Performance of Hepatitis C Virus (HCV) Core Antigen Assay in the Diagnosis of Recently Acquired HCV Infection among High-Risk Populations

Sun, Hsin‐Yun; Liu, Wang-Da; Wang, Chih‐Wen; Wei, Yu‐Ju; Lin, Kuan‐Yin; Huang, Yu‐Shan; Su, Li‐Hsin; Chen, Yi-Ting; Su, Yi-Chin; Chuang, Yi‐Fang; Lu, Po‐Liang; Hung, Chien‐Ching; Yu, Ming‐Lung

doi:10.1128/spectrum.00345-22

Cited by 12 publications

(7 citation statements)

References 32 publications

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“…The risk of bias was high in three articles (4%) for the patient selection domain, 40,86,99 seven studies (9.3%) for the index test domain, 30,66,68,75,82,83,96 and five studies (6.7%) for the flow and timing. 56,66,67,79,88 A similar trend was reported for concern regarding the applicability, where most studies (n = 61, 81.3%) reported low concerns. Moreover, all studies had low concerns regarding the applicability of the reference standard domain.…”

Section: Risk Of Bias Assessmentsupporting

confidence: 67%

“…Twenty‐one studies (28%) were found to have an overall low risk of bias. The risk of bias was high in three articles (4%) for the patient selection domain, 40,86,99 seven studies (9.3%) for the index test domain, 30,66,68,75,82,83,96 and five studies (6.7%) for the flow and timing 56,66,67,79,88 . A similar trend was reported for concern regarding the applicability, where most studies ( n = 61, 81.3%) reported low concerns.…”

Section: Resultsmentioning

confidence: 53%

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Diagnostic performance of hepatitis C core antigen assay to identify active infections: A systematic review and meta‐analysis

Sepúlveda‐Crespo

Treviño‐Nakoura

Bellón

et al. 2023

Reviews in Medical Virology

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Hepatitis C virus (HCV) core antigen (HCVcAg) assay is an alternative for diagnosing HCV infection in a single step. This meta‐analysis aimed to evaluate the Abbott ARCHITECT HCV Ag assay's diagnostic performance (validity and utility) for diagnosing active hepatitis C. PubMed, EMBASE, Scopus, Web of Science, and Cochrane Library were searched until 10 January 2023. The protocol was registered at the prospective international register of systematic reviews (PROSPERO: CRD42022337191). Abbott ARCHITECT HCV Ag assay was the test for evaluation, and nucleic acid amplification tests with a cut‐off ≤50 IU/mL were the gold standard. Statistical analysis was performed using STATA with the MIDAS module and random‐effects models. The bivariate analysis was conducted on 46 studies (18,116 samples). The pooled sensitivity was 0.96 (95% CI = 0.94–0.97), specificity 0.99 (95% CI = 0.99–1.00), positive likelihood ratio 141.81 (95% CI = 72.39–277.79), and negative likelihood ratio 0.04 (95% CI = 0.03–0.06). The area under the summary receiver operating characteristic curve was 1.00 (95% CI = 0.34–1.00). For active hepatitis C prevalence values of 0.1%–15%, the probability that a positive test was a true positive was 12%–96%, respectively, indicating that a confirmatory test should be necessary, particularly with a prevalence ≤5%. However, the probability that a negative test was a false negative was close to zero, indicating the absence of HCV infection. The validity (accuracy) of the Abbott ARCHITECT HCV Ag assay for screening active HCV infection in serum/plasma samples was excellent. Although the HCVcAg assay showed limited diagnostic utility in low prevalence settings (≤1%), it might help diagnose hepatitis C in high prevalence scenarios (≥5%).

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Section: Risk Of Bias Assessmentsupporting

confidence: 67%

Section: Resultsmentioning

confidence: 53%

Diagnostic performance of hepatitis C core antigen assay to identify active infections: A systematic review and meta‐analysis

Sepúlveda‐Crespo

Treviño‐Nakoura

Bellón

et al. 2023

Reviews in Medical Virology

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“…65 Because of the possibility of reinfection in PWID after DAA treatment, testing for HCV reinfection at least annually and following any alanine aminotransferase elevation in PWID with SVR is recommended. 38 Posttreatment surveillance for HCV reinfection can be performed using pooled HCV RNA testing or HCV core antigen, 66,67 and retreatment should be offered in PWID with HCV reinfection to avoid continued transmission. Therefore, the combination of harm reduction services, treatment as prevention and regular posttreatment HCV surveillance is critical to substantially reduce HCV transmission and prevalence in PWID.…”

