Efthymiou Maria, Lane Philip J, Isenberg David, Cohen Hannah, Mackie Ian J
Haemostasis Research Unit, Department of Haematology, University College London, London WC1E 6HX, UK.
Department of Rheumatology, University College London Hospitals NHS Foundation Trust, London NW1 2PG, UK.
J Clin Med. 2021 Dec 23;11(1):69. doi: 10.3390/jcm11010069.
Acquired activated protein C resistance (APCr) has been identified in antiphospholipid syndrome (APS) and systemic lupus erythematosus (SLE).
To assess agreement between the ST-Genesia and CAT analysers in identifying APCr prevalence in APS/SLE patients, using three thrombin generation (TG) methods.
APCr was assessed with the ST-Genesia using STG-ThromboScreen and with the CAT using recombinant human activated protein C and Protac in 105 APS, 53 SLE patients and 36 thrombotic controls. Agreement was expressed in % and by Cohen's kappa coefficient.
APCr values were consistently lower with the ST-Genesia compared to the CAT, using either method, in both APS and SLE patients. Agreement between the two analysers in identifying APS and SLE patients with APCr was poor (≤65.9%, ≤0.20) or fair (≤68.5%, ≥0.29), regardless of TG method, respectively; no agreement was observed in thrombotic controls. APCr with both the ST Genesia and the CAT using Protac, but not the CAT using rhAPC, was significantly greater in triple antiphospholipid antibody (aPL) APS patients compared to double/single aPL patients ( < 0.04) and in thrombotic SLE patients compared to non-thrombotic SLE patients ( < 0.05). Notably, the ST-Genesia, unlike the CAT, with either method, identified significantly greater APCr in pregnancy morbidity (median, confidence intervals; 36.9%, 21.9-49.0%) compared to thrombotic (45.7%, 39.6-55.5%) APS patients ( = 0.03).
Despite the broadly similar methodology used by CAT and ST-Genesia, agreement in APCr was poor/fair, with results not being interchangeable. This may reflect differences in the TG method, use of different reagents, and analyser data handling.
在抗磷脂综合征（APS）和系统性红斑狼疮（SLE）中已发现获得性活化蛋白C抵抗（APCr）。
使用三种凝血酶生成（TG）方法，评估ST-Genesia分析仪和CAT分析仪在确定APS/SLE患者中APCr患病率方面的一致性。
采用STG-ThromboScreen在ST-Genesia分析仪上评估APCr，采用重组人活化蛋白C和Protac在CAT分析仪上评估105例APS患者、53例SLE患者和36例血栓形成对照者的APCr。一致性以百分比和Cohen's kappa系数表示。
在APS和SLE患者中，无论使用哪种方法，与CAT相比，ST-Genesia测得的APCr值始终较低。两种分析仪在识别APCr的APS和SLE患者方面的一致性较差（≤65.9%，≤0.20）或一般（≤68.5%，≥0.29），无论采用何种TG方法；在血栓形成对照者中未观察到一致性。与双/单抗磷脂抗体（aPL）患者相比，三联aPL APS患者使用Protac时，ST-Genesia分析仪和CAT分析仪测得的APCr均显著更高（<0.04）；与非血栓形成SLE患者相比，血栓形成SLE患者使用Protac时，ST-Genesia分析仪和CAT分析仪测得的APCr也显著更高（<0.05）。值得注意的是，与CAT不同，ST-Genesia分析仪采用任何一种方法，在妊娠并发症患者中测得的APCr均显著高于血栓形成的APS患者（中位数、置信区间；36.9%，21.9 - 49.0%）与（45.7%，39.6 - 55.5%）（P = 0.03）。
尽管CAT分析仪和ST-Genesia分析仪使用方法大致相似，但APCr的一致性较差/一般，结果不可互换。这可能反映了TG方法、不同试剂的使用以及分析仪数据处理方面的差异。
