[P4–467]: LUMIPULSE ^® G TOTAL TAU: KEY PERFORMANCES OF A FULLY AUTOMATED CHEMILUMINESCENT IMMUNOASSAY

Today levels of β-amyloid(1–42) peptide and total Tau in cerebrospinal fluid (CSF) are well-accepted biomarkers representing Alzheimer's disease (AD) from the earliest stages on. Widespread use of these biomarkers in AD diagnosis requires reliable, highly precise, and accurate measurements. Analytical requirements and performance on CSF samples of the novel Lumipulse G Total Tau assay (CE-marking ongoing), a fully automated chemiluminescent enzyme immunoassay were verified. The LUMIPULSE G instruments use single analyte, ready-to-use immunoreaction cartridges with a throughput of 60 and 120 tests/hour for the G600II and the G1200 instrument, respectively. Sequential immunoreaction steps are carried out while the cartridge is transported through the system. Each cartridge generates quantitative results within approximately 30 minutes and multiple assays can be easily combined in the system. The Lumipulse G Total Tau assay has been developed using established monoclonal antibodies. The analytical assay performance was characterized according to CLSI guidelines. Quantitative determination of total Tau levels on CSF samples from patients visiting a memory clinic was performed at an external lab and used for a measurement comparison versus INNOTEST® hTau Ag. Using a panel of CSF and control samples, assay variability was determined and the obtained coefficient of variation seen for the different variability components show a high level of precision: a clear result from the use of a standardized and automated assay platform. Low concentrated CSF samples were used to demonstrate the good analytical sensitivity (LoD and LoQ) of the assay. Linearity was shown across the clinical relevant range. A method comparison study with the routinely used INNOTEST hTau Ag assay resulted in a good correlation (r=0.93) and strong agreement (slope = 0.91, intercept = 22 pg/mL). Automation, the mono test cartridge principle, short throughput times, and instrument flexibility are key attributes of the LUMIPULSE G instrument series making it the ideal platform to fulfill today's needs for rapid and accurate quantification of CSF biomarkers in both low and high throughput clinical laboratories. The novel Lumipulse G Total Tau assay shows good sensitivity and precision, and correlates well with the established INNOTEST assay.