A new set of CE-IVD marked kits is now available for specific diagnosis of Alzhiemer’s disease, and additional kits will help diagnose Parkinson’s and Creutzfeld-Jakob diseases.

Analytik Jena AG (Jena, Germany) now offers 2 new kits for diagnosing Alzheimer’s disease from cerebrospinal (CSF) fluid of patients with suspected Alzheimer’s: hTAU total ELISA kit for analyzing total tau and pTAU rel ELISA kit for analyzing a new form of tau. These CE-IVD marked kits enable a diagnostic quality that achieves exceptional results in terms of specificity and sensitivity. The standardized kits are quick and easy to use, and well suited to automation on relevant platforms in routine diagnostics.

Analytik will also continue to provide kits for detecting human α-synuclein (Human α-Synuclein MONO ELISA kit) and its pathological aggregates (Human α-Synuclein PATHO ELISA kit). Initial clinical trials have already shown their suitability as diagnostic tests for the detection of Parkinson’s disease (Unterberger et al. 2014). “The high specificity is down to the unique characteristics of the 5G4 antibody, which has set new standards in the diagnostics of conditions such as Parkinson’s disease (Kovacs et al. 2012 and 2014),” said Dr. Ingolf Lachmann, head of Research & Development at Analytik Jena’s subsidiary AJ Roboscreen GmbH (Leipzig, Germany).

A third area of focus is the differential diagnostics of rapid-onset Creutzfeld-Jakob disease (CJD), which is caused by prions. Distinguishing CJD from forms of dementia such as Alzheimer’s is a major challenge in neurochemical diagnostics. A recent study showed that atypical cases of Alzheimer’s could be clearly distinguished from CJD via the detection of prions in CSF samples (Dorey et al. 2015). “The BetaPrion HUMAN EIA ELISA enables precisely this quantification of the biomarker and will turn into an essential test for distinguishing CJD from Alzheimer’s disease,” said Dr. Lachmann.

“Some neurodegenerative diseases are the result of protein aggregation, which can now be measured in a highly specific way and in different stages. To do this, we take all neurodegenerative diseases into consideration and develop diagnostic tests that enable a multiparameter analysis. This puts us in a position to be able to differentiate more effectively between different diseases that may have similar symptomatic profiles,” explained Dr. Lachmann. Recombinant proteins, and the development and manufacture of innovative monoclonal antibodies that bind specifically to the biomarkers in the patient, form the basis for development of these immunoassays.

The number of people with dementia in the aging societies of some developed countries is estimated to double by about 2050. “Care requirements are very high, and improved diagnostics could help promising therapies be implemented more quickly and in a more targeted way,” said Alexander Berka, head of Life Science at Analytik.

Analytik will present its innovative neurodegenerative disease immunoassays and antibodies for clinical diagnostics and for research and development at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD) in Nice (France) in March 18–22, 2015, and at the Neuroscience event in Chicago (USA) on October 17–21, 2015.

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