勞工醫院SYSMEX XN-3000全自動血球分析儀之驗證評估

Performance Evaluation of SYSMEX XN-3000 Automated Blood Cell Analyzer in Labor Hospital

林慶元(Ching-Yuan Lin)；利佳蓉(Chia-Jung Li)；商弘昇(Hung-Sheng Shang)；張錦標(Jin-Biou Chang)

勞工健康檢查 ； 血球常規檢驗 ； SYSMEX XN-3000血球分析儀 ； 驗證 ； Labor physical checkup ； Regular complete blood count ； SYSMEX XN-3000 blood cell analyzer ； verification

中華職業醫學雜誌

22卷2期（2015 / 04 / 25）

123 - 136

繁體中文

目的：勞工健康檢查是職業衛生預防與保健重要措施之一。血球常規檢驗為勞工體檢必要項目之一。SYSMEX XN-3000血球分析儀為台灣地區醫院新進之儀器，適合勞工醫院等級使用。檢驗科在採用新儀器前都應先作驗證評估，以確保血球常規檢驗之品質及提升醫療品質。方法：SYSMEX XN-3000血球分析儀驗證項目包括：精確度測試（within-Run）、精確度測試（between Day）、準確性測試、儀器間相關性比對、儀器間CBC Bias比對、儀器間DC Bias比對、生物參考區間驗證、殘漬性測試（carry-over）、儀器分析線性範圍驗證、干擾物測試、Pipette系統測試、體液-低值精密度測試、體液-Lower Limit of Quantitation（LOQ）、體液相關性比對、QC performance-品管規則之評估、LIS連線確認及分析數據傳遞正確性查核。結果：精確度測試（within-run）評估15項分析結果，各項的CV%都小於允收標準值。精確度測試（between-day）評估14項，各項的CV%都小於允收標準值。準確性測試評估14項，各項的評估結果都落在原廠範圍內。儀器間相關性比對11項結果，其R2都符合CLSI EP-9A及SYSMEX建議的範圍內。儀器間CBC Bias比對結果證實不超出CLIA所訂定的TEa範圍內。儀器間DC Bias比對結果都未超出原廠標準。生物參考區間驗證，評估結果符合CLSI C28-A3要求。殘漬性測試（Carry-over）評估結果都低於原廠標準。儀器分析線性範圍驗證結果小於原廠建議範圍。干擾物測試及Pipette系統測試以原廠文件的評估內容為依據。體液－低值精密度測試的CV%值顯示符合原廠標準。體液-Lower Limit of Quantitation結果差異範圍都小於原廠標準。體液相關性比對結果都符合原廠標準。QC performance-品管規則以EZ rule選擇適當之品管規則。LIS連線確認及分析數據傳遞正確性符合認證要求。結論：SYSMEX XN-3000血球分析儀驗證結果，可符合臨床檢驗室之分析品質及醫療品質。

Purpose: Labor physical checkup is one of the most important measure of prevention and cure of occupational healthcare. Regular complete blood count is an essential parameter in labor physical checkup. SYSMEX XN-3000 blood cell analyzer is an advanced instrument in Taiwan available for assigned hospital for labors’ physical checkup. Before adoption of new instruments, laboratory should complete the performance evaluation in advance to assure the quality of complete blood count testing and enhance the medical quality. Methods: Performance evaluation items of SYSMEX XN-3000 including : Within-run imprecision testing, between day imprecision testing, accuracy testing, comparison between instruments, CBC bias between instruments, DC bias between instruments, verification of reference interval, carry-over testing, verification of analytical measurement range, interference testing, pipette system testing, imprecision testing for body fluid, lower limit of quantitation for body fluid, comparison between instrument and manual method for body fluid, evaluation of quality control rules, verification of data transportation between instrument and laboratory information system. Results: All CV% values of within-run imprecision testing are within limits assigned by manufacturer in 15 items. All CV% values of between-day imprecision testing are within limits assigned by manufacturer in 14 items. All results of accuracy testing are within limits assigned by manufacturer in 14 items. All R2 values of comparison between instruments are within limits according to CLIA or manufacturer in 11 items. The CBC bias between instruments are within total error allowable assigned by CLIA and DC bias between instruments are within limits assigned by manufacturer. The results of verification of reference interval are compliant with the requirement in CLIS C28-A3. The results of carry-over testing are within limits assigned by manufacturer. The results of verification of analytical measurement range are pass. Interference testing and pipette system testing are based on evaluation documents from manufacturer. The CV% values of within-run imprecision testing for body fluid are within limits assigned by manufacturer. The results of lower limit of quantitation for body fluid and comparison between instrument and manual method for body fluid are acceptable. QC rules were decided based on the evaluation of EZ rule software. Verification of data transportation between instrument and laboratory information system is compliant with requirement of certification. Conclusion: Based on performance evaluation, SYSMEX XN-3000 blood cell analyzer is qualified on providing reliable report for clinical use.