Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

Cadieux, Geneviève; Campbell, Jennifer V.; Dendukuri, Nandini

doi:10.9778/cmajo.20160084

Cited by 18 publications

(18 citation statements)

References 31 publications

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“…Several studies have evaluated the currently available anti-HCV assays, with the sensitivity of each assay demonstrating variability TA B L E 3 Sensitivity comparisons of the three anti-HCV CLIA assays in patients with HCV infection (n = 90) from 61.0% to 100% and the specificity being high, ranging from 97.5% to 100%. 6,7,[12][13][14] In the present study, we evaluated the diag- These results are consistent with those of several previous studies in which the diagnostic performance of the Elecsys anti-HCV II assay was compared with that of the Architect anti-HCV assay. 7,15 The prevalence of HCV infection was reported to be 0.43% in China.…”

Section: Screening Tests For the Diagnosis Of Infectious Diseases Neesupporting

confidence: 86%

“…Several studies have evaluated the currently available anti‐HCV assays, with the sensitivity of each assay demonstrating variability from 61.0% to 100% and the specificity being high, ranging from 97.5% to 100% . In the present study, we evaluated the diagnostic performance of the Mindray anti‐HCV assay for the detection of HCV infection and showed a high sensitivity of 95.6% and excellent specificity of 99.2%.…”

Section: Discussionmentioning

confidence: 93%

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Performance evaluation of the mindray anti‐HCV assay for the detection of hepatitis C virus infection

Yue

Xia

Wang

2018

Clinical Laboratory Analysis

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Section: Screening Tests For the Diagnosis Of Infectious Diseases Neesupporting

confidence: 86%

Section: Discussionmentioning

confidence: 93%

Performance evaluation of the mindray anti‐HCV assay for the detection of hepatitis C virus infection

Yue

Xia

Wang

2018

Clinical Laboratory Analysis

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“…The second test is a reverse-transcription polymerase-chain reaction (RT-PCR) viral RNA test to confirm the serologic test, and to determine whether the HCV infection had been cleared spontaneously. The RT-PCR test has a sensitivity between 61.0% and 81.8% and a specificity between 97.5 and 99.7% [29]. The third test concerned a fibroscan examination, which is a quantitative analysis technique to support the diagnostics of liver fibrosis in patients and to determine the METAVIR score (F0-F4).…”

Section: Hepatitis C Virus Testingmentioning

confidence: 99%

Cost-effectiveness of hepatitis C virus screening, and subsequent monitoring or treatment among pregnant women in the Netherlands

et al. 2020

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Background The prevalence of diagnosed chronic hepatitis C virus (HCV) infection among pregnant women in the Netherlands is 0.26%, yet many cases remain undiagnosed. HCV screening and treatment of pregnant HCV carriers could reduce the burden of disease and limit vertical transmission from mother to child. We assessed the impact of HCV screening and subsequent treatment with new direct-acting antivirals (DAAs) among pregnant women in the Netherlands. Methods An HCV natural history Markov transition state model was developed, to evaluate the public-health and economic impact of HCV screening and treatment. Besides all 179,000 pregnant women in the Netherlands (cohort 1), we modelled 3 further cohorts: all 79,000 first-time pregnant women (cohort 2), 33,000 pregnant migrant women (cohort 3) and 16,000 first-time pregnant migrant women (cohort 4). Each cohort was analyzed in various scenarios: i no intervention, i.e., the current practice, ii screen-and-treat, i.e., the most extensive approach involving treatment of all individuals found HCV-positive, and iii screen-and-treat/monitor, i.e., a strategy involving treatment of symptomatic (F1–F4) patients and follow-up of asymptomatic (F0) HCV carriers with subsequent treatment only at progression. Results For all cohorts, comparison between scenarios (ii) and (i) resulted in ICERs between €9,306 and €10,173 per QALY gained and 5 year budget impacts varying between €6,283,830 and €19,220,405. For all cohorts, comparison between scenarios (iii) and (i) resulted in ICERs between €1,739 and €2,749 per QALY gained and budget impacts varying between €1,468,670 and €5,607,556. For all cohorts, the ICERs (scenario iii versus ii) involved in delayed treatment of asymptomatic (F0) HCV carriers varied between €56,607 and €56,892, well above the willingness-to-pay (WTP) threshold of €20,000 per QALY gained and even above a threshold of €50,000 per QALY gained. Conclusion Universal screening for HCV among all pregnant women in the Netherlands is cost-effective. However, it would be reasonable to consider smaller risk groups in view of the budget impact of the intervention.

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“…However, HCV antibody remains positive independent of virologic cure or ongoing infection. Current HCV third-generation enzyme-linked immunosorbent assays have intermediate sensitivity ranging from 61 to 81.8%, but excellent specificity of 97.5-99.7% for detection of HCV for detection of HCV in the general population [6].…”

Section: Introductionmentioning

confidence: 99%

Factors associated with hepatitis C antibody seroconversion after transplantation of kidneys from hepatitis C infected donors to hepatitis C naïve recipients

et al. 2020

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Background: We aimed to assess the probability and factors associated with the presence of hepatitis C virus (HCV) antibody among HCV seronegative kidney transplant recipients receiving HCV-infected (nucleic acid testing positive) donor kidneys. Methods: This is a retrospective review examining HCV antibody seroconversion of all kidney transplant recipients receiving an organ from an HCV-infected donor between 1 March 2018 and 2 December 2019 at a high-volume kidney transplant center in the southeast United States. Results: Of 97 patients receiving HCV-infected kidneys, the final cohort consisted of 85 recipients with 5 (5.9%) recipients noted to have HCV antibody seroconversion in the setting of HCV viremia. The HCV RNA level at closest time of antibody measurement was higher in the seroconverted patients versus the ones who never converted [median and (interquartile range): 1,091,500 (345,000-8,360,000) vs 71,500 (73-313,000), p ¼ 0.02]. No other significant differences including type of immunosuppression were noted between the HCV antibody positive group and HCV antibody negative group. Donor donation after cardiac death status [Odds Ratio (OR) and 95% Confidence Interval (CI) was: 8.22 (1.14-59.14)], donor age [OR (95% CI) (þ5 years) was: 3.19 (1.39-7.29)] and Kidney Donor Profile Index [OR (95% CI) (þ1) was:1.07 (1.01-1.15)] showed a statistically significant association with HCV seroconversion. Conclusions: HCV antibody should not be considered routine screening for presence of infection in previously HCV naïve kidney transplant recipients receiving kidneys from HCV-infected donors, as only a modest percentage have antibody despite active viremia. The assessment of HCV viral load should be routine in all transplant recipients receiving organs from public health service increased risk donors.

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Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

Cited by 18 publications

References 31 publications

Performance evaluation of the mindray anti‐HCV assay for the detection of hepatitis C virus infection

Performance evaluation of the mindray anti‐HCV assay for the detection of hepatitis C virus infection

Cost-effectiveness of hepatitis C virus screening, and subsequent monitoring or treatment among pregnant women in the Netherlands

Factors associated with hepatitis C antibody seroconversion after transplantation of kidneys from hepatitis C infected donors to hepatitis C naïve recipients

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