目的：Abbott Alinity ci為台灣地區，第一台新一代新機型全自動生化免疫複合型分析儀，適用於健檢中心或中小型醫院檢驗科使用。提供健康檢查及臨床醫療的生化檢驗與免疫項目之分析。檢驗室在採用新儀器前都應先作驗證評估，以符合認證要求及臨床需求。材料與方法：評估儀器為Abbott Alinity ci全自動生化免疫分析儀，驗證26項目(生化19項及免疫7項)。驗證期間：109年12月1日至110年1月10日。驗證方法以CLSI指引為主。驗證項目包括：精確度測試、準確性測試、儀器間相關性比對、生物參考區間驗證、分析線性範圍(AMR)驗證、殘留度驗證(carry-over)、干擾物驗證、automatic pipette準確度驗證、自動稀釋(Auto-dilute verification) 驗證，各項允收標準以原廠宣告值為依據。以EZ rule選擇各項目品管規則及品管頻率。免疫項目增加LoB之驗證。以CAP survey、TSLM能力試驗、CAP-LN、CAP-IFS、BioRad 生化品管血清、Technopath Multichem IA Plus 免疫品管血清、健康者血液等驗證上述各項目。以EP Evaluator™ 統計分析結果。結果：驗證26項目的精確度within-run及between-day的CV%都低於原廠允收標準值。準確性驗證結果都落在CAP及 TSLM的可接受範圍內。儀器間相關性比對結果，其R2符合CLSI EP-9A的建議範圍內。各項目的生物參考區間驗證，結果符合CLSI EP 28-A3的要求。殘留度驗證結果都低於原廠標準。分析線性範圍驗證都符合原廠範圍值。干擾物驗證、automatic pipette準確度驗證與自動稀釋的驗證都符合要求。免疫項目的LoB結果都低於原廠宣告值。應用EZ rule設定各項sigma值，多數項目為單一品管規則。結論：Abbott Alinity ci分析儀各項驗證的結果，可符合認證要求及臨床需求。

Purpose: Abbott Alinity ci, a new generation of automatic analyzer first introduced in Taiwan, is used for biochemistry analysis and immunoassay in laboratory. It is suitable for application in health checkup centers and small/medium-sized hospitals. Before adapting Abbott Alinity ci, our laboratory conducted verification to assess whether it meets the requirements of clinical testing. Materials and methods: The Abbott Alinity ci automatic analyzer was evaluated by conducting 26 assays (19 biochemistry items and 7 immune items). The verification period was from December 1, 109 to January 10, 110. The verification method is based on CLSI guidelines, including accuracy, precision, method comparison test, reference interval validation, analytical measurement range (AMR), carry-over rate, LOB, linearity, calibration verification, automatic dilution verification and interference test. The acceptance standards are based on the original manufacturer's declared values. EZ Rules was adopted to select the quality control rules and quality control frequency of each project. Data analysis was carried out using Microsoft Excel 2013 (Microsoft Corporation, WA, USA) and EP Evaluator 10 (Data Innovations, VT, USA). Result: The values of within-run CV% and between-day CV% of the analytes tested are lower than the original factory acceptable standard. The accuracy verification results are all within the acceptable range of CAP and TSLM. The correlation comparison between the instruments (R2) is within the recommended range of CLSI EP-9A. The validation of biological reference interval of each item meets the requirements of CLSI EP 28-A3. The results of carry-over and LoB are lower than the claimed values. In linearity test and calibration verification, all assays satisfy the acceptable criteria. Interference verification, accuracy verification and automatic dilution verification all meet the requirements. EZ Rules Software was used to set the Sigma values with single quality control rules in most projects. Conclusion: The verification results of the Abbott Alinity ci analyzer can meet the certification requirements and clinical testing needs.