news news letter.pdf · news the ivd industry is moving towards nucleic acid based diagnostics for...

NEWSNEWSThe IVD industry ismoving towardsnucleic acidbaseddiagnosticsforfasterdetectionofinfectiousdiseases.Thechallengeforlaboratoriesis�indingeffective and affordable control technology tomonitorprocessesfromstartto�inish,andreportpatient results. Aalto Bio Reagents entered themolecular diagnostics market in 2015 withAaltoCC, our new range of external run controlsdesigned to address the quality and regulatorycha l lenges fac ing molecular d iagnost icslaboratories.TheAaltoCCcontrolsactlikehumanpatientsamplesandaresuitablefordailycontrolofboththeextractionandampli�icationprocesses.AaltoCC controls are supplied in kits of 10 vials(200ul or 1ml) and will be available for thefollowingtargets:

· Cytomegalovirus(plasma)· Chlamydiatrachomatis(exudate)· Chlamydiatrachomatis(urine)· Chlamydiatrachomatis/Neisseriagonorrhoeae (exudate)· Chlamydiatrachomatis/Neisseriagonorrhoeae (urine)· EpsteinBarrVirus(plasma)· HSV-1(CSF)·HSV-1(plasma)·HSV-1/HSV-2(CSF)·HSV-1/HSV-2(plasma)· HSV-2(CSF)·HSV-2(plasma)·HSV-1/HSV-2/VZV(exudate)·Mycobacteriumtuberculosis(sputum)·MycobacteriumtuberculosisINHresistant strains(sputum)·MycobacteriumtuberculosisRIFresistant strains(sputum)· Neisseriagonorrhoeae(exudate)· Neisseriagonorrhoeae(urine)· VZV(CSF)

Underdevelopment·BKVirus(plasma)· JCVirus(plasma)·HPV(exudate)

Molecular MolecularDiagnostics

Controls

DiseaseState

Plasmas

Antisera

InfectiousDiseaseAntigens

Antibodies

Proteins

Tumour Markers

CardiacMarkers

QualityISO 9001:2008

NSAI Certied

ArbovirusesArthropod-borneviruses(arboviruses)are importantcausesofhumandiseasenearlyworldwide. In recentyearsthenumbersofreportedcasesofArbovirussuchas Dengue, Chikungunya and Zika virus has beenincreasing.ThesevirusesarespreadbythebiteofaninfectedAedesmosquitoandcannotbespreaddirectlyfrompersontoperson.Outbreaksofendemicmosquito-borne illnesses are common in the tropical and sub-tropicalclimatesofAustralia,Asia,tropicalAfricaandSouthAmerica.

Arboviruses, particularly Dengue, can be seriousdiseaseswithsymptomsincludinghighfever,headache,painbehindtheeyes,jointpain,muscleandbonepainandrash.WithDengue,patientsmayexperiencemildbleeding(e.g.gumsandnosebleeds).TheearlyclinicalmanifestationsofDengue,ChikungunyaandZikavirusare very similar so it is important to differentiatebetweenthethreeinordertoeliminateDengue.NSAIDscanalleviatesymptomsinChikungunyaandZikavirusbutshouldbeavoidedinpatientswithDengueduetoriskofhaemorrhaging.

Laboratory diagnosis is generally accomplished bytesting serumorplasma todetect virus, viralnucleicacid, or virus-speci�ic immunoglobulin M andneutralizing antibodies. Aalto Bio Reagents are nowsupplyingafullrangeofZika,ChikungunyaandDenguevirus antigens. These antigens can be used ascomponentsfordevelopmentofdiagnosticassays.

Ÿ RecombinantChikungunyaE1antigen,mutantŸ RecombinantChikungunyaE1antigen,wildtypeŸ RecombinantChikungunyaE2antigenŸ RecombinantZikavirusenvelopeantigenŸ RecombinantZikavirusNS1antigenŸ RecombinantDengueNS1(types1–4)Ÿ RecombinantDengueenvelopeproteins(type1–4)

Pleasecontactusforfurtherinformation.

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MonoclonalAntibodies

RecombinantAntigens

SERUMPROTEINS· CRPconcentrate· ASOconcentrate· RFconcentrateMYELOMAPLASMA· IgG· IgM· IgA· IgE

INFECTIOUSDISEASESTATEPLASMA· EBVIgG/IgM· ChlamydiapneumoniaeIgG/IgA/IgM· Infectiousmononucleosis· HAVIgM· LymeIgG/IgM· Measles/Mumps/RubellaNegative· TORCHIgG/IgM· Syphilis/RPR· ChagasIgG/IgM· DengueIgG/IgM· HBsAgadanday· Anti-HBc(totalandIgM)· Anti-Leishmania· Anti-Parasitic

THYROIDFUNCTION· Anti-Thyroglobulin· Anti-ThyroidPeroxidase

AUTOIMMUNITYANDALLERGY· Anti-tissueTransglutaminase· Anti-Gliadin· CardiolipinIgG/IgM/IgA· Myastheniagravis· Allergenspeci�icIgE· TotalIgE

