| Kitsize | 12x8 |
| Method | ELISA |
| Incubationtime | 1x1h,1x30min,1x15min |
| Standardrange | cut-offindex |
| Specimen/Volumes | 10µLserum,plasma |
| Substrate/isotope | TMB450nm |
| RegulatoryStatus: | EU:CE |
RelatedProduct:LegionellapneumophilaIgGELISA
IntroducingournewsensitiveLegionellapneumophilaIgG-andIgMELISAsSEROlogicalantibodytestingisincreasinglyrecognizedasavaluabletoolforthediagnosisoflegionellosis.ThedetectionofantibodiesusingELISAmethodshowshighersensitivityandbettercharacteristicsintermsofautomationforroutineapplicationandobjectivemeasurementthanimmunofluorescence.Moreoverithasbeenshowntobeavaluabletoolinepidemiologicalstudies.
IBLInternationalintroducesitsnewLegionellapneumophilaIgG-andIgMELISAsforthequalitativedeterminationofantibodiesagainstLegionellapneumophilaserovars1-7inhumanserumorplasma(citrate).
Diseasebackground
LegionellosisisalungdiseasemostcommonlycausedbyLegionellapneumophilaserogroup1andwithtwodistinctclinicalpresentations:Legionnaires"disease,asevereformofpneumoniathatcanbefatal.Pontiacfeverisamilderflulikeillness.
Legionellaisnaturallyfoundinstagnantwater,especiallywarmwater.Alsospas(hottubs)canbecomecontaminatedwithLegionella.Legionellosiscanbeacquiredbytheinhalationofcontaminatedaerosols,butitisnotcontagious(itcannotbepassedfrompersontoperson).
Detectionmethods
CommonlyusedmethodsfordetectionofaLegionellainfectioninvolvedirectdetectionmethodsusingculturing,directfluorescentstainingorantigendetectioninurineandindirectmethodswhichmeanstheassessmentofhumoralimmuneresponsebyantibodydetection.
Althoughculturingremainsthegoldstandardforthediagnosisoflegionellosis,itssensitivitymaybelimitedforclinicalroutineapplication.Directfluorescentstainingishamperedbylowandvariablesensitivity.
Directcomparisonstudies
DirectcomparisonstudiesshowedthatthediagnosticperformanceofIBL´sLegionellapneumophilaIgG-andIgMELISAsissimilartothatofcurrentlyavailableLegionellapneumophilaIgG-andIgMassays(Tables1and2),andcanbesummarizedasfollows:
| IBLInternationalLegionellapneumophilaELISAs | ||
| IgG | IgM | |
| Diagnosticsensitivity | 90.0% | 100% |
| Diagnosticspecificity | 100% | 95.7% |
| Agreement | 96.1% | 96.4% |
Table1
Diagnosticsensitivityandspecificity(internal+external)of
IBL´sLegionellapneumophilaIgGELISAissimilartothatofacommerciallyavailableLegionellapneumophilaIgGassay.
| SerionIgGELISA | ||||
| positive | negative | ∑ | ||
| IBLInternationalIgGELISA | positive | 18 | 0 | 18 |
| negative | 2 | 31 | 33 | |
| ∑ | 20 | 31 | 51 | |
Table2
Diagnosticsensitivityandspecificity(internal+external)of
IBL´sLegionellapneumophilaIgMELISAissimilartothatofacommerciallyavailableLegionellapneumophilaIgMassay.
| SerionIgMELISA | ||||
| positive | negative | ∑ | ||
| IBLInternationalIgMELISA | positive | 9 | 2 | 11 |
| negative | 0 | 44 | 44 | |
| ∑ | 9 | 46 | 55 | |
ExerptfromtheInstructionsforUse
Legionellaeareaerobicgram-negativefacultativeintracellularparasitesofcertainprotozoa.Theyarefoundinfreshwaterenvironmentsworldwideandcancauserespiratorydisease(legionellosis)inhumans.Legionellawasfirstidentifiedafteranoutbreakofpneumoniainvolvingdelegatesofthe1976AmericanLegionConventionataPhiladelphiahotel.ThegenusLegionellacurrentlyhasatleast50speciescomprising70distinctserogroups.OnespeciesofLegionella,L.pneumophila,istheaetiologicalagentofapproximately90%oflegionellosiscases,andserogroup1(Sg1)accountsforabout84%ofthesecases.
L.pneumophilamultipliesitselfattemperaturesbetween25and42C,withanoptimalgrowthtemperatureof35°C.Legionellathrivesinwarm,stagnantwaterintheenvironmentandinartificialsystemssuchascoolingtowers,evaporativecondensers,hotandcoldwatersystemsandspapoolsthatmimicthenaturalenvironmentinwhichtheorganismthrives.Thesesystemsalsoprovidethemeansbywhichaerosols/dropletsaregeneratedandtheorganismdispersedintotheatmosphere.LegionellosiscanbeacquiredbytheinhalationofaerosolscontainingLegionellabacteriaorbymicro-aspirationofingestedwatercontaminatedwithLegionella.Person-to-persontransmissionisnotthoughttobearisk.Legionellosiscanappearintwodistinctclinicalpresentations:Legionellapneumonia(Legionnaires’disease)withanincubationperiodofapprox.2-10days(mayextendupto16-20days)andPontiacfever(incubationperiod:normally12-48hours).
Legionellapneumonia(Legionnaires’disease)isaseriousformofpneumoniathatcarrieswithitacase-fatalityratioof10-15%.Legionnaires’diseasepatientsinitiallypresentwithcough,feverandnonspecificsymptomsincludingmalaise,myalgiaandheadache.Somepatientsdevelopshakingchills,chestpain,diarrhea,deliriumorotherneurologicsymptoms.Extrapulmonaryinvolvementisrare.
Thepresenceofbacteriaresp.infectionmaybeidentifiedby:
- Culture
- Urinaryantigendetection
- PCR
- Serology:DetectionofantibodiesbyIF,ELISA
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