Product overviewLumipulse® G pTau 217 Plasma is an in vitro diagnostic (IVD) assay for use on the automated LUMIPULSE G System for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human plasma (K2EDTA). The assay is intended to aid healthcare providers in identifying patients with amyloid pathology associated with Alzheimer’s disease. It is indicated for patients aged 50 years and over presenting with signs or symptoms of cognitive decline in a specialized care setting. For professional use only. The assay is intended to be used as an adjunct to other diagnostic evaluations.
Kit components / formats- Lumipulse® G pTau 217 Plasma Immunoreaction Cartridges — Product number: 81544 — Packaging: 3 x 14 Tests
- Lumipulse® G pTau 217 Plasma Calibrators — Product number: 81545 — Packaging: 1 × 5 Concentrations
Regulatory / intended use notesCE marked (IVDR). For in vitro diagnostic (IVD) use on the automated LUMIPULSE G System. For professional use only. Intended as an aid to identify amyloid pathology associated with Alzheimer’s disease and to be used as an adjunct to other diagnostic evaluations.
Technical characteristics / specifications- Analyte measured: Tau phosphorylated at threonine 217 (pTau 217)
- Sample type: Human plasma (K2EDTA)
- System compatibility: Automated LUMIPULSE G System
- Intended population: Patients aged 50 years and over with signs or symptoms of cognitive decline (specialized care setting)
- Purpose: Aid in identification of amyloid pathology associated with Alzheimer’s disease; adjunct to other diagnostic evaluations
- Regulatory marking: CE marked (IVDR)
- Available formats/products and codes: Immunoreaction Cartridges (81544, 3 x 14 Tests); Calibrators (81545, 1 × 5 Concentrations)