Background: PR3-ANCA, the serological marker of granulomatosis with polyangiitis (GPA), is usually detected by immunometric assays, with purified PR3 directly coated onto the solid-phase. Novel methods for PR3-ANCA detection have been developed to improve the performance of traditional PR3-ANCA specific assays, but little is known about their diagnostic performance in real-life clinical settings. This study aimed to compare the performance of nine different commercial PR3-ANCA specific assays, including traditional and newer ones, for the diagnosis of GPA. Methods: The evaluated assays for PR3-ANCA detection were representative of the first, second, and third generation tests (direct, capture and anchor assays, respectively). A third-generation assay employing both human and recombinant PR3 was also evaluated. The study population consisted of 55 GPA patients, 175 disease controls (representing most diseases in differential diagnosis with primary small-vessel vasculitis) including 52 with microscopic polyangiitis, and 20 healthy subjects. We performed the primary evaluation of test sensitivity using cut-off points which provided adequate and identical specificity for each test. Results: Although specificity and area under the ROC curve did not differ significantly between the different assays, substantial differences in sensitivity at 98%-specificity were found in some instances (p<0.001). Compared to first generation direct PR3-ANCA specific assays, some of the second and third generation tests increased the positive predictive value (PPV) for GPA diagnosis. Conclusions: Some of the newer PR3-ANCA specific assays have better PPV than traditional ones. © 2013 by Walter de Gruyter Berlin Boston.

Radice, A., Bianchi, L., Maggiore, U., Vaglio, A., Sinico, R. (2013). Comparison of PR3-ANCA specific assay performance for the diagnosis of granulomatosis with polyangiitis (Wegener's). CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 51(11), 2141-2149 [10.1515/cclm-2013-0308].

Comparison of PR3-ANCA specific assay performance for the diagnosis of granulomatosis with polyangiitis (Wegener's)

SINICO, RENATO ALBERTO
Ultimo
2013

Abstract

Background: PR3-ANCA, the serological marker of granulomatosis with polyangiitis (GPA), is usually detected by immunometric assays, with purified PR3 directly coated onto the solid-phase. Novel methods for PR3-ANCA detection have been developed to improve the performance of traditional PR3-ANCA specific assays, but little is known about their diagnostic performance in real-life clinical settings. This study aimed to compare the performance of nine different commercial PR3-ANCA specific assays, including traditional and newer ones, for the diagnosis of GPA. Methods: The evaluated assays for PR3-ANCA detection were representative of the first, second, and third generation tests (direct, capture and anchor assays, respectively). A third-generation assay employing both human and recombinant PR3 was also evaluated. The study population consisted of 55 GPA patients, 175 disease controls (representing most diseases in differential diagnosis with primary small-vessel vasculitis) including 52 with microscopic polyangiitis, and 20 healthy subjects. We performed the primary evaluation of test sensitivity using cut-off points which provided adequate and identical specificity for each test. Results: Although specificity and area under the ROC curve did not differ significantly between the different assays, substantial differences in sensitivity at 98%-specificity were found in some instances (p<0.001). Compared to first generation direct PR3-ANCA specific assays, some of the second and third generation tests increased the positive predictive value (PPV) for GPA diagnosis. Conclusions: Some of the newer PR3-ANCA specific assays have better PPV than traditional ones. © 2013 by Walter de Gruyter Berlin Boston.
Articolo in rivista - Articolo scientifico
antineutrophil cytoplasmic autoantibodies (ANCA); granulomatosis with polyangiitis (GPA); proteinase 3 (PR3); Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Antineutrophil Cytoplasmic; Female; Granulomatosis with Polyangiitis; Humans; Immunoenzyme Techniques; Luminescent Measurements; Male; Middle Aged; Myeloblastin; ROC Curve; Young Adult; Clinical Biochemistry; Biochemistry (medical)
English
2141
2149
9
Radice, A., Bianchi, L., Maggiore, U., Vaglio, A., Sinico, R. (2013). Comparison of PR3-ANCA specific assay performance for the diagnosis of granulomatosis with polyangiitis (Wegener's). CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 51(11), 2141-2149 [10.1515/cclm-2013-0308].
Radice, A; Bianchi, L; Maggiore, U; Vaglio, A; Sinico, R
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/139229
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