- 學位論文
比較自動化RPR與手工RPR測試方法試驗的定量之研究
A study for comparison of two quantitative methods between automated and manual Rapid Plasma Reagin
摘要
梅毒主要是梅毒螺旋體（Treponema pallidum）經由性行為感染的一種慢性全身性疾病，在感染的早期很難做診斷，目前國內實驗室大多利用手工法快速血漿反應素卡片試驗法（Rapid Plasma Reagin（RPR）Card Test）來做為梅毒篩檢。然而這個傳統試驗除了容易有偽陽性的報告外，在效價的目測判讀方面也不具客觀性。 因此，本研究使用自動化RPR試劑（MediaceRRPR）來進行兩種新舊方法的評估。首先，我們篩選10例手工法RRR陽性檢體進行倍數稀釋分析，由結果顯示自動化RPR試劑在各個不同倍數的重複性測試方面再現性良好（CV＜1.0％），另外，當手工法RPR呈現高價數時，使用自動化RPR試劑會出現Prozone effect的現象，在價數低於1:8的檢體則呈現良好的線性結果。 在臨床檢體實測上，我們使用自動化RPR試劑來分析已使用手工法RPR檢測過的1381例臨床血清進行兩種方法的一致性評估，並使用TPPA（Treponema pallidum particle agglutination）的方法做為陽性檢體之確認試驗。自動化RPR試劑在臨床診斷結果的統計分析呈現高敏感度（100％）與高專一性（99.2％）。115例造成手工法RPR偽陽性的原因中，有90例（78.2％）為接受過梅毒治療的案例，但是依其臨床診斷結果顯示這些實為治療成功之案例，自動化RPR試劑正確反應陰性結果。 綜合以上結果，自動化RPR試劑在臨床檢測上優於手工法RPR，我們期待可以藉由此計畫將傳統手工法RPR試驗更換成快速且具定量數值的自動化檢驗，讓臨床醫師在做診斷時有更正確的依據。
並列摘要
Syphilis is a sexually transmitted chronic infectious disease caused by the Treponema pallidum. Syphilis is difficult to diagnose clinically in early stage. Currently, manual rapid plasma reagin test is widely used screening test for syphilis in domestic laboratories. However, as the manual rapid plasma reagin (RPR) test provide false positives occasionally, the visual estimation of the titer is not objective. Therefore, the effectiveness of manual and automatic RPR reagent （MediaceRRPR） were to evaluated in this study. 10 manual RPR positive cases were selected for multiple dilution analysis. The data shows that automatic RPR reagent have good reproducibility in every dilution rate repetition test(CV＜1.0％.) With the high titer of the manual RPR, prozone effect phenomenon was demonstrated in automatic RPR reagent test. In addition, automatic RPR reagent showed good linearility at low titer result. Then we analyzed 1381 clinical samples using both methods to assess consistency and TPPA (Treponema pallidum particle agglutination) was used as the confirm test for positive results. The clinical diagnosis analysis also showed high sensitivity（100％） and specificity（99.2％）of automatic RPR reagent . Furthermore, automatic RPR reagent showed lower false positive rate in false biologic positive reactions. Of 115 false positive cases from manual RPR test, 90 (78.2%) were the cases that treated for syphilis successful. However, of those 90 cases, the automatic RPR test demonstrated true negative as the results. In conclusion, automatic RPR reagent was verified as the superior method in diagnosing syphilis when compared to manual RPR clinically. We expect that automatic Rapid Plasma Reagin (RPR) assay will become the common diagnostic tool for Syphilis treatment at our hospital.