OPTIGEN Brochure - Hitachi Chemical Diagnostics

Optigen ® Universal Panel 20TECHNOLOGY I N ACTIONALLERGENBirch, WhiteRagweed Mix ITimothy GrassMugwortLatexSoybeanRiceCodfishWheatPeanutEgg whiteCow’s MilkAspergillusCladosporiumAlternariaDogCatCockroach MixMite pMite fLATIN NAMEBetula verrucosa (alba, pendula)Ambrosia elatior/Ambrosia trifidaPhleum pratenseArtemisia vulgarisHevea brasiliensisGlycine maxOryza sativaGadus morhuaTriticum aestirumArachis hypogaeaGallus gallusN/AAspergillus fumigatusCladosporium herbarum/Cladosporium cladosporiodesAlternaria alternata (tenuis)CanisFelis domesticusBlatella germanica/Periplaneta americanaDermatophagoides pteronyssinusDermatophagoides farinaeWith its headquarters in the heart of Silicon Valley and offices around the world, Hitachi Chemical Diagnostics is aglobal leader of in vitro allergy diagnostics with a legacy of innovation. Hitachi Chemical Diagnostics was the firstcompany to introduce a multiple diagnostic test for allergies and one of the first to introduce a chemiluminescentassay system for the detection of lgE antibodies. In addition to OPTIGEN, HCD also produces the reliable CLA ®Allergy Test and the AP 720S Semi-Automated Instrument.Hitachi Chemical Diagnostics, an integral member of the Hitachi Group, works with industry leaders, laboratoriesand distributors around the world to provide the medical community access to the latest in vitro allergy testingtechnology. Hitachi Chemical Diagnostics is committed to innovation, quality, and the strength of the Hitachi brand.Our products are marketed to over 40 countries worldwide. To learn more about Hitachi Chemical Diagnostics andOPTIGEN, please contact us or your local representative, or visit us on the web at www.hcdiagnostics.com.For more performance data and information about the technology behindOPTIGEN, please see Hitachi Chemical Diagnostics’ Monograph, “OPTIGEN:A New Technology for the In Vitro Determination of Allergen-SpecificIgE Levels in Patient Serum.”United States OfficeHitachi Chemical Diagnostics, Inc.630 Clyde CourtMountain ViewCA 94043-2239650.961.5501800.233.6278www.hcdiagnostics.comEuropean OfficeHitachi Chemical Diagnostics, Inc.Hitachi Europe Ltd.Whitebrook ParkLower Cookham RoadMaidenhead, Berkshire, SL6 8YAUnited Kingdom44 (0) 1628.585.590OPTIGEN ® | ALLERGEN-SPECIFIC IgE ASSAYHelping the medical community providequality and affordable allergy care.©Hitachi Chemical Diagnostics, Inc. All rights reserved.Doc. No. 0674 Rev. 01OPTIGEN is a registered trademark and CLA-1 and AP 720S are trademarks ofHitachi Chemical Diagnostics, Inc. in the United States and other countries.

Why OPTIGEN?OPTIGEN Delivers:Over the last few decades, in vitro diagnosis of allergic diseases has become animportant cornerstone. Clinicians have found that allergic diseases can be controlledand their symptoms prevented or minimized. The key is the early diagnosisof the allergic condition and identification of the allergens responsible.Using OPTIGEN as a ‘front-line’ allergy test, the clinician can devise a plan for preventionor treatment of allergic conditions that can make the difference between a chronicillness and a productive, healthy lifestyle.Lenslets collimatethe light output.CoverslipPartition blocks the light emissionfrom adjacent wells.Pette BodyProduct ProfileThe fundamental component of the OPTIGENsystem is the test chamber called a PETTE—a small plastic high-tech device. The device ismade of three molded parts: a body, a coverslip,and a partition.The patient’s blood sample is drawn and theserum is separated and aspirated into thedevice. IgE antibodies in the serum bind tospecific allergens in the device. The operatorthen adds reagents to the device, which produceslight in varying strengths proportionalto the amount of allergen-specific IgE inthe patient sample. Results are measured inthe CLA-1 LUMINOMETER.OPTIGEN for the LabOPTIGEN offers accurate, reliable and reproducible results and user-friendly functionality.• Optimal Sensitivity, Specificity and Efficiency• Simple, Three-Step Process and Same-Day Assay• Affordability• Optimised Panel Format• Minimal Serum Requirement• Internal Quality Controls• Quality and ReliabilityOPTIGEN for the ClinicianOPTIGEN provides prompt and reliable allergy diagnosis for the symptomatic patient.Early diagnosis of allergy in a child has a high predictive value for the developmentof other atopic diseases such as asthma. OPTIGEN easily enables the clinician tointervene at an early stage allowing the child to avoid the development of significantallergic disability.Hitachi QualityOPTIGEN results are accurate, reliable and reproducible,and correlate well with skin testing and single allergensystems. Consistency of OPTIGEN’s allergens isassured with Hitachi Chemical Diagnostics’ AllergenStandardization Program.Light emitted from wellGeometric features in thepette body enhance thewashing ability and fluidicsof the device.OPTIGEN specifically addresses the issues important to the Clinician:• Identification of Early Sensitization Patterns• Beneficial when Diagnosing Patients with Unclear Case History• Good Predictive Value for Identifying Patients at Risk• Identification or Confirmation of Polysensitization• Ideal Alternative when Skin Prick Test is not Indicated• Requires Minimal Amount of Patient SerumLow SerumRequirementsValueOPTIGEN requires minimal serum to be drawn, enablingearly diagnosis in children.With OPTIGEN, clinicians can receive 20 to 36 specificIgE results.Allergen wellPartitionThe partition separatesthe individual wells intodiscrete compartments.Recommended Allergens Based on Symptoms and Age:DiseaseSymptomsAge CategoriesChildren < 3-4 Years Children > 3-4 YearsLow CostOPTIGEN is state-of-the-art allergy testing technology.It eliminates inventory of individual allergens anddecreases waste. With lower serum requirements,smaller volumes of serum controls are necessary,further reducing cost.CoverslipThe coverslip containswells on the channel sidefor the binding of allergensand lenslets on the outerside for light collimation.AsthmaAllergic Rhino-Conjunctivitis(“Hay Fever”)Wheezing, cough,shortness ofbreathNasal and/orocular pruritis• Foods• Pets• Dust Mites• Pollens• Dust Mites• Pollens• Pets• Airborne Mold ParticlesFunctionalityOPTIGEN, with its simple, three-step process and samedayresults, requires minimal training. It provides plentyof “walk-away” time, allowing staff to perform otherduties. The panel format also decreases “handling”for technicians.Pette BodyThe primary function ofthe body is to channelthe stream of fluids.Atopic Dermatitis(Allergic Eczema)Pruritic dermatitiswith or withouturticaria (hives)• Foods• Inhalants (to testatopic risk)- House dust mites- Cat, dog, etc.- Pollens• Foods• Inhalants (to testatopic risk)- House dust mites- Cat, dog, etc.- Pollens