Validation of a novel point-of-care test for alanine aminotransferase measurement: A pilot cohort study.
Jessica HowellHuy VanMinh D PhamRohit SawhneyFan LiPurnima BhatJohn LubelWilliam W KempStephen BloomAvik MajumdarGeoffrey W McCaughanSamuel HallTimothy SpelmanJoseph S DoyleMargaret HellardKumar VisvanathanAlexander ThompsonHeidi E DrummerDavid AndersonPublished in: Liver international : official journal of the International Association for the Study of the Liver (2023)
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%).