New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV)

A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Diagnostic Microbiology and Infectious Disease".

Deadline for manuscript submissions: closed (1 March 2021) | Viewed by 34118

Special Issue Editors

Hospital Universitari Germans Trias i Pujol, Badalona, Spain
Interests: hepatitis C virus; molecular virology; microbiology; microbial molecular biology; molecular diagnostics; infectious disease diagnostics; PCR; genotyping; DNA sequencing; epidemiology; public health

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Guest Editor
Surveillance Evaluation and Research Program, Kirby Institute, Level 6, Wallace Wurth Building, UNSW, Sydney, NSW 2052, Australia
Interests: hepatitis C virus; virology; clinical research; drug resistance

Special Issue Information

Dear Colleagues,

WHO has set the ambitious goal of eliminating hepatitis C virus (HCV) as a major global public health threat by 2030. Simplified and affordable strategies to massively scale up the diagnosis of active HCV infection among the millions of people who remain unaware of their infection and effectively link them to treatment are essential to achieving this goal. The burden of chronic HCV infection remains higher in low- and middle-income countries and key populations, including people who inject drugs, prisoners, sex workers, men who have sex with men, and people living with HIV. Many people from these communities continue to have limited access to mainstream healthcare services. A range of HCV testing strategies integrated within decentralized services, including prisons, community health and outreach services, needle and syringe programs, and drug and alcohol and sexual health clinics in rural or remote areas are essential to reach the communities in need.

This Special Issue will compile studies focusing on the evaluation of novel HCV diagnostic strategies including the following topics:

  • The analytical or diagnostic performance of tests of active HCV infection or multiple infections (e.g., HCV / HBV / HIV), either at the point of care or high-throughput to facilitate large-scale screening efforts;
  • Simplified methods of sample collection (e.g., oral fluid, capillary whole blood, dried blood spots) and testing strategies based on these samples (e.g., self-testing, or assisted or self-collection of samples for testing);
  • Real-world evaluation of novel diagnostic strategies implemented outside health facilities in different settings and populations (from sample collection to delivery of results and linkage to care);
  • Evaluations across a range of settings to assess the effect of HCV prevalence, HCV genotype (especially 5 and 6), HIV positivity (viral load, antiretroviral treatment, CD4 counts), sample storage and transport conditions, etc.;
  • HCV diagnosis and treatment delivery systems.

text

Dr. Elisa Martró
Dr. Tanya Applegate
Guest Editors

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Keywords

  • HCV, Hepatitis C
  • Diagnostics, testing, screening
  • HCV core antigen, HCV RNA
  • Simplified, rapid
  • Point-of-care
  • Dried blood spot
  • Self-testing, self-sample collection
  • Vulnerable populations, people who inject drugs (PWID), men who have sex with men (MSM), sex workers, transgender people, migrants, prisons
  • Diagnostic accuracy, cost, cost-effectiveness
  • Comparative trials, implementation studies, demonstration projects
  • HCV microelimination, models of care

Published Papers (10 papers)

