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Validation of a novel point‐of‐care test for alanine aminotransferase measurement: A pilot cohort study.
- Source :
-
Liver International . May2023, Vol. 43 Issue 5, p989-999. 11p. 1 Diagram, 4 Charts, 2 Graphs. - Publication Year :
- 2023
-
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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 14783223
- Volume :
- 43
- Issue :
- 5
- Database :
- Academic Search Index
- Journal :
- Liver International
- Publication Type :
- Academic Journal
- Accession number :
- 163337645
- Full Text :
- https://doi.org/10.1111/liv.15531