基于智能手机的快速即时检测人免疫缺陷病毒和梅毒感染抗体电子阅读器的实验室评估
Laboratory Evaluation of a Smartphone-Based Electronic Reader of Rapid Dual Point-of-Care Tests for Antibodies to Human Immunodeficiency Virus and Treponema pallidum Infections.
作者信息
Herbst de Cortina Sasha, Bristow Claire C, Humphries Romney, Vargas Silver Keith, Konda Kelika A, Caceres Carlos F, Klausner Jeffrey D
机构信息
From the *Division of Infectious Diseases, Department of Medicine, University of California Los Angeles, Los Angeles, CA; †Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA; ‡Department of Pathology and Laboratory Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA; §Unit of Health, Sexuality and Human Development, and Laboratory of Sexual Health, Universidad Peruana Cayetano Heredia, Miraflores, Lima, Peru; and ¶Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA.
出版信息
Sex Transm Dis. 2017 Jul;44(7):412-416. doi: 10.1097/OLQ.0000000000000628.
BACKGROUND
Dual point-of-care tests for antibodies to human immunodeficiency virus (HIV) and Treponema pallidum allow for same-day testing and treatment and have been demonstrated to be cost-effective in preventing the adverse outcomes of HIV infection and syphilis. By recording and transmitting data as they are collected, electronic readers address challenges related to the decentralization of point-of-care testing.
METHODS
We evaluated a smartphone-based electronic reader using 201 sera tested with 2 dual rapid tests for detection of antibodies to HIV and T. pallidum in Los Angeles, USA, and Lima, Peru. Tests were read both visually and with the electronic reader. Enzyme immunoassay followed by Western blot and T. pallidum particle agglutination were the reference tests for HIV and T. pallidum, respectively.
RESULTS
The sensitivities of the 2 rapid tests for detection of HIV were 94.1% and 97.0% for electronic readings. Both tests had a specificity of 100% for detection of HIV by electronic reading. The sensitivities of the 2 rapid tests for detection of T. pallidum were 86.5% and 92.4% for electronic readings. The specificities for detection of T. pallidum were 99.1% and 99.0% by electronic reading. There were no significant differences between the accuracies of visual and electronic readings, and the performance did not differ between the 2 study sites.
CONCLUSIONS
Our results show the electronic reader to be a promising option for increasing the use of point-of-care testing programs.
背景
针对人类免疫缺陷病毒（HIV）和梅毒螺旋体抗体的双床旁检测可实现当日检测和治疗，并且已被证明在预防HIV感染和梅毒的不良后果方面具有成本效益。通过在数据收集时进行记录和传输，电子阅读器解决了与床旁检测分散化相关的挑战。
方法
我们在美国洛杉矶和秘鲁利马使用201份血清评估了一种基于智能手机的电子阅读器，这些血清用2种双重快速检测法检测HIV和梅毒螺旋体抗体。检测结果通过视觉和电子阅读器读取。酶免疫测定法随后进行蛋白质印迹法以及梅毒螺旋体颗粒凝集试验分别作为HIV和梅毒螺旋体的参考检测方法。
结果
两种快速检测法检测HIV的电子读数灵敏度分别为94.1%和97.0%。两种检测法通过电子读数检测HIV的特异性均为100%。两种快速检测法检测梅毒螺旋体的电子读数灵敏度分别为86.5%和92.4%。通过电子读数检测梅毒螺旋体的特异性分别为99.1%和99.0%。视觉读数和电子读数的准确性之间无显著差异，且两个研究地点的检测性能也无差异。
结论
我们的结果表明，电子阅读器是增加床旁检测项目使用的一个有前景的选择。
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