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Research

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10 pages, 790 KiB  
Article
Evaluation of Hepatitis C Virus Core Antigen Assay in a Resource-Limited Setting in Pakistan
by Adeel Abid, Murad Uddin, Taj Muhammad, Safia Awan, Tanya Applegate, Gregory J. Dore, Gavin Cloherty and Saeed Hamid
Diagnostics 2021, 11(8), 1354; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11081354 - 28 Jul 2021
Cited by 5 | Viewed by 2878
Abstract
The diagnosis of Hepatitis C virus (HCV) infection can be challenging due to its cost and a lack of access to centralized testing. There is an urgent need to develop simplified HCV testing algorithms. The aim of this study was to evaluate the [...] Read more.
The diagnosis of Hepatitis C virus (HCV) infection can be challenging due to its cost and a lack of access to centralized testing. There is an urgent need to develop simplified HCV testing algorithms. The aim of this study was to evaluate the performance characteristics of a Hepatitis C core antigen (HCVcAg) assay in a decentralized, resource-limited setting. This is a descriptive cross-sectional study from a highly endemic area of Karachi, Pakistan. Between October 2019 and July 2020, subjects aged 12 years and above who screened positive for HCV antibodies were simultaneously tested for HCV RNA (Xpert HCV Viral Load, GeneXpert® IV, Cepheid, France) and HCVcAg (ARCHITECT HCV Ag assay, Abbott® Diagnostics) to confirm active HCV infection. An Abbott ARCHITECT® i1000SR Immunoassay Analyser was installed at a local district hospital as a point-of-care (POC) facility for HCVcAg testing, while samples for HCV RNA were tested in a central lab. Two hundred individuals (mean age 46.4 ± 14.5 years, 71.5% females), who screened positive for HCV antibody, were included in the study. HCV RNA was detected in 128 (64.0%) while HCVcAg was reactive in 119 (59.5%) cases. Performance of the Immunoassay Analyser was excellent with a higher throughput and quicker readout value compared to the GeneXpert System. The sensitivity and specificity of HCVcAg (≥10 fmol/L) at HCV RNA thresholds of ≥12 was 99.1% (95% CI: 95–100%) and 87.6% (95%CI: 78.4–94%). A strong agreement was observed between the HCVcAg assay and HCV RNA. The ARCHITECT HCV Ag assay showed high sensitivity and specificity compared to HCV RNA in a decentralized, resource-limited setting. It can therefore be used as a confirmatory test in HCV elimination programs, particularly for low-income countries such as Pakistan. Full article
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
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11 pages, 412 KiB  
Article
A Feasibility Study to Increase Chronic Hepatitis C Virus RNA Testing and Linkage to Care among Clients Attending Homeless Services in Amsterdam, The Netherlands
by Ellen Generaal, Hilje Logtenberg van der Grient, Eberhard Schatz, Daniela K. van Santen, Anders Boyd, Sara K. Woods, Bert L. C. Baak and Maria Prins
Diagnostics 2021, 11(7), 1197; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11071197 - 30 Jun 2021
Cited by 1 | Viewed by 2172
Abstract
People who inject drugs (PWID) are disproportionately affected by hepatitis C virus (HCV) infections and are frequently homeless. To improve HCV case finding in these individuals, we examined the feasibility of rapid HCV RNA testing in homeless services in Amsterdam. In 2020, we [...] Read more.
People who inject drugs (PWID) are disproportionately affected by hepatitis C virus (HCV) infections and are frequently homeless. To improve HCV case finding in these individuals, we examined the feasibility of rapid HCV RNA testing in homeless services in Amsterdam. In 2020, we provided a comprehensive service to homeless facilities, which included workshops on HCV for personnel, a “hepatitis ambassador” at each facility, a rapid, onsite HCV RNA fingerstick test service, and assistance with linkage to care. Risk factors for HCV RNA-positive status were examined using Bayesian logistic regression. Of the 152 participants enrolled, 150 (87% men; median age: 47 years) accepted rapid HCV testing. Seven tested HCV RNA positive (4.7%, 95%CrI = 1.31–8.09; 7/150). Of these, five (71%) were linked to care, of whom four (57%, 4/7) initiated treatment and one (14%, 1/7) delayed treatment due to a drug–drug interaction. Of these four people, two completed treatment (50%), of whom one (25%) achieved sustained virologic response after 12 weeks. HCV RNA-positive individuals were more likely to originate from Eastern Europe (posterior-odds ratio (OR) = 3.59 (95% credible interval (CrI) = 1.27–10.04)) and to inject drugs (ever: posterior-OR = 3.89 (95% CrI = 1.37–11.09); recent: posterior-OR = 3.94 (95% CrI = 1.29–11.71)). We identified HCV RNA-positive individuals and linkage to care was relatively high. Screening in homeless services with rapid testing is feasible and could improve HCV case finding for PWID who do not regularly attend primary care or other harm reduction services for people who use drugs. Full article
