Division of Infectious Diseases, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA.
Sci Transl Med. 2012 Sep 19;4(152):152ra129. doi: 10.1126/scitranslmed.3003981.
In developed nations, monitoring for drug-induced liver injury through serial measurements of serum transaminases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)] in at-risk individuals is the standard of care. Despite the need, monitoring for drug-related hepatotoxicity in resource-limited settings is often limited by expense and logistics, even for patients at highest risk. This article describes the development and clinical testing of a paper-based, multiplexed microfluidic assay designed for rapid, semiquantitative measurement of AST and ALT in a fingerstick specimen. Using 223 clinical specimens obtained by venipuncture and 10 fingerstick specimens from healthy volunteers, we have shown that our assay can, in 15 min, provide visual measurements of AST and ALT in whole blood or serum, which allow the user to place those values into one of three readout "bins" [<3× upper limit of normal (ULN), 3 to 5× ULN, and >5× ULN, corresponding to tuberculosis/HIV treatment guidelines] with >90% accuracy. These data suggest that the ultimate point-of-care fingerstick device will have high impact on patient care in low-resource settings.
在发达国家，通过对高危人群进行血清转氨酶（天冬氨酸转氨酶（AST）和丙氨酸转氨酶（ALT））的连续测量来监测药物性肝损伤，是标准的护理方法。尽管有这种需求，但在资源有限的环境中监测与药物相关的肝毒性，往往受到费用和后勤的限制，即使是对风险最高的患者也是如此。本文描述了一种基于纸张的、多重微流控分析的开发和临床测试，该分析用于快速、半定量测量指尖血样中的 AST 和 ALT。我们使用 223 份来自静脉穿刺的临床标本和 10 份来自健康志愿者的指尖血标本进行了研究，结果表明，我们的检测方法可以在 15 分钟内提供全血或血清中 AST 和 ALT 的可视化测量值，用户可以将这些值放入三个读取“箱”中的一个（<3×正常上限（ULN）、3 至 5×ULN 和>5×ULN，分别对应于结核病/艾滋病毒治疗指南），准确率>90%。这些数据表明，最终的即时指尖检测设备将对资源匮乏环境中的患者护理产生重大影响。
