Institut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar der Technischen Universität München, München, Germany.
Zentrallabor, Zentrum Innere Medizin-A4, Universitätsklinikum Würzburg, Würzburg, Germany.
PLoS One. 2019 Jul 24;14(7):e0220033. doi: 10.1371/journal.pone.0220033. eCollection 2019.
Persistent antiphospholipid antibodies (aPL) constitute the serological hallmark of the antiphospholipid syndrome (APS). Recently, various new assay technologies for the detection of aPL better suited to multiplex reaction environments than ELISAs emerged. We evaluated the diagnostic performance of such a novel line immunoassay (LIA) for the simultaneous detection of 10 different aPL.
Fifty-three APS patients and 34 healthy controls were investigated for criteria (antibodies against cardiolipin [aCL], β2-glycoprotein I [aβ2-GPI]) and non-criteria aPL (antibodies against phosphatidic acid [aPA], phosphatidyl-choline [aPC], -ethanolamine [aPE], -glycerol [aPG], -inositol [aPI], -serine [aPS], annexin V [aAnnV], prothrombin [aPT]) IgG and IgM by LIA. Criteria aPL were additionally determined with the established Alegria (ALE), AcuStar (ACU), UniCap (UNI), and AESKULISA (AES) systems and non-criteria aPL with the AES system. Diagnostic performance was evaluated with a gold standard for criteria aPL derived from the results of the four established assays via latent class analysis and with the clinical diagnosis as gold standard for non-criteria aPL.
Assay performance of the LIA for criteria aPL was comparable to that of ALE, ACU, UNI, and AES. For non-criteria aPL, sensitivities of the LIA for aPA-, aPI-, aPS-IgG and aPA-IgM were significantly higher and for aPC-, aPE-, aAnnV-IgG and aPC- and aPE-IgM significantly lower than AES. Specificities did not differ significantly.
The LIA constitutes a valuable diagnostic tool for aPL profiling. It offers increased sensitivity for the detection of aPL against anionic phospholipids. In contrast, ELISAs exhibit strengths for the sensitive detection of aPL against neutral phospholipids.
持续存在的抗磷脂抗体（aPL）构成了抗磷脂综合征（APS）的血清学标志。最近，出现了各种新的检测技术，这些技术比 ELISA 更适合于多重反应环境，用于检测 aPL。我们评估了这种新型的线免疫分析（LIA）同时检测 10 种不同 aPL 的诊断性能。
我们对 53 例 APS 患者和 34 例健康对照者进行了研究，以确定（针对心磷脂[aCL]、β2-糖蛋白 I[aβ2-GPI]的抗体）和非标准 aPL（针对磷脂酸[aPA]、磷脂酰胆碱[aPC]、-乙醇胺[aPE]、-甘油[aPG]、-肌醇[aPI]、-丝氨酸[aPS]、膜联蛋白 V[aAnnV]、凝血酶原[aPT]的抗体）IgG 和 IgM 的 LIA。通过 LIA 还确定了标准 aPL 的 Alegria（ALE）、AcuStar（ACU）、UniCap（UNI）和 AESKULISA（AES）系统，非标准 aPL 的 AES 系统。通过潜在类别分析从四个已建立的检测方法的结果中得出的金标准来评估标准 aPL 的诊断性能，并以非标准 aPL 的临床诊断为金标准。
LIA 对标准 aPL 的检测性能与 ALE、ACU、UNI 和 AES 相当。对于非标准 aPL，LIA 对 aPA-、aPI-、aPS-IgG 和 aPA-IgM 的敏感性明显更高，而对 aPC-、aPE-、aAnnV-IgG 和 aPC-和 aPE-IgM 的敏感性明显更低。特异性无显著差异。
LIA 是一种有价值的 aPL 分析诊断工具。它提供了对阴离子磷脂的 aPL 检测的更高敏感性。相比之下，ELISA 对中性磷脂的 aPL 检测具有较高的灵敏度。
