Sensitivity and specificity of rapid hepatitis C antibody assays in freshly collected whole blood, plasma and serum samples: A multicentre prospective study

Vetter, Beatrice; Tyshkovskiy, Alexander; Alkhazashvili, Maia; Chitadze, Nazibrola; Choun, Kimcheng; An, Shengli; Weggheleire, Anja De; Vanroye, Fien; Reipold, Elena Ivanova

doi:10.1371/journal.pone.0243040

Cited by 4 publications

(3 citation statements)

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“… 7 36 The performance of the anti-HCV screening test was estimated based on a published review of multiple screening technologies, of which we used data on the performance of the SD Biosensor Standard Q HCV test on account of its superior performance. 37 The performance of POC NAT testing was estimated based on two studies that reported the performance of the GeneXpert POC system under field conditions ( table 1 ). The performance of centralised NAT testing was based on a synthesis of results of evaluations of the performance of the cobas ® 6800/8800 system under field conditions.…”

Section: Methodsmentioning

confidence: 99%

“…The population prevalence of HCV in Pakistan was obtained from the published literature 7 36. The performance of the anti-HCV screening test was estimated based on a published review of multiple screening technologies, of which we used data on the performance of the SD Biosensor Standard Q HCV test on account of its superior performance 37. The performance of POC NAT testing was estimated based on two studies that reported the performance of the GeneXpert POC system under field conditions (table 1).…”

Section: Methodsmentioning

confidence: 99%

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Assessing the potential cost-effectiveness of centralised versus point-of-care testing for hepatitis C virus in Pakistan: a model-based comparison

et al. 2023

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ObjectivesPakistan has a hepatitis C virus (HCV) infection prevalence of 6%–9% and aims to achieve World Health Organisation (WHO) targets for elimination of HCV by the year 2030. We aim to evaluate the potential cost-effectiveness of a reference laboratory-based (centralised laboratory testing; CEN) confirmatory testing approach versus a molecular near-patient point-of-care (POC) confirmatory approach to screen the general population for HCV in Pakistan.Study designWe used a decision tree-analytic model from a governmental (formal healthcare sector) perspective.Study settingIndividuals were assumed to be initially screened with an anti-HCV test at home, followed by POC nucleic acid test (NAT) at nearby district hospitals or followed by NAT at centralised laboratories.ParticipantsWe included the general testing population for chronic HCV in Pakistan.InterventionScreening with an anti-HCV antibody test (Anti-HCV) followed by either POC NAT (Anti-HCV-POC), or reference laboratory NAT (Anti-HCV-CEN), was compared, using data from published literature and the Pakistan Ministry of Health.MeasuresOutcome measures included: number of HCV infections identified per year, percentage of individuals correctly classified, total costs, average costs per individual tested, and cost-effectiveness (assessed as cost per additional HCV infection identified). Sensitivity analysis was also performed.ResultsAt a national level (25 million annual screening tests), the Anti-HCV-CEN strategy would identify 142 406 more HCV infections in 1 year and increase correct classification of individuals by 0.57% compared with the Anti-HCV-POC strategy. The total annual cost of HCV testing was reduced using the Anti-HCV-CEN strategy by US$7.68 million (US$0.31/person). Thus, incrementally, the Anti-HCV-CEN strategy costs less and identifies more HCV infections than Anti-HCV-POC. The incremental difference in HCV infections identified was most sensitive to the probability of loss to follow-up (for POC confirmatory NAT).ConclusionsAnti-HCV-CEN would provide the best value for money when scaling up HCV testing in Pakistan.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Assessing the potential cost-effectiveness of centralised versus point-of-care testing for hepatitis C virus in Pakistan: a model-based comparison

et al. 2023

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“…12,31 The performance of the anti-HCV screening test was estimated based on a published review of multiple screening technologies, of which we used data on the performance of the SD Biosensor Standard Q HCV test on account of its superior performance. 32 The performance of POC NAT testing was estimated based on multiple studies that reported the performance of the GeneXpert POC system under field conditions. 13,33 The performance of central NAT testing was based on a synthesis of results of evaluations of the performance of the cobas ® 6800/8800 system under field conditions.…”

Section: Probabilitiesmentioning

confidence: 99%

Assessing the potential cost-effectiveness of centralized vs point-of-care testing for hepatitis C virus in Pakistan: a model-based comparison