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
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12 pages, 895 KiB  
Article
Hepatitis C Micro-Elimination beyond Prison Walls: Navigator-Assisted Test-and-Treat Strategy for Subjects Serving Non-Custodial Sentences
by Joaquin Cabezas, Susana Llerena, Miguel Mateo, Rocío Álvarez, Carmen Cobo, Victoria González, Elisa Martró, Antonio Cuadrado and Javier Crespo
Diagnostics 2021, 11(5), 877; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11050877 - 14 May 2021
Cited by 13 | Viewed by 2897
Abstract
Background and Aims: The Spanish prison population includes two groups: people in prison and those who are serving non-custodial sentences. The latter has not yet been studied. This study aims to describe this population and the results of a test-and-treat strategy for hepatitis [...] Read more.
Background and Aims: The Spanish prison population includes two groups: people in prison and those who are serving non-custodial sentences. The latter has not yet been studied. This study aims to describe this population and the results of a test-and-treat strategy for hepatitis C including a holistic health assessment. Method: This prospective study included all subjects serving non-custodial sentences at the Center for Social Integration. It was assisted by the medical team, a navigator, and a systematic screening of HCV (Hepatitis C Virus) performed by point-of-care tests. All cases with active infection are evaluated using telemedicine by a specialist to prescribe antiviral treatment. The navigator facilitates continuity for medical and social assistance. Results: The screening rate reached 92.8% (548/590). HCV seroprevalence and viraemia prevalence were 8% (44) and 2.9% (16), respectively. Regarding comorbidities: problems related to drug dependence were detected in 264 (48.2%), suspected serious mental disorder in 44 (8.3%), and previous stay in prison in 122 cases (22.2%). The navigator monitored 59 (15.2%) patients regarding HCV treatment or comorbidities. All patients (10/10) completing 12 weeks follow-up achieved sustained virological response. Conclusions: The population serving non-custodial sentences is a challenging group with a high prevalence of HCV infection. Micro-elimination programs using point of care diagnostic tests, telemedicine, and a navigator are necessary in this underserved vulnerable population. Full article
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
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10 pages, 722 KiB  
Article
Diagnostic Performance and Usability of the Genedrive® HCV ID Kit in Two Decentralized Settings in Cameroon and Georgia
by Francois M. J. Lamoury, Richard Njouom, Marie Amougou-Atsama, Euloge Yiagnigni Mfopou, Nino Berishvili, Manana Sologashvili, Emmanuel Fajardo, Agnes Malobela, Aurélien Macé, Maxwell Chirehwa, Maia Alkhazashvili and Elena Ivanova Reipold
Diagnostics 2021, 11(5), 746; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11050746 - 22 Apr 2021
Cited by 4 | Viewed by 2961
Abstract
Point-of-care diagnostics have the potential to increase diagnosis and linkage to care and help reach the WHO targets to eliminate hepatitis C virus (HCV) by 2030. Here, we evaluated the diagnostic accuracy of Genedrive HCV ID assay for the qualitative detection of HCV [...] Read more.
Point-of-care diagnostics have the potential to increase diagnosis and linkage to care and help reach the WHO targets to eliminate hepatitis C virus (HCV) by 2030. Here, we evaluated the diagnostic accuracy of Genedrive HCV ID assay for the qualitative detection of HCV RNA in decentralized settings in two low- and middle-income countries using fresh plasma specimens from 426 participants. The Abbott RealTime HCV assay was used as the gold standard. Genedrive HCV ID assay was conducted by different users. Users also completed questionnaires to assess the usability of Genedrive. At detection thresholds of 12 IU/mL or 30 IU/mL, 1000 IU/mL, and 2362 IU/mL, the sensitivity was 96.2% (95% CI: 92.7–98.4), 100% (98.2–100), and 100% (98.2–100), respectively; the specificity was 99.5% (95% CI: 97.4–100), 99.5% (97.5–100), and 98.7% (96.1–100), respectively. All genotypes detected using the gold-standard assay were also detected with Genedrive. Users found Genedrive easy to use. Genedrive is a simple and accurate test to confirm chronic HCV infection in decentralized, real-life, resource-limited settings. This novel diagnostic tool could contribute to closing the current gap in HCV diagnosis. Full article
