Authors' objectives: To assess the diagnostic accuracy, safety, cost implication as well as organisational aspect of available antibody and antigen screening against nucleic acid testing using PCR in detecting HCV infection in dialysis patients.

Authors' results and conclusions: 1-Diagnostic Accuracy Against PCR, HCV-core antigen showed better performance in terms in sensitivity and specificity compared with anti-HCV antibody and combined HCV-core antigen/anti-HCV antibody tests in detecting HCV infection among dialysis patients. 2-Economic Implication PCR alone and combination of anti-HCV antibody test + PCR were the most expensive screening strategy compared with other strategies. Combination of anti-HCV antibody test and PCR was more expensive than combination of anti-HCV antibody test and RIBA as confirmatory test in dialysis patients. Replacing Anti-HCV antibody test with HCV-core antigen in screening active HCV infection among haemodialysis patients would not be feasible due to higher cost. However, combining Anti-HCV and HCV-core antigen in detecting HCV infection among haemodialysis patients would generate cost savings. 3-Organisational Three evidence-based guidelines; WHO Guidelines on Hepatitis B and C Testing (2017), our national evidence-based Clinical Practice Guidelines (CPG) Management of Chronic Hepatitis C in Adults (MoH CPG) (2019) and Centers for Disease Control (CDC) Recommendations for Hepatitis C Screening among Adults 2020 suggested two-level of testing. First level of testing being the detection of anti-HCV antibody using either laboratory-based immunoassays or rapid diagnostic test. Following a reactive anti-HCV antibody, WHO (2017) recommended the use the use of quantitative NAT for detection of HCV RNA as the preferred strategy to diagnose viraemic infection. An assay to detect HCV-core antigen, which has comparable clinical sensitivity to NAT, is an alternative to NAT to diagnose viraemic infection based on moderate level of evidence. While MoH CPG (2019) recommended the use of either molecular testing or HCV-core antigen to confirm diagnosis. Patients with on-going risk factors are encouraged to be screened every year which includes patients on long-term haemodialysis.

Authors' recommendations: HCV-core antigen may be considered as complement, if not replace, anti-HCV antibody testing for regular screening of HCV infection in dialysis patients due to better diagnostic accuracy.

Authors' methods: Electronic databases searched through the Ovid interface: • Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R) • EBM Reviews - Cochrane Clinical Answers • EBM Reviews - Cochrane Methodology Register • EBM Reviews - Health Technology Assessment • EBM Reviews - NHS Economic Evaluation Database Other databases: • Pubmed • INAHTA Additional articles were identified from reviewing the references of retrieved articles. General search engine was used to get additional web-based information. The search was limited to English articles on humans. Appendix 1 showed the detailed strategies. The last search was conducted on 30 April 2021.

Project Status: Completed

Year Published: 2020

URL for published report: http://www.moh.gov.my/index.php/database_stores/store_view_page/30/365

Requestor: Ministry of Health

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Malaysia

Organisation Name: Malaysian Health Technology Assessment

Contact Address: Malaysian Health Technology Assessment Section, Ministry of Health Malaysia, Federal Government Administrative Centre, Level 4, Block E1, Parcel E, 62590 Putrajaya Malaysia Tel: +603 8883 1229

Contact Name: htamalaysia@moh.gov.my

Contact Email: htamalaysia@moh.gov.my

Copyright: Malaysian Health Technology Assessment Section (MaHTAS)