用于黄曲霉毒素B1快速检测的胶体金试剂盒质量评价

Quality Evaluation of Colloidal Gold Kits for Rapid Detection of Aflatoxin B1

摘要:

为评估黄曲霉毒素B₁（aflatoxin B₁，AFB₁）胶体金快速检测试剂盒性能，对6个胶体金快速检测试剂盒生产厂家的产品进行质量评价。以大豆油为基质，通过人为加入标准物质的方法制备盲样，对6个生产厂家的试剂盒组成、前处理过程、显色情况、性能指标、检测时间等进行评价，并将其用于国家及河南省抽检食用油样品的检测。结果表明，6个生产厂家的试剂盒组成完整，前处理快速，易操作，检测时间短（均在25 min以内），但合格率仅50%，有3个生产厂家的试剂盒因较高的假阴性率而不达标。由此可知，质量优良的快速检测试剂盒能很好地满足实际样品检测需求，但目前市场上的快速检测试剂盒整体质量还有待提升，生产企业应严格按照国家相关标准进行研发和生产，同时国家相关部门要继续完善评价体系，加强监管。

Abstract:

In order to evaluate the performance of colloidal gold rapid detection kit of aflatoxin B₁ (AFB₁), the quality of kits from six colloidal gold rapid detetion kit manufacturers was assessed. Blind samples were prepared by artificially spiked method using soybean oil as the matrix. The kit composition, pretreatment process, color development, performance indicators, and detection time of the products from six manufacturers were evaluated, and these kits were applied in the detection of edible oil samples in national and Henan province random inspections. The results showed that all product kits of six manufacturers had complete composition, fast and easy pretreatment processes, and short detection durations (all within 25 min). However, the pass rate was only 50%, with three kits failing due to high false-negative rates. Therefore, high-quality rapid detection kits can well meet the actual sample detection needs, however, the overall quality of rapid detection kits on the current market needs improvement. Manufacturers should strictly follow national standards for research and production. Meanwhile, relevant national departments should continue to improve the evaluation system and strengthen supervision.