Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan
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...
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MDPI AG
2021-07-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/11/8/1354 |
| _version_ | 1797524191988154368 |
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| author | Adeel Abid Murad Uddin Taj Muhammad Safia Awan Tanya Applegate Gregory J. Dore Gavin Cloherty Saeed Hamid |
| author_facet | Adeel Abid Murad Uddin Taj Muhammad Safia Awan Tanya Applegate Gregory J. Dore Gavin Cloherty Saeed Hamid |
| author_sort | Adeel Abid |
| collection | DOAJ |
| description | 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<sup>®</sup> IV, Cepheid, France) and HCVcAg (ARCHITECT HCV Ag assay, Abbott<sup>®</sup> Diagnostics) to confirm active HCV infection. An Abbott ARCHITECT<sup>®</sup> 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. |
| first_indexed | 2024-03-10T08:53:53Z |
| format | Article |
| id | doaj.art-b7a8e2cb330842f4a64e826f0b99a52e |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-10T08:53:53Z |
| publishDate | 2021-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-b7a8e2cb330842f4a64e826f0b99a52e2023-11-22T07:19:18ZengMDPI AGDiagnostics2075-44182021-07-01118135410.3390/diagnostics11081354Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in PakistanAdeel Abid0Murad Uddin1Taj Muhammad2Safia Awan3Tanya Applegate4Gregory J. Dore5Gavin Cloherty6Saeed Hamid7Department of Medicine, Aga Khan University, Stadium Road, Karachi 74800, PakistanDepartment of Medicine, Aga Khan University, Stadium Road, Karachi 74800, PakistanDepartment of Medicine, Aga Khan University, Stadium Road, Karachi 74800, PakistanDepartment of Medicine, Aga Khan University, Stadium Road, Karachi 74800, PakistanKirby Institute, Viral Hepatitis Clinical Research Program, UNSW Sydney, Sydney, NSW 2052, AustraliaKirby Institute, Viral Hepatitis Clinical Research Program, UNSW Sydney, Sydney, NSW 2052, AustraliaAbbott Diagnostics, Abbott Park, IL 60064-3500, USADepartment of Medicine, Aga Khan University, Stadium Road, Karachi 74800, PakistanThe 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<sup>®</sup> IV, Cepheid, France) and HCVcAg (ARCHITECT HCV Ag assay, Abbott<sup>®</sup> Diagnostics) to confirm active HCV infection. An Abbott ARCHITECT<sup>®</sup> 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.https://www.mdpi.com/2075-4418/11/8/1354Hepatitis CHCV Core antigenGeneXpert® IVdededecentralized |
| spellingShingle | Adeel Abid Murad Uddin Taj Muhammad Safia Awan Tanya Applegate Gregory J. Dore Gavin Cloherty Saeed Hamid Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan Diagnostics Hepatitis C HCV Core antigen GeneXpert® IV dededecentralized |
| title | Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan |
| title_full | Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan |
| title_fullStr | Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan |
| title_full_unstemmed | Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan |
| title_short | Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan |
| title_sort | evaluation of hepatitis c virus core antigen assay in a resource limited setting in pakistan |
| topic | Hepatitis C HCV Core antigen GeneXpert® IV dededecentralized |
| url | https://www.mdpi.com/2075-4418/11/8/1354 |
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