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Pract Lab Med. 2017 Oct 20;9:58-68. doi: 10.1016/j.plabm.2017.10.003. eCollection 2017 Dec.

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

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Diagnostics Division, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, USA.
Translational Sciences, MedImmune, One MedImmune Way, Gaithersburg, MD 20878, USA.
Clinical Pharmacology and DMPK, MedImmune, 319 N Bernardo Ave, Mountain View, CA 94043, USA.
Antibody Discovery and Protein Engineering, MedImmune, One MedImmune Way, Gaithersburg, MD 20878, USA.
Translational Medicine, MedImmune, One MedImmune Way, Gaithersburg, MD 20878, USA.



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 1305 ng/mL; the limit of quantitation was 19.2 ng/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.


Asthma; Automated immunoassay; BGG, bovine gamma globulin; BMI, body mass index; Biomarker; CI, confidence interval; CLSI, Clinical Laboratory Standards Institute; CV, coefficient of variation; DPP-4, dipeptidyl peptidase-4; Dipeptidyl peptidase-4; HAMA, human anti-mouse antibodies; IL-13; IL-13, interleukin-13; IUO, Investigational Use Only; Ig, immunoglobulin; LoB, Limit of Blank; LoD, Limit of Detection; LoQ, Limit of Quantitation; PI, prediction interval; RF, rheumatoid factor; RLU, relative light units; SRT, serum tube-red top; SST, serum separator tube; Th2, T-helper-2; mAb, monoclonal antibody

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