Comparison of Two Real-Time PCR Assays for Apolipoprotein E Genotyping / 임상검사와정도관리

ABSTRACT

Apolipoprotein E (APOE) polymorphisms are used as biological markers to assess the risk of cardiovascular disease, dyslipidemia, and Alzheimer's disease. Consequently, APOE genotyping is one of the most frequently conducted tests in clinical molecular laboratories. Although APOE genotyping may appear to be uncomplicated and a relatively easy test to perform, genotyping errors can still occur due to polymorphisms near codons 112 and 158 in the human APOE gene. Therefore, validation and verification of APOE genotyping assays before clinical use are essential. So far, we have been using the TaqMan SNP Genotyping Assay (Life Technologies, USA). However, recently, the Real-Q ApoE genotyping kit (BioSewoom, Korea) was approved by the Korean Ministry of Food and Drug Safety, which led us to compare the results obtained from this genotyping kit to those of the TaqMan SNP Genotyping Assay. The Real-Q ApoE genotyping kit yielded correct genotyping results for all six APOE genotypes and provided concordant results with the TaqMan SNP Genotyping Assay in a series of blinded comparison samples. Thus, we validated its use in clinical tests.