Development and validation of a lateral flow assay (LFA) for the determination of IgG-antibodies to Pr3 (cANCA) and MPO (pANCA)

The timely diagnosis of vasculopathies, such as granulomatosis with polyangiitis, has important implications for the favorable clinical outcome of these diseases. In the clinical setting, autoantibodies to proteinase 3 (Pr3) and myeloperoxidase (MPO) have been shown to be valuable adjuncts to an early and accurate diagnosis. The sensitive and specific detection of anti-Pr3 and anti-MPO was shown using a point of care device that employed rapid Lateral Flow Technologies. The validation of the lateral flow assay (LFA) was performed with serum samples collected in two Reference Laboratories and showed excellent results that were comparable to widely accepted and used ELISA. The advantage of the LFA is the flexibility to be used as an economical, point of care diagnostic device, features that are especially important for an early and accurate diagnosis and the prompt initiation of appropriate treatment so as to avoid inevitable development of undue complications of these diseases such as disseminated organ involvement, e.g. renal failure. •Evaluation of novel point-of-care autoimmune diagnostics device•Suitable for the detection of anti-Pr3 and anti-MPO antibodies•High sensitivity and specificity when compared to IFA, current ELISA and CLIA tests•Point-of-care test enables early and accurate diagnosis