Sponsored Content by QuanterixReviewed by Olivia FrostJun 4 2024
Tau is a microtubule-stabilizing protein predominately revealed in central nervous system (CNS) neurons and astrocytes and oligodendrocytes at low levels. Tau is comprised of six isoforms in the human brain with molecular weights from 48-67 kDa.
In normal conditions, tau is predominately located in the neurons. Increased tau in cerebrospinal fluid (CSF) is a key indicator of severe brain injuries and neurodegenerative diseases, revealing an extracellular release during neuronal damage.
Among its phosphorylation sites, aberrant phosphorylation of tau at threonine 181 (p-Tau 181) leads to the formation of neurofibrillary tangles, a hallmark pathological feature of Alzheimer's disease (AD).
Increases in p-Tau 181 in CSF and blood are frequently connected to cognitive impairment and neurodegeneration in AD patients. This makes p-Tau 181 a vital diagnostic and prognostic indicator.
How to measure p-Tau 181
The Simoa® p-Tau 181 assay is an ultra-sensitive digital immunoassay providing a quantitative determination of p-Tau 181 in human serum, EDTA plasma and CSF. Quanterix provides Simoa® p-Tau 181 testing in human EDTA plasma and CSF as a Laboratory Developed Test (LucentAD) that was validated under CLIA. The U.S. FDA has not yet approved this test as an in vitro diagnostic.
What is the Simoa® difference?
Simoa® is an innovative digital immunoassay technology providing up to x1000 times more sensitivity than standard sandwich-based immunoassay methods.
Traditional ELISA measurements are restricted to pg/ml levels of identification. Quanterix Simoa®, on the other hand, achieves sensitivity at femtogram (fg/ml) levels and provides an exceptional standard in early, ultra-sensitive identification and determination of proteins below the typical lower limit of quantification (LLOQ).
Simoa® is based on the segregation of individual immunocomplexes on paramagnetic beads utilizing standard ELISA reagents. The biggest distinction between Simoa® and traditional immunoassays is its ability to contain single molecules in femtoliter-sized wells and produce a "digital" readout for each individual bead, determining if it has bound to the target analyte.
Simoa® p-Tau 181 testing is provided by Quanterix as a lab-developed test (Lucent AD) per CLIA and CLSI guidelines. Quanterix's modern facility has a CLIA-licensed laboratory that provides services to over 400 customers globally.
Neurological disorders are one of the most difficult to diagnose and treat early. Symptoms can be invisible, resulting in neuronal injury and neurodegeneration being overlooked or misdiagnosed. Subtle symptoms and the biased nature of assessments make early identification of these diseases complicated.
There are no conclusive tests for the early detection of neurodegenerative diseases like AD. Only when symptoms appear can clinicians provide a definitive diagnosis. As a result, many patients wait years for a diagnosis and a comprehensive treatment plan.
p-Tau 181 has become a vital biomarker of AD pathology and neuronal injury. It has been established as a valuable addition to assessing AD pathology. Its specific connection to AD pathology differentiates it from other biomarkers and highlights how vital it is to clinical research and practice.
Advancements in assay methodology, like Simoa® technology, have simplified the precise and ultra-sensitive evaluation of p-Tau 181 levels in biofluids, increasing its value for early detection and differential diagnosis of AD.
A large number of studies have validated the use of Simoa® immunoassays in detecting and measuring biomarkers that promise early identification and prognosis for a variety of neurodegenerative diseases and conditions.
About Quanterix 
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Quanterix’s Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Limit of Quantification (LoQ) of conventional analog methods.
Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 2,500 peer-reviewed journals.
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