ANCA检测国际共识

Immunopathology/ADDENDUMTOCONSENSUSSTATEMENTONTESTINGANDREPORTINGOFANCA312AmJClinPathol2003;120:312-318312DOI:10.1309/WAEPADW0K4LPUHFN©AmericanSocietyforClinicalPathologyAbstractAntineutrophilcytoplasmicantibody(ANCA)testsareusedtodiagnoseandmonitorinflammatoryactivityinWegenergranulomatosis,microscopicpolyangiitisanditsrenal-limitedvariant(pauci-immunecrescenticglomerulonephritis),andChurg-Strausssyndrome.TheInternationalConsensusStatementontestingandreportingofANCAstatesthatANCAaredemonstratedmostreadilyintheseconditionsbyusingacombinationofindirectimmunofluorescence(IIF)ofnormalperipheralbloodneutrophilsandenzyme-linkedimmunosorbentassays(ELISAs)thatdetectANCAspecificforproteinase3ormyeloperoxidase.ThegroupthatproducedtheInternationalConsensusStatementhasdevelopedguidelinesforthecorrespondingqualitycontrolactivities,examplesofcommentsforvariousIIFpatternsandELISAresults,andrecommendationsforANCAtestingwheninflammatoryboweldiseaseandothernonvasculiticANCA-associatedautoimmunediseasesaresuspected.AddendumtotheInternationalConsensusStatementonTestingandReportingofAntineutrophilCytoplasmicAntibodiesQualityControlGuidelines,Comments,andRecommendationsforTestinginOtherAutoimmuneDiseasesJudySavige,FRACP,FRCPA,PhD,WayneDimech,FAIMS,MarvinFritzler,MD,JamesGoeken,MD,E.ChrisHagen,MD,J.CharlesJennette,MD,RobMcEvoy,PhD,CharlesPusey,MD,WendyPollock,MichelleTrevisin,AllanWiik,MD,andRichardWong,FRACP,FRCPA,fortheInternationalGroupforConsensusStatementonTestingandReportingofAntineutrophilCytoplasmicAntibodies(ANCA)KeyWords:Antineutrophilcytoplasmicantibodies;Churg-Strausssyndrome;Microscopicpolyangiitis;Qualitycontrol;Renal-limitedvasculitis;Vasculitis;WegenergranulomatosisDOI:10.1309/WAEPADW0K4LPUHFNAntineutrophilcytoplasmicantibody(ANCA)testsareusedtodiagnoseandtomonitorinflammatoryactivityinthesmallvesselvasculitides,namelyWegenergranulomatosis,microscopicpolyangiitisanditsrenal-limitedvariant(pauci-immunecrescenticglomerulonephritis),andChurg-Strausssyndrome.1-4TheInternationalConsensusStatementontestingandreportingofANCA5statesthatANCAaremostreadilydemonstratedintheseconditionsbyusingacombina-tionofindirectimmunofluorescence(IIF)ofnormalperiph-eralbloodneutrophilsandenzyme-linkedimmunosorbentassays(ELISAs)thatdetectANCAspecificforproteinase3(PR3)ormyeloperoxidase(MPO).3,6,7ThegroupthatproducedtheInternationalConsensusStatementhasdevel-opedthefollowingguidelinesforANCAqualitycontrol(QC)activities,examplesofcommentsthatdescribedifferentIIFpatternsandELISAresults,andrecommendationsforANCAtestingwheninflammatoryboweldiseaseandothernonvas-culiticANCA-associatedautoimmunediseasesaresuspected.ThefollowingQCguidelinesweredevelopedat2meet-ingsof30AustralianscientistsfromlaboratoriesthattestforANCA.Thecommentswerederivedfromthosesubmittedby8laboratories.Therecommendationsfortestinginnonvas-culiticdiseaseswerepreparedbythecoordinatorofthisdocument(J.S.)togetherwith3internationalexpertswhosubsequentlyattendedtheFifthAustralasianANCAWork-shop(M.F.,J.G.,A.W.).AdraftoftheQCguidelines,thecomments,andtherecommendationsfortestinginnonvas-culiticdiseasesweredistributedtoall70participantsattheFifthAustralasianANCAWorkshop.Atthismeeting,thedocumentwasdebatedvigorously,asubsequentdraftwasImmunopathology/SPECIALARTICLEAmJClinPathol2003;120:312-318313313DOI:10.1309/WAEPADW0K4LPUHFN313©AmericanSocietyforClinicalPathologycirculatedforcommentstotheparticipantsand3othercontributorstotheoriginalconsensusstatement,andthefinaldocumentwaspreparedandsubsequentlyratifiedbyalloftheparticipatingauthors.Theirrecommendationsaresummarizedin❚❚Table1❚.QCGuidelinesIndirectImmunofluorescenceMinimumRequirements•ControlserumsamplesthatproducecytoplasmicANCA(C-ANCA)andperinuclearANCA(P-ANCA)patternsaretestedoneachnewlotofslides.Theworkingconcentrationofeachlotoffluorochrome-labeledantihumanimmunoglobulinconjugateisdeterminedforanANCAsubstratebya“checkerboard”titrationifnotdonealreadybythemanufacturer.AnegativeandapositiveIgGANCAreactionaredemonstratedineachIIFrun.OptimalRecommendationsControlserumsamplesthatproduceC-ANCA,C-ANCA(atypical),P-ANCA,andatypicalANCAaretestedoneachnewlotofslidestoensurethattypicalandatypicalIIFpatternscanbedistinguished.Theworkingconcentrationofeachlotoffluorochrome-labeledantihumanimmunoglobulinconjugateisdeterminedforeachlotofANCAsubstratebyacheckerboardtitration.C-ANCAandP-ANCApatternsaredemonstratedineachIIFrun.Aborderlinepositiveoratitratablepositivecontrolsampleistestedineachrun.AnegativeandapositiveIgGANCAreactionaredemonstratedoneachIIFslide.Enzyme-LinkedImmunosorbentAssayMinimumRequirementsProductionismonitoredforeachlotofin-houseassays,includingcheckingtheantigenpurity,theefficacyofantigencoatingtowells,andtheamountofnonspecificbinding.In-houseandcommercialassaysareevaluatedby❚Table1❚MinimumQualityControlRequirementsforTestingandReportingAntineutrophilCytoplasmicAntibodies(ANCA)IndirectImmunofluorescence(IIF)•ControlserumsamplesthatproduceC-ANCAandP-ANCApatternsaretestedoneachnewlotofslides.Theworkingconcentrationo