Test description and reagents composition
The e4Risk test is a CE-marked and commercially available immunoturbidimetry test composed of two ready-to-use reagents (R1 and R2), one calibrator, and positive and negative controls, which are used as quality controls of the assay.
R1 is provided as a solution containing an anti-apoE4 antibody in a Bis-Tris buffer, BSA, and sodium azide. R2 is a suspension containing latex particles, in a Tris buffer with sodium azide. Calibrator and controls are provided as a lyophilized powder. Calibrator consists of a matrix composed of a pool of plasmas from APOE ε4 non-carriers and sucrose, spiked with human recombinant ApoE4. Positive and negative controls consist of a pool of plasmas from APOE ε4 carriers and APOE ε4 non-carriers.
Materials and reagents
The following key raw materials were used during the validation process:
Human recombinant ApoE4…
