Performance of a rapid diagnostic test for screening of hepatitis C in a real-life prison setting.
Adult
Enzyme-Linked Immunosorbent Assay
False Negative Reactions
False Positive Reactions
Hepacivirus
Hepatitis C
/ blood
Hepatitis C Antibodies
/ blood
Humans
Iran
Male
Mass Screening
Middle Aged
Point-of-Care Systems
/ standards
Prisoners
/ statistics & numerical data
Prisons
Prospective Studies
RNA, Viral
/ genetics
Reproducibility of Results
Sensitivity and Specificity
Serologic Tests
/ instrumentation
Hepatitis C
Hepatitis C antibodies
Rapid test
Screening
Journal
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671
Informations de publication
Date de publication:
04 2019
04 2019
Historique:
received:
05
11
2018
revised:
07
02
2019
accepted:
25
02
2019
pubmed:
3
3
2019
medline:
21
5
2020
entrez:
3
3
2019
Statut:
ppublish
Résumé
Hepatitis C virus (HCV) point-of-care testing using rapid diagnostic test (RDT) is the solution for large-scale, feasible, fast and reliable screening of HCV infection. The aim of this study was to evaluate the diagnostic performance of HCV RDT for screening of HCV infection in a real-life prison setting. This study was conducted on individuals admitted and incarcerated in the Central Prison of Karaj, 2017-2018. For all inmates, anti-HCV testing using a RDT on finger-stick blood in the prison and ELISA at the laboratory were performed. For evaluation of reproducibility, more than 1000 cases were recruited for re-evaluation of the HCV RDT using anticoagulated blood in the laboratory. Among 1788 participants, 76 (4.25%) and 106 (5.93%) were positive for anti-HCV using RDT and ELISA, respectively. Among 34 cases with discordant results using the RDT and ELISA, 17 were the result of testing error in prison, 7 false positive of ELISA and 10 false negative of RDT in individuals with HCV spontaneous clearance. The sensitivity of the RDT with inclusion of testing error in prison for detection of anti-HCV was 75%. However, with exclusion of testing error in prison and considering HCV RNA as the reference method for diagnosis of current HCV infection the sensitivity reached 100%. The RDT was 100% reproducible using both evaluations in prison and the laboratory. The RDT is a reliable and feasible method for screening of anti-HCV in settings such as a prison. However, the testing should be performed in a standard procedure to have the optimal diagnostic performance.
Sections du résumé
BACKGROUND
Hepatitis C virus (HCV) point-of-care testing using rapid diagnostic test (RDT) is the solution for large-scale, feasible, fast and reliable screening of HCV infection.
OBJECTIVES
The aim of this study was to evaluate the diagnostic performance of HCV RDT for screening of HCV infection in a real-life prison setting.
STUDY DESIGN
This study was conducted on individuals admitted and incarcerated in the Central Prison of Karaj, 2017-2018. For all inmates, anti-HCV testing using a RDT on finger-stick blood in the prison and ELISA at the laboratory were performed. For evaluation of reproducibility, more than 1000 cases were recruited for re-evaluation of the HCV RDT using anticoagulated blood in the laboratory.
RESULTS
Among 1788 participants, 76 (4.25%) and 106 (5.93%) were positive for anti-HCV using RDT and ELISA, respectively. Among 34 cases with discordant results using the RDT and ELISA, 17 were the result of testing error in prison, 7 false positive of ELISA and 10 false negative of RDT in individuals with HCV spontaneous clearance. The sensitivity of the RDT with inclusion of testing error in prison for detection of anti-HCV was 75%. However, with exclusion of testing error in prison and considering HCV RNA as the reference method for diagnosis of current HCV infection the sensitivity reached 100%. The RDT was 100% reproducible using both evaluations in prison and the laboratory.
CONCLUSIONS
The RDT is a reliable and feasible method for screening of anti-HCV in settings such as a prison. However, the testing should be performed in a standard procedure to have the optimal diagnostic performance.
Identifiants
pubmed: 30825832
pii: S1386-6532(19)30029-0
doi: 10.1016/j.jcv.2019.02.005
pii:
doi:
Substances chimiques
Hepatitis C Antibodies
0
RNA, Viral
0
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
20-23Informations de copyright
Copyright © 2019 Elsevier B.V. All rights reserved.