Analytical validation of hepatitis B core-related antigen (HBcrAg) using dried blood spots (DBS).
analytical validation
diagnostic test
dried blood spot
hepatitis B core-related antigen
resource-limited country
Journal
Journal of viral hepatitis
ISSN: 1365-2893
Titre abrégé: J Viral Hepat
Pays: England
ID NLM: 9435672
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
revised:
05
02
2021
received:
06
01
2021
accepted:
09
02
2021
pubmed:
19
2
2021
medline:
2
10
2021
entrez:
18
2
2021
Statut:
ppublish
Résumé
Limited access to nucleic acid testing (NAT) to quantify HBV DNA levels, an essential tool to determine anti-HBV treatment eligibility, represents a significant barrier to scale up HBV diagnostic services in resource-limited countries. Hepatitis B core-related antigen (HBcrAg) has the potential to become an affordable alternative because of its low cost (US$ <15/assay) and strong correlation with HBV DNA levels in treatment-naïve patients. However, the current assay requires plasma or serum. To further facilitate its application to decentralized settings, we developed and evaluated a standardized procedure to quantify HBcrAg using dried blood spots as a tool to diagnose HBV-infected people with high viraemia. We evaluated the following elution method optimized to quantify HBcrAg: suspension of a punched blood-soaked disc (11 mm) of Whatman 903 Protein Saver Card in 450 µL of PBS 0.05% Tween 20, followed by an incubation for 4 h at room temperature and a centrifugation at 10,000 g for 10 minutes. 150 µL of DBS eluate was used to quantify HBcrAg using chemiluminescent enzyme immunoassay (LUMIPULSE
Identifiants
pubmed: 33599049
doi: 10.1111/jvh.13489
pmc: PMC8247985
doi:
Substances chimiques
DNA, Viral
0
Hepatitis B Core Antigens
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
837-843Subventions
Organisme : Fujirebio Europe
Informations de copyright
© 2021 The Authors. Journal of Viral Hepatitis published by John Wiley & Sons Ltd.
Références
Liver Int. 2017 Jul;37(7):995-1001
pubmed: 27992681
Clin Microbiol Rev. 2010 Jul;23(3):550-76
pubmed: 20610823
BMC Infect Dis. 2017 Nov 1;17(Suppl 1):693
pubmed: 29143616
Pediatrics. 1963 Sep;32:338-43
pubmed: 14063511
Aliment Pharmacol Ther. 2018 Jan;47(1):43-54
pubmed: 29035003
Epidemiol Infect. 2016 Jul;144(10):2087-97
pubmed: 26833270
Lancet Glob Health. 2019 Sep;7(9):e1180-e1188
pubmed: 31353061
Clin Gastroenterol Hepatol. 2021 Jan;19(1):46-60.e8
pubmed: 32360825
BMC Public Health. 2017 Aug 4;17(1):636
pubmed: 28778194
BMC Infect Dis. 2017 Nov 1;17(Suppl 1):700
pubmed: 29143672
Hepatol Int. 2016 Jan;10(1):1-98
pubmed: 26563120
Hepatology. 2016 Jan;63(1):261-83
pubmed: 26566064
J Int AIDS Soc. 2017 Sep 14;20(1):21856
pubmed: 28953324
J Clin Microbiol. 2002 Feb;40(2):439-45
pubmed: 11825954
Lancet Gastroenterol Hepatol. 2018 Jun;3(6):383-403
pubmed: 29599078
Lancet Infect Dis. 2021 Jan;21(1):85-96
pubmed: 32805201
Int J Drug Policy. 2015 Nov;26(11):1050-5
pubmed: 26118799
Lancet HIV. 2016 Jun;3(6):e259-65
pubmed: 27240788
J Virol. 2017 Apr 13;91(9):
pubmed: 28228589
J Hepatol. 2016 Jul;65(1):48-56
pubmed: 27034253
J Virol Methods. 2021 Mar;289:114057
pubmed: 33359613
Lancet Infect Dis. 2021 Jan;21(1):70-84
pubmed: 32805200
BMC Infect Dis. 2017 Nov 1;17(Suppl 1):696
pubmed: 29143609
Gastroenterology. 2019 Dec;157(6):1518-1529.e3
pubmed: 31470004
Clin Infect Dis. 2020 Mar 17;70(7):1442-1452
pubmed: 31102406
J Hepatol. 2017 Aug;67(2):370-398
pubmed: 28427875
J Gastroenterol Hepatol. 2018 Apr;33(4):918-925
pubmed: 28914957