利用凝血酶原時間校正液降低不同凝血酶原試劑間INR之差異

Using Prothrombin time Multi-calibrator to Reduce the International Normalized Ratio (INR) Variation Between Different Prothrombin time Reagents

張永達(Yung-Ta Chang) ； 黃獻立(Hsien-Li Huang) ； 鄧金堂(Chin-Tang Teng) ； 郭明宗(Ming-Chung Kuo) ； 甯孝真(Hsiao-Chen Ning)

《Journal of Biomedical & Laboratory Sciences》 23卷3期 (2011/09) Pp. 119-125

https://doi.org/10.30046/JBLS.201109.0006

摘要

1983年世界衛生組織針對凝血酶原時間（Prothrombin Time；PT）測試所提出的INR報告方式讓實驗室的PT報告得以標準化，而INR的準確性取決於正確的平均正常凝血酶原時間（Mean Normal PT；MNPT）與國際敏感度指數（International Sensitivity Index；ISI）值。繼INR標準化後，近幾年探討的議題多為如何提高INR報告的精確度，因此相繼有ISI校正法與Direct INR方法開始被運用在提昇實驗室INR報告精確度與精準度。本次研究是探討如何導入ISI校正法與Direct INR方法來降低不同試劑間INR之差異性，利用市售PT校正液（Dade Behring PT Multi-calibrator），分析248支病人檢體在未校正前與使用上述兩種方法後，在Thromborel S、Thromboplastin C Plus、Innovin三種試藥測出的INR值之差異性。校正前三種試劑測得之INR在統計上具顯著差異，經過兩種方法校正之後，不同種類試藥間的INR差異就變成不具統計學上意義，研究個案在不同試藥間差異在10%以內的比例由校正前的42.9%提升到校正後的80%。尤其在高ISI值的試劑，其INR與其他種類試劑的偏差更明顯縮小，INR的校正已成為現階段熱門的話題，不管在外部品管表現或臨床檢驗表現，INR校正都有利於提高實驗室INR報告的精確度。

關鍵字

INR ； 本地的國際敏感度指數 ； 本地的平均正常凝血酶原時間 ； 直接INR測定法 ； 國際敏感度指數校正液

並列摘要

Objective: In 1983, the World Health Organization introduced the International Normalized Ratio (INR) reporting system to normalize the Prothrombin time (PT) reports. The accuracy of INR depends on the accuracy of International Sensitivity Index (ISI) and Mean Normal PT (MNPT). Since then, much effort has been devoted to improve the accuracy of INR report. In this study, we compared the INR derived from three methods, namely, un-calibration method (calculate INR with generic ISI), ISI calibration and Direct INR method among three thromboplastin reagents (Thromborel S, Thromboplastin C Plus, Innovin). Using commercial Dade Behring PT Multi-calibrator, 248 samples were analyzed. A statistically significant difference of INR (P = 0.0003) exists among 3 reagents with un-calibration method. However, after ISI calibration or direct INR correction, the difference of the 248 pairs INR results between three reagents are no longer statistically significant (P = 0.66). Moreover, the proportion of INR bias within 10 % deviations among three thromboplastin reagents are 42.9% and 80% between un-calibration method and ISI calibration method (or Direct INR method) respectively. In conclusion, either ISI calibration or direct INR method can reduce the variation of INR results among different thromboplastin reagents.

並列關鍵字

INR ； ISI calibration ； Direct INR ； PT Multi-calibrator