用于丙氨酸氨基转移酶测量的新型即时检验的验证：一项试点队列研究。

Validation of a novel point-of-care test for alanine aminotransferase measurement: A pilot cohort study.

作者信息

Howell Jessica, Van Huy, Pham Minh D, Sawhney Rohit, Li Fan, Bhat Purnima, Lubel John, Kemp William, Bloom Stephen, Majumdar Avik, McCaughan Geoffrey W, Hall Samuel, Spelman Timothy, Doyle Joseph S, Hellard Margaret, Visvanathan Kumar, Thompson Alexander, Drummer Heidi E, Anderson David

机构信息

Burnet Institute, Melbourne, Australia.

St Vincent's Hospital and University of Melbourne, Melbourne, Australia.

出版信息

Liver Int. 2023 May;43(5):989-999. doi: 10.1111/liv.15531. Epub 2023 Feb 16.

DOI:10.1111/liv.15531

PMID:36719055

Abstract

BACKGROUND

Alanine aminotransferase (ALT) measurement is essential for evaluation of liver disease. We validated a novel rapid point-of-care (POC) test for ALT1 against laboratory ALT.

METHODS

Stored plasma samples from adults with chronic liver disease (Test cohort n = 240; Validation cohort n = 491) were analysed using the BioPoint® antigen immunoassay POC ALT1 lateral flow test, which provides quantitative ALT results (Axxin handheld reader) or semi-quantitative results (visual read, cut off 40 IU/ml). The accuracy of POC ALT1 to detect ALT > 40 IU/L was determined by ROC analysis. In patients with chronic hepatitis B, treatment eligibility (EASL criteria) was determined using POC ALT1 and compared to laboratory ALT.

RESULTS

POC ALT1 test had good accuracy for laboratory ALT > 40 IU/L: AUROC 0.93 (95% CI: 0.89-0.96) in the Test cohort and AUROC 0.92 (95% CI: 0.88-0.95) in the Validation cohort. POC ALT1 cut off of 0.8 for ALT > 40 IU/L maximised sensitivity (97%) and specificity (71%) in the Test cohort (42% laboratory ALT > 40 IU/L) and yielded PPV 84% and NPV 91% in the Validation cohort (19% laboratory ALT > 40 IU/L). Semi-quantitative POC ALT1 had good accuracy for laboratory ALT in the Validation cohort (AUROC 0.85, 95% CI: 0.81-0.99; sensitivity 77% and specificity 93%). Combined with HBV DNA and transient elastography, both quantitative and semi-quantitative POC ALT1 tests had good accuracy for excluding hepatitis B treatment needs (sensitivity 96%, specificity 78% and NPV 99%).

CONCLUSION

The POC ALT1 test had good accuracy for elevated ALT levels and for determining treatment eligibility among people with chronic hepatitis B.

摘要

背景

丙氨酸氨基转移酶（ALT）检测对于肝病评估至关重要。我们针对实验室ALT验证了一种新型的快速即时检验（POC）ALT1检测方法。

方法

使用BioPoint®抗原免疫分析POC ALT1侧向流动检测法对患有慢性肝病的成人储存血浆样本进行分析（测试队列n = 240；验证队列n = 491），该检测法可提供定量ALT结果（Axxin手持式读数仪）或半定量结果（目视读取，临界值为40 IU/ml）。通过ROC分析确定POC ALT1检测ALT>40 IU/L的准确性。在慢性乙型肝炎患者中，使用POC ALT1确定治疗资格（欧洲肝脏研究学会标准），并与实验室ALT进行比较。

结果

对于实验室ALT>40 IU/L，POC ALT1检测具有良好的准确性：测试队列中的AUROC为0.93（95% CI：0.89 - 0.96），验证队列中的AUROC为0.92（95% CI：0.88 - 0.95）。对于ALT>40 IU/L，POC ALT1临界值为0.8时，测试队列（42%的实验室ALT>40 IU/L）的灵敏度（97%）和特异性（71%）达到最大化，验证队列（19%的实验室ALT>40 IU/L）的阳性预测值为84%，阴性预测值为91%。在验证队列中，半定量POC ALT1对实验室ALT具有良好的准确性（AUROC 0.85，95% CI：0.81 - 0.99；灵敏度77%，特异性93%）。结合乙肝病毒DNA和瞬时弹性成像，定量和半定量POC ALT1检测在排除乙肝治疗需求方面均具有良好的准确性（灵敏度96%，特异性78%，阴性预测值99%）。