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Abstract Number: 1505

The Point-of-Care Ichroma Anti-CCP Test Showed a Competitive Measurement Accuracy, in Comparison to the Conventional Automated Tests

Sejin Byun1, Chinhee Mun2, Mi-Sook Lee3, Sang-Won Lee4, Jason Jungsik Song4 and Yong-Beom Park5, 1Rheumatology, Internal medicine, Chuncheon Sacred Heart Hospital, Chuncheon-si, Gangwon-do, Korea, Republic of (South), 2Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seodaemun-gu, Seoul, Korea, Republic of (South), 3Central Lab, R&D Center, BodiTech Med Inc., Chuncheon-si, Korea, Republic of (South), 4Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of (South), 5Yonsei University College of Medicine, Seoul, Korea, Republic of (South)

Meeting: ACR/ARHP Annual Meeting 2018

Keywords:

Session Information

Date: Monday, October 22, 2018

Title: Rheumatoid Arthritis – Diagnosis, Manifestations, and Outcomes Poster II: Diagnosis and Prognosis

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Anti-cyclic citrullinated peptide (CCP) antibody test is a very important test for the diagnosis of rheumatoid arthritis (RA), but one of the disadvantages of the existing enzyme-linked immunosorbent assay (ELISA) is that its method is labor-intensive and time-consuming. The aim of this study was to assess the measurement characteristics of a rapid point-of-care (POC) anti-CCP test compared to the conventional anti-CCP test.

Methods: We used the POC ichroma anti-CCP test of Boditech Med and two anti-CCP assays (Elecsys¢ç Anti-CCP by Roche Diagnostics and the FCCP600 of Axis-Shield Diagnostics) and rheumatoid factor (RF) by latex agglutination test (LAT) respectively.

Results: A total of 430 subjects (199 RA patients, 112 non-RA patients and 119 healthy controls) were enrolled in this study. For the RA patients, the anti-CCP test were positive for 136 (68.3%), 155 (77.8%), and 158 patients (79.3%) with the ichroma anti-CCP, the Elecsys anti-CCP, and FCCP600, respectively. For the non-RA patients, the anti-CCP test were positive for 5 (4.5%), 7 (6.3%), and 5 patients (4.5%) with the ichroma anti-CCP, the Elecsys anti-CCP, and FCCP600, respectively. The overall agreement between the ichroma system and other tests was 91.6% (Elecsys) and 88.8% (FCCP) and 76.7% for RF. The difference between three areas under the ROC curves, including the POCT test, was not statistically significant (ichroma, 0.903 (0.874-0.933); Elecsys, 0.909 (0.877-0.941); and FCCP600, 0.892 (0.858-0.926)). There was, however, a significant difference from RF (0.770 (CI 0.721-0.819)).

Conclusion: The POC ichroma anti-CCP test is not only a quick and convenient test, but also provides a comparable and reliable diagnostic performance of conventional methods.

Table. Diagnostic performance of the three anti-CCP assays and one rheumatoid factor test for diagnosis of RA

Abbreviation : PPV, positive predictive value; NPV, negative predictive value

Fig.  Scatter plots of anti-CCP level according to the concentrations of anti-CCP antibodies and rheumatoid factor for different groups of patients

Disclosure: S. Byun, None; C. Mun, None; M. S. Lee, None; S. W. Lee, None; J. J. Song, None; Y. B. Park, None.

To cite this abstract in AMA style:

Byun S, Mun C, Lee MS, Lee SW, Song JJ, Park YB. The Point-of-Care Ichroma Anti-CCP Test Showed a Competitive Measurement Accuracy, in Comparison to the Conventional Automated Tests [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/the-point-of-care-ichroma-anti-ccp-test-showed-a-competitive-measurement-accuracy-in-comparison-to-the-conventional-automated-tests/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-point-of-care-ichroma-anti-ccp-test-showed-a-competitive-measurement-accuracy-in-comparison-to-the-conventional-automated-tests/