Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin.
Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité University Medicine Berlin.
Rheumatology (Oxford). 2022 Aug 3;61(8):3396-3400. doi: 10.1093/rheumatology/keab875.
To evaluate and compare the diagnostic accuracy of SIGLEC1, a surrogate marker of type I IFN, with established biomarkers in an inception cohort of systemic lupus erythematosus (SLE).
SIGLEC1 was analysed by flow cytometry in 232 patients referred to our institution with suspected SLE between October 2015 and September 2020.
SLE was confirmed in 76 of 232 patients (32.8 %) according to the 2019 EULAR/ACR classification criteria and their SIGLEC1 values were significantly higher compared with patients without SLE (P <0.0001). A sensitivity of 98.7 %, a specificity of 82.1 %, a negative predictive value (NPV) of 99.2 % and a positive predictive value (PPV) of 72.8 % were calculated for SIGLEC1. Adjusted to the highest reported prevalence of SLE, the NPV and PPV were >99.9 % and 0.1 %, respectively. Using receiver operating characteristic (ROC) analysis and DeLong testing, the area under the curve (AUC) for SIGLEC1 (AUC = 0.95) was significantly higher than for ANA (AUC = 0.88, P = 0.031), C3 (AUC = 0.83, P = 0.001) and C4 (AUC = 0.83, P = 0.002) but not for anti-dsDNA antibodies (AUC = 0.90, P = 0.163).
IFN-I pathway activation is detectable in almost all newly diagnosed SLE patients. Thus, a negative test result for SIGLEC1 is powerful to exclude SLE in suspected cases.
评估和比较 SIGLEC1（I 型干扰素的替代标志物）与既定生物标志物在系统性红斑狼疮（SLE）的起始队列中的诊断准确性。
在 2015 年 10 月至 2020 年 9 月期间，我们对 232 例疑似 SLE 患者的标本进行了流式细胞术分析。
根据 2019 年 EULAR/ACR 分类标准，232 例患者中确诊为 SLE 的有 76 例（32.8%），其 SIGLEC1 值明显高于未患 SLE 的患者（P<0.0001）。SIGLEC1 的灵敏度为 98.7%，特异度为 82.1%，阴性预测值（NPV）为 99.2%，阳性预测值（PPV）为 72.8%。根据最高报道的 SLE 患病率进行校正，NPV 和 PPV 分别为>99.9%和 0.1%。使用 ROC 分析和 DeLong 检验，SIGLEC1 的曲线下面积（AUC）（AUC=0.95）明显高于 ANA（AUC=0.88，P=0.031）、C3（AUC=0.83，P=0.001）和 C4（AUC=0.83，P=0.002），但与抗 dsDNA 抗体（AUC=0.90，P=0.163）无显著差异。
IFN-I 通路的激活可在几乎所有新诊断的 SLE 患者中检测到。因此，SIGLEC1 检测结果阴性有力地排除了疑似病例中的 SLE。
