Validation of a novel point-of-care test for alanine aminotransferase measurement: A pilot cohort study.
Liver Int
; 43(5): 989-999, 2023 05.
Article
en En
| MEDLINE
| ID: mdl-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.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Hepatitis B Crónica
/
Hepatitis B
Tipo de estudio:
Diagnostic_studies
/
Etiology_studies
/
Incidence_studies
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Observational_studies
/
Risk_factors_studies
Límite:
Adult
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Humans
Idioma:
En
Año:
2023
Tipo del documento:
Article