Exagen Inc, Vista, California, USA
Exagen Inc, Vista, California, USA.
Lupus Sci Med. 2021 Jul;8(1). doi: 10.1136/lupus-2021-000528.
To evaluate the clinical utility of the multianalyte assay panel (MAP), commercially known as AVISE Lupus test (Exagen Inc.), in patients suspected of SLE.
A systematic review of medical records of ANA-positive patients with a positive (>0.1) or negative (<-0.1) MAP score was conducted when the MAP was ordered (T0), when the test results were reviewed (T1) and at a later time (T2, ≥8 months after T1). Confidence in the diagnosis of SLE and initiation of hydroxychloroquine (HCQ) were assessed.
A total of 161 patient records from 12 centres were reviewed at T0 and T1. T2 occurred for 90 patients. At T0, low, moderate and high confidence in SLE diagnosis was reported for 58%, 30% and 12% patients, respectively. Confidence in SLE diagnosis increased for the MAP positive, while MAP negative made SLE less likely. Odds of higher confidence in SLE diagnosis increased by 1.74-fold for every unit of increase of the MAP score (p<0.001). Using the MAP-negative/anti-double-stranded DNA-negative patients as reference, the HR of assigning an International Classification of Diseases, Tenth Revision lupus code was 7.02-fold, 11.2-fold and 14.8-fold higher in the low tier-2, high tier-2 and tier-1 positive, respectively (p<0.001). The HR of initiating HCQ therapy after T0 was 2.90-fold, 4.22-fold and 3.98-fold higher, respectively (p<0.001).
The MAP helps increase the confidence in ruling-in and ruling-out SLE in patients suspected of the disease and informs on appropriate treatment decisions.
评估多分析物检测面板(MAP)的临床效用,该检测商品名为 AVISE Lupus 测试(Exagen Inc.),用于疑似 SLE 患者。
对 ANA 阳性且 MAP 评分阳性(>0.1)或阴性(<-0.1)的患者的病历进行系统回顾,在 MAP 检测时(T0)、当检测结果被审查时(T1)和稍后时间(T2,T1 后≥8 个月)。评估 SLE 诊断的置信度和羟氯喹(HCQ)的起始治疗。
共回顾了 12 个中心的 161 名患者的记录,在 T0 和 T1 时进行。T2 发生在 90 名患者身上。在 T0 时,分别有 58%、30%和 12%的患者报告 SLE 诊断的低、中、高置信度。MAP 阳性患者的 SLE 诊断置信度增加,而 MAP 阴性患者则降低 SLE 的可能性。MAP 评分每增加一个单位,SLE 诊断置信度增加 1.74 倍(p<0.001)。以 MAP 阴性/抗双链 DNA 阴性患者为参考,低 2 级、高 2 级和 1 级阳性患者的分配国际疾病分类第十版狼疮编码的 HR 分别为 7.02 倍、11.2 倍和 14.8 倍(p<0.001)。T0 后开始 HCQ 治疗的 HR 分别为 2.90 倍、4.22 倍和 3.98 倍(p<0.001)。
MAP 有助于增加对疑似疾病患者中 SLE 的确诊和排除的信心,并为适当的治疗决策提供信息。