Article(id=1320389027946156470, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388968923902012, articleNumber=null, orderNo=null, doi=10.11876/mimt202505009, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1792734875904, onlineDateStr=2026-10-23, pubDate=1760025600000, pubDateStr=2025-10-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792734875904, onlineIssueDateStr=2026-10-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792734875904, creator=13701087609, updateTime=1792734875904, updator=13701087609, issue=Issue{id=1320388968923902012, tenantId=1146029695717560320, journalId=1319373289681944729, year='2025', volume='31', issue='5', pageStart='1', pageEnd='108', issueExtLink='null', onlineDate='null', pubDate='1760025600000', pubDateStr='2025-10-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792734861832, creator='13701087609', updateTime=1792746392297, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1320437331253900271, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388968923902012, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1320437331253900272, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388968923902012, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=58, endPage=63, ext={EN=ArticleExt(id=1320389028222980535, articleId=1320389027946156470, tenantId=1146029695717560320, journalId=1319373289681944729, language=EN, title=Calibration and post-calibration verification protocol for SYSMEX XN-3000 automated hematology analyzer, columnId=null, journalTitle=Modern Instruments & Medical Treatment, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective

To establish a comprehensive quality management system based on ISO 15189, performing calibration and post-calibration verification for the SYSMEX XN-3000 automated hematology analyzer system, ensuring compliance with routine laboratory testing requirements and ISO 15189 accreditation.

Methods

Following established calibration and post-calibration verification protocols for the SYSMEX XN-3000 automated hematology analyzer—based on WS/T 347—2024 Guidelines for Calibration of Blood Cell Analyzers, WS/T 406—2024 Quality Standards for Common Clinical Hematology Testing Items, CNAS-CL02: 2023 Accreditation Criteria for Quality and Competence of Medical Laboratories, CNAS-CL02-A001: 2023 Application Requirements for the Accreditation of Medical Laboratories and SYSMEX XN-3000 Instrument Operation Manua, the SYSMEX XN-3000 automated hematology analyzer was calibrated. Before calibration, it's necessary to confirm that the instrument's working environment and performance requirements comply with standards. Post-calibration verification was conducted for eight key hematological parameters: WBC, RBC, Hb, Hct, Plt, MCV, MCH, and MCHC. Verification methods included quality control testing and evaluation across different sampling modes.

Results

The SYSMEX XN-3000 automated hematology analyzer passed calibration, and post-calibration validation was successful, confirming its suitability for clinical testing within the defined calibration interval.

Conclusion

The SYSMEX XN-3000 automated hematology analyzer met calibration standards and post-calibration verification requirements, fulfilling the demands of clinical hematology laboratories and satisfying the instrument calibration requirements for ISO 15189 accreditation.

, authors=Rongqin Xu, Yuquan Shi, Dongye Wang, Yanzhong Zhu, Jie Li*, authorsList=Rongqin Xu, Yuquan Shi, Dongye Wang, Yanzhong Zhu, Jie Li, authorCompany=null, correspAuthors=Jie Li, authorNote=null, correspAuthorsNote=null, copyrightStatement=All copyrights in 2025 belong to the sponsor of the journal.Not content published by the journal may be reproduced or abridged without authorization., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1320389029103784376, articleId=1320389027946156470, tenantId=1146029695717560320, journalId=1319373289681944729, language=CN, title=SYSMEX XN-3000全自动血液分析仪的校准及校准后验证方案应用, columnId=1320381056239387017, journalTitle=现代仪器与医疗, columnName=医学工程, runingTitle=null, highlight=null, articleAbstract=
目的

基于ISO 15189建立全面质量管理体系,对SYSMEX XN-3000全自动血液分析仪检测系统进行校准及校准后验证,为满足日常检验工作及ISO 15189认可需求提供保障。

