Publications & Reports

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

Howell J, Van H, Pham MD, Sawhney R, Li F, Bhat P, Lubel J, Kemp W, Bloom S, Majumdar A, McCaughan GW, Hall S, Spelman T, Doyle JS, Hellard M, Visvanathan K, Thompson A, Drummer HE, Anderson D
Burnet Institute, Melbourne, Australia.


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, cutoff 40IU/mL). Accuracy of POC ALT1 to detect ALT > 40IU/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 > 40IU/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 > 40IU/L maximised sensitivity (97%) and specificity (71%) in the Test cohort (42% laboratory ALT > 40IU/L) and yielded PPV 84% and NPV 91% in the Validation cohort (19% laboratory ALT > 40IU/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%, specificity 93%). Combined with HBV DNA and transient elastography, both quantitative and semi-quantitative POC ALT1 test had good accuracy for excluding hepatitis B treatment need (sensitivity 96%, specificity 78%, NPV 99%).

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