Validation of novel point‐of‐care test for alanine aminotransferase measurement: A pilot cohort study

Howell, Jessica; Van, Hung Nguyen; Pham, Minh Duc; Sawhney, Rohit; Li, Fan; Bhat, Purnima; Lubel, John S; Kemp, William; Bloom, Stephen; Majumdar, Avik; McCaughan, Geoffrey W.; Hall, Samuel; Spelman, Timothy; Doyle, Joseph; Hellard, Margaret; Visvanathan, Kumar; Thompson, Alexander; Drummer, Heidi E; Anderson, David A.

doi:10.1002/cld.1261

Cited by 1 publication

(2 citation statements)

References 9 publications

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“…ALT testing is cheap ($2–$5 in Vietnam), does not entail additional visits or investigations, and can be performed in most laboratories. Novel point-of-care ALT tests from finger prick specimens could negate the need for a laboratory entirely 15. Assuming a positive predictive valueof 46% (Figure 1), a negative predictive value of 100%, and a cure rate of 95%, this screening strategy would reduce NAT by 51%.…”

Section: Discussionmentioning

confidence: 99%

“…Novel point-of-care ALT tests from finger prick specimens could negate the need for a laboratory entirely. [15] Assuming a positive predictive valueof 46% (Figure 1), a negative predictive value of 100%, and a cure rate of 95%, this screening strategy would reduce NAT by 51%. In Vietnam, this translates to a saving of US$18-$46,000 per thousand patients treated (equivalent to ~36-90 courses of DAA therapy).…”

Section: Discussionmentioning

confidence: 99%

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Rise in alanine aminotransferase after HCV treatment is a highly sensitive screen for treatment failure

Flower

Ngoc

McCabe

et al. 2023

Clinical Liver Disease

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Nucleic acid testing to confirm sustained virological response (SVR) after HCV therapy is technical, often expensive, and frequently unavailable where disease prevalence is highest. Alternative surrogate biomarkers merit evaluation. In a short-treatment trial in Vietnam (SEARCH-1; n = 52) we analysed how changes in alanine transaminase (ΔALT) and aspartate transaminase (ΔAST), from end of treatment (EOT) to EOT + 12 weeks, related to SVR, defined as HCV RNA < lower limit of quantification 12 weeks after EOT. In a separate UK trial (STOPHCV1; n = 202), we then tested the hypothesis that any elevation in ALT or AST between EOT and EOT12 is a sensitive screen for treatment failure.In SEARCH-1, among 48 individuals with data, 13 failed to achieve SVR. Median ΔALT and ΔAST were negative in cured patients but elevated when treatment failed [median ΔALT (IQR): −2 IU/L (−6, +2)] versus +17 IU/L (+7.5, +38) (p < 0.001). Amongst treatment failures, 12/13 had increase in ALT and 13/13 had increase in AST after EOT, compared with 12/35 in those cured. In STOPHCV1, 196/202 patients had evaluable data, of which 57 did not achieve SVR. A rise in ALT after EOT was 100% sensitive (95% C.I. [93.7 -100%]) and 51% specific (42.4 -59.7%) for detecting treatment failure. ΔAST > 0 IU/L was 98.1% (89.9 -99.9%) sensitive and 35.8% (27.3 -45.1%) specific. A rise in ALT or AST after HCV therapy is a highly sensitive screen for treatment failure in mild liver disease. This finding could reduce costs and complexity of managing HCV.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%