· CagAproteinofHelicobacterpylori· CarcinoembryonicAntigen· Chikungunyaenvelope NEW· CRPNEW· CyclosporinANEW· IGF-1· In�luenzavirus,typesAandB· Listeriamonocytogenes· NeuronSpeci�icEnolase· PregnancyAssociatedPlasmaProteinA· ProcalcitoninNEW· SexHormoneBindingGlobulin· Testosterone· ThyroidStimulatingHormone· TroponinI

· Aspergillusfumigatus· Bordetellapertussis· Borreliaafzelii· Borreliagarinii· Brucellaabortus· Campylobacterjejuni· Chlamydiapneumoniae· Chlamydiatrachomatis· CoxsackievirusNEW· Cytomegalovirus· EchinococcusgranulosusNEW· Helicobacterpylori· In�luenzaTypeAandB· Legionellapneumophila· Leishmaniainfantum· Leptospirabi�lexa· Measles(Rubeola)· Mumps· Mycoplasmapneumoniae· Parain�luenza1,2and3· RespiratorySyncytialVirus· Rotavirus· Rubella· Tick-BorneEncephalitis· Toxoplasmagondii· Treponemapallidum· VaricellaZosterVirus· VZVGlycoproteinNEW· YersiniaenterocoliticaYOPsNEW

· Borreliaafzelii· Borreliagarinii· Borreliaburgdorferisensustricto· Borreliaspielmanii· ChikungunyaE1(wildtype)NEW· ChikungunyaE1(A226V)NEW· ChikungunyaE2NEW· DengueNS1(types1–4)· Dengueenvelopeprotein(types1–4)· EbolaVirusDiseaseNEW· ChlamydiatrachomatisMOMP· HepatitisBsurfaceantigen–adsubtype· HepatitisBsurfaceantigen–aysubtype· HepatitisBcore· ParvovirusB19NEW· ProcalcitoninNEW· Typespeci�icgG1proteinofHSV-1· Typespeci�icgG2proteinofHSV-2NEW· StreptolysinO(SLO)· Treponemapallidump15,p17andp47· TreponemapallidumchimericantigenNEW· ZikavirusNS1proteinNEW· ZikavirusenvelopeproteinNEW

HumanPlasmaProducts

InfectiousDiseaseNativeAntigensRebranding

NEWS NEWSNEWSNEWProduct

CA15-3

PolyclonalAntibodies

· Alpha-1-microglobulin,af�initypuri�ied(goat)NEW· Albumin,IgGfraction(goat)· AntithrombinIII(goat)NEW· ApoA1(goat)· ApoB(goat)· ApoE,IgGfraction(goat)· Beta-2-Microglobulin,IgGfraction(goat)· CreatineKinaseMM,af�initypuri�ied(goat)· CRP,IgGfraction(goat)· CystatinC,af�initypuri�ied(goat)· EstradiolNEW· Ferritin(rabbit)NEW· Ferritin,IgGfraction(goat)· Fibrinogen(goat)NEW· Haemoglobin,af�initypuri�ied(goat)· HBsAg,IgGfraction,af�initypuri�ied(goat)· IgG(goat)· IgA(goat)· IgM(goat)· Lp(a)(goat)NEW· Myoglobin,IgGfraction(goat)NEW· Progesterone· 17-alpha-hydroxyprogesterone· Rotavirus,IgGfraction(rabbit)· SerumamyloidA(rabbit)NEW· Testosterone(rabbit)NEW

SERUMPROTEINS· Albumin· ComplementC3c· ComplementC4c· CReactiveProtein(CRP)· D-Dimer· FattyAcidBindingProtein· Beta-2-Glycoprotein-1· Haptoglobin· IgA· IgENEW· IgGFcFragment· IgM· Alpha-2-Macroglobulin

DIABETES· GlycatedHaemoglobin(HbA1c)· HbA1csolution,<3.5%· HbA1csolution,>25%

NUTRITIONAL· Prealbumin· RetinolBindingProtein· Transferrin(carbohydratede�icient)· Transferrin(iron-free)· Transferrin(partiallyironsaturated)· TransferrinReceptor

THYROIDFUNCTION· Thyroglobulin(TG)· ThyroidMicrosomalAntigen(TMA)· ThyroidPeroxidase(TPO)· ThyroxineBindingGlobulin(TBG)· ThyroidStimulatingHormone

CANCERMARKERS· AlphaFetoprotein· Beta-2-Microglobulin· CA15-3NEW· CA19-9· CA125· CK-MB,recombinantNEW· Ferritin(liver)· Ferritinlightchain,recombinantNEW· ProstaticSpeci�icAntigen(PSA)· PSA-ACTComplex· ProstaticAcidPhosphatase(PAP)

