Performance of Hepatitis C Virus (HCV) Core Antigen Assay in the Diagnosis of Recently Acquired HCV Infection among High-Risk Populations
ABSTRACT How the hepatitis C virus (HCV) core antigen (HCVcAg) assay performs in detecting recently acquired HCV infection among people living with HIV (PLWH) and HIV-negative men who have sex with men (MSM) is rarely assessed in the Asia-Pacific region. High-risk participants, including PLWH with s...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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American Society for Microbiology
2022-06-01
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| Series: | Microbiology Spectrum |
| Subjects: | |
| Online Access: | https://journals.asm.org/doi/10.1128/spectrum.00345-22 |
| _version_ | 1811238113051148288 |
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| author | Hsin-Yun Sun Wang-Da Liu Chih-Wen Wang Yu-Ju Wei Kuan-Yin Lin Yu-Shan Huang Li-Hsin Su Yi-Ting Chen Wen-Chun Liu Yi-Chin Su Yea-Wen Chen Yu-Chung Chuang Po-Liang Lu Chien-Ching Hung Ming-Lung Yu |
| author_facet | Hsin-Yun Sun Wang-Da Liu Chih-Wen Wang Yu-Ju Wei Kuan-Yin Lin Yu-Shan Huang Li-Hsin Su Yi-Ting Chen Wen-Chun Liu Yi-Chin Su Yea-Wen Chen Yu-Chung Chuang Po-Liang Lu Chien-Ching Hung Ming-Lung Yu |
| author_sort | Hsin-Yun Sun |
| collection | DOAJ |
| description | ABSTRACT How the hepatitis C virus (HCV) core antigen (HCVcAg) assay performs in detecting recently acquired HCV infection among people living with HIV (PLWH) and HIV-negative men who have sex with men (MSM) is rarely assessed in the Asia-Pacific region. High-risk participants, including PLWH with sexually transmitted infections (STIs), HCV clearance by antivirals or spontaneously, or elevated aminotransferases, HIV-negative MSM with STIs or on HIV preexposure prophylaxis, and low-risk PLWH were enrolled. Blood samples were subjected to 3-stage pooled-plasma HCV RNA testing every 3 to 6 months until detection of HCV viremia or completion of the 1-year follow-up. The samples at enrollment and all of the archived samples preceding the detection of HCV RNA during follow-up were tested for HCVcAg. During June 2019 and February 2021, 1,639 blood samples from 744 high-risk and 727 low-risk PLWH and 86 HIV-negative participants were tested for both HCV RNA and HCVcAg. Of 62 samples positive for HCV RNA, 54 (87.1%) were positive for HCVcAg. Of 1,577 samples negative for HCV RNA, 1,568 (99.4%) were negative for HCVcAg. The mean HCV RNA load of the 8 individual samples positive for HCV RNA but negative for HCVcAg was 3.2 (range, 2.5 to 3.9) log10 IU/mL, and that of the remaining 54 samples with concordant results was 6.2 (range, 1.3 to 8.5) log10 IU/mL. The positive predictive value (PPV) and negative predictive value (NPV) of HCVcAg were 85.7% and 99.5%, respectively. In at-risk populations, HCVcAg has a high specificity and NPV but lower sensitivity and PPV, particularly in individuals with low HCV RNA loads. IMPORTANCE The HCV core antigen assay has a high specificity of 99.4% and negative predictive value of 99.5% but a lower sensitivity of 87.1% and positive predictive value of 85.7% in the diagnosis of recently acquired HCV infection in high-risk populations. Our findings are informative for many countries confronted with limited resources to timely identify acute HCV infections and provide effective direct-acting antivirals to halt onward transmission. |
| first_indexed | 2024-04-12T12:36:06Z |
| format | Article |
| id | doaj.art-3d44a9b00df843829f029cb728a7d7d7 |
| institution | Directory Open Access Journal |
| issn | 2165-0497 |
| language | English |
| last_indexed | 2024-04-12T12:36:06Z |
| publishDate | 2022-06-01 |
| publisher | American Society for Microbiology |
| record_format | Article |
| series | Microbiology Spectrum |