Section: Reinfection and Preventionmentioning

confidence: 99%

Hepatitis C virus micro‐elimination in people who inject drugs: Challenges and chance in Taiwan and worldwide

Tai,

2023

The Kaohsiung J of Med Scie

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With the introduction of direct‐acting antivirals, elimination of hepatitis C virus (HCV) infection is becoming possible. People who inject drugs (PWID) represent a population with a high risk for HCV infection, which has been reported as high as 90% in Taiwanese PWID. To reach the goal of HCV elimination, PWID is a key population deserving special attention. Barriers in HCV care cascade still exist in PWID, and interventions to promote access to HCV diagnosis, link‐to‐care, treatment, and prevention for PWID are warranted. Although HCV micro‐elimination can be achieved in some prisons and opioid substitution therapy (OST) centers by a multidisciplinary team and integrated care in Taiwan, there are still several unmet needs for HCV elimination in PWID. Continuous efforts, such as the participation of OST specialists and the continuum of care for HCV among PWID, are needed to achieve HCV elimination in Taiwan. In addition, the combination of harm reduction services, treatment as prevention and regular posttreatment HCV surveillance is critical to substantially reduce HCV transmission and prevalence in PWID.

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“…It is estimated that approximately 71 million individuals worldwide are living with chronic HCV infection, with an annual increase of 1.75 million new HCV infections 1,2 . Currently, HCV infection occurs predominantly in high‐risk populations, such as people who inject drugs (PWID), men who have sex with men (MSM), and human immunodeficiency virus (HIV)‐infected people 3–5 . The modeling demonstrated that the high‐risk populations, which represents only 7% of the population, accounts for 94% of all HCV infections 6 .…”

Section: Introductionmentioning

confidence: 99%

“…who have sex with men (MSM), and human immunodeficiency virus (HIV)-infected people. [3][4][5] The modeling demonstrated that the highrisk populations, which represents only 7% of the population, accounts for 94% of all HCV infections. 6 Although the advent of all-oral, highly effective direct-acting antiviral drugs that can cure HCV infection has made HCV infection a curable disease.…”

mentioning

confidence: 99%

Comparison of effectiveness and cost of different HCV testing strategies in high‐risk populations in China

Chen,

Xu,

Cui

et al. 2024

Journal of Medical Virology

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High‐risk populations are the predominant populations affected by hepatitis C virus (HCV) infection, and there is an urgent need for efficient and cost‐effective HCV testing strategies for high‐risk populations to identify potential undiagnosed HCV‐infected individuals. This study compared several commonly used testing strategies and conducted effectiveness and cost analysis to select the appropriate testing strategy for diagnosing HCV infection in high‐risk populations. Among the 2093 samples from high‐risk populations in this study, 1716 were HCV negative, 237 were current HCV infection, 137 were past HCV infection, and three were acute early HCV infection. It was found that out of 237 patients with HCV current infection, Strategy A could detect 225 cases, with a missed detection rate of 5.06%, and the total cost was 33 299 RMB. In addition, Strategy B could detect 237 cases of current HCV infection, and the HCV missed detection rate was 0.00%, and the total cost was 147 221 RMB. While 137 cases of past HCV infection could be distinguished by strategy C, but 14 cases with current HCV infection were missed, with an HCV‐positive missed detection rate of 5.91%, and the total cost for Strategy C was 43 059 RMB. In conclusion, in high‐risk populations, the HCV positivity rate is typically higher. If feasible, the preferred approach is to directly conduct HCV RNA testing, which effectively minimizes the risk of missing cases. However, in situations with limited resources, it is advisable to initially choose a highly sensitive method for anti‐HCV screening, followed by HCV RNA testing on reactive samples.

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Performance of Hepatitis C Virus (HCV) Core Antigen Assay in the Diagnosis of Recently Acquired HCV Infection among High-Risk Populations

Cited by 12 publications

References 32 publications

Diagnostic performance of hepatitis C core antigen assay to identify active infections: A systematic review and meta‐analysis

Diagnostic performance of hepatitis C core antigen assay to identify active infections: A systematic review and meta‐analysis

Hepatitis C virus micro‐elimination in people who inject drugs: Challenges and chance in Taiwan and worldwide

Comparison of effectiveness and cost of different HCV testing strategies in high‐risk populations in China

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