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Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan
Adeel Abid1, Murad Uddin1, Taj Muhammad1
1Department of Medicine, Aga Khan University, Stadium Road, Karachi 74800, Pakistan.
Insights
A new Hepatitis C core antigen (HCVcAg) assay offers a sensitive and specific tool for diagnosing Hepatitis C virus (HCV) infection. This point-of-care test is ideal for resource-limited settings, aiding global HCV elimination efforts.
Area of Science:
- Hepatology
- Infectious Diseases
- Clinical Diagnostics
Background:
- Hepatitis C virus (HCV) diagnosis is hindered by high costs and limited access to centralized testing.
- Simplified HCV testing algorithms are crucial for effective public health interventions.
- Decentralized testing solutions are needed, especially in resource-limited endemic areas.
Purpose of the Study:
- To evaluate the performance of a Hepatitis C core antigen (HCVcAg) assay.
- To assess its utility in a decentralized, resource-limited setting for diagnosing active HCV infection.
- To compare HCVcAg assay performance against HCV RNA detection.
Main Methods:
- A descriptive cross-sectional study conducted in Karachi, Pakistan (October 2019 - July 2020).
- Included 200 individuals aged 12+ years who screened positive for HCV antibodies.
- Simultaneous testing for HCV RNA (central lab) and HCVcAg (point-of-care facility) using Abbott ARCHITECT®.
Main Results:
- HCV RNA detected in 64.0% (128/200) and HCVcAg reactive in 59.5% (119/200) of participants.
- HCVcAg assay demonstrated high sensitivity (99.1%) and specificity (87.6%) compared to HCV RNA.
- The ARCHITECT® system offered excellent performance with higher throughput and quicker results.
Conclusions:
- The ARCHITECT HCVcAg assay is highly sensitive and specific for confirming active HCV infection in decentralized settings.
- This assay is a valuable tool for HCV elimination programs, particularly in low-income countries.
- Point-of-care HCVcAg testing can overcome barriers to diagnosis in resource-limited areas.
Abstract:
The diagnosis of Hepatitis C virus (HCV) infection can be challenging due to its cost and a lack of access to centralized testing. There is an urgent need to develop simplified HCV testing algorithms. The aim of this study was to evaluate the performance characteristics of a Hepatitis C core antigen (HCVcAg) assay in a decentralized, resource-limited setting. This is a descriptive cross-sectional study from a highly endemic area of Karachi, Pakistan. Between October 2019 and July 2020, subjects aged 12 years and above who screened positive for HCV antibodies were simultaneously tested for HCV RNA (Xpert HCV Viral Load, GeneXpert® IV, Cepheid, France) and HCVcAg (ARCHITECT HCV Ag assay, Abbott® Diagnostics) to confirm active HCV infection. An Abbott ARCHITECT® i1000SR Immunoassay Analyser was installed at a local district hospital as a point-of-care (POC) facility for HCVcAg testing, while samples for HCV RNA were tested in a central lab. Two hundred individuals (mean age 46.4 ± 14.5 years, 71.5% females), who screened positive for HCV antibody, were included in the study. HCV RNA was detected in 128 (64.0%) while HCVcAg was reactive in 119 (59.5%) cases. Performance of the Immunoassay Analyser was excellent with a higher throughput and quicker readout value compared to the GeneXpert System. The sensitivity and specificity of HCVcAg (≥10 fmol/L) at HCV RNA thresholds of ≥12 was 99.1% (95% CI: 95-100%) and 87.6% (95%CI: 78.4-94%). A strong agreement was observed between the HCVcAg assay and HCV RNA. The ARCHITECT HCV Ag assay showed high sensitivity and specificity compared to HCV RNA in a decentralized, resource-limited setting. It can therefore be used as a confirmatory test in HCV elimination programs, particularly for low-income countries such as Pakistan.
