Apolipoprotein E (ApoE) reagent kit APO-Easy® (CE-IVDR)

solutiondiagnosticfor DNA extraction

APO-Easy® is a CE-IVDR genotyping test based on qPCR, intended for the detection of two single-nucleotide-polymorphisms (SNP) rs429358 and rs7412 in human genomic DNA from whole blood, saliva and buccal swab through the use of fluorescently labeled probes (FAM and VIC) allowing allelic discrimination and determination of six Apolipoprotein E (APOE) genotypes: e2/e2, e2/e3, e3/e3, e2/e4, e3/e4, and e4/e4. • 100% ACCURACY RATE, exhibiting outstanding analytical performance with perfect reproducibility and repeatability. • 2 HOURS to complete the entire process • 20% REDUCTION IN MASTER MIX VOLUME, yet the reliability is maintained demonstrating its robustness • LIMIT OF DETECTION of 12ng, ensuring sensitivity in detecting target genetic material. Process: 1. Extract: Genomic DNA (gDNA) extraction from whole human blood, saliva and buccal swab collected into PAXgene Blood DNA tubes and quantification. 2. Run: qPCR amplification and fluorogenic detection of APOE mutations using QS™ 5 Dx RT-PCR System and CFX Opus 96 Dx RT-PCR System 3. Analyze: Sample result analysis and interpretation. Key assay parameters: • OPERATING TIME: The procedure comprises two phases-30 minutes for plate preparation and 1 hour and 29 minutes for the qPCR cycle. • ASSAY VALIDATION: Validated on the QuantStudio 5 Dx Real-Time PCR system • KIT STORAGE: The kit can be stored at -20°C for 6 months, ongoing stability studies will determine its long-term stability. • SAMPLE STORAGE: PAXgene® Blood DNA Tube Samples are stable for 14 days in RT, 28 days between 2-8°C, and 12 months at -20°C (up to 3 FTCs).