Key result
HCV-antigen assays perform comparably to RNA assays for Hepatitis C detection with ~4% false negatives.
Why the study?
The complexity and cost of current HCV diagnostics may limit treatment scale-up in developing countries, prompting evaluation of simpler antigen tests.
Does Hepatitis C Virus antigen testing perform as well as RNA-PCR analysis for detecting Hepatitis C Virus?
Systematic Review (n=8,136)
Does Hepatitis C Virus antigen testing perform as well as RNA-PCR analysis for detecting Hepatitis C Virus?
Absolute Event Rate: 0.57% vs 3.52%
HCV antigen detection performs comparably to RNA-based assays, offering a simpler and cheaper diagnostic alternative that could improve access to care in underresourced settings.
Antigen assays show low discordance with RNA testing (0.57% FP, 3.52% FN); supports adoption to expand HCV diagnosis in resource-limited settings.
The complexity and cost of current diagnostics for hepatitis C virus (HCV) may act as a prevention to the scale-up of treatment in the developing world. Currently, ribonucleic acid (RNA)-polymerase chain reaction tests are the gold standard. However, there is potential for the use of simpler and cheaper antigen tests to confirm HCV infection in different clinical settings. We evaluated the sensitivity and specificity of antigen assays. This was compared with the reference-standard RNA assays. A subanalysis also assessed Architect core antigen test, which is the only commercially available antigen test on the market. In 24 datasets, evaluating HCV-antigen assays in 8136 samples, the percentage of HCV-antigen positive, HCV-RNA negative was 0.57%. The percentage HCV-antigen negative, HCV-RNA positive was 3.52%. There is strong evidence that antigen detection performs as well as RNA-based assays for HCV management. The use of antigen tests could improve access to HCV care in underresourced healthcare settings.
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Khan et al. (2017) conducted a systematic review in Hepatitis C Virus (n=8,136). HCV-antigen assays vs. RNA-polymerase chain reaction assays was evaluated on Discordant test results (HCV-antigen positive/HCV-RNA negative and HCV-antigen negative/HCV-RNA positive). HCV-antigen assays performed comparably to RNA-based assays for detecting Hepatitis C virus, with 0.57% false positives and 3.52% false negatives across 8,136 samples.
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