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For more information about PreciseType™ HEA test, please call
855.IMMUCOR (855.466.8267) or visit www.immucor.com.
3130 Gateway DriveP.O. Box 5625Suite A7Norcross, Georgia 30091
In Canada:
©2014 Immucor, Inc. | 510-00008 Rev. B
The PreciseType™ HEA Test Kit
Provides 96 tests in two formats:•8-chipslides(12)•96-chipmicroplate(1)
Supplied in two boxes:•PCR,post-PCR,signal-developmentreagents,andanegativecontrol•BarcodedBeadChipslides/microplateandadiskwiththechip-specific
bead-mapkeyforpost-assayanalysis
CPT Code: 81403
OrderingInformation
Catalog Number Description Number of Chips per Kit
800-20202-08 PreciseType HEA Slide Kit 8x12 Slides; Total 96
800-20202-96 PreciseType HEA Plate Kit 96x1 Plate; Total 96
The first and only FDA-approved in-vitro diagnostic (IVD) for molecular typing of red blood cell (RBC) antigens
NEW Test of Record for Extended Red Blood Cell Antigen Typing!
PreciseType™ HEA (human erythrocyte antigen) Test
Transfuse | Transplant | Transform a life
PreciseType™ HEA test overcomes today’s limitations: •Providesdetailedgenotypicandphenotypicpatientprofiles-acriticalcomponentofthemedicalhealthrecord•Simplifiestheidentificationofrareantigens•AsTestofRecord,confirmationwithantiseraisnotrequired•Enablesroutinecharacterizationofdonorunitsforthemostrelevantantigens•Determinestrueantigenmake-upofrecentlytransfusedpatients•Unaffectedbyautoantibodiesordifferencesinreagentreactivity
References: 1. PreciseType Package Insert.
*HgbS is not intended for the diagnosis of sickle cell disease.
PreciseType™ HEA Test Results are Repeatable and Reproducible*:
PreciseTypeTM HEA test provides clinicians with an exceptional new tool to assist in determining donor-patient compatibility and may enhance patient care.
*Results from a multi-site, multi-operator study assessing reproducibility and repeatability using a fully characterized panel of 11 human genomic DNA samples tested over five (5) days.
RepeatabilityConcordance(%)
Site 1 Site 2 Site 3 TotalWithin-Site 100 100 100 100Within-Operator 100 100 100 100Within-Day 100 100 100 100Within-Sample 100 100 100 100
Reproducibility P-value
SitetoSite 1.00OperatortoOperator 1.00DaytoDay 1.00
Proven Performance...Robust & Efficient! RaisingtheStandardofCare:AdvantagesofMolecularTechnologyFor testing patient and
donor samples. . .
Blood Group RBC Antigens
Rh C (RH2), c (RH4), E (RH3), e (RH5), V (RH10), VS (RH20)
Kell K (KEL1), k (KEL2), Kpa (KEL3), Kpb (KEL4), Jsa (KEL6), Jsb (KEL7)
Duffy Fya (FY1), Fyb (FY2), GATA (FY-2), Fyx (FY2W)
Kidd Jka (JK1), Jkb (JK2)
MNS M (MNS1), N (MNS2), S (MNS3), s (MNS4), Uvar (MNS-3,5W), Uneg (MNS-3,-4,-5)
Lutheran Lua (LU1), Lub (LU2)
Dombrock Doa (DO1), Dob (DO2), Hy (DO4), Joa (DO5)
Landsteiner-Wiener LWa (LW5), LWb (LW7)
Diego Dia (DI1), Dib (DI2)
Colton Coa (CO1),Cob (CO2)
Scianna Sc1(SC1), Sc2 (SC2)
ProvenAccuracy
Knowledge inAction
Power to Maximize
Compatibility
PreciseType™ HEA test generates detailed molecular information from patient and donor samples, rapidly detecting genotypes for accurate prediction of phenotypes.
PreciseType™ HEA test results can be applied to a number of clinical situations and may enhance patient care in certain situations:
•HospitalTransfusionServices•Reducetheriskofalloimmunizationandpainful,potentiallylife-threateningtransfusionreactions•Createadetaileddatabasewithantibodyandmolecularantigentypinginformation
•DonorCenters•Identifyandmaximizeuseofsamplescontainingrareantigens•Providephenotype-matchedproductsforspecialpatientpopulations•Deliverantigen-negativeproductsforpatientswithalloantibodies
Next-generation transfusion diagnostics:PreciseType™ HEA test is a multiplexed molecular assay that:
•TestsforawiderangeofgeneticvariantsaffectingRBCantigenexpression1•Automatedarrayimaging•Computerizeddatamanagement
•Detects24genemutationsandonepolymorphismassociatedwithhemoglobinopathies(HgbS)*•Identifiesthemostrelevant35RBCantigensplusthreephenotypicvariantsfrom11bloodgroupssimultaneously
