艾滋病病毒快速测试用于自我检测的市场和技术前景

Market and technology landscape of HIV rapid tests for self-testing

艾滋病病毒(HIV)自我检测是HIV检测服务的补充途径,是实现扩大检测的有效方式。截至2018年7月有59个国家有HIV自我检测的支持性政策,其中有28个国家实施了HIV自我检测,14种HIV自我检测试剂通过批准,还有6种HIV自我检测试剂正在开发。我国目前没有批准的用于HIV自我检测的试剂,但有16个厂家在网络上销售HIV快速检测试剂。HIV自我检测试剂或用于自我检测的快速检测试剂在不同的研究中特异性高,但灵敏度有很大差异,不同人群对HIV自我检测的接受度也有很大差异,且在检测操作和结果读取过程中都有可能发生错误从而影响测试结果。当为受试者提供简单的使用说明,视频教程时,结果的准确性明显提高。

HIV self-testing is an additional approach to complement existing HIV testing services.Up to July of 2018,28 countries had implemented HIV self-testing services,59 countries had carried out supportive policies relating to HIV self-testing.In addition,14 HIV self-testing products had been approved and at least another 6 were under development.Currently,there are no approved reagents for HIV self-tests in China,but 16 manufacturers sell reagents for HIV rapid tests online.Both HIV self-test reagents and rapid test reagents used for self-test have high specificity and different sensitivity in different researches.Different people show great differences in the acceptance of HIV self-testing.Errors may occur in collection of the specimen and result reading.The accuracy of the test results can be significantly improved when instructions or video courses are provided.