Abstract
Analyses for the presence of anti-neutrophil cytoplasmic antibodies (ANCA) are important in the diagnostic work-up of patients with small vessel vasculitis. Since current immuno-assays are predominantly designed for diagnosis of patients with ANCA-associated vasculitis (AAV), implementation in routine clinical practice, internal and external quality control, and harmonization are focused on this particular use. However, ANCA testing may also be relevant for monitoring therapy efficacy and for predicting a clinical relapse in AAV patients, and even for diagnostic purposes in other clinical situations. In the current review, the topics of implementation, quality control, and standardization vs. harmonization are discussed while taking into account the different applications of the ANCA assays in the context of AAV.
Highlights
The history of the detection of anti-neutrophil cytoplasmic antibodies (AAV), with hallmark developments, has been described before [1,2,3]
Agency (EMEA) classification algorithm for epidemiological studies [4], anti-neutrophil cytoplasmic antibodies (ANCA) are not included yet in the classification criteria for the distinct entities of ANCA-associated vasculitis (AAV), i.e., granulomatosis with polyangiitis [(E)GPA] and microscopic polyangiitis (MPA), but it has been recommended for future criteria [5, 6]
This paper summarizes the distinct items to be taken into account for antigen-specific ANCA testing, i.e., MPOand proteinase 3 (PR3)-ANCA, in routine clinical practice with respect to implementation, quality control, and standardization
Summary
The history of the detection of anti-neutrophil cytoplasmic antibodies (AAV), with hallmark developments, has been described before [1,2,3]. In particular for follow-up ANCA testing in AAV patients in order to predict a clinical relapse there are multiple open issues: is it possible at all, for which patients this applies best (cf, MPO- vs PR3-ANCA; limited vs generalized AAV; primary small vessel vasculitis vs drug-induced vasculitis), how is an ANCA-rise defined, which type of assay is to be used, do we need alternative IQC and EQC, and is harmonization feasible for this purpose. To answer these questions, well-designed, prospective multi-center studies are needed that take into account novel immune-assays and therapeutic strategies, like. The report should define whether the change in ANCA level is relevant, for instance in respect to the risk of a clinical relapse as defined during the validation of the assay
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