AD Risk Detection Kit (Gen.1)

Based on novel monoclonal antibody (world-wide patent application (PCT) submitted), the kit consists of two complementary ELISAs for reliable (>95% ) diagnostics of early dementia stages. Being recently tested on Shanghai cohort, the kit showed much superior performance compared to other blood biomarkers.

Our ELISA kit contains:

A. In-house developed Monoclonal Antibody for isoAsp detection.

B. Aged HSA for complementary detection of natural anti-isoAsp antibodies in blood.

C. Associated generic secondary antibody, detection solution, buffer, and Maxi-sorbent ELISA plate; instruction manual.

Discovery & Background

  • LC-MS/MS revealed LVNEVTEFAK peptide from a functionally important HSA domain to exhibit the highest deamidation rate in aged  HSA.

  • A novel monoclonal antibody (mAb) 1A3 generated against LVNEVTEFAK showed excellent specificity to isoAsp in HSA and no cross-reactivity with other aged proteins.
  • Using indirect ELISA with chemiluminescence we have measured the range of isoAsp in HSA of healthy blood for the first time, determining the safe region being (0.7±0.3)%.
  • We also discovered natural anti-isoAsp antibodies in blood, with their level being reduced in AD. Thus we developed another ELISA using artificially aged HSA as a bait.
  • Combination of both ELISA results  provides a >95% sensitivity in diagnostics of early dementia.

Find more information in our Publications.

Clinical Study outcome

More information on our clinical studies in EU and China can be found in our publications. Briefly, in our latest clinical study the performance validation our kit was found superior compared to other tested blood biomarkers (Aß40, Aß42, NfL, GFAP and pTau181) for mild cognitive impairment (MCI) ahead of dementia diagnosis. The association of deamidation biomarkers with other analysed parameters showed strong correlation with cognitive scores of patients and controls.