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

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NEWS NEWS The IVD industry is moving towards nucleic acid based diagnostics for faster detection of infectious diseases. The challenge for laboratories is inding effective and affordable control technology to monitor processes from start to inish, and report patient results. Aalto Bio Reagents entered the molecular diagnostics market in 2015 with AaltoCC, our new range of external run controls designed to address the quality and regulatory challenges facing molecular diagnostics laboratories. The AaltoCC controls act like human patient samples and are suitable for daily control of both the extraction and ampliication processes. AaltoCC controls are supplied in kits of 10 vials (200ul or 1ml) and will be available for the following targets : · Cytomegalovirus (plasma) · Chlamydia trachomatis (exudate) · Chlamydia trachomatis (urine) · Chlamydia trachomatis/Neisseria gonorrhoeae (exudate) · Chlamydia trachomatis/Neisseria gonorrhoeae (urine) · Epstein Barr Virus (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) · Mycobacterium tuberculosis (sputum) · Mycobacterium tuberculosis INH resistant strains (sputum) · Mycobacterium tuberculosis RIF resistant strains (sputum) · Neisseria gonorrhoeae (exudate) · Neisseria gonorrhoeae (urine) · VZV (CSF) Under development · BK Virus (plasma) · JC Virus (plasma) · HPV (exudate) Molecular Molecular Diagnostics Controls Disease State Plasmas Antisera Infectious Disease Antigens Antibodies Proteins Tumour Markers Cardiac Markers Quality ISO 9001:2008 NSAI Certied Arboviruses Arthropod-borne viruses (arboviruses) are important causes of human disease nearly worldwide. In recent years the numbers of reported cases of Arbovirus such as Dengue, Chikungunya and Zika virus has been increasing. These viruses are spread by the bite of an infected Aedes mosquito and cannot be spread directly from person to person. Outbreaks of endemic mosquito- borne illnesses are common in the tropical and sub- tropical climates of Australia, Asia, tropical Africa and South America. Arboviruses, particularly Dengue, can be serious diseases with symptoms including high fever, headache, pain behind the eyes, joint pain, muscle and bone pain and rash. With Dengue, patients may experience mild bleeding (e.g. gums and nose bleeds). The early clinical manifestations of Dengue, Chikungunya and Zika virus are very similar so it is important to differentiate between the three in order to eliminate Dengue. NSAIDs can alleviate symptoms in Chikungunya and Zika virus but should be avoided in patients with Dengue due to risk of haemorrhaging. Laboratory diagnosis is generally accomplished by testing serum or plasma to detect virus, viral nucleic acid, or virus-speciic immunoglobulin M and neutralizing antibodies. Aalto Bio Reagents are now supplying a full range of Zika, Chikungunya and Dengue virus antigens. These antigens can be used as components for development of diagnostic assays. Ÿ Recombinant Chikungunya E1 antigen, mutant Ÿ Recombinant Chikungunya E1 antigen, wild type Ÿ Recombinant Chikungunya E2 antigen Ÿ Recombinant Zika virus envelope antigen Ÿ Recombinant Zika virus NS1 antigen Ÿ Recombinant Dengue NS1 (types 1 – 4) Ÿ Recombinant Dengue envelope proteins (type 1 – 4) Please contact us for further information.

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Page 1: NEWS news letter.pdf · NEWS The IVD industry is moving towards nucleic acid based diagnostics for faster detection of infectious diseases. ... can alleviate symptoms in Chikungunya

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.

Rebranding

Page 2: NEWS news letter.pdf · NEWS The IVD industry is moving towards nucleic acid based diagnostics for faster detection of infectious diseases. ... can alleviate symptoms in Chikungunya

NEWSNEWS

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

Page 3: NEWS news letter.pdf · NEWS The IVD industry is moving towards nucleic acid based diagnostics for faster detection of infectious diseases. ... can alleviate symptoms in Chikungunya

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

Rebranding

Page 4: NEWS news letter.pdf · NEWS The IVD industry is moving towards nucleic acid based diagnostics for faster detection of infectious diseases. ... can alleviate symptoms in Chikungunya

NEWSNEWS

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:[email protected]:www.aaltobioreagents.com

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

Rebranding