基于质量评价的孔雀石绿快检试剂盒筛选策略

Screening strategy of malachite green rapid detection kit based on quality evaluation

目的建立快速筛选出技术指标合格的市售水产品孔雀石绿残留快速检测试剂盒的方法。方法选用5种市售孔雀石绿快检试剂盒比较其操作步骤、检测时间、提取效率,同时参考SN/T 2775-2011和GB/T19857-2005进行灵敏度、特异性、假阴性率与假阳性率等技术指标测试,提出基于质量评价的试剂盒快速筛选策略。结果5个品牌的孔雀石绿检测试剂盒质量参差不齐,品牌A、B与C的灵敏度<99%,特异性≥85%、假阴性率>1%,假阳性率≤15%,不符合试剂盒评价标准;品牌D与品牌E的灵敏度≥99%、特异性≥85%、假阴性率≤1%,假阳性率≤15%,符合试剂盒评价标准。结论对市场销售的水产品中孔雀石绿残留检测试剂盒要进行采购前、采购中的质量评价,在评价时综合考虑操作步骤的简便性、时效性、评价批次、样品来源等,同时兼顾灵敏度、特异性、假阴性率与假阳性率技术指标,快速筛选出符合标准的试剂盒。

Objective To establish a rapid screening method of malachite green residue detection kit in aquatic products.Methods Five kinds of malachite green rapid detection kits were selected to compare their operation steps,detection time and extraction efficiency.Meanwhile,the sensitivity,specificity,false negative rate and false positive rate were tested with reference to SN/T 2775-2011 and GB/T 19857-2005,and the rapid screening strategy based on quality evaluation was proposed.Results The quality of malachite green test kits of five brands were uneven.The sensitivity of brands A,B and C were less than 99%,specificity were more than or equal to 85%,false negative rate were more than 1%,false positive rate were less than or equal to 15%,which did not meet the evaluation criteria of kits.The sensitivity of brands D and E were more than or equal to 99%,specificity were more than or equal to 85%,false negative rate were less than or equal to 1%,false positive rate were less than or equal to 15%,which met the evaluation criteria of kits.Conclusion It is necessary to evaluate the quality of malachite green residue detection kit in aquatic products sold on the market before and during the purchase.In the evaluation,the convenience of operation steps,timeliness,evaluation of batches,sample source,etc.should be taken into account,and the technical indexes of sensitivity,specificity,false negative rate and false positive rate should be tested also,so as to quickly select the kit that meets the standard.