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Method Validation of Dipeptidyl Peptidase 3 Assay
Leslie J Donato1, Jeffrey W Meeusen1, Renee' J Scott1
1Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine and Science, Rochester, MN, United States.
The Journal of Applied Laboratory Medicine
|November 13, 2025
Summary
A new assay precisely measures Dipeptidyl peptidase 3 (DPP3) in plasma, a marker linked to poor outcomes in shock patients. Careful sample handling is needed to avoid hemolysis, which affects DPP3 measurements.
Area of Science:
- Biochemistry
- Clinical Chemistry
- Assay Development
Background:
- Dipeptidyl peptidase 3 (DPP3) is released from dying cells and impacts the renin-angiotensin pathway.
- Elevated DPP3 levels correlate with adverse outcomes, especially in shock patients.
Purpose of the Study:
- To evaluate the analytical performance of a novel immunoluminometric assay for DPP3 in human plasma.
- To establish the reliability and applicability of the DPP3 assay for clinical use.
Main Methods:
- DPP3 concentration was measured using an immunoluminometric assay.
- Analytical performance characteristics including precision, linearity, accuracy, and stability were assessed.
- Interference from common substances and hemolysis was evaluated.
Main Results:
- The assay demonstrated a limit of detection of 1.6 ng/mL with high precision (CV ≤ 6%).
- Linearity and comparability were confirmed across a wide range (7.7–195.2 ng/mL).
- Hemolysis interfered with measurements, while lipemia and bilirubin did not; DPP3 was stable in EDTA plasma.
Conclusions:
- The immunoluminometric DPP3 assay provides precise measurements in EDTA plasma.
- Clinical application in critical care is feasible, but pre-analytical hemolysis must be avoided during sample collection.
