Validation of a novel point-of-care test for alanine aminotransferase measurement: A pilot cohort study.
hepatitis B
liver inflammation
novel diagnostics
public health
Journal
Liver international : official journal of the International Association for the Study of the Liver
ISSN: 1478-3231
Titre abrégé: Liver Int
Pays: United States
ID NLM: 101160857
Informations de publication
Date de publication:
05 2023
05 2023
Historique:
revised:
15
01
2023
received:
28
09
2022
accepted:
23
01
2023
medline:
17
5
2023
pubmed:
1
2
2023
entrez:
31
1
2023
Statut:
ppublish
Résumé
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. 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. 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%). The POC ALT1 test had good accuracy for elevated ALT levels and for determining treatment eligibility among people with chronic hepatitis B.
Sections du résumé
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.
Substances chimiques
Alanine Transaminase
EC 2.6.1.2
DNA, Viral
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
989-999Informations de copyright
© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Références
Global Burden of Disease Collaborators. The global, regional, and national burden of cirrhosis by cause in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020;5(3):245-266.
Younossi Z, Tacke F, Arrese M, et al. Global perspectives on nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Hepatology. 2019;69(6):2672-2682.
Paik JM, Golabi P, Younossi Y, Mishra A, Younossi ZM. Changes in the global burden of chronic liver diseases from 2012 to 2017: the growing impact of nonalcoholic fatty liver disease. Hepatology. 2020;72:1605-1616.
Akinyemiju T, Abera S, Ahmed M, et al. The burden of primary liver cancer and underlying etiologies from 1990 to 2015 at the global, regional, and National Level: results from the global burden of disease study 2015. JAMA Oncol. 2017;3(12):1683-1691.
Howell J, Pedrana A, Schroeder SE, et al. A global investment framework for the elimination of hepatitis B. J Hepatol. 2021;74(3):535-549.
Razavi H. The cost-effectiveness of hepatitis C virus elimination in low- and middle-income countries. J Viral Hepat. 2021;28(2):445.
Moon AM, Singal AG, Tapper EB. Contemporary epidemiology of chronic liver disease and cirrhosis. Clin Gastroenterol Hepatol. 2020;18(12):2650-2666.
Cooke GS, Andrieux-Meyer I, Applegate TL, et al. Accelerating the elimination of viral hepatitis: a Lancet Gastroenterology & Hepatology Commission. Lancet Gastroenterol Hepatol. 2019;4(2):135-184.
European Association for the Study of the Liver. EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67(2):370-398.
European Association for the Study of the Liver. EASL clinical practice guidelines: management of alcohol-related liver disease. J Hepatol. 2018;69(1):154-181.
AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology. 2015;62(3):932-954.
Williams B, Howell J, Doyle J, et al. Point-of-care hepatitis C testing from needle and syringe programs: an Australian feasibility study. Int J Drug Policy. 2019;72:91-98.
Latham NH, Pedrana A, Doyle JS, et al. Community-based, point-of-care hepatitis C testing: perspectives and preferences of people who inject drugs. J Viral Hepat. 2019;26(7):919-922.
Peeling RW, Boeras DI, Marinucci F, Easterbrook P. The future of viral hepatitis testing: innovations in testing technologies and approaches. BMC Infect Dis. 2017;17(Suppl 1):699.
Waked I, Esmat G, Elsharkawy A, et al. Screening and treatment program to eliminate hepatitis C in Egypt. N Engl J Med. 2020;382(12):1166-1174.
Dashtseren B, Bungert A, Bat-Ulzii P, et al. Endemic prevalence of hepatitis B and C in Mongolia: a nationwide survey amongst Mongolian adults. J Viral Hepat. 2017;24(9):759-767.
World Health Organisation (WHO). Global Hepatitis Report 2017. World Health Organisation; 2017. http://appswhoint/iris/bitstream/handle/10665/255016/9789241565455-engpdf;jsessionid=9DECA1FF83BC4A8C41B74E3BE2649662?sequence=1
Rafter I, Graberg T, Kotronen A, et al. Isoform-specific alanine aminotransferase measurement can distinguish hepatic from extrahepatic injury in humans. Int J Mol Med. 2012;30(5):1241-1249.
Bloom S, Kemp W, Nicoll A, et al. Liver stiffness measurement in the primary care setting detects high rates of advanced fibrosis and predicts liver-related events in hepatitis C. J Hepatol. 2018;69(3):575-583.
Hall SAL, Vogrin S, Wawryk O, et al. Discontinuation of nucleot(s)ide analogue therapy in HBeAg-negative chronic hepatitis B: a meta-analysis. Gut. 2021;71:1629-1641.
Goutzamanis S, Spelman T, Harney B, et al. Patient-reported outcomes of the treatment and prevention study: a real-world community-based trial of direct-acting antivirals for hepatitis C among people who inject drugs. J Viral Hepat. 2021;28(7):1068-1077.
European Association for Study of the Liver. EASL-ALEH clinical practice guidelines: non-invasive tests for evaluation of liver disease severity and prognosis. J Hepatol. 2015;63(1):237-264.
Shimakawa Y, Njie R, Ndow G, et al. Development of a simple score based on HBeAg and ALT for selecting patients for HBV treatment in Africa. J Hepatol. 2018;69(4):776-784.
Howell J, Anderson D, Bloom S, et al. Validation of the TREAT-B score for hepatitis B treatment eligibility in a large Asian cohort: TREAT-B improves with age. J Hepatol. 2020;73(5):1282-1284.
Schroeder SE, Pedrana A, Scott N, et al. Innovative strategies for the elimination of viral hepatitis at a national level: a country case series. Liver Int. 2019;39:1818-1836.
Lafferty L, Cochrane A, Sheehan Y, Treloar C, Grebely J, Lloyd AR. “That was quick, simple, and easy”: patient perceptions of acceptability of point-of-care hepatitis C RNA testing at a reception prison. Int J Drug Policy. 2021;99:103456.
Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67(4):1560-1599.
World Health Organisation (WHO). Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. World Health Organisation; 2015.
Sarin SK, Kumar M, Lau GK, et al. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016;10(1):1-98.
Yoshida K, Post G, Shimakawa Y, et al. Clinical utility of TREAT-B score in African and non-African HBV-infected patients living in Europe. J Hepatol. 2019;70(6):1295-1297.
Johannessen A, Aberra H, Desalegn H, Gordien E, Berhe N. A novel score to select patients for treatment in chronic hepatitis B: results from a large Ethiopian cohort. J Hepatol. 2019;71(4):840-841.
Bajis S, Maher L, Treloar C, et al. Acceptability and preferences of point-of-care finger-stick whole-blood and venepuncture hepatitis C virus testing among people who inject drugs in Australia. Int J Drug Policy. 2018;61:23-30.
Lemoine M, Shimakawa Y, Njie R, et al. Acceptability and feasibility of a screen-and-treat programme for hepatitis B virus infection in The Gambia: the prevention of liver fibrosis and cancer in Africa (PROLIFICA) study. Lancet Glob Health. 2016;4(8):e559-e567.
Hutton J, Doyle J, Zordan R, et al. Point-of-care Hepatitis C virus testing and linkage to treatment in an Australian inner-city emergency department. Int J Drug Policy. 2019;72:84-90.