验证用于丙氨酸氨基转移酶测量的新型即时检验：一项试点

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验证用于丙氨酸氨基转移酶测量的新型即时检验：一项试点队列研究
杰西卡·豪厄尔、Huy Van、Minh Pham、Rohit Sawhney、Fan Li、Purnima Bhat、John Lubel、William Kemp、Stephen Bloom、Avik Majumdar、Geoff McCaughan、Samuel Hall、Timothy Spelman、Joseph S. Doyle、Margaret Hellard、Kumar Visvanathan、 Alexander J. Thompson、Heidi E. Drummer、David Anderson ... 看到更少的作者
首次发布：2022 年 10 月 10 日
https://doi.org/10.1002/cld.1261

Jessica Howell 和 Huy Van 共同第一作者。
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介绍

慢性肝病是一项重大的全球公共卫生挑战：如果不及时诊断，未经治疗的慢性肝病（如乙型肝炎和丙型肝炎）会导致肝硬化和肝癌死亡。 1, 2 丙氨酸氨基转移酶 (ALT) 是一种基于血液的肝病标志物用于诊断、评估和监测慢性肝病的急性肝炎症。3-6 然而，在资源匮乏和偏远地区，常规病理学检测受限，传统的 ALT 测量对及时进行肝病管理构成重大障碍。 7, 8

我们开发了一种新型、易于使用的快速即时 (POC) 免疫分析侧向流动测试，可测量总酶 ALT 的肝脏特异性 ALT1 成分。使用单滴血液或血浆，POC ALT1 测试可在 30 分钟内为 40 IU/L 的 ALT 截止值或使用 Axxin 手持式流量测试阅读器提供定量 ALT1 的半定量视觉结果。原型 POC ALT1 测试由南京 BioPoint Diagnostics（中国）提供。

在这项初步研究中，与病毒性肝炎患者的实验室金标准检测相比，我们证明了 POC ALT1 检测对 ALT 临床显着升高的诊断准确性。

StephenW

Validation of novel point-of-care test for alanine aminotransferase measurement: A pilot cohort study
Jessica Howell, Huy Van, Minh Pham, Rohit Sawhney, Fan Li, Purnima Bhat, John Lubel, William Kemp, Stephen Bloom, Avik Majumdar, Geoff McCaughan, Samuel Hall, Timothy Spelman, Joseph S. Doyle, Margaret Hellard, Kumar Visvanathan, Alexander J. Thompson, Heidi E. Drummer, David Anderson … See fewer authors
First published: 10 October 2022
https://doi.org/10.1002/cld.1261

Jessica Howell and Huy Van co- first author.
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INTRODUCTION

Chronic liver disease is a major global public health challenge: without timely diagnosis, untreated chronic liver diseases such as hepatitis B and C can lead to death from cirrhosis and liver cancer.1, 2 Alanine aminotransferase (ALT) is a blood-based marker of acute liver inflammation used to diagnose, evaluate, and monitor chronic liver disease.3-6 However, conventional ALT measurement poses a significant barrier to timely liver disease management in low resource and remote settings where access to routine pathology testing is limited.7, 8

We developed a novel, easy-to-use rapid point-of-care (POC) immunoassay lateral flow test that measures the liver-specific ALT1 component of total enzymatic ALT. Using a single droplet of blood or plasma, the POC ALT1 test provides a semi-quantitative visual result for an ALT cutoff of 40 IU/L, or quantitative ALT1 using the Axxin hand-held flow test reader, within 30 minutes. Prototype POC ALT1 tests were provided by Nanjing BioPoint Diagnostics (PR China).

In this pilot study, we demonstrate the diagnostic accuracy of the POC ALT1 test for clinically significant elevations in ALT compared to the laboratory gold standard assay in people with viral hepatitis.

StephenW

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