評估商品化aPTT試劑在抗磷脂症候群診斷中的靈敏度和特異性

Evaluate the sensitivity, specificity, and clinical implications of commercial aPTT reagents in the diagnosis of antiphospholipid syndrome

抗磷脂症候群（Antiphospholipid Syndrome, APS）是一種自體免疫疾病，其特徵是血液中存在抗磷脂抗體（Antiphospholipid Antibody, APA），且與血栓和妊娠等臨床問題密切相關。APS診斷需要合併臨床徵狀與實驗室檢測，其中，狼瘡抗凝血因子（LAC）作為抗磷脂抗體之一，其檢驗是診斷的關鍵。本研究分析正常人及本院醫師診斷為APS的患者樣本各60例，評估LAC試驗三種試劑的靈敏度與特異性，包括（1）活化部分凝血時間（aPTT）試劑：Silica-based Siemens Pathromtin SL、（2）aPTT試劑：Ellagic acid-based Siemens Actin FSL及（3）稀釋羅素毒蛇毒液試驗（Dilute Russell Viper Venom Time, DRVVT）試劑。結果顯示，DRVVT在靈敏度及特異性上表現最佳，適合作為確診工具。而aPTT試劑在檢驗中的廣泛性、便捷性與成本效益，可以作為初篩試驗。其中，Pathromtin SL靈敏度（66.7%）優於Actin FSL（48.3%），較適合做為LAC篩檢工具。最終建議結合Pathromtin SL進行初步篩檢，再以DRVVT確認，以提升診斷準確性。

Antiphospholipid syndrome (APS) is an autoimmune disease characterized by antiphospholipid antibodies (APA), strongly linked to thrombosis and pregnancy complications. Diagnosis depends on clinical criteria and laboratory testing, with lupus anticoagulant (LAC) testing being essential. This study analyzed 60 plasma samples each from healthy individuals and APS patients diagnosed at our institution to assess the sensitivity and specificity of three LAC testing reagents: (1) Siemens Pathromtin SL (silica-based aPTT), (2) Siemens Actin FSL (ellagic acid-based aPTT), and (3) Dilute Russell Viper Venom Time (DRVVT). DRVVT exhibited superior sensitivity and specificity, making it the optimal confirmatory tool. However, aPTT reagents, particularly Pathromtin SL (66.7% sensitivity), are recommended for initial screening due to their accessibility and cost-effectiveness. Combining Pathromtin SL for screening with DRVVT for confirmation is suggested to improve diagnostic accuracy.