互联网上销售的HIV抗体快速检测试剂物理性能和灵敏度调查  

Physical performance and analytical sensitivity of rapid diagnostic test reagents sold online to screen HIV infection

作　　者：任雅楠 马仲慧 徐冰 王俊 裴丽健[1] 蒋岩[1] 邢文革[1] REN Yanan;MA Zhonghui;XU Bing;WANG Jun;PEI Lijian;JIANG Yan;XING Wenge(National Center for AIDS/STD Control and Prevention,China CDC,National HIV/AIDS Reference Laboratory,NARL.Beijing 102206,China)

机构地区：[1]中国疾病预防控制中心,性病艾滋病预防控制中心,参比实验室,北京102206

出　　处：《中国艾滋病性病》2020年第3期243-246,共4页Chinese Journal of Aids & STD

基　　金：中美艾滋病防治合作项目。

摘　　要：目的了解互联网上销售艾滋病病毒(HIV)抗体快速检测试剂的现状,评价试剂的物理性能和分析灵敏度,分析用于自我检测时可能存在的问题。方法通过比较互联网上购买HIV抗体快速检测试剂的包装、预期用途、样本类型等,评价其物理性能;通过检测最低检出限样本,评价其分析灵敏度。结果 32种互联网上销售的HIV抗体快速检测试剂包装中9种有图片式说明材料(9/32),31种有样本采集装置(31/32)。说明书中2种的预期用途为无偿献血现场初筛(2/32),5种为自愿咨询检测(5/32),1种为消费者自检(1/32);25种结果解释中没有后续处理方法(25/32);13种互联网销售的HIV抗体血液快速检测剂没有指尖血采集步骤(13/18),1种只能检测血清和血浆(1/18)。29种互联网上销售HIV抗体快速检测试剂检测最低检出限样本均为反应性结果(29/29)。结论专业实验室使用的试剂用于自我检测时存在的问题:HIV血液抗体快速检测试剂没有配备采血针、没有指尖血采集步骤;没有图片式说明材料;结果解释中没有介绍后续处理方法等。Objective To learn about HIV rapid diagnostic test reagents sold online, evaluate their physical performance and analytical sensitivity and determine whether the reagents used by professional laboratories can be used for HIV self-testing. Methods Evaluation was made by investigating their packaging, intended use, sample type, etc. to know their physical performance, and analytical sensitivity by testing minimum detection limit samples of the national reference laboratory. Results There were 32 HIV rapid diagnostic test reagents sold on line and 9 had pictorial instructional materials(9/32), and 31 had sample collection devices(31/32). In the user guide, 2 reagents showed for the on-site screening of unpaid blood donation(1/32), 5 reagents for voluntary counseling and testing(5/32), and one for consumer self-testing(1/32). All of the testing results were reactive(29/29) based on the minimum detection limit samples with 29 reagents sold online. Conclusion There are many problems with the reagents used in professional laboratories for HIV self-testing, including HIV rapid diagnostic test reagents sold online, such as no blood collection needles equipped, no description of fingertip blood collection procedure, and no pictorial instruction in the user guide, and no subsequent measures introduced in the interpretation of screening results.

关 键 词：互联网 艾滋病病毒 快速检测 性能评价 

分 类 号：R512.91[医药卫生—内科学] R373.9[医药卫生—临床医学]