Performance evaluation of three platforms with ultrasensitive ligand-binding assay potential.

AIM: We evaluated three immunoassay-based technologies and their biomarker kits, by determining precision, parallelism and detectability of analytes of interest. MATERIALS & METHODS: We compared ultrasensitive assays for three biomarkers: interleukins IL-6, IL-13 and IL-17A using kits obtained from Roche (IMPACT platform - proprietary platform), Singulex (Erenna®) and Quanterix (Simoa™). We defined the true LLOD as the LLOQs, and provided disease-specific parallelism results and detectability levels for endogenous analyte, which were good across platforms, though they varied from analyte to analyte. CONCLUSION: We highlight a simplified approach employed for evaluating ultrasensitive kits and provide an overview of the methodologies used to compare available assays. All three platforms are able to detect very low-level analytes. We recommend all three platforms for detection of very low-level analytes.

Bioanalytical challenges and improved detection of circulating levels of IL-13.

BACKGROUND: IL-13 is a key mediator of type 2 inflammation-driven diseases. Circulating IL-13 levels are very low and challenging to detect reliably. We assessed the ability of immunoassays on the Erenna(®) and IMPACT platforms to measure serum IL-13 in asthma, idiopathic pulmonary fibrosis (IPF) and atopic dermatitis (AD) patients and in healthy controls (HC). RESULTS: The Erenna IL-13 assay exhibited significant specificity issues and had limited ability to detect IL-13 in serum samples. The IMPACT IL-13 assay had excellent specificity and detected IL-13 in 100% of serum samples tested from asthma, IPF and AD patients and HC. Serum IL-13 levels were significantly elevated in asthma, IPF and AD patients, relative to HC. CONCLUSION: The IMPACT IL-13 assay had fg/ml sensitivity and excellent specificity, enabling reliable detection of circulating levels of IL-13.