Apolipoprotein E (ApoE) reagent kit APO-EASY™

solutionfor PCRdiagnostic

APO-Easy® is the first FDA De Novo authorized and CE-IVDR certified qPCR APOE genotyping kit for clinical laboratories. Designed for routine molecular diagnostics, it enables rapid and accurate determination of the six APOE genotypes (ε2/ε2, ε2/ε3, ε3/ε3, ε2/ε4, ε3/ε4 and ε4/ε4) through the detection of the two clinically relevant single nucleotide polymorphisms (SNPs), rs429358 and rs7412, in human genomic DNA extracted from whole blood, saliva or buccal swab samples.

APO-Easy® supports APOE genotyping for Alzheimer's disease patient stratification using fluorescently labeled FAM and VIC probes for reliable allelic discrimination. The assay is designed to integrate seamlessly into routine molecular diagnostic workflows while delivering fast, robust and easy-to-interpret results.

Why choose APO-Easy®?

• First FDA De Novo authorized and CE-IVDR certified APOE genotyping kit
• Results in less than 2 hours after DNA extraction
• Ready-to-use master mixes requiring only two pipetting steps, reducing hands-on time and minimizing pipetting errors
• High analytical sensitivity with a limit of detection of only 12 ng of genomic DNA
• Compatible with standard real-time PCR systems, including the QuantStudio™ 5 Dx and CFX Opus 96 Dx platforms
• Easy result interpretation directly from the qPCR software, with no dedicated bioinformatics tools required

Workflow

1. Extract
Genomic DNA extraction from whole blood, saliva or buccal swab samples, followed by DNA quantification.

2. Run
Real-time PCR amplification and fluorescent detection of APOE variants using validated qPCR platforms.

3. Analyze
Automatic allelic discrimination and straightforward interpretation of the six APOE genotypes.

Key assay specifications

• Application: Clinical APOE genotyping for Alzheimer's disease patient stratification
• Technology: Real-time PCR (qPCR)
• Target variants: rs429358 and rs7412
• Detected genotypes: ε2/ε2, ε2/ε3, ε3/ε3, ε2/ε4, ε3/ε4 and ε4/ε4
• Operating time: Approximately 2 hours (30 minutes hands-on time for plate preparation and 89-minute PCR run)
• Validated instruments: QuantStudio™ 5 Dx Real-Time PCR System and CFX Opus 96 Dx Real-Time PCR System
• Kit storage: Stable for 6 months at -20°C (ongoing stability studies for extended shelf life)
• Sample stability: PAXgene® Blood DNA Tube samples remain stable for 14 days at room temperature, 28 days at 2–8°C and up to 12 months at -20°C (maximum of 3 freeze-thaw cycles).