BiogateLabs/HCV/RHE-049C/

HepatitisCvirus(HCV)nowisrecognizedasamajoragentofchronichepatitis,transfusionacquirednon-A,non-B hepatitisandliverdiseasethroughouttheworld.HCVisanenvelopedpositive-sense,single-strandedRNAvirus. ClinicaldiagnosticissuesrelatedtoHCVisthedetectionofHCVantibodiesinhumanserum,plasmaorwholeblood byimmunoassay.WehaveconstructedHCVgenesfortheexpressionofrecombinantantigensinbacteriumsystems suchasE.coliandfocusedonstructuralandnon-structuralregionsofHCV-encodedpolyprotein,whicharedefinitely immunogenic.Themajorimmunoreactiveantigensoftheseproteinshavebeenreportedascore,NS3,NS4andNS5 regionsofHCVgenome,whichareknowntobehighlyimmunodominantregions.FordiagnosisofHCVinfection, theserecombinantproteinswereusedascapturematerialsofaimmunochromatographic(rapid)test.Comparedto thefirstgenerationHCVtestusingsinglerecombinantantigens,multipleantigensusingrecombinantproteinshave beenaddedinnewSEROlogicteststoavoidnonspecificcross-activityandtoincreasethesensitivityoftheHCV antibodytest.

  TheOneStepHCVTestisaqualitativemembranestripbasedimmunoassayforthedetectionofHCVantibodiesin WholeBlood/Serum/Plasma.Inthistestprocedure,recombinantHCVantigenisimmobilizedinthetestlineregionof thedevice.AfteraWholeBlood/Serum/Plasmaspecimenisplacedinthespecimenwell,itreactswithHCVantigen coatedparticlesthathavebeenappliedtothespecimenpad.Thismixturemigrateschromatographicallyalongthe lengthoftheteststripandinteractswiththeimmobilizedHCVantigen.IfthespecimencontainsHCVantibodies,a coloredlinewillappearinthetestlineregionindicatingapositiveresult.IfthespecimendoesnotcontainHCV antibodies,acoloredlinewillnotappearinthisregionindicatinganegativeresult.Toserveasaproceduralcontrol,a coloredlinewillalwaysappearatthecontrollineregionindicatingthatpropervolumeofspecimenhasbeenadded andmembranewickinghasoccurred.