极端环境条件对胶体金免疫层析产品的影响评估

摘要

Objective To assess the limit of detection(LOD),sensitivity and specificity of collodial gold immunochrom-atography(GICA)products purchased from two manufacturers under special environmental conditions.Methods The sensitivity and specificity of GICA made in InTec Products, INC.and Beijing WANTAI Biological Pharmacy Enterprise Co., LTD.for detecting HBsAg, anti-HCV and anti-Treponema pallidum(TP)serum samples were evaluated under different conditions(conventional facilities,simulated hot and humid environments and simulated low pressure and hypoxia environments)according to the protocol of kits.LOD was estimated by detecting the standard materials obtained from the National Center for Clinical Laboratory(NCCL)of China.Results LOD for syphilis improved from 2 NCU to 1 NCU using GICA from InTec Products in hot and humid environments.The extreme conditions did not influence the specificity of GICA from the two manufacturers in the course of detection of clinical samples,but the sensitivity of detection was affected.For InTec Products,the sensitivity of hepatitis B virus and syphilis detection was improved in hot and humid environments,but was reduced in low pressure and hypoxia environments.In addition,the sensitivity of hepatitis C virus detection by InTec Products decreased in hot and humid environments.As for WANTAI products,the sensitivity of hepatitis B virus detection was reduced under extreme conditions and that of hepatitis C virus was only influenced by hot and humid environments. Interestingly, extreme conditions had no impact on the sensitivity of syphilis.Conclusion LOD of InTec Products is better than that of the WANTAI products for detection of standard materials from blood-borne diseases.In the process of detecting clinical samples,the sensitivity of the two manufacturers′GICA is influenced by extreme conditions, with the specificity unchanged.Overall, WANTAI products are more stable than those of InTec, and are also less influenced by extreme conditions.%目的 在特殊环境气候条件下评估市场占有率较大的两个厂家的胶体金快速免疫层析类产品在进行血液传染病筛查时的检测下限、灵敏度和特异性等指标.方法 评估实验分别采用英科新创(厦门)科技有限公司和北京万泰生物药业有限公司的免疫层析产品.在普通实验室环境(温度22 ~26℃,湿度25%~35%,气压101 kPa)、模拟高温高湿环境(温度37℃,湿度75%~85%,气压101 kPa)及模拟低压低氧环境(温度22~26℃,湿度25%~35%,气压56 kPa),3种条件下考察产品,检测乙型肝炎病毒、丙型肝炎病毒及梅毒感染血清样本的灵敏度和特异性,严格按照说明书进行操作和记录结果;检测下限评估则是采用中华人民共和国国家卫生和计划生育委员会临床检验中心的标准物质.结果在对标准物质检测下限的评估中,高温高湿环境下,新创产品对梅毒的检测下限从2国家临床单位(national clinical unit,NCU)提升至1 NCU.临床样本检测中,两家产品的特异性均为100.0%,不受极端环境影响,而其灵敏度受到影响:对于新创产品而言,高温高湿提升乙肝及梅毒检测灵敏度,低压低氧降低其灵敏度,高温高湿下丙肝产品敏感性下降;而万泰产品,乙肝检测的敏感性在两种极端条件下均降低,丙肝检测敏感性受到高温高湿影响,而梅毒检测不受环境影响.结论 新创产品相比万泰产品,检测3种血液传染病标准物质时具有更低的检测下限.在临床样本检测中,两家产品的检测灵敏度均受到极端环境影响,而特异性基本不受影响.相比之下,万泰产品稳定性更好,受到极端条件影响小.