Comparison of different assays for the detection of anticyclic citrullinated peptide antibodies in patients with rheumatoid arthritis

Abstract

ObjectiveTo evaluate a novel fully automated immunoturbidimetric assay developed by Qiangsheng Biotechnology Company for the detection of anticyclic citrullinated peptide antibodies (anti-CCP) in serum of patients with rheumatoid arthritis (RA) and compare it to the conventional EUROIMMUN- anti-CCP ELISA. Two other commonly used automated assays, the Elecsys anti-CCP assay, an ECLIA that is run on the Modular Analystics E170 (Cobas Diagnostics, Germany), and an anti-CCP CLIA developed by YHLO that is run on the iFlash 3000 Chemiluminescence Immunoassay Analyzer, were included as reference standards.MethodsA total of 264 serum samples were collected from patients attending the First People’s Hospital of Wenling affiliated to Wenzhou Medical University between July 2020 and November 2020. These included 131 serum samples collected from patients with RA, 70 serum samples collected from patients with other autoimmune diseases, and 63 serum samples collected from healthy controls at a physical examination. The clinical performance and sensitivity and specificity of the four anti-CCP assays for the diagnosis of RA were compared using receiver operating characteristic (ROC) curve analysis.ResultsThe Kappa statistic indicated almost perfect agreement between the EUROIMMUN-anti-CCP ELISA and the Elecsys anti-CCP ECLIA (Cobas) (0.863), the EUROIMMUN-anti-CCP ELISA and the anti-CCP CLIA (YHLO) (0.862), and the Elecsys anti-CCP ECLIA (Cobas) and the anti-CCP CLIA (YHLO) (0.816). On ROC curve analysis, AUC values were 0.955 for the EUROIMMUN-anti-CCP ELISA, 0.948 for the anti-CCP CLIA (YHLO), 0.947 for the Elecsys anti-CCP ECLIA (Cobas) and 0.903 for Qiangsheng, indicating all the assays had a good diagnostic performance for RA.ConclusionThe anti-CCP assays provided similar diagnostic information. The novel fully automated immunoturbidimetric assay for anti-CCP developed by Qiangsheng Biotechnology Company may be especially useful for large scale clinical screening in RA as it has a shorter testing time than the commercially available alternatives.

Interleukin -21 gene RS 2221903 polymorphisms in rheumatoid arthritis patients

“…A positive reaction, characterized by the agglutination of latex particles, indicates the presence of CRP at a level that can be measured. Normal: High: 10 mg/L or higher, low: 10 mg/L or higher When comparing the first and second generation ACCP enzyme-linked immunosorbent assays (ELISAs), the third generation ELISA offers higher sensitivity for detecting of RA [10] . Reference Range: Negative less than 20u/ml, Low/weak positive20-39 u/ml, moderate positive more than 40-59u/ml, strong positive more than 60 u/ml.…”

Commentary: Comparison of different assays for the detection of anticyclic citrullinated peptide antibodies in patients with rheumatoid arthritis

“…In their recent article, Ma et al. evaluated a novel fully automated immunoturbidimetric assay (ITA) developed by Zhejiang Qiangsheng Biological Technology Co. Ltd. for the detection of antibodies against cyclic citrullinated peptide (anti-CCP) in patients with rheumatoid arthritis (RA) ( 1 ). Using 131 serum samples from patients with RA, 70 samples from patients with other autoimmune diseases and 63 samples from healthy controls, the diagnostic characteristics of the Qiangsheng assay were compared with three other commercially available assays: [i] EUROIMMUN enzyme-linked immunosorbent assay (ELISA), [ii] Roche Elecsys electrochemiluminescence immunoassay (ECLIA), and [iii] YHLO chemiluminescence immunoassay (CLIA).…”