Analytical validation of a novel multi-analyte plasma test for lung nodule characterization

Area of Science:

• Biochemistry
• Medical Diagnostics
• Oncology

Background:

• Lung nodules found on CT scans are often benign (96.4%) but require differentiation from malignant ones.
• Accurate characterization of lung nodules is crucial to avoid unnecessary invasive procedures and patient harm.
• A novel multi-analyte immunoassay aims to improve lung nodule risk assessment.

Purpose of the Study:

• To analytically validate multiplexed plasma protein assays for a new lung nodule risk characterization test.
• To confirm the performance of assays measuring Epidermal Growth Factor Receptor (EGFR), Prosurfactant protein B (ProSB), and Tissue Inhibitor of Metalloproteinases 1 (TIMP1).

Main Methods:

• A multiplexed immunoassay panel was evaluated in a clinical laboratory setting.
• Assay sensitivity, reproducibility, precision, and analyte recovery were assessed across various conditions.
• Interference from substances and sample storage effects were analyzed. Lung nodule risk score reproducibility was also evaluated.

Main Results:

• Assay sensitivities were 0.10 ng/mL (EGFR), 0.02 ng/mL (ProSB), and 0.29 ng/mL (TIMP1).
• Assays demonstrated robustness to pre-analytical handling and plasma storage up to 4 days at 4°C.
• Total imprecision remained under 9%, with risk score variability within ±10%.

Conclusions:

• The multi-analyte plasma test assays for lung nodule characterization demonstrated acceptable analytical performance in a clinical laboratory.
• This validated test has the potential to aid in distinguishing benign from malignant lung nodules.
• Improved risk stratification may lead to more appropriate patient management, reducing unnecessary procedures.