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.

中文翻译：

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基于磁性粒子的化学发光免疫法测定血清中人降钙素的进展

背景

血清降钙素原（PCT）已被认为是细菌感染的主要生物标志物，监测其浓度可有助于评估败血症的预后并指导抗生素的使用。我们旨在为PCT定量建立快速准确的免疫分析方法。

方法

我们通过酶联免疫吸附试验对我们新开发的针对人PCT的单克隆抗体（mAbs）进行了初步评估，然后用于化学发光酶免疫分析（CLEIA）。对拟议的CLEIA进行分析性能评估，并将其用于血清PCT的测量。

结果

分别选择mAb 2D3和mAb 8F6作为捕获抗体和检测抗体，这是因为PCT检测具有最高的灵敏度，并且与降钙素基因相关肽没有交叉反应。拟议的基于2D3 / 8F6-AP单克隆抗体对的CLEIA的工作范围为0.03至100μg/ L。在我们提出的检测方法与VIDAS BRAHMS PCT检测方法之间观察到极好的相关性（r：0.9825）。

结论

我们最新开发的mAb和CLEIA可以作为测量血清中人PCT的重要诊断工具。