- 期刊
評估羅氏分析儀cobas e602檢測B型肝炎病毒血清的性能與確效
Performance and System Validation of Roche cobas e602 Serum Analyzer
摘要
過去本實驗室以Abbott（亞培）Architect i2000SR分析Anti-HBc、Anti-HBc IgM、Anti-HBe、HBeAg、Anti-HBs與HBsAg，目前欲將此六種有關B型肝炎之檢測項目轉換至Cobas e602免疫分析儀，因此擬定此評估計畫來確認項目在新平台的分析效能與現用平台之相關性，作為平台轉換之依據，以確保未來提供給臨床醫師的報告不會因為更換分析儀而影響病患的治療。評估項目囊括精密度（precision）、相關性（correlation）、準確度（accuracy）與參考值（reference range）驗證。評估結果呈現e602具皆符合廠商所宣稱的精密度，此外與外部品管API比對皆具一致性。然而，e602與i2000SR具有不良的相關性，但幾乎不會影響結果的判讀，因此，吾等認為羅氏血清分析儀e602可以取代i2000SR，成為常規執行B型肝炎相關的檢驗分析儀。
並列摘要
In the past, our laboratory used Abbott Architect i2000SR to analyze Anti-HBc, Anti-HBc IgM, Anti-HBe, HBeAg, Anti-HBs, and HBsAg. Currently, we intend to substitute Cobas e602 immune analyzer for i2000SR to make sure these six detection items related to hepatitis B to perform well. This evaluation plan is developed to determine whether precision, correlation, accuracy and reference intervals verification are able to reach the qualities, and to ensure that the reports provided to clinicians in the future will not be affected by changing the analyzer for patient treatment. The evaluation results show that the e602 instruments are in accordance with the precision claimed by the manufacturer. In addition, they are consistent with the API external quality control proficiency test. Although the correlation between e602 with i2000SR is poor, it will hardly affect the interpretation of the results. Therefore, it is considered that the Roche serum analyzer e602 can replace the i2000SR as a routine hepatitis B-related test analyzer.