It was reported that the sample (b)(6), from (b)(4), was tested with serology.The test result was positive (c+), which contrasted with the molecular typing performed on (b)(6) 2023, using the id core xt assay which provided negative results (c-), with id core xt analysis software v3.0.2.
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The genomic dna sample was sent to grifols laboratory solution for sequencing.Next generation sequencing interrogated rh genes proximal promoter, exons 1-10, and portions of intron 2-3.No variant was found in rh genes and sequencing provided a genotype rhce*ce, rhce*ce, but id core xt reported a genotype rhce*ce.Id core xt determines c antigen interrogating polymorphism rhce: (b)(6) in rhce gene intron 2.The presence of the 109 bp insert is associated with c antigen.However, this sample contains the rare rhce*02.37 allele, as identified by the isbt, which is characterized by the absence of the 109 bp insert and results in a c+ phenotype.Id core xt predicted a c- phenotype, however the serology data from the user indicated a c+, due to the presence of rare rhce*02.37 allele.Since id core xt obtained a false negative result, this is considered a discrepant result and then a malfunction this limitation is covered by the general assay limitation described in the id core xt package insert (limitation 1).
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