Details

Autor(en) / Beteiligte

• Hemken, Philip M.
• Jeanblanc, Nicolette M.
• Rae, Tracey
• Brophy, Susan E.
• Datwyler, Maria J.
• Xu, Ying
• Manetz, T. Scott
• Vainshtein, Inna
• Liang, Meina
• Xiao, Xiaodong
• Chowdhury, Partha S.
• Chang, Chien-ying
• Streicher, Katie
• Greenlees, Lydia
• Ranade, Koustubh
• Davis, Gerard J.

Titel

Development and analytical performance of a new ARCHITECT automated dipeptidyl peptidase-4 immunoassay

Ist Teil von

• Practical laboratory medicine, 2017-12, Vol.9, p.58-68

Ort / Verlag

Netherlands: Elsevier B.V

Erscheinungsjahr

2017

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Dipeptidyl peptidase-4 (DPP-4) may be a suitable biomarker to identify people with severe asthma who have greater activation of the interleukin-13 (IL-13) pathway and may therefore benefit from IL-13-targeted treatments. We report the analytical performance of an Investigational Use Only immunoassay and provide data on the biological range of DPP-4 concentrations. We assessed assay performance, utilising analyses of precision, linearity and sensitivity; interference from common endogenous assay interferents, and from asthma and anti-diabetic medications, were also assessed. The assay was used to measure the range of serum DPP-4 concentrations in healthy volunteers and subjects with diabetes and severe, uncontrolled asthma. The total precision of DPP-4 concentration measurement (determined using percentage coefficient of variation) was ≤5% over 20 days. Dilution analysis yielded linear results from 30 to 1305ng/mL; the limit of quantitation was 19.2ng/mL. No notable endogenous or drug interferences were observed at the expected therapeutic concentration. Median DPP-4 concentrations in healthy volunteers and subjects with asthma or Type 1 diabetes were assessed, with concentrations remaining similar in subjects with diabetes and asthma across different demographics. These analyses indicate that the ARCHITECT DPP-4 Immunoassay is a reliable and robust method for measuring serum DPP-4 concentration. [Display omitted] •DPP-4 may be a suitable biomarker for identifying people with IL-13-driven asthma.•The new automated DPP-4 immunoassay is performed on the ARCHITECT i System.•This Investigational Use Only assay reliably measures serum DPP-4 concentrations.•This assay could be used to identify subjects who might respond to tralokinumab.•This assay is being utilised in Phase III severe asthma studies of tralokinumab.