Gambino Caterina Maria, Agnello Luisa, Ciaccio Anna Maria, Scazzone Concetta, Vidali Matteo, Di Stefano Vincenzo, Milano Salvatore, Brighina Filippo, Candore Giuseppina, Lo Sasso Bruna, Ciaccio Marcello
Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Clinical Laboratory Medicine, University of Palermo, 90127 Palermo, Italy.
Department of Laboratory Medicine, University Hospital "P. Giaccone", 90127 Palermo, Italy.
J Clin Med. 2023 Jul 19;12(14):4781. doi: 10.3390/jcm12144781.
The detection of serum anti-acetylcholine receptor (AChR) antibodies is currently an important tool for diagnosing myasthenia gravis (MG) since they are present in about 85% of MG patients. Many serological tests are now available. Nevertheless, results from these tests can be different in some patients. The aim of this study is to compare the sensitivity of a commercially available fixed cell-based assay (F-CBA) to that of enzyme-linked immunosorbent assay (ELISA) kits for anti-AChR detection in patients with a diagnosis of MG. Overall, 143 patients with a confirmed MG diagnosis were included in the study. The detection and measurement of serum anti-AChR antibodies were performed by three analytical methods, namely, a competitive ELISA (cELISA), an indirect ELISA (iELISA), and an F-CBA, according to the manufacturers' instructions. Anti-AChR antibody titers were positive in 94/143 (66%) using the cELISA, in 75/143 (52%) using the iELISA and in 61/143 (43%) using the F-CBA (adult and/or fetal). Method agreement, evaluated by concordant pairs and Cohen's kappa, was as follows: cELISA-iELISA: 110/143 (77%), k = 0.53 (95%CI 0.40-0.66); cELISA-F-CBA: 108/143 (76%), k = 0.53 (95%CI 0.41-0.66); iELISA-F-CBA: 121/143 (85%), k = 0.70 (95%CI 0.57-0.80). Our findings show that the cELISA has better analytical performance than the iELISA and F-CBA. However, the iELISA and F-CBA show the highest concordance.
血清抗乙酰胆碱受体（AChR）抗体检测是目前诊断重症肌无力（MG）的一项重要手段，因为约85%的MG患者体内存在该抗体。目前有多种血清学检测方法。然而，这些检测方法在部分患者中的结果可能存在差异。本研究旨在比较一种市售的基于固定细胞的检测方法（F-CBA）与酶联免疫吸附测定（ELISA）试剂盒在诊断MG患者中检测抗AChR抗体的灵敏度。本研究共纳入143例确诊为MG的患者。根据制造商的说明，采用三种分析方法，即竞争ELISA（cELISA）、间接ELISA（iELISA）和F-CBA，对血清抗AChR抗体进行检测和测定。使用cELISA时，94/143（66%）的抗AChR抗体滴度呈阳性；使用iELISA时，75/143（52%）呈阳性；使用F-CBA（成人和/或胎儿）时，61/143（43%）呈阳性。通过一致性配对和Cohen's kappa评估的方法一致性如下：cELISA-iELISA：110/143（77%），k = 0.53（95%CI 0.40 - 0.66）；cELISA-F-CBA：108/143（76%），k = 0.53（95%CI 0.41 - 0.66）；iELISA-F-CBA：121/143（85%），k = 0.70（95%CI 0.57 - 0.80）。我们的研究结果表明，cELISA的分析性能优于iELISA和F-CBA。然而，iELISA和F-CBA的一致性最高。
