ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology.The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to determine the genotype for multiple blood groups using a nucleic acid technique (NAT). The blood group systems to be genotyped may include Rhesus (CcDEe), Kell (K, k, Kp^a, Kp^b), Duffy (Fy^a, Fy^b, Fy^x), Kidd (Jk^a, Jk^b), Lewis (Le^a, Le^b), MNS (M, N, S, s, U), Xg (Xg^a), Dombrock (Do^a, Do^b), Colton (Co^a, Co^b), Cartwright (Yt^a, Yt^b), Lutheran (Lu^a, Lu^b) and/or Diego (Di^a, Di^b). Some types may, in addition determine ABO blood groups.