Author information

• ¹Burnet Institute, Melbourne, Australia.
• ²St Vincent's Hospital and University of Melbourne, Melbourne, Australia.
• ³School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
• ⁴Department of Gastroenterology, Eastern Health, Box Hill, Victoria, Australia.
• ⁵Department of Medicine, Monash University, Melbourne, Australia.
• ⁶Canberra Hospital, Canberra, Australia.
• ⁷Central Clinical School, Monash University, Melbourne, Australia.
• ⁸A.W.Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.
• ⁹Centenary Institute, Sydney, Australia.
• ¹⁰Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Australia.
• ¹¹Department of Microbiology, Monash University, Clayton, Victoria, Australia.
• ¹²Department of Microbiology at The Peter Doherty Institute for Infection and Immunity, The University of Melbourne, Parkville, Australia.

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.