Comparison of fixed cell-based assay to radioimmunoprecipitation assay for acetylcholine receptor antibody detection in myasthenia gravis

Comparison of fixed cell-based assay to radioimmunoprecipitation assay for acetylcholine receptor antibody detection in myasthenia gravis
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DOI:
10.1016/j.jns.2021.120084
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发表时间:
2022-01-15
影响因子:
4.4
通讯作者:
Budhram, Adrian
Budhram, Adrian
中科院分区:
医学3区
文献类型:
--
作者:
Mirian, Ario;Nicolle, Michael W.;Budhram, Adrian

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目的:比较市售固定细胞法(F-CBA)与放射免疫沉淀法(RIPA)检测乙酰胆碱受体抗体的特异性和灵敏度方法:在这项回顾性诊断队列研究中,我们回顾了在伦敦健康科学中心MG诊所接受过抗AChR RIPA和F-CBA治疗的疑似MG患者的临床信息,将其分为MG和非MG。每个患者的分类为抗AChR F-CBA阴性/阳性,RIPA阴性/阳性,MG/非MG允许的特异性和敏感性计算为每个assay.Results:六百十八例患者被纳入研究分析。样本采集时的中位患者年龄为45.8岁(范围:7.5-87.5岁),312/618(50.5%)为女性。在618例患者中,395例(63.9%)被归类为MG。F-CBA和RIPA的特异性均为99.6%,与100%比较,P > 0.99。1例F-CBA阳性患者被归类为非MG,尽管回顾性分析发现眼部MG伴功能性重叠难以排除。F-CBA的敏感性显著高于RIPA(76.7% vs. 72.7%,P = 0.002)。总的来说,20/97(21%)的其他血清阴性MG(SNMG)患者后,RIPA评估有抗AChR检测F-CBA。结论:在我们的研究中,抗AChR F-CBA和RIPA都有很好的特异性,而F-CBA有4%的敏感性高出MG和21%的SNMG患者中检测到抗AChR。我们的研究结果表明,F-CBA是一个可行的替代RIPA抗AChR检测。需要进行前瞻性研究,比较F-CBA,RIPA和L-CBA,以确定MG的最佳抗AChR检测算法。
Objective: To compare specificity and sensitivity of a commercially available fixed cell-based assay (F-CBA) to radioimmunoprecipitation assay (RIPA) for acetylcholine receptor antibody (anti-AChR) detection in myasthenia gravis (MG).Methods: In this retrospective diagnostic cohort study we reviewed the clinical information of suspected MG patients evaluated at the London Health Sciences Centre MG clinic who had anti-AChR RIPA and then F-CBA performed, in order to classify them as MG or non-MG. Classification of each patient as anti-AChR F-CBA-negative/positive, RIPA-negative/positive, and MG/non-MG permitted specificity and sensitivity calculations for each assay.Results: Six-hundred-eighteen patients were included in study analysis. The median patient age at time of sample collection was 45.8 years (range: 7.5-87.5 years) and 312/618 (50.5%) were female. Of 618 patients, 395 (63.9%) were classified as MG. Specificity of both F-CBA and RIPA was excellent (99.6% vs. 100%, P > 0.99). One F-CBA-positive patient was classified as non-MG, although in retrospect ocular MG with functional overlay was challenging to exclude. Sensitivity of F-CBA was significantly higher than RIPA (76.7% vs. 72.7%, P = 0.002). Overall, 20/97 (21%) otherwise seronegative MG (SNMG) patients after RIPA evaluation had anti-AChR detected by F-CBA.Conclusions: In our study anti-AChR F-CBA and RIPA both had excellent specificity, while F-CBA had 4% higher sensitivity for MG and detected anti-AChR in 21% of SNMG patients. Our findings indicate that F-CBA is a viable alternative to RIPA for anti-AChR detection. Prospective studies comparing F-CBA, RIPA and L-CBA are needed to determine optimal anti-AChR testing algorithms in MG.