NYU Grossman School of Medicine, New York City, New York, USA
Rheumatology, NYU Grossman School of Medicine, New York City, New York, USA.
Lupus Sci Med. 2023 Nov;10(2). doi: 10.1136/lupus-2023-001012.
OBJECTIVE: Anti-dsDNA antibodies (anti-dsDNA) are a component of all classification schemes in SLE and comprise one of the domains in validated activity indices. Anti-dsDNA is frequently measured commercially by an enzyme immunoassay (EIA) or immunofluorescence test (CLIFT). To address the clinical impact of measuring these antibodies by two different assays, this study leveraged a well-phenotyped multiethnic/racial cohort. METHODS: All patients fulfilled the classification criteria for SLE by at least one of the validated schemes: American College of Rheumatology, Systemic Lupus Erythematosus International Collaborating Clinics and/or American College of Rheumatology/European League Against Rheumatism classification criteria. Patients with one or more simultaneously paired anti-dsDNA by multiplex EIA and CLIFT were identified. Analysis of concordance or discordance, titre comparability of assays and association with hybrid SLE Disease Activity Index score, prevalence of lupus nephritis (LN), ability to predict a flare and classification criteria was performed. RESULTS: 207 patients were simultaneously tested by EIA and CLIFT at least once for anti-dsDNA, generating 586 paired results. 377 pairs were concordant and 209 were discordant. 41 of 207 patients always had discordant paired results and 39 patients always had results with titre discordance. In 100 patients with LN, 60 were positive by EIA and 72 by CLIFT. Sensitivities and specificities for patients with LN versus patients without LN were EIA 60% and 47%, and CLIFT 72% and 37%, respectively. 42 patients had flare assessment within 90 days of their paired result. Six of seven patients with mild flares and all four patients with severe flares had concordant positive results. CONCLUSION: Our data demonstrate that discordance of positivity between both assays for anti-dsDNA is relatively common, occurring in a fifth of patients overall and a third of visits. EIA positivity is associated with LN less often than CLIFT positivity. With the significant discordance of results between anti-dsDNA assays, obtaining both CLIFT and EIA assays may be beneficial for classification and routine monitoring of SLE.
目的：抗双链 DNA 抗体（anti-dsDNA）是 SLE 所有分类方案的组成部分，也是经验证的活性指标的一个领域。抗 dsDNA 通常通过酶免疫分析（EIA）或免疫荧光检测（CLIFT）进行商业检测。为了了解两种不同检测方法检测这些抗体的临床影响，本研究利用了一个经过良好表型分析的多种族/种族队列。
方法：所有患者均符合至少一种经验证方案的 SLE 分类标准：美国风湿病学会、系统性红斑狼疮国际合作临床和/或美国风湿病学会/欧洲抗风湿病联盟分类标准。确定了同时具有多个 EIA 和 CLIFT 同时配对的抗 dsDNA 的患者。分析了一致性或不一致性、检测方法的可比性以及与混合 SLE 疾病活动指数评分、狼疮肾炎（LN）患病率、预测发作的能力和分类标准的相关性。
结果：207 名患者至少一次同时通过 EIA 和 CLIFT 检测抗 dsDNA，产生了 586 对结果。377 对结果一致，209 对结果不一致。41 名患者始终存在不一致的配对结果，39 名患者始终存在结果不一致。在 100 名 LN 患者中，60 名患者的 EIA 阳性，72 名患者的 CLIFT 阳性。EIA 对 LN 患者与非 LN 患者的敏感性和特异性分别为 60%和 47%，CLIFT 为 72%和 37%。42 名患者在配对结果后 90 天内进行了发作评估。轻度发作的 7 名患者中有 6 名和严重发作的 4 名患者中均有一致的阳性结果。
结论：我们的数据表明，两种抗 dsDNA 检测方法之间的阳性结果不一致相对常见，在所有患者中占五分之一，在就诊患者中占三分之一。EIA 阳性与 CLIFT 阳性相比，与 LN 的相关性较低。鉴于抗 dsDNA 检测结果存在显著不一致性，同时获得 CLIFT 和 EIA 检测可能有助于 SLE 的分类和常规监测。
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