PITUITARYHORMONES· FollicleStimulatingHormone· RecombinantFollicleStimulatingHormone· GrowthHormone· LuteinizingHormone· Prolactin· Prolactin,recombinantNEW· ThyroidStimulatingHormone· RecombinantThyroidStimulatingHormone

Tumour Markers

CardiacMarkers

Puri�iedHumanProteins

DiseaseState

Plasmas

Antisera

InfectiousDiseaseAntigens

Antibodies

Proteins

CA15-3isusedprimarilyasamarkerforbothearlydetection and relapse of breast cancer. Increasedlevels are also associated with colon, lung andhepatic tumours. It is becoming increasinglydif�iculttosourcethehumanrawmaterialneededtoproduce native CA15-3. Aalto Bio are pleased toannounceavailabilityofpartiallypuri�iedCA15-3,codeBF3315producedfromhuman�luids.Therawmaterialwillbeavailableonacontinuousbasissoiteliminates the insecurity often associated withnative material. The native CA15-3 complementsourexpandingrangeofcancermarkers:

Ÿ CA15-3,nativeŸ CA15-3,cellculturederived

MolecularDiagnostics

Controls

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HIV-1gp120env

HIV-1p24gag

NEWProductPartiallyPuri�iedIgE

AaltoBioReagentsispleasedtoannounceavailabilityofour partially puri�ied cell culture derived IgE (AaltocodeAU3296).IgEisamemberoftheimmunoglobulinfamilyofproteinsthatwas �irstdescribed inthe1960s.IgE,likeallimmunoglobulins,isproducedbyplasmacellsinresponsetoantigenicstimuli.IgEisuniquehoweverincertainstructuralaspectsandtheroleitplaysinallergicdiseases.MeasurementoftotalserumIgEisoftenusedasatoolinthediagnosisandmanagementofatopicdiseasessuchasasthma,hayfever,atopicdermatitisandurticaria.It has been used to distinguish atopic from non-atopicindividualspresentingallergy-likesymptoms.Inaddition,studieshavealsoshownthatincreasedlevelsofIgEincordblood and infants may be predictive of future atopictendencies.

Normal levels of circulating IgE are extremely low incomparison to other immunoglobulins. Levels of IgE atbirtharealmostundetectablebutincreaseinnon-allergicadults. Elevated levels are commonly seen in cases ofallergic diseases, parasitic infections, pulmonaryaspergillosis, Wiskott-Aldrich Syndrome, and myeloma.MyelomaIgEplasmahasbeentherawmaterialofchoicefor many years for manufacturers of IgE control andcalibrators. Locating this natural product can bechallengingandoftencompaniesareforcedtoholdlargevolumesinstockorfacepotentialoutofstocksituation.

Compared to native myeloma plasma our cell culturederived IgE has the distinct advantage of always beingavailable.Thematerialisderivedfromahumanmyelomacell line which means that lot to lot consistency isguaranteedwithouthaving toworry about relyingon adonorandalloftheconcernsthatcanaccompanyanaturalproduct.Givenanaccurateforecastwecanmanufactureandhaveavailablequantitiesrangingfromafewmgstomultiple grams. Additionally the price per mg will notchangedependingonthetitre,aswouldbethecasewhenpurchasingnaturalmaterialbytheml.Pleasecontactustodayforaquotation.

AaltoBioprovidesarangeof“do-it-yourself(DIY)”researchassayprotocolsfordetectionofHIV-1p24gagandHIV-1gp120env.TheseDIYELISAassaysarebeingwidelyusedbyAIDSresearchlaboratoriesinEurope,theUnitedStates,Australia,AfricaandChinaformonitoringHIV-1replicationinarangeofresearchapplications.

Demandforouraf�initypuri�iedanti-HIV-1gp120env(codeD7324)continuestogrowamongAIDSresearchlaboratories.WehaveavailableaDIYELISAprotocolfordetectionofHIV-1gp120envincorporatingcodeD7324asthecaptureantibody.Thecapturedgp120proteinisrecognisedataseparatesitebyasecondantibodythatis,inturn,detectedusingathird,enzymelabelled,anti-antibody

Three different DIY ELISA protocols are available withvaryingrangesofsensitivityfordetectionofHIV-1p24gag.Theseassaysuseouraf�initypuri�iedanti-HIV-1p24gag(codeD7320),asthecaptureelement.OurbiotinylatedconjugateoralkalinephosphataseconjugateofMAbtoHIV-1 p24gag (respective codes BC1071-BIOT andBC1071-AP)areusedaslabel,togetherwithappropriatedetectionsystems.

“Do-It-Yourself”ELISAProtocolsforDetectionofHIV-1proteins

ForfurtherInformationpleasecontact:

AaltoBioReagentsLtd.ChurchLane,RathfarnhamVillage,

D14RK22,Ireland.

Tel:+353-1-4900685-Fax:+353-1-4900122E:info@aaltobioreagents.com-W:www.aaltobioreagents.com

16-19 November 2015Dusseldorf - GermanyPlease visit us at: Hall 3 / C64

Rebranding