Presentation: Anti-MCV Antibody Test for the Diagnosis of Rheumatoid Arthritis Using a POCT-Immunoassay (2008)

1630 Anti-MCV Antibody Test for the Diagnosis of Rheumatoid Arthritis Using a POCT-Immunoassay

Purpose: Autoantibodies against mutated and citrullinated vimentin (MCV, a member of the citrullinated protein family) are highly specific markers for rheumatoid arthritis (RA), a disorder difficult to recognize in the critical early period of disease manifestation. Point-of-care testing (POCT) may be useful for the detection of such disease specific autoantibodies in order to aid diagnosis and to rapidly prompt further evaluation and treatment. To develop and evaluate a simple and fast test for the detection of anti-MCV autoantibodies, which can be easily performed by trained and non-trained users immediately upon a patient visit.
Methods: Anti-MCV-POCT is a lateral-flow immunoassay (LFIA) for the qualitative detection of anti-MCV antibodies. The assay is based on the ability of autoantibodies in test samples (whole blood, plasma, or sera) to bind to MCV. This immunochromatographic assay does not require washing steps, no special equipment and gives results within 15 minutes. The samples (approximately 20 µl of whole blood by finger prick) wick through the pads of the test strip, together with the labelled anti-human immunglobulin (detector reagent). At the capture lines, the detector reagent interacts with the bound autoantibodies to the capture reagent, which has been immobilized on the membrane. The test result is evaluated visually by the test line (MCV) and one control line. A commercially available anti-MCV antibody ELISA was used for comparison of antibody reactivities.
Results: Analysis of blood samples from healthy blood donors (n = 200, age: 47.4 ± 19.1 years, sex: 60 m, 140 fm), patients with rheumatoid arthritis (n = 108, age: 58.0 ± 13.9 years, sex: 21 m, 87 fm) and patients with other joint diseases (n = 122, age: 57.0 ± 14.0 years, sex: 38 m, 84 fm) were performed using Anti-MCV-POCT. The sensitivity of Anti-MCV-POCT was 69.3 % in blood samples of patients with RA. In anti-MCV seropositive patients, the sensitivity of Anti-MCV-POCT was 70.2 % in whole blood. The specificity of Anti-MCV-POCT was 99.7 % in blood samples.
Conclusions: Anti-MCV-POCT provides high specificity for the diagnosis of RA. The test is useful in clinical practice due to the simple and reliable performance. Novel rapid test systems for the detection of disease specific autoantibodies can thus greatly improve a timely management of RA and may help in screening patients with suspected RA in non-specialized settings prompting early referrals.

 F. Renger, None; H. Bang, ORGENTEC Diagnostika, 3; G. Fredenhagen, ORGENTEC Diagnostika, 3; A. Natusch, None; M. Backhaus, None; E. Feist, ORGENTEC Diagnostika, 8; K. Egerer, None; G.R. Burmester, None.