| Kitsize | 12x8 |
| Method | ELISA |
| Incubationtime | 1x1h,3x30min,1x15min |
| Standardrange | cut-offindex |
| Specimen/Volumes | 10µlserum |
| Substrate/isotope | TMB450nm |
| RegulatoryStatus: | EU:CE |
IBLInternationaloffersahighlysensitiveandspecificELISAtestintendedforthediagnosticwork-upofchikungunyafever,aninfectiousdiseasewhoseincidencehasbeenincreasingsteADIlyinrecentyears.Itscharacteristicsare:
- µ-capturetechnology
- Diagnosticsensitivityof>98%anddiagnosticspecificityof100%
- Indicatedforthedifferentialdiagnosisofchikungunyafeveranddenguefever
- Qualitativeresults(positive,negative,cut-offcontrol)
- Adaptabletoopen-systemELISAanalyzers
Chikungunyafeverisaviralfebrileillnesstransmittedbyseveralmosquitospecies.Itmayleadtoseverearthralgiathatmaypersistforweekstomonths.Nevertheless,chikungunyafeverisessentiallyself-limitingandnon-fatal.ChikungunyahashistoricallybeenlimitedtocountriesinAfrica,theIndiansubcontinentandSoutheastAsia.However,manytouristareasarenowalsoaffectedbyextensiveoutbreaksandincreasingincidence,whichishowthevirusmadeitswaytotheWesternHemisphere,resultinginimportedcasesinanumberofEuropeancountries.In2006,severalimportedchikungunyacaseswerediagnosedinNorthernItalyduetothepresenceofcompetentmosquitovectorsforthechikungunyavirus.
Laboratorydiagnosisisgenerallyaccomplishedbytestingseraumorplasmatodetectvirus-specificimmunoglobulin(IgM,IgG)bymeansofanimmunoassay.Sincethesymptomsandgeographicspreadofchikungunyaanddenguefeveroverlap,adifferentialdiagnosticwork-upisofutmostimportance,puttingspecialperformancedemandsupondiagnostictests.Moreover,duetotheabsenceofwidespreadSEROpositivityintheEuropeanpopulation,anypositiveantibodytestissUSPiciousforinfection.InadditiontotheChikungunyaIgMµ-captureELISA,IBLInternationaloffersanIgGcaptureELISA.Bothassaysboastoutstandingperformancedata.
EvaluationofdiagnosticperformanceoftheChikungunyaIgMµ-captureELISA
1.ExternalmethodcomparisonoftheChikungunyaIgMµ-captureELISAofferedbyIBLInternationalwithanin-houseimmunofluorescencetest(TheBernhardNochtInstituteforTropicalMedicine,Hamburg)
Thecomparisonof31positiveandnegativeserarevealedaconcordanceof96.8%.
| Immunofluorescence | |||
| positive | negative | ||
| IBLInternational | positive | 21 | 0 |
| negative | 1 | 9 | |
2.Analysisofselectedpositiveandnegativesera(DGHS,NewDelhi)usingtheIBLInternationalChikungunyaIgMµ-captureELISAassay
Theanalysisof88serarevealedanagreementof100%.
| DGHS | |||
| positive | negative | ||
| IBLInternational | positive | 52 | 0 |
| negative | 0 | 36 | |
ExcerptfromtheInstructionsforUse
ChikungunyavirusisanarthropodbornevirusofthegenusAlphavirus(familyTogaviridae).TheAlphavirusgenuscontainsatleast24distinctspecies.Thesearelipid-envelopedvirionswithadiameterof50to60nm.Alphavirusinfectionsareinitiatedbythebiteofaninfectedmosquito,whichresultsinthedepositionofvirusinsubcutaneousandpossiblycutaneoustissues.Afteranincubationperiodof1to12daystheChikungunyafeverdevelops.Chikungunyafever(Chikungunyameans“thatwhichbendsup”,inreferencetothecripplingmanifestationsofthedisease)isanacuteviralinfectioncharacterizedbyarapidtransitionfromastateofgoodhealthtoillnessthatincludesseverearthralgiaandfever.Temperaturerisesabruptlytoashighas40°Candisoftenaccompaniedbyshakingchills.Afterafewdays,fevermayabateandrecrudesce,givingrisetoa“saddleback”fevercurve.Arthralgiaispolyarticular,favoringthesmalljointsandsitesofpreviousinjuries,andismostintenseonarising.Patientstypicallyavoidmovementasmuchaspossible.Jointsmayswellwithoutsignificantfluidaccumulations.Thesesymptomsmaylastfrom1weektoseveralmonthsandareaccompaniedbymyalgia.Therashcharacteristicallyappearsonthefirstdayofillness,butonsetmaybedelayed.Itusuallyarisesasaflushoverthefaceandneck,whichevolvestoamaculopapularormacularformthatmaybepruritic.Thelatterlesionsappearonthetrunk,limbs,face,plamsandsoles,inthatorderoffrequency.Petechialskinlesionshavealsobeennoted.Headache,photophobia,retro-orbitralpain,sorethroatwithobjectivesignsofpharyngitis,nauseaandvomitingalsooccurinthissetting.Occasionally,howeverpersistentarthralgiaandpolyarthritis(lastingmonthsorevenyears)dooccur,sometimesinvolvingjointdestruction.Evenrarer,sequelaeincludeencephalitisandmeningoencephalitiswithhighlethalityrates.ThevirushasmajorimportanceinAfricaandAsia.From20%tomorethan90%ofthepopulationoftropicalandsubtropicalshowserologicevidenceofinfection.BecauseAedesmosquitoesareincreasinglyprevalentinNorthAfricaandSouthAmerica,wherethepopulationwouldbeuniformlysusceptibletoinfection,thepossibilityforepidemicsisevident.ChikungunyavirusinfectionsareimportedtocentralEuropemainlybytravellerstotropicalandsubtropicalcountries.Thepresenceofvirusresp.infectionmaybeidentifiedbySerology:DetectionofantibodiesbyIF,ELISA
