A population-based screening for hepatitis C antibodies and active infection using a point-of-care test in a low prevalence area

Carvalho-Gomes, Ângela; Cubells, Almudena; Pallarés, Carmina; Hontangas, V.; Conde, Isabel; Maira, Tommaso Di; Peiró, Salvador; Sanfélix‐Gimeno, Gabriel; López‐Labrador, F. Xavier; Berenguer, Marina

doi:10.1371/journal.pone.0228351

Cited by 14 publications

(16 citation statements)

References 34 publications

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“…Our study finding reemphasis the importance of point-of-care testing for HCV which has been proven cost-effective even in low HCV prevalence setting. [ 31 32 ] While point-of-care testing could be cost-effective, still the coverage of target population could be a crucial factor which will determine the outcomes. In our study setting, the access of decentralized health services at primary health care level has remained suboptimal and hence implementation of HCV screening at this decentralized level may be less utilized.…”

Section: Discussionmentioning

confidence: 99%

Economic Evaluation of Implementing a Rapid Point-of-Care Screening Test for the Identification of Hepatitis C Virus under National Viral Hepatitis Control Programme in Tamil Nadu, South India

Muniyandi

Nagarajan

Tyagi

et al. 2021

Journal of Global Infectious Diseases

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Introduction: Viral hepatitis is a crucial public health problem in India. Hepatitis C virus (HCV) elimination is a national priority and a key strategy has been adopted to strengthen the HCV diagnostics services to ensure early and accurate diagnosis. Methods: To conduct an economic evaluation of implementing a rapid point-of-care screening test for the identification of HCV among the selected key population under the National Viral Hepatitis Control Programme in Tamil Nadu, South India. Economic evaluation of a point-of-care screening test for HCV diagnosis among the key population attending the primary health care centers. A combination of decision tree and Markov model was developed to estimate cost-effectiveness of point-of-care screening test for HCV diagnosis at the primary health care centers. Total costs, quality-adjusted life years (QALYs) of the intervention and comparator, and incremental cost-effectiveness ratio (ICER) were calculated. The model parameter uncertainties which would influence the cost-effectiveness outcome has been evaluated by one-way sensitivity analysis and probabilistic sensitivity analysis. Results: When compared to the tertiary level diagnostic strategy for HCV, the point-of-care screening for selected key population at primary health care level results in a gain of 57 undiscounted QALYs and 38 discounted QALYs, four undiscounted life years and two discounted life years. The negative ICER of the new strategy indicates that it is less expensive and more effective compared with the current HCV diagnosis strategy. Conclusions: The proposed strategy for HCV diagnosis in the selected key population in Tamil Nadu is dominant and cost-saving compared to the current strategy.

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Section: Discussionmentioning

confidence: 99%

Economic Evaluation of Implementing a Rapid Point-of-Care Screening Test for the Identification of Hepatitis C Virus under National Viral Hepatitis Control Programme in Tamil Nadu, South India

Muniyandi

Nagarajan

Tyagi

et al. 2021

Journal of Global Infectious Diseases

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“…This is substantiated by published evidence which claims that in the absence of effective screening and testing up to 75% chronically infected patients remain unaware of their diagnosis even after developing marked complications. It is indicative of the fact that our current estimates of the healthcare burden associated with HCV are inaccurate and largely underappreciated [17][18][19][20].…”

Section: Discussionmentioning

confidence: 99%

Enhanced Access to Testing & Diagnosis & Hepatitis C Burden; A Public Health Intervention

Bhatti¹,

Bhanbro²,

Kumar³

et al. 2021

JPRI

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Objective: To gauge the effect of increasing access to care and streamlining testing and diagnosis on hepatitis C burden (incidence of disease, rate (%) of complications, adverse events and mortality) in a rural population. Methodology: This quasi-experimental research was conducted at Taluka Gambat (Khairpur, Sindh, Pakistan) from August 2019 to January 2021. This public health intervention, comprised of establishing collection points, near healthcare centers in Gambat Taluka, that facilitated the sample collection, transport and testing of patient samples (for Hep C). The test results along with basic biodata, sociodemographic details, disease particulars, presenting signs and symptoms (and their duration), of consenting patients, were recorded onto a structured questionnaire and the data analyzed using SPSS. v. 21.0. Results: A total of 492 individuals were studied. The mean age of the sample was 32.5± 6.9 years with an age range of 18 to 65 years. Pre-Intervention (establishment of collection units) records showcased a lower frequency of cases being reported, which jumped to more than three-fold following provision of greater access to testing and diagnosis. The number of cases presenting with Hep C complications though, steadily declined (from 66.7% to 12.1% - p: < 0.05), and the mortality rate took a significant dive (33.3% to 0% - p: < 0.05). The incidence of diagnosed cases presenting with adverse outcomes (liver cirrhosis, liver failure and hepatic carcinoma) fell sharply, from 33% to 6.1% - p: < 0.05. Conclusion: Enhanced access to care and streamlining testing and diagnosis, overtime reduced the disease burden associated with Hepatitis C, by identifying patients with the disease early before the disease progresses and leads to adverse events.

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“…Other aspects that may have affected sensitivity include the possibility that some patients participating in the study had cleared their HCV infections, as evidenced by the absence of detectable VL in around one third of samples, and the improved sensitivity in the subset of samples with detectable viral load. Other studies have noted declines in HCV antibody levels following treatment-induced or spontaneous HCV clearance [ 16 , 17 ], and a recent study observed reduced sensitivity of an HCV RDT in subjects with treatment-induced clearance [ 18 ]. While this would have affected all three sample types, it may have had a larger impact on sensitivity in whole blood as antibody concentrations would have been closer to the lower LOD compared with plasma and serum.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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Background This study evaluated performance of two hepatitis C virus (HCV) rapid diagnostic tests (RDTs) performed by intended users in resource-limited settings. Methods Testing was conducted at three facilities in two countries (Georgia, Cambodia) using matched fingerstick whole blood, plasma and serum samples. Investigational RDTs were compared with a composite reference standard (CRS) comprised of three laboratory tests, and a reference RDT. Results In matched samples from 489 HCV positive and 967 HCV negative participants, specificity with both investigational RDTs was high using either reference method (≥98.4% in all sample types). Sensitivity was lower in whole blood versus plasma and serum for both RDTs compared with the CRS (86.5–91.4% vs 97.5–98.0% and 97.3–97.1%) and reference RDT (93.6–97.8% vs 100% and 99.4%). Sensitivity improved when considering only samples with detectable HCV viral load. Conclusion Sensitivity was highest in serum and plasma versus whole blood. The World Health Organization prequalification criterion (≥98%) was narrowly missed by both RDTs in serum, and one in plasma, possibly due to the intended user factor. Performance in whole blood was considered adequate, given potential roles of HCV infection history, improved sensitivity with detectable viral load and performance similarities to the reference RDT.

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A population-based screening for hepatitis C antibodies and active infection using a point-of-care test in a low prevalence area

Cited by 14 publications

References 34 publications

Economic Evaluation of Implementing a Rapid Point-of-Care Screening Test for the Identification of Hepatitis C Virus under National Viral Hepatitis Control Programme in Tamil Nadu, South India

Economic Evaluation of Implementing a Rapid Point-of-Care Screening Test for the Identification of Hepatitis C Virus under National Viral Hepatitis Control Programme in Tamil Nadu, South India

Enhanced Access to Testing & Diagnosis & Hepatitis C Burden; A Public Health Intervention

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

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