| spelling | doaj.art-3d44a9b00df843829f029cb728a7d7d72022-12-22T03:32:54ZengAmerican Society for MicrobiologyMicrobiology Spectrum2165-04972022-06-0110310.1128/spectrum.00345-22Performance of Hepatitis C Virus (HCV) Core Antigen Assay in the Diagnosis of Recently Acquired HCV Infection among High-Risk PopulationsHsin-Yun Sun0Wang-Da Liu1Chih-Wen Wang2Yu-Ju Wei3Kuan-Yin Lin4Yu-Shan Huang5Li-Hsin Su6Yi-Ting Chen7Wen-Chun Liu8Yi-Chin Su9Yea-Wen Chen10Yu-Chung Chuang11Po-Liang Lu12Chien-Ching Hung13Ming-Lung Yu14Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanHepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, TaiwanDepartment of Internal Medicine, Kaohsiung Medical University Hospital and College of Medicine, Kaohsiung Medical University, Kaohsiung, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Internal Medicine, Kaohsiung Medical University Hospital and College of Medicine, Kaohsiung Medical University, Kaohsiung, TaiwanDepartment of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, TaiwanHepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, TaiwanABSTRACT How the hepatitis C virus (HCV) core antigen (HCVcAg) assay performs in detecting recently acquired HCV infection among people living with HIV (PLWH) and HIV-negative men who have sex with men (MSM) is rarely assessed in the Asia-Pacific region. High-risk participants, including PLWH with sexually transmitted infections (STIs), HCV clearance by antivirals or spontaneously, or elevated aminotransferases, HIV-negative MSM with STIs or on HIV preexposure prophylaxis, and low-risk PLWH were enrolled. Blood samples were subjected to 3-stage pooled-plasma HCV RNA testing every 3 to 6 months until detection of HCV viremia or completion of the 1-year follow-up. The samples at enrollment and all of the archived samples preceding the detection of HCV RNA during follow-up were tested for HCVcAg. During June 2019 and February 2021, 1,639 blood samples from 744 high-risk and 727 low-risk PLWH and 86 HIV-negative participants were tested for both HCV RNA and HCVcAg. Of 62 samples positive for HCV RNA, 54 (87.1%) were positive for HCVcAg. Of 1,577 samples negative for HCV RNA, 1,568 (99.4%) were negative for HCVcAg. The mean HCV RNA load of the 8 individual samples positive for HCV RNA but negative for HCVcAg was 3.2 (range, 2.5 to 3.9) log10 IU/mL, and that of the remaining 54 samples with concordant results was 6.2 (range, 1.3 to 8.5) log10 IU/mL. The positive predictive value (PPV) and negative predictive value (NPV) of HCVcAg were 85.7% and 99.5%, respectively. In at-risk populations, HCVcAg has a high specificity and NPV but lower sensitivity and PPV, particularly in individuals with low HCV RNA loads. IMPORTANCE The HCV core antigen assay has a high specificity of 99.4% and negative predictive value of 99.5% but a lower sensitivity of 87.1% and positive predictive value of 85.7% in the diagnosis of recently acquired HCV infection in high-risk populations. Our findings are informative for many countries confronted with limited resources to timely identify acute HCV infections and provide effective direct-acting antivirals to halt onward transmission.https://journals.asm.org/doi/10.1128/spectrum.00345-22men who have sex with mensexually transmitted infectionviral hepatitispreexposure prophylaxisHCV viremiapooled-plasma HCV RNA testing |
| spellingShingle | Hsin-Yun Sun Wang-Da Liu Chih-Wen Wang Yu-Ju Wei Kuan-Yin Lin Yu-Shan Huang Li-Hsin Su Yi-Ting Chen Wen-Chun Liu Yi-Chin Su Yea-Wen Chen Yu-Chung Chuang Po-Liang Lu Chien-Ching Hung Ming-Lung Yu Performance of Hepatitis C Virus (HCV) Core Antigen Assay in the Diagnosis of Recently Acquired HCV Infection among High-Risk Populations Microbiology Spectrum men who have sex with men sexually transmitted infection viral hepatitis preexposure prophylaxis HCV viremia pooled-plasma HCV RNA testing |
| title | Performance of Hepatitis C Virus (HCV) Core Antigen Assay in the Diagnosis of Recently Acquired HCV Infection among High-Risk Populations |
| title_full | Performance of Hepatitis C Virus (HCV) Core Antigen Assay in the Diagnosis of Recently Acquired HCV Infection among High-Risk Populations |
| title_fullStr | Performance of Hepatitis C Virus (HCV) Core Antigen Assay in the Diagnosis of Recently Acquired HCV Infection among High-Risk Populations |
| title_full_unstemmed | Performance of Hepatitis C Virus (HCV) Core Antigen Assay in the Diagnosis of Recently Acquired HCV Infection among High-Risk Populations |
| title_short | Performance of Hepatitis C Virus (HCV) Core Antigen Assay in the Diagnosis of Recently Acquired HCV Infection among High-Risk Populations |
| title_sort | performance of hepatitis c virus hcv core antigen assay in the diagnosis of recently acquired hcv infection among high risk populations |
| topic | men who have sex with men sexually transmitted infection viral hepatitis preexposure prophylaxis HCV viremia pooled-plasma HCV RNA testing |
| url | https://journals.asm.org/doi/10.1128/spectrum.00345-22 |
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