Human mBDNF ELISA Assay:
Well Validated, Outstanding Performance and Independently Tested
BDNF belongs to the neurotrophin family and regulates the survival and differentiation of neurons during development. The alterations in BDNF expression induced by various kinds of brain insult including stress, ischemia, seizure activity and hypoglycemia, may contribute to some pathologies such as depression, epilepsy, Alzheimer's, and Parkinson's disease. FUNCTION: Promotes the survival of neuronal populations that are all located either in the central nervous system or directly connected to it. Major regulator of synaptic transmission and plasticity at adult synapses in many regions of the CNS. The versatility of BDNF is emphasized by its contribution to a range of adaptive neuronal responses including long-term potentiation (LTP), long-term depression (LTD), certain forms of short-term synaptic plasticity, as well as homeostatic regulation of intrinsic neuronal excitability. Human BDNF has been assigned the UnitProt ID P23560.
Biosensis' BDNF Rapid ELISA was independently evaluated by Allesio Polacchini and colleagues at the Department of Life Sciences, University of Triesta, Triesta, Italy. Their findings were published in Nature's Scientific Reports, an open access journal publishing original research from across all areas of the natural sciences, psychology, medicine and engineering.
Table 1. BDNF ELISA Kits. Description and main characteristics of the tested BDNF ELISA kits, as declared by the manufacturers (1).
Allesio Polacchini and colleagues found the "Biosensis kit is built on a unique strategy, because it uses the same antibody for both capture and detection, based on the fact that BDNF is naturally occurring as a dimer and therefore, once a monomer is captured, the other monomer is available for detection. The Biosensis kit also provides the quickest procedure (results in less than four hours for a full 96 well plate)" (1).
Table 2. BDNF ELISA Kits Performance. Comparison between declared performances and actual tested performances of the specified BDNF ELISA Kits. Median and range values, intra- and inter-assay coefficients of variation (CV) were assessed by measuring BDNF serum level from healthy volunteers (1).
The Biosensis BDNF Rapid ELISA kit provides uses with the fastest time to results, the best tested inter-assay CV and the best intra-assay CV in comparison to competitor kits. In particular, our BDNF Rapid ELISA showed the lowest coefficient of variation even after the third replica and no significant difference between three independent measurements (1).
Understanding the importance of parallelism studies
The classical purpose of parallelism is to demonstrate that the sample-dilution response curve is parallel to the standard-calibrator response curve, thus confirming that the calibrator material is suitable for measurement of the endogenous analyte (2). That is to say that successful demonstration of parallelism indicates that the selected surrogate matrix (the assay buffer used to carry the standard curve) is appropriate for the assay. It is important to recognize that the sample being measured was taken from a human (or animal) and that sample can contain serum or plasma. There is no serum or plasma in the buffer carrying the standard curve. Testing parallelism accounts for this difference and the potential for a negative impact. Our technical note on parallelism is a great resource.
The difference between parallelism and dilutional linearity
In principle, a parallelism assessment is similar to a dilutional linearity experiment. The major difference between dilutional linearity and parallelism is that dilutional linearity employs control samples with a known quantity of analyte spiked into analyte-free matrix, while parallelism is performed by serial dilution of incurred samples (samples taken from a test subject for assay validation purposes). For biomarker assays, the parallelism experiment enables an assessment of the performance of the assay with respect to endogenous analyte upon dilution. In an ideal situation, samples assessed in the parallelism experiment have high enough concentrations to allow measurement of multiple dilutions that span the assay range, but this is iften not possible when endogenous levels are low (3). In dilutional linearity experiments, the recombinant calibrator is spiked into matrix above the ULOQ (upper level of quantification) and diluted into and then below the range of the standard curve. Each dilution is then calculated for concentration based on the dilution (4). Dilutional linearity results is used to ensure that a sample's measured concentration remains accurate and proportional to its actual concentration after being serially diluted and the data is used to determine if an assay is well developed.
A Well Validated ELISA
Validation against proBDNF. Our extensive technical note provides data regarding potential cross reactivity with proBDNF.
We use the WHO (World Health Organization) standard. The WHO strengthens assay compatibility through its Expert Committee on Biological Standardization (ECBS), which establishes International Standards and Reference Reagents - often recombinant proteins with assigned unitage. Distributed via NIBSC with detailed instructions, these materials serve as primary calibrators for ELISAs/CLIAs, enabling traceability, parallelism checks, and lot-to-lot bridging while reducing bias from glycosylation, folding, or matrix differences. For neuroscience biomarkers like brain-derived neurotrophic factor (BDNF) - where circulating levels are low and preanalytical variables can be large - anchoring kit calibrators to a WHO-endorsed recombinant reference material helps normalize results across platforms and studies, improving longitudinal and multicenter comparability. WHO standards provide the most widely accepted foundation for harmonized reporting, supporting method transfer, regulatory review, and confident interpretation of biomarker trends in both research and translational settings.
Catalog number BEK-2211 allows the quantification of mature BDNF in less than 3 hours in cell culture supernatants, serum, plasma (citrate and EDTA), pig serum, cell lysates, brain extracts, human milk and Sheep CSF. The amino acid sequence of mature BDNF is identical for human, mouse, rat and a number of other species. This kit is therefore suitable to measure mature BDNF in all these species and uses the same antibodies and antigen.
Catalog number BEK-2211-CE is suitable for human samples. This CE Marked BDNF Rapid ELISA Kit is approved for in-vitro diagnostic (IVD) applications in the European Economic Area (EEA). It is not approved for IVD applications in the United States. Catalog number BEK-2211-CE is suitable only for human serum or citrate plasma samples.
Related BDNF products:
- Human proBDNF Rapid ELISA Assay
- Human mBDNF/proBDNF Combo Rapid ELISA Assay
- Human Multi-Neurotrophin Screening Rapid ELISA Assay
- Rat Multi-Neurotrophin Screening Rapid ELISA Assay
Be sure to check out all our ELISA kits!
Related Products and Services:
Our coating buffers, blocking buffers, assay buffers, sample diluents, substrates and stop solutions are ideal for PK, ADA and ELISA assay development.
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References
1. Polacchini A, Metelli G, Francavilla R, Baj G, Florean M, Mascaretti LG, Tongiorgi E. A method for reproducible measurements of serum BDNF: comparison of the performance of six commercial assays. Sci Rep. 2015 Dec 10;5:17989.
2. Mehta D, Purushothama S, Stevenson L. Parallelism: the foundation of biomarker assay development and validation. Bioanalysis. 2018 Jun 1;10(12):897-899.
3. Ciotti, S., Purushothama, S., & Ray, S. (2013). What is Going on with My Samples? A General Approach to Parallelism Assessment and Data Interpretation for Biomarker Ligand-Binding Assays. Bioanalysis, 5(16), 1941–1943.
4. Lee JW, Devanarayan V, Barrett YC, Weiner R, Allinson J, Fountain S, Keller S, Weinryb I, Green M, Duan L, Rogers JA, Millham R, O'Brien PJ, Sailstad J, Khan M, Ray C, Wagner JA. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res. 2006 Feb;23(2):312-28.