方法

按照WS/T 347—2024《血细胞分析校准指南》、WS/T 406—2024《临床血液检验常用项目分析质量标准》、CNAS-CL02:2023《医学实验室质量和能力认可准则》、CNAS-CL02-A001:2023《医学实验室质量和能力认可准则的应用要求》、SYSMEX XN-3000仪器操作手册等建立SYSMEX XN-3000全自动血液分析仪校准及校准后验证程序,对SYSMEX XN-3000全自动血液分析仪进行校准,校准前需确认仪器工作环境和性能要求符合标准,校准后针对白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、血细胞比容(Hct)、血小板(Plt)、平均红细胞体积(MCV)、平均红细胞血红蛋白含量(MCH)、平均红细胞血红蛋白浓度(MCHC)8个主要检测项目进行校准后验证,包括质控检测、不同吸样模式检测等。

结果

SYSMEX XN-3000全自动血液分析仪校准合格,校准后验证通过,在规定校准周期内可进行相关检测。

结论

SYSMEX XN-3000全自动血液分析仪达到了临床血液实验室要求,满足ISO 15189认可关于仪器校准的要求。

, authors=许荣琴, 施玉泉, 汪东烨, 朱燕忠, 李洁*, authorsList=许荣琴, 施玉泉, 汪东烨, 朱燕忠, 李洁, authorCompany=null, correspAuthors=李洁, authorNote=

许荣琴,女,本科,主管技师,研究方向:临床血液体液检验

, correspAuthorsNote=
李洁,女,本科,主管技师,研究方向:临床生化免疫检验
, copyrightStatement=2025年版权归本刊主办单位所有未经本刊书面许可, 不得转载、摘编本刊所有文章内容。, copyrightOwner=中国科学器材公司, extLink=null, articleAbsUrl=null, sourceXml=WEBMN98RB3WOoigQXdFoJQ==, magXml=jD197cFomHqatktoE+g/kQ==, pdfUrl=null, pdf=mJLtollHhzV/9Loi65k1TQ==, pdfFileSize=1592466, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=sldYeZ9A0RQpftBPmdVe3w==, mapNumber=null, fund=null)}, authors=[Author(id=1320389029942645181, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389027946156470, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1320389030055891391, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389027946156470, authorId=1320389029942645181, language=EN, stringName=Rongqin Xu, firstName=Rongqin, middleName=null, lastName=Xu, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Department of Clinical Laboratory, Taihu Rehabilitation Hospital of Jiangsu Province, Wuxi 214086, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1320389030320132544, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389027946156470, authorId=1320389029942645181, language=CN, stringName=许荣琴, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=江苏省太湖康复医院检验科,无锡 214086, bio={"content":"

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(2024-04-02) [2025-07-29]. https://www.nhc.gov.cn/wjw/s9492/202404/47c19ec2a3c249f7862bc67e0f787e56/files/1739781662686_47753.pdf., articleTitle=null, refAbstract=null), Reference(id=1320389036317987296, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389027946156470, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=中华人民共和国国家卫生健康委员会. 临床血液检验常用项目分析质量标准: WS/T 406—2024[S/OL]. (2024-05-09). [2025-07-29]. https://www.nhc.gov.cn/wjw/s9492/202407/0f555e069dca439c8982b8583ce4da7d/files/1739781690556_81927.pdf., articleTitle=null, refAbstract=null), Reference(id=1320389036380901857, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389027946156470, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=SYSMEX. XN-3000 brochure[EB/OL]. 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(2022-11-02) [2025-07-29]. https://www.nhc.gov.cn/wjw/s9492/202211/141c88c070474ecf866582532b71d329/files/1739781651907_95419.pdf., articleTitle=null, refAbstract=null), Reference(id=1320389036552868323, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389027946156470, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=谢楠, 杨斯桀, 刘丽萍, 等. 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(2012-12-25) [2025-07-29]. https://www.nhc.gov.cn/wjw/s9492/201301/6cdf57d92f6a4250847ba532df5ed488/files/1739781485245_84960.pdf., articleTitle=null, refAbstract=null), Reference(id=1320389036695474661, tenantId=1146029695717560320, journalId=1319373289681944729, articleId=1320389027946156470, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=中国合格评定国家认可委员会. 医学实验室定量检验程序结果可比性验证指南: CNAS-GL047: 2021[S/OL]. 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SYSMEX XN-3000全自动血液分析仪的校准及校准后验证方案应用
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许荣琴 , 施玉泉 , 汪东烨 , 朱燕忠 , 李洁 *
现代仪器与医疗 | 医学工程 2025,31(5): 58-63
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现代仪器与医疗 |医学工程 2025 , 31 (5) : 58 -63
SYSMEX XN-3000全自动血液分析仪的校准及校准后验证方案应用
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许荣琴, 施玉泉, 汪东烨, 朱燕忠, 李洁*
作者信息
  • 江苏省太湖康复医院检验科,无锡 214086
通讯作者:
李洁,女,本科,主管技师,研究方向:临床生化免疫检验
作者简介:

许荣琴,女,本科,主管技师,研究方向:临床血液体液检验

Calibration and post-calibration verification protocol for SYSMEX XN-3000 automated hematology analyzer
Rongqin Xu, Yuquan Shi, Dongye Wang, Yanzhong Zhu, Jie Li*
Affiliations
  • Department of Clinical Laboratory, Taihu Rehabilitation Hospital of Jiangsu Province, Wuxi 214086, China
出版时间: 2025-10-10 doi: 10.11876/mimt202505009
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目的

基于ISO 15189建立全面质量管理体系,对SYSMEX XN-3000全自动血液分析仪检测系统进行校准及校准后验证,为满足日常检验工作及ISO 15189认可需求提供保障。

方法

按照WS/T 347—2024《血细胞分析校准指南》、WS/T 406—2024《临床血液检验常用项目分析质量标准》、CNAS-CL02:2023《医学实验室质量和能力认可准则》、CNAS-CL02-A001:2023《医学实验室质量和能力认可准则的应用要求》、SYSMEX XN-3000仪器操作手册等建立SYSMEX XN-3000全自动血液分析仪校准及校准后验证程序,对SYSMEX XN-3000全自动血液分析仪进行校准,校准前需确认仪器工作环境和性能要求符合标准,校准后针对白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、血细胞比容(Hct)、血小板(Plt)、平均红细胞体积(MCV)、平均红细胞血红蛋白含量(MCH)、平均红细胞血红蛋白浓度(MCHC)8个主要检测项目进行校准后验证,包括质控检测、不同吸样模式检测等。

结果

SYSMEX XN-3000全自动血液分析仪校准合格,校准后验证通过,在规定校准周期内可进行相关检测。

结论

SYSMEX XN-3000全自动血液分析仪达到了临床血液实验室要求,满足ISO 15189认可关于仪器校准的要求。

ISO 15189  /  质量管理体系  /  全自动血液分析仪  /  校准  /  校准后验证
Objective

To establish a comprehensive quality management system based on ISO 15189, performing calibration and post-calibration verification for the SYSMEX XN-3000 automated hematology analyzer system, ensuring compliance with routine laboratory testing requirements and ISO 15189 accreditation.

Methods

Following established calibration and post-calibration verification protocols for the SYSMEX XN-3000 automated hematology analyzer—based on WS/T 347—2024 Guidelines for Calibration of Blood Cell Analyzers, WS/T 406—2024 Quality Standards for Common Clinical Hematology Testing Items, CNAS-CL02: 2023 Accreditation Criteria for Quality and Competence of Medical Laboratories, CNAS-CL02-A001: 2023 Application Requirements for the Accreditation of Medical Laboratories and SYSMEX XN-3000 Instrument Operation Manua, the SYSMEX XN-3000 automated hematology analyzer was calibrated. Before calibration, it's necessary to confirm that the instrument's working environment and performance requirements comply with standards. Post-calibration verification was conducted for eight key hematological parameters: WBC, RBC, Hb, Hct, Plt, MCV, MCH, and MCHC. Verification methods included quality control testing and evaluation across different sampling modes.

Results

The SYSMEX XN-3000 automated hematology analyzer passed calibration, and post-calibration validation was successful, confirming its suitability for clinical testing within the defined calibration interval.

Conclusion

The SYSMEX XN-3000 automated hematology analyzer met calibration standards and post-calibration verification requirements, fulfilling the demands of clinical hematology laboratories and satisfying the instrument calibration requirements for ISO 15189 accreditation.