Babigumira

Karichu

Clark

et al. 2022

Preprint

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Background Pakistan has a hepatitis C virus (HCV) infection prevalence of 6-9% and aims to achieve World Health Organization (WHO) targets for elimination of HCV by the year 2030 through scaling HCV diagnosis and accelerating access to care. The clinical and economic benefits of various HCV testing strategies have not yet been evaluated in Pakistan. Objective To evaluate the potential cost-effectiveness of a reference laboratory-based (CEN) confirmatory testing approach vs a molecular near-patient point-of-care (POC) confirmatory approach to screen the general population for HCV in Pakistan. Methods We developed a decision-analytic model comparing HCV testing under two scenarios: screening with an anti-HCV antibody test (Anti-HCV) followed by either POC nucleic acid testing (NAT) (Anti-HCV-POC), or reference laboratory NAT (Anti-HCV-CEN), using data from published literature, the Pakistan Ministry of Health, and expert judgment. Outcome measures included: number of HCV infections identified per year, percentage of individuals correctly classified, total costs, average costs per individual tested, and cost-effectiveness. Sensitivity analysis was also performed. Results At a national level for a tested population of 25 million, the Anti-HCV-CEN strategy would identify 142,406 more HCV infections in one year and increase correct classification of individuals by 0.57% compared with the Anti-HCV-POC strategy. The total annual cost of HCV testing was reduced using the Anti-HCV-CEN strategy by $7.68 million ($0.31 per person). Thus, incrementally, the Anti-HCV-CEN strategy costs less and identifies more HCV infections than Anti-HCV-POC. Conclusions Anti-HCV-CEN would provide the best value for money when scaling up HCV testing in Pakistan.

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Evaluation of Hepatitis C Virus Transmission Through Endoscopy Procedures in the Country of Georgia

Baliashvili,

Merabishvili,

Tskhomelidze

et al. 2024

Journal of Viral Hepatitis

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Exposure to healthcare procedures might be a source of hepatitis C virus (HCV) transmission in Georgia, one of the few countries currently on track to eliminate hepatitis C. While there has been a history of iatrogenic transmission of HCV, the risk of HCV transmission related to endoscopic procedures has not been previously assessed in Georgia. The goal of this study was to assess HCV seroconversion among individuals undergoing endoscopic procedures to estimate the relative role and incidence of HCV infection attributable to endoscopic procedures. A prospective cohort study was conducted in four endoscopy units in two cities (Tbilisi and Kutaisi) of Georgia during April–September, 2021. Recruitment of study participants was conducted using convenience sampling, and every eligible patient was approached and invited to participate in the study. Study population included adults (age ≥ 18 years) who received an endoscopic procedure (gastroscopy, colonoscopy and bronchoscopy) in inpatient or outpatient unit at the study sites. HCV antibody (anti‐HCV) testing was conducted using rapid diagnostic test (RDT) on the same day they underwent the endoscopic procedure. Patients with a non‐reactive anti‐HCV baseline test were retested after 6 months. Patients with reactive baseline tests were excluded from the study and linked to further testing and care. Participants with a reactive result on follow‐up RDTs were retested using a lab‐based anti‐HCV and HCV ribonucleic acid (RNA) test. A total of 981 HCV antibody non‐reactive participants were enrolled; 590 (64.8%) of them were reached and retested after 6 months. At retesting, two out of 590 (0.3%) individuals had a reactive anti‐HCV result on RDT and both were negative on laboratory‐based anti‐HCV and HCV RNA tests. Based on the results of this study, endoscopic procedures were not shown to contribute to HCV transmission in Georgia.

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Sensitivity and specificity of rapid hepatitis C antibody assays in freshly collected whole blood, plasma and serum samples: A multicentre prospective study

Cited by 4 publications

References 20 publications

Assessing the potential cost-effectiveness of centralised versus point-of-care testing for hepatitis C virus in Pakistan: a model-based comparison

Assessing the potential cost-effectiveness of centralised versus point-of-care testing for hepatitis C virus in Pakistan: a model-based comparison

Assessing the potential cost-effectiveness of centralized vs point-of-care testing for hepatitis C virus in Pakistan: a model-based comparison

Evaluation of Hepatitis C Virus Transmission Through Endoscopy Procedures in the Country of Georgia

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