
Kitsize | 12x8 |
Method | ELISA |
Incubationtime | 1x1h,1x15min |
Standardrange | 0.25-100pg/mL |
Specimen/Volumes | 25µLserum |
Substrate/isotope | TMB450nm |
RegulatoryStatus: | EU:CE |
Improvedversion
EnzymeimmunoassayforthequantitativedeterminationofFreeTestosteroneinhumanserum.
TheimprovedIBLInternationalFreeTestosteroneELISAiscalibratedtotheRIAGoldstandardmethod.
Benefitsoftheassay- Nointerferenceofheterophileantibodies
- CalibrationtotheRIAGoldStandardAssay
- Clearlydefinedreferencevalues
- Assayadaptedonautomatedplatforms
CalibrationtotheGoldStandard

Clearlydefinedreferencevalues
ThereferencevaluesmeasuredwiththeIBLInternationalFreeTestosteroneELISAhavebeencarefullyevaluatedinrelationtogenderandage.Serumfrom179apparentlyhealthywomenand179apparentlyhealthymenhasbeencollectedandmeasuredintheFreeTestosteroneELISA.Theexactdataarelistedintheinstructionsforuse,chapter14.Expectedvalues.Itisrecommendedthateachlaboratoryestablishesitsownrangeofnormalvalues.
Automation
TheIBLInternationalFreeTestosteroneELISA(DB52181)canbeadaptedondifferentELISAprocessors.OpenautomatedplatformsliketheEVOlyzer®fromTecanhavebeentestedandshowgoodcorrelationtothemanualruns:

Thecombineduseofassays,processscriptandautomatehastobevalidatedindividuallyonsitebyeachlaboratory.
InformationfromtheInstructionsforUse
Testosterone,aC19-Steroid,isthemosteffectivenaturalhormoneinthefamilyofandrogens.Inmales,itismainlyproducedintheLeydigcellsofthetestes,onlyasmallamountisproducedintheadrenalcortex.Onthewhole,adultmaleshave10to20foldhighertestosteroneplasmaconcentrationsthanfemales.Inthecirculation,themainpartoftestosteroneisboundtoplasmaproteinslikesexhormonebindingglobuline(SHBG)andalbumine.
Testosteroneisresponsibleforthedevelopmentofsecondarymalesexcharacteristicsanditsmeasurementsarehelpfulinevaluatingthehypogonadalstates.Inwom-en,highlevelsoftestosteronearegenerallyfoundinhirsutismandvirilization,poly-cysticovaries,ovariantumors,adrenaltumorsandadrenalhyperplasia.Inmen,highlevelsoftestosteroneareassociatedtothehypothalamicpituitaryunitdiseases,testiculartumors,congenitaladrenalhyperplasiaandprostatecancer.Lowlevelsoftestosteronecanbefoundinpatientswiththefollowingdiseases:hy-popituitarism,Klinefelter"ssyndrome,testicularfeminization,OrchidectomyandCryptorchidism,enzymaticdefectsandsomeautoimmunediseases.
Testosteronecirculatesinthebloodboundtothreeproteins:sexhormonebindingglobulin(60-80%),albuminandcortisolbindingglobulin.Onlyabout1-2%ofthetotalcirculatingtestosteroneremainsunboundorfree.Eventhoughitisstillunderinvestigation,mostresearchersacceptthefreetestosteronedeterminationasameasureoftheBIOLOGicallyactivefraction.Freetestosteronedeterminationsarerecommendedtoovercometheinfluencescausedbyvariationsintransportproteinsonthetotaltestosteroneconcentration.
ForconcretedatapleaseconsulttheInstructionforUseinthedownloadboxontherightside.