Development of magnetic particle-based chemiluminescence immunoassay for measurement of human procalcitonin in serum.

Background: Serum procalcitonin (PCT) has been recognized as a primary biomarker in bacterial infections, and monitoring its concentration could help to evaluate the prognosis of sepsis and guide the antibiotic administration. We aimed to establish a fast and accurate immunoassay for PCT quantitation.

Methods: Our newly developed monoclonal antibodies (mAbs) against human PCT were preliminarily evaluated by enzyme-linked immunosorbent assay and then used to develop a chemiluminescence enzyme immunoassay (CLEIA). The proposed CLEIA was assessed in analytical performance and applied to measurement of serum PCT.

Results: mAb 2D3 and mAb 8F6 were selected as capture and detection antibody respectively, due to the highest sensitivity for PCT detection with no cross reaction to calcitonin gene-related peptides. The proposed CLEIA based on mAb pair of 2D3/8F6-AP was characterized for a working range from 0.03 to 100 μg/L. An excellent correlation was observed between our proposed assay and the VIDAS BRAHMS PCT assay (r: 0.9825).

Conclusion: Our newly developed mAbs and CLEIA can serve as important diagnostic tools for measurement of human PCT in serum.