistently produce copy concentrations of b3a2 and
ABL
1-ref, as well as the
BCR
-
ABL
1/
ABL
1 ratio (CV < 2.0%). This work suggests that the RM can be employed in establishing metrological traceability for detecting mutations in the
BCR
-
ABL
1 fusion gene, as well as in quality control for testing laboratories.
Graphical Abstract</description><subject>Analytical Chemistry</subject><subject>Biochemistry</subject><subject>Characterization and Evaluation of Materials</subject><subject>Chemistry</subject><subject>Chemistry and Materials Science</subject><subject>Chronic myeloid leukemia</subject><subject>Food Science</subject><subject>Fusion protein</subject><subject>Gene fusion</subject><subject>Genomics</subject><subject>Homogeneity</subject><subject>Laboratories</subject><subject>Laboratory Medicine</subject><subject>Leukemia</subject><subject>Monitoring/Environmental Analysis</subject><subject>Mutation</subject><subject>Myeloid leukemia</subject><subject>Polymerase chain reaction</subject><subject>Quality control</subject><subject>Quantitative analysis</subject><subject>Reference materials</subject><subject>Research Paper</subject><subject>Reverse transcription</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>RNA-directed DNA polymerase</subject><subject>Testing laboratories</subject><issn>1618-2642</issn><issn>1618-2650</issn><issn>1618-2650</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9kLtOwzAUQC0EgvL4AQZkiYUlcP1MMrZVeUgVoApmy3FuIFWTFDsZ-HsMLSAxMNmSzz22DyGnDC4ZQHoVADjTCXCZgJI5T_QOGTHNsoRrBbs_e8kPyGEISwCmMqb3yYHIuWKS6xG5n4XeFqs6vDbY9rSr6Au2XVM7urgfU48Vemwd0sb26Gu7CrTqPJ1MF8l4Mmf0kTOgDdowePwUHJO9KkJ4sl2PyPP17Gl6m8wfbu6m43niuNJ9IpyTUqSps67gDoq05IoXhbCVFSlLIUtLV-bA0DFeQaalklgWupCq1JXlUhyRi4137bu3AUNvmjo4XK1si90QjGCxis4zpSJ6_gdddoNv4-sixbJcaIAsUnxDOd-FEP9t1r5urH83DMxnbbOpbaLXfNU2Og6dbdVD0WD5M_KdNwJiA4R41L6g_737H-0HfyiH3w</recordid><startdate>20241101</startdate><enddate>20241101</enddate><creator>Yang, Yi</creator><creator>Wang, Xia</creator><creator>Niu, Chunyan</creator><creator>Zhou, Shujun</creator><creator>Gao, Huafang</creator><creator>Jin, Xiaohua</creator><creator>Wang, Shangjun</creator><creator>Du, Meihong</creator><creator>Cheng, Xiaoyan</creator><creator>Zhu, Lingxiang</creator><creator>Dong, Lianhua</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QF</scope><scope>7QO</scope><scope>7QQ</scope><scope>7SC</scope><scope>7SE</scope><scope>7SP</scope><scope>7SR</scope><scope>7TA</scope><scope>7TB</scope><scope>7U5</scope><scope>7U7</scope><scope>8BQ</scope><scope>8FD</scope><scope>C1K</scope><scope>F28</scope><scope>FR3</scope><scope>H8D</scope><scope>H8G</scope><scope>JG9</scope><scope>JQ2</scope><scope>K9.</scope><scope>KR7</scope><scope>L7M</scope><scope>L~C</scope><scope>L~D</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20241101</creationdate><title>Establishment of genomic RNA reference materials for BCR-ABL1 P210 measurement</title><author>Yang, Yi ; Wang, Xia ; Niu, Chunyan ; Zhou, Shujun ; Gao, Huafang ; Jin, Xiaohua ; Wang, Shangjun ; Du, Meihong ; Cheng, Xiaoyan ; Zhu, Lingxiang ; Dong, Lianhua</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c256t-3cc44377cacb2c0b7d252bb3afa3717087dcd901ec12f086454edb6b45d6fa243</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Analytical Chemistry</topic><topic>Biochemistry</topic><topic>Characterization and Evaluation of Materials</topic><topic>Chemistry</topic><topic>Chemistry and Materials Science</topic><topic>Chronic myeloid leukemia</topic><topic>Food Science</topic><topic>Fusion protein</topic><topic>Gene fusion</topic><topic>Genomics</topic><topic>Homogeneity</topic><topic>Laboratories</topic><topic>Laboratory Medicine</topic><topic>Leukemia</topic><topic>Monitoring/Environmental Analysis</topic><topic>Mutation</topic><topic>Myeloid leukemia</topic><topic>Polymerase chain reaction</topic><topic>Quality control</topic><topic>Quantitative analysis</topic><topic>Reference materials</topic><topic>Research Paper</topic><topic>Reverse transcription</topic><topic>Ribonucleic acid</topic><topic>RNA</topic><topic>RNA-directed DNA polymerase</topic><topic>Testing laboratories</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yang, Yi</creatorcontrib><creatorcontrib>Wang, Xia</creatorcontrib><creatorcontrib>Niu, Chunyan</creatorcontrib><creatorcontrib>Zhou, Shujun</creatorcontrib><creatorcontrib>Gao, Huafang</creatorcontrib><creatorcontrib>Jin, Xiaohua</creatorcontrib><creatorcontrib>Wang, Shangjun</creatorcontrib><creatorcontrib>Du, Meihong</creatorcontrib><creatorcontrib>Cheng, Xiaoyan</creatorcontrib><creatorcontrib>Zhu, Lingxiang</creatorcontrib><creatorcontrib>Dong, Lianhua</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Aluminium