Molecular genetic blood group typing by the use of PCR-SSP technique

BACKGROUND: DNA-based methods are useful for enhancing immunohematology typings. Ready-to-use Conformite Europeenne (CE)-marked test kits based on polymerase chain reaction with sequence-specific priming (PCR-SSP) have been developed, which enable the examination of weak, unexpected, or unclear serologic findings. DEVELOPMENT AND VALIDATION: Primers were designed according to established mutation databases. Proficiency testing for CE marking was performed in accordance with Directive 98/79EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostic medical devices using pretyped in-house and external samples. INTENDED USE: BAGene PCR-SSP kits are in vitro diagnostic devices. Genotyping of ABO and RHD/RHCE as well as HPA and KEL, JK, and FY specificities has to be performed after the conclusion of the serologic determination. APPLICATION: Ready-to-use PCR-SSP typing kits allow the determination of common, rare, or weak alleles of the ABO blood group, Rhesus, and Kell/Kidd/ Duffy systems as well as alleles of the human platelet antigens. RESULTS: The investigations showed clear-cut results in accordance with serology or molecular genetic pretyping. CONCLUSION: PCR-SSP is a helpful supplementary technique for resolving most of the common problems caused by discrepant or doubtful serologic results, and it is an easy-to-handle robust method. Questionable cases in donor, recipient, and patient typing can be examined with acceptable cost.