以Beckman Coulter AU 5800生化分析儀免疫比濁法測定尿液Microalbumin之效能評估

目的：目前尿液microalbumin大多以免疫散射法（nephelometry）分析，檢驗室必須購置免疫分析儀器，且無法提供門診病人急件分析結果。本研究主要使用Beckman Coulter AU 5800生化分析儀免疫比濁法（turbidimetry）測定尿液microalbumin，方法效能評估為實驗室認證規範，以確保方法符合臨床需求及提升服務品質。材料與方法：依據CLSI EP10及CLSI EP12-A2要求執行。以Beckman Coulter AU 5800生化儀免疫比濁法分析尿液microalbumin。評估項目包括：（1）精確度：包括within-run與between-run，以Bio-Rad品管液分析。（2）準確度：以CAP-LN20-B能力試驗檢體分析。（3）線性：以CAP-LN20-B能力試驗檢體分析。（4）交叉汙染：以正常濃度檢體及異常高濃度檢體分析。（5）靈敏度：以濃度0的校正液及接近濃度0的臨床檢體分析。（6）儀器間相關性比對：以40支病人檢體分析，濃度涵蓋分析範圍，比較與Beckman Immage 800之相關性。以EP-8 Evaluator進行統計分析。結果：精確度：within-run分別為1.3%及0.8%（合格）；between-run分別為2.0%及2.1%（合格）。準確度：＜1/2 TEA，25%（合格）。線性：6.7%（＜1/4 TEA：25%，合格）。交叉汙染：-0.014（＜0.04，合格）。分析靈敏度：濃度0校正液平均值為-0.068（合格），臨床檢體平均值為 0.084（＜0.07mg/dl，合格）。儀器間相關性比對： Immage 800及AU5800的Comparison，R為0.9997（＞0.975，合格），Error Index（Y-X）/TEa:0.38（＜6.9%，合格），平均差為6.9%（合格）。結論：Beckman Coulter AU 5800尿液比濁法分析microalbumin檢驗項目，經上述各項效能評估皆符合原廠要求，並可確保方法符合臨床需求。其優點包括：（1）降低檢驗室購買免疫散射法儀器之成本，（2）集中檢驗項目於生化儀器分析，可降低儀器保養維修成本，（3）提供門診病人急件分析報告，提升醫療與服務品質，（4）同時提供ACR值（microalbumin/Creatinine ratio），減少microalbumin因喝水導致稀釋效應。

關鍵字

Beckman Coulter AU 5800 ； microalbumin ；檢驗效能；儀器評估；品質

並列摘要

Objective: At present, most of the urine microalbumin test is analyzed by nephelometry method. The laboratory not only to purchase immunoassay instrument for analysis, but also not provide outpatient urgent report. This study mainly used the Beckman Coulter AU 5800 biochemical analyzer to determine the urine microalbumin by turbidimetry. Method performance assessment is defined by laboratory accreditation regulation to ensure that the method meets clinical needs and improves service quality. Materials and Methods: The assessment is according to the requirements of CLSI EP10 and CLSI EP 12-A2 guidelines. Urine microalbumin was analyzed by Beckman Coulter AU 5800 biochemical immunoturbidimetry. To evaluate: (1) Precision: include within-run and between-run. Analyze with Bio-Rad QC products. (2) Accuracy: Analysis by CAP-LN20-B PT survey. (3) Linearity: Analysis by CAP-LN20-B PT survey. (4) Carry-Over: Analysis by normal and high-level samples. (5) Sensitivity: Analysis of the calibration sample with concentration 0 and clinical sample close to concentration 0. (6) Comparison: Use 40 patient samples which are cover the analytical measurement range (to correlate with Beckman Immage 800). Statistical analysis with EP-8 Evaluator. Results: Precision: Within-run was 1.3% and 0.8% respectively, acceptable; Between-run was 2.0% and 2.1% respectively, acceptable. Accuracy: ＜1/2 TEA: 25%, acceptable. Linearity: 6.7%, acceptable (＜1/4 TEA: 25%). Carry-Over: -0.014, acceptable (＜0.04). Sensitivity: Concentration 0 calibration solution was mean-0.068, acceptable. The clinical samples mean were 0.084, acceptable (＜0.07 mg/dl). Correlation: The Comparison of Immage 800 and Beckman Coulter AU 5800, R: 0.9997, acceptable (＞0.975). Error Index (Y-X)/TEa: 0.38, acceptable (＜6.9%), and the average difference is 6.9%, acceptable. Conclusion: Beckman Coulter AU 5800 is a turbidimetric method for the analysis of microalbumin. All the above performance evaluations are meet original requirements and to ensure that the method meets clinical needs. The advantages are: (1) no need to purchase the immuno-scattering instrument in the laboratory, (2) to analyze micro-albumin test in major biochemical analyzer, for reducing the cost of maintenance and repair, (3) to provide outpatient urgent microalbumin report, also to improve medical service quality. (4) Also provide ACR value (microalbumin/Creatinine ratio) simultaneously, to reduce the dilution effect of microalbumin due to drinking water.

並列關鍵字

Beckman Coulter AU 5800 ； microalbumin ； Efficiency Evaluation ； Instrument evaluation ； Quality

國際替代計量

以Beckman Coulter AU 5800生化分析儀免疫比濁法測定尿液Microalbumin之效能評估

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