梅毒自動化RPR定量法與手工RPR定性方法試驗的結果比較

A Study for Comparison of Two Quantitative Methods Between Automated and Manual Rapid Reagin

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(Mediace®RPR)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％)。在臨床檢體實測上，我們使用自動化RP R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 (Tre ponema 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(78.3％)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。

Background: Urinary casts are a common finding in u rine sediment microscopy. However, the correlation between the types of casts and the glomerular filtration r ate has been seldom investigated.
Syphilis is a sexually transmitted chronic infectious dise ase caused by the Treponema pallidum. Syphilis is difficult to diagnosed clinically in early stage. Current ly, manual rapid plasma reagin test is widely used screening test for syphilis in domestic laboratories. How ever, as the manual rapid plasma reagin (RPR) test providing false positives occasionally, the visual estim ation of the tilter is not objective. Therefore, the effectiveness of manual and automated RPR reagent ( Mediace®RPR) were to evaluated in this study. 10 manual RPR positive cases were selected for multiple dil ution analysis. The data shows that automated RPR reagent have good reproducibility in every dilution rate repetition test (CV＜1.0％) Then we analyzed 1381 clinical samples using both methods to assess consistency and TPPA was used as the confirm test for positive results. The clinical diagnosis analysis also showed hi gh sensitivity (100％) and specificity (99.2％) of automated RPR reagent . Furthermore, automated RPR reagent showed lower false positive rate in false biologic positive reactions. Of 115 false positive cases fr om manual RPR test, 90 (78.3%) were the cases that treated for syphilis successful. However, of those 90 cases, the automated RPR test demonstrated true negative as the results. In conclusion, automated RPR reagent was verified as the superior method in diagnosing syphilis when compared to manual RPR clinically.