Amyloid beta (1-42) (Abeta42) and phosphorylated tau (pTau181) cerebrospinal fluid (CSF) biomarkers' role is increasingly recognized in supporting Alzheimer’s disease (AD) and mild cognitive impairment (MCI) diagnosis.²

Implementation of biomarkers in routine clinical use has been difficult as the only assays available were performed with manual enzyme-linked immunoabsorbent (ELISA) technique.²

Roche has launched Elecsys® Elecsys® β-Amyloid (1-42) CSF II and Phospho-Tau (181P) CSF assays.

The Elecsys® AD pTau181/Abeta42 ratio demonstrates high within laboratory precision, with a coefficient of variation of ≤ 3.8%.¹ on the cobas® e 601 analyzer¹

The performance of the test for African American, Asian and other races had a high uncertainty due to the limited number of patients studied¹

Currently, physician confidence in diagnosing based on cognitive tests, clinical signs, and other nonspecific tests is low.⁴ However, confirmation of amyloid pathology increases diagnostic confidence and may lead to reduction in some diagnostic procedures.^4,5

The Elecsys® pTau181/Abeta42 ratio is designed to quantify levels of key biomarkers of AD (Abeta42 and pTau181), with a high degree of reliability and precision.¹

Proven concordance of Elecsys® pTau181/Abeta42 ratio with amyloid positron emission tomography (PET) in assessing amyloid pathology is high and robust across a range of amyloid PET tracers and quantification methods, as validated in independent studies in various patient populations and study cohorts.^6-10

Elecsys® Abeta42 assay has been standardized against the 3 certified reference materials (CRMs), ERM®-DA480/IFCC, ERM®- DA481/IFCC, and ERM®-DA482/IFCC.¹

Elecsys pTau181 assay has been standardized against a purified reference material Tau(172‑205)[pThr181]amide, absolutely quantified via amino acid analysis.¹

Elecsys® pTau181/Abeta42 ratio runs on all cobas e immunoassay platforms: cobas e 411, e 601/602, e 801, and e 402.

cobas e instruments are fully automated, providing results in 18 minutes.¹

Roche's extensive install base in the U.S. allows for easily accessible cobas e platforms.¹¹

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