We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
LGC Clinical Diagnostics

Roche Diagnostics

Develops, manufactures, and markets a wide range of in vitro diagnostic systems, instruments, reagents, and tests read more Featured Products: More products

Download Mobile App




Events

09 Apr 2024 - 12 Apr 2024
15 Apr 2024 - 17 Apr 2024
23 Apr 2024 - 26 Apr 2024

CSF Immunoassays Aid Diagnosis of Early Alzheimer’s Disease

By LabMedica International staff writers
Posted on 21 Dec 2022
Print article
Image: The Cobas Е 801 Analyzer analytical unit is a high throughput immunochemistry module that performs a broad range of heterogeneous immunoassay tests (Photo courtesy of Dialogue Diagnostics LLC)
Image: The Cobas Е 801 Analyzer analytical unit is a high throughput immunochemistry module that performs a broad range of heterogeneous immunoassay tests (Photo courtesy of Dialogue Diagnostics LLC)

The pathological processes underlying Alzheimer’s disease (AD) begin many years before clinical presentation. Ongoing drug discovery efforts in AD focus on developing disease-modifying treatments aiming to delay onset or progression of dementia and must be initiated early in the disease process.

Cerebrospinal fluid (CSF) biomarkers beta-amyloid (1–42) (Aβ42), phosphorylated tau 181P (pTau181), and total tau (tTau) accurately identify early AD by detecting pathophysiological changes underlying the disease. CSF biomarkers should be measured robustly to aid diagnosis of AD; however, there are difficulties with CSF measurement, including pre-analytical and analytical factors.

Clinical Scientists at the Skåne University Hospital (Malmö, Sweden) and their colleagues assessed the analytical performance of second-generation (Gen II) Elecsys CSF immunoassays (Roche Diagnostics International Ltd, Penzberg, Germany), and adjusted existing cut-offs, to evaluate their potential utility in clinical routine. Samples were analyzed using Elecsys CSF Aβ42, pTau181, and tTau Gen II immunoassays on the Roche Diagnostics’ cobas e 801 analyzer. CSF samples (n>100) were analyzed using a single reagent lot with the three immunoassays on cobas e 801, e 402, e 601, and e 411 analyzers.

The investigators reported that the Gen II immunoassays demonstrated good analytical performance, including repeatability, intermediate precision, lot-to-lot agreement, and platform agreement. Aβ42 Gen I/Gen II immunoassay measurements were strongly correlated. Aβ42 Gen II immunoassay cut-offs were adjusted to 1,030 and 800 ng/L, and pTau181/Aβ42 ratio cut-offs to 0.023 and 0.029, for Gen II and I protocols, respectively. No observations were below the lower limit of the measuring range; above the upper limit, there were none from the AD cohort, and 2.6 and 6.8% from the mild cognitive impairment (MCI) and cognitively normal cohorts, respectively.

The authors concluded that the Elecsys CSF Gen II immunoassays demonstrated good analytical performance on extended cobas e platforms, including precision, lot-to-lot comparisons, and platform agreement, supporting their use in clinical routine to aid diagnosis of early AD. Elecsys CSF Gen II immunoassays provide additional benefits over the Gen I immunoassays, without compromising technical performance. Good technical performance of the immunoassays, plus reduced pre-analytical variability (a result of the new protocol), may provide a solution towards unified biomarker testing and timely diagnosis for patients with early AD. The study was published on October 24, 2022 in the journal Clinical Chemistry And Laboratory Medicine.

Related Links:
Skåne University Hospital
Roche Diagnostics International

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Specimen Collection & Transport
Complement 3 (C3) Test
GPP-100 C3 Kit
New
Gold Member
Plasma Control
Plasma Control Level 1

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria (Photo courtesy of Roche)

First FDA-Approved Molecular Test to Screen Blood Donors for Malaria Could Improve Patient Safety

Malaria, a serious illness that often leads to death, is spread by a specific mosquito species that infect humans with a parasite. Other transmission modes include blood transfusions, organ transplants,... Read more

Hematology

view channel
Image: The low-cost portable device rapidly identifies chemotherapy patients at risk of sepsis (Photo courtesy of 52North Health)

POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.