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A precise diagnostic tool

Learn about what to expect from the Elecsys® Phospho-Tau (181P) CSF and β-Amyloid (1-42) CSF II assays

Reliable results with Elecsys® β-Amyloid (1-42) CSF II and Phospho-Tau (181P) CSF assays1

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

Elecsys® pTau181/Abeta42 ratio: accurate and precise AD tool3

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® assays run on cobas® immunoassay platforms

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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1. Elecsys® Method Sheet: ms_08821941501, ms_08846715501
2. Bittner T, et al. Alzheimers Dement. 2016;12(5):517-526.
3. Alzheimer's Association Quality Control: 2014 (Round 14) to 2019 (Round 30).
4. Sabbagh, et al, Neurol Ther. 2017 Jul;6(Suppl 1):83-95.
5. Cognat E, et al. BMJ Open. 2019;9(5):e026380.
6. Hansson O, et al. Alzheimers Dement. 2018; 14(11):1470-1481.
7. Schindler SE, et al. Alzheimers Dement. 2018; 14(11):1460-1469.
8. Shaw LM, et al. Alzheimers Dement (Amst). 2018;10:698-705.
9. Salvado G, et al. Alzheimers Res Ther. 2019;11(1):27.
10. Doecke JD, et al. Alzheimers Res Ther. 2020;12(1):36.
11. CPS Finance Report from Tableau, Yend 2018 IP and ICB Report.