ISO 15189  /  Quality management system  /  Automated hematology analyzer  /  Calibration  /  Post-calibration verification
许荣琴, 施玉泉, 汪东烨, 朱燕忠, 李洁. SYSMEX XN-3000全自动血液分析仪的校准及校准后验证方案应用. 现代仪器与医疗, 2025 , 31 (5) : 58 -63 . DOI: 10.11876/mimt202505009
Rongqin Xu, Yuquan Shi, Dongye Wang, Yanzhong Zhu, Jie Li. Calibration and post-calibration verification protocol for SYSMEX XN-3000 automated hematology analyzer[J]. Modern Instruments & Medical Treatment, 2025 , 31 (5) : 58 -63 . DOI: 10.11876/mimt202505009

参考文献 引证文献
排序方式:
[1]
中华人民共和国国家卫生健康委员会. 血细胞分析校准指南: WS/T 347—2024[S/OL]. (2024-04-02) [2025-07-29]. https://www.nhc.gov.cn/wjw/s9492/202404/47c19ec2a3c249f7862bc67e0f787e56/files/1739781662686_47753.pdf.
[2]
中华人民共和国国家卫生健康委员会. 临床血液检验常用项目分析质量标准: WS/T 406—2024[S/OL]. (2024-05-09). [2025-07-29]. https://www.nhc.gov.cn/wjw/s9492/202407/0f555e069dca439c8982b8583ce4da7d/files/1739781690556_81927.pdf.
[3]
SYSMEX. XN-3000 brochure[EB/OL]. [2025-07-29]. https://www.sysmex-ap.com/wp-content/uploads/2020/05/XN-3000-Ebook-March-2019.pdf.
[4]
中华人民共和国国家卫生健康委员会. 临床血液与体液检验基本技术标准: WS/T 806—2022[S/OL]. (2022-11-02) [2025-07-29]. https://www.nhc.gov.cn/wjw/s9492/202211/141c88c070474ecf866582532b71d329/files/1739781651907_95419.pdf.
[5]
谢楠, 杨斯桀, 刘丽萍, 等. SYSMEX XN-550全自动血液分析仪的校准及性能评价[J]. 现代仪器与医疗, 2022, 28(2): 5-9.
[6]
中华人民共和国卫生部. 医疗机构内定量检验结果的可比性验证指南: WS/T 407-2012[S/OL]. (2012-12-25) [2025-07-29]. https://www.nhc.gov.cn/wjw/s9492/201301/6cdf57d92f6a4250847ba532df5ed488/files/1739781485245_84960.pdf.
[7]
中国合格评定国家认可委员会. 医学实验室定量检验程序结果可比性验证指南: CNAS-GL047: 2021[S/OL]. (2021-04-25) [2025-07-29]. https://www.cnas.org.cn/rkfw/sys/rkyq/rkzn/art/2024/art_1367616758.html.
[8]
中国合格评定国家认可委员会. 医学实验室质量和能力认可准则: CNAS-CL02: 2023[S/OL]. (2023-06-01) [2025-07-29]. https://www.cnas.org.cn/rkfw/sys/rkyq/rkzz/art/2024/art_717098409.html.
[9]
中国合格评定国家认可委员会. 医学实验室质量和能力认可准则的应用要求: CNAS-CL02-A001: 2023[S/OL]. (2023-08-01) [2025-07-29]. https://www.cnas.org.cn/rkgf/sysrk/rkyyzz/art/2024/art_9a46afffeaa144c8b2e065f691045aea.html.
[10]
中国合格评定国家认可委员会. 实验室认可规则: CNAS-RL01: 2025[S/OL]. (2025-06-30) [2025-07-29]. https://www.cnas.org.cn/rkfw/sys/rkyq/rkgz/art/2024/art_580995811.html.
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doi: 10.11876/mimt202505009
  • 首发时间:2026-10-23
  • 出版时间:2025-10-10
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    江苏省太湖康复医院检验科,无锡 214086

通讯作者:

李洁,女,本科,主管技师,研究方向:临床生化免疫检验
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