Immunoassays to Bring Your Neurodegenerative Therapeutics to Market
Rules-Based Medicine recently added new Simoa-based, ultrasensitive immunoassays to support the development of new diagnostics and therapeutics. RBM has developed and manufactured high quality assays that are validated to clinical laboratory standards. CNS biomarkers show promise in diagnosing neurological disorders and injuries, monitoring disease progression, and evaluating potential therapies in clinical trials.
While CSF protein biomarkers remain the gold standard, blood-based biomarkers offer the advantages of providing broader, more equitable access to testing, faster and easier sample collection, and ultimately, opportunities for earlier diagnosis and treatment. The Simoa ultrasensitive immunoassay platform has proven itself to be the most reliable method for accurately quantifying the lower levels of CSF biomarkers leaking into the blood stream.
Rules-Based Medicine offers the following ultrasensitive immunoassays, which have been validated in serum, plasma and CSF:
| Biomarker | LLOQ* (Serum and Plasma) |
LLOQ* (Undiluted Samples) |
Volume Required | |
|---|---|---|---|---|
| Serum or plasma | Other fluids** | |||
| Alpha-synuclein Simoa (A-Syn Simoa) | 0.20 ng/mL | 0.01 ng/mL | 100 µL | 150 µL |
| Beta Amyloid 40 (AB40) | 28 pg/mL | 5.6 pg/mL | 100 µL | 150 µL |
| Beta Amyloid 42 (AB42) | 47 pg/mL | 4.7 pg/mL | 50 µL | 150 µL |
| Glial Fibrillary Acidic Protein (GFAP) | 0.70 pg/mL | 0.175 pg/mL | 100 µL | 150 µL |
| Myeloid cell surface antigen CD33 (CD33) | 0.11 ng/mL | 0.0022 ng/mL | 100 µL | 150 µL |
| Neurofilament Light Chain (NF-L) | 1.00 pg/mL | 0.25 pg/mL | 100 µL | 150 µL |
| Neurofilament heavy polypeptide – phosphorylated (pNF-H) | 3.8 pg/mL | 0.95 pg/mL | 100 µL | 150 µL |
| Phospho-Tau181 (pTau181) | 0.28 pg/mL | 1.4 pg/mL | 150 µL | 150 µL |
| Phospho-Tau217 (pTau217) | 0.027 pg/mL | 0.00675 pg/mL | 100 µL | 150 µL |
| Tau | 0.22 pg/mL | 0.055 pg/mL | 100 µL | 150 µL |
| Triggering Receptor Expressed On Myeloid Cells 2 Simoa (TREM2 Simoa) | 0.59 ng/mL | 0.59 ng/mL | 100 µL | 150 µL |
* Lower limit of quantitation (LLOQ) represents the lowest amount of an analyte that can be quantitatively determined with acceptable precision. LLOQ is determined by performing 2-fold serial dilutions of Standard to be tested in triplicate over three runs. The percent coefficient of variation (CV) is calculated for each of the dilution replicates, and the LLOQ is determined as the concentration at which the CV is 30%.
** Cerebrospinal fluid, urine, tissue culture supernatants, bronchoalveolar lavage, synovial fluid, tissue extracts, tears, skin washings, etc.