Development of chemiluminescent enzyme immunoassay for the detection of aristolochic acid I in patent medicines and cosmetics

Aristolochic acids (AAs) are a family of nitrophenanthrene carboxylic acids. Some AAs-containing herbs are used as raw materials in medicines, health foods, cosmetics, and dietary supplements. However, aristolochic acid I (AAI) as the main active component of AAs, is nephrotoxic, mutagenic, and carcinogenic to humans. Thus, it is essential to develop effective techniques for determining AAI in relevant products. In this study, an anti-AAI monoclonal antibody (mAb) with high sensitivity was generated. Based on the mAb, a chemiluminescence enzyme immunoassay (CLEIA) was developed, exhibiting an IC 50 of 20 ng/mL and a linear range from 2.5 ng/mL to 250 ng/mL. The limit of detection (LOD) of the CLEIA was 1.96 ng/mL. The recovery rates of AAI in spiked patent medicines and cosmetics ranged from 79.7 % to 121.7 % with coefficient of variations (CVs) ranging from 1.2 % to 13.6 %. A good correlation coefficient of 0.9591 was observed between CLEIA and high-performance liquid chromatography (HPLC) results, indicating that the developed CLEIA is accurate and reliable for the determination of AAI in patent medicines and cosmetics.