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Calibration and post-calibration verification protocol for SYSMEX XN-3000 automated hematology analyzer
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Rongqin Xu, Yuquan Shi, Dongye Wang, Yanzhong Zhu, Jie Li*
Modern Instruments & Medical Treatment | 2025, 31(5) : 58 - 63
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Modern Instruments & Medical Treatment | 2025, 31(5): 58-63
Calibration and post-calibration verification protocol for SYSMEX XN-3000 automated hematology analyzer
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Rongqin Xu, Yuquan Shi, Dongye Wang, Yanzhong Zhu, Jie Li*
Affiliations
  • Department of Clinical Laboratory, Taihu Rehabilitation Hospital of Jiangsu Province, Wuxi 214086, China
Published: 2025-10-10 doi: 10.11876/mimt202505009
Outline
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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
Year 2025 volume 31 Issue 5
47
9
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doi: 10.11876/mimt202505009
  • Online Date:2026-10-23
  • Published:2025-10-10
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    Department of Clinical Laboratory, Taihu Rehabilitation Hospital of Jiangsu Province, Wuxi 214086, China
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表12种不同金属材料的力学参数
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Family
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Number of
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Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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