Industry Abstracts</collection><collection>Biotechnology Research Abstracts</collection><collection>Ceramic Abstracts</collection><collection>Computer and Information Systems Abstracts</collection><collection>Corrosion Abstracts</collection><collection>Electronics & Communications Abstracts</collection><collection>Engineered Materials Abstracts</collection><collection>Materials Business File</collection><collection>Mechanical & Transportation Engineering Abstracts</collection><collection>Solid State and Superconductivity Abstracts</collection><collection>Toxicology Abstracts</collection><collection>METADEX</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ANTE: Abstracts in New Technology & Engineering</collection><collection>Engineering Research Database</collection><collection>Aerospace Database</collection><collection>Copper Technical Reference Library</collection><collection>Materials Research Database</collection><collection>ProQuest Computer Science Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Civil Engineering Abstracts</collection><collection>Advanced Technologies Database with Aerospace</collection><collection>Computer and Information Systems Abstracts Academic</collection><collection>Computer and Information Systems Abstracts Professional</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Analytical and bioanalytical chemistry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yang, Yi</au><au>Wang, Xia</au><au>Niu, Chunyan</au><au>Zhou, Shujun</au><au>Gao, Huafang</au><au>Jin, Xiaohua</au><au>Wang, Shangjun</au><au>Du, Meihong</au><au>Cheng, Xiaoyan</au><au>Zhu, Lingxiang</au><au>Dong, Lianhua</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Establishment of genomic RNA reference materials for BCR-ABL1 P210 measurement</atitle><jtitle>Analytical and bioanalytical chemistry</jtitle><stitle>Anal Bioanal Chem</stitle><addtitle>Anal Bioanal Chem</addtitle><date>2024-11-01</date><risdate>2024</risdate><volume>416</volume><issue>26</issue><spage>5733</spage><epage>5742</epage><pages>5733-5742</pages><issn>1618-2642</issn><issn>1618-2650</issn><eissn>1618-2650</eissn><abstract>Quantitation of
BCR
-
ABL
1 with the quantitative reverse transcriptase polymerase chain reaction (RT-PCR) is very important in monitoring chronic myeloid leukemia (CML), which relies on an RNA reference material. A genomic RNA reference material (RM) containing the
BCR
-
ABL
1 P210 fusion mutation was developed, and an absolute quantitative method based on one-step reverse transcription digital PCR (RT-dPCR) was established for characterizing the RM. The proposed dPCR method demonstrates high accuracy and excellent analytical sensitivity, as shown by the linear relationship (0.94 < slope < 1.04, R
2
≧0.99) between the measured and nominal values of b2a2, b3a2, and
ABL
1-ref within the dynamic range (10
4
–10
1
copies/reaction). Homogeneity and stability assessment based on dPCR indicated that the RM was homogeneous and stable for 24 months at −80 °C. The RM was used to evaluate inter-laboratory reproducibility in eight different laboratories, demonstrating that participating laboratories could consistently produce copy concentrations of b3a2 and
ABL
1-ref, as well as the
BCR
-
ABL
1/
ABL
1 ratio (CV < 2.0%). This work suggests that the RM can be employed in establishing metrological traceability for detecting mutations in the
BCR
-
ABL
1 fusion gene, as well as in quality control for testing laboratories.
Graphical Abstract</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>39251426</pmid><doi>10.1007/s00216-024-05492-6</doi><tpages>10</tpages></addata></record> |
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| subjects | Analytical Chemistry Biochemistry Characterization and Evaluation of Materials Chemistry Chemistry and Materials Science Chronic myeloid leukemia Food Science Fusion protein Gene fusion Genomics Homogeneity Laboratories Laboratory Medicine Leukemia Monitoring/Environmental Analysis Mutation Myeloid leukemia Polymerase chain reaction Quality control Quantitative analysis Reference materials Research Paper Reverse transcription Ribonucleic acid RNA RNA-directed DNA polymerase Testing laboratories |
| title | Establishment of genomic RNA reference materials for BCR-ABL1 P210 measurement |
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