在自動化生化分析儀建立ICG項目

Establishment of ICG Assay on Automatic Chemistry Analyzer

吲哚氰綠（ICG）清除試驗主要用以測定肝功能殘餘率。傳統測量血漿濃度中的ICG定量方法是基於在波長805nm處，其化學分子具有最高的吸光值測定。在我們實驗室中測量ICG，是藉由ELISAreader讀取吸光值後再加以計算分析，而這樣子的手工操作過程中，此檢驗必然存在個人手法的誤差。在這項研究中，我們在全自動生化分析儀（Toshiba c16000）上建立了一個ICG檢測方法，並評估其性能。自動法ICG線性範圍為0.0 - 6.0 mg/dL，測量精密度（Precision）在日內精密度與異日精密度之總變異係數為：1.5%、5.4%（濃度0.1 mg/dL）; 5.1%、6.8%（濃度0.5 mg/dL）；在新舊兩方法比較上，相關係數（R2）為0.9611（slope 1.007, Y intercept +0.9203）和平均差偏差為1.7%。使用自動法ICG結果比手動法ICG結果略低，但皆在可接受誤差範圍內。考量提高ICG檢測效率，而且具有優秀的一致性、精度度和線性，因此建議實驗室可採用自動生化分析儀檢驗ICG。

The indocyanine green (ICG) clearance test was used to evaluate the reserve of hepatic function. Conventional ICG quantified method is based on the spectrometric measurement of its plasma concentration at maximum wavelength of 805 nm. The ICG measurements in our laboratory were using the ELISA reader, however, the individual errors during analysis were inevitable. In this study, we established an ICG assay using an existing automatic chemistry analyzer (Toshiba c16000) and evaluated its performance. ICG analysis on automatic chemistry analyzer showed linearity from 0.0 to 6.0 mg/dL, total CVs for within-run and between-run at each level were as follows: 0.7% and 4.6% for 0.1 mg/dL; 2.6% and 6.9% for 0.5 mg/dL respectively, and detection limit 0.01 mg/dL. The comparison between the new ICG method using automatic chemistry analyzer and the conventional ICG methods demonstrated correlation coefficient (R2) was 0.9611(slope 1.007, Y intercept +0.9203) and mean difference bias was 1.7%. ICG results using the automatic chemistry analyzer were slightly lower than the manual ICG results, with the acceptable differences. The ICG test using the automatic chemistry analyzer can replace the conventional method, considering assay efficiency improvement and the good agreement, precision and linearity.