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
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14 pages, 994 KiB  
Article
HCV Diagnosis and Sequencing Using Dried Blood Spots from Patients in Kinshasa (DRC): A Tool to Achieve WHO 2030 Targets
by Teresa Carrasco, David Barquín, Adolphe Ndarabu, Mirian Fernández-Alonso, Marina Rubio-Garrido, Silvia Carlos, Benit Makonda, África Holguín and Gabriel Reina
Diagnostics 2021, 11(3), 522; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11030522 - 15 Mar 2021
Cited by 8 | Viewed by 2378
Abstract
The World Health Organization has established an elimination plan for hepatitis C virus (HCV) by 2030. In Sub-Saharan Africa (SSA) access to diagnostic tools is limited, and a number of genotype 4 subtypes have been shown to be resistant to some direct-acting antivirals [...] Read more.
The World Health Organization has established an elimination plan for hepatitis C virus (HCV) by 2030. In Sub-Saharan Africa (SSA) access to diagnostic tools is limited, and a number of genotype 4 subtypes have been shown to be resistant to some direct-acting antivirals (DAAs). This study aims to analyze diagnostic assays for HCV based on dried blood spots (DBS) specimens collected in Kinshasa and to characterize genetic diversity of the virus within a group of mainly HIV positive patients. HCV antibody detection was performed on 107 DBS samples with Vidas® anti-HCV and Elecsys anti-HCV II, and on 31 samples with INNO-LIA HCV. Twenty-six samples were subjected to molecular detection. NS3, NS5A, and NS5B regions from 11 HCV viremic patients were sequenced. HCV seroprevalence was 12.2% (72% with detectable HCV RNA). Both Elecsys Anti-HCV and INNO-LIA HCV were highly sensitive and specific, whereas Vidas® anti-HCV lacked full sensitivity and specificity when DBS sample was used. NS5B/NS5A/NS3 sequencing revealed exclusively GT4 isolates (50% subtype 4r, 30% 4c and 20% 4k). All 4r strains harbored NS5A resistance-associated substitutions (RAS) at positions 28, 30, and 31, but no NS3 RAS was detected. Elecsys Anti-HCV and INNO-LIA HCV are reliable methods to detect HCV antibodies using DBS. HCV subtype 4r was the most prevalent among our patients. RASs found in subtype 4r in NS5A region confer unknown susceptibility to DAA. Full article
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
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10 pages, 1561 KiB  
Article
Utility of the Cobas® Plasma Separation Card as a Sample Collection Device for Serological and Virological Diagnosis of Hepatitis C Virus Infection
by Fernando Velásquez-Orozco, Ariadna Rando-Segura, Joan Martínez-Camprecios, Paula Salmeron, Adrián Najarro-Centeno, Àngels Esteban, Josep Quer, María Buti, Tomás Pumarola-Suñe and Francisco Rodríguez-Frías
Diagnostics 2021, 11(3), 473; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11030473 - 08 Mar 2021
Cited by 6 | Viewed by 3695
Abstract
Diagnosis and clinical management of people infected with hepatitis C virus (HCV) relies on results from a combination of serological and virological tests. The aim of this study was to compare the performance of dried plasma spots (DPS), prepared using the cobas® [...] Read more.
Diagnosis and clinical management of people infected with hepatitis C virus (HCV) relies on results from a combination of serological and virological tests. The aim of this study was to compare the performance of dried plasma spots (DPS), prepared using the cobas® Plasma Separation Card (PSC), to plasma and serum from venipuncture, for HCV diagnosis. We carried out a prospective study using DPS and paired plasma or serum samples. Serum and DPS samples were analyzed by immunoassay using Elecsys® Anti-HCV II (Roche). Plasma and DPS samples were analyzed using the cobas® HCV viral load and cobas® HCV genotyping tests (Roche). All DPS samples that had high anti-HCV antibody titers in serum were also antibody-positive, as were five of eight samples with moderate titers. Eight samples with low titers in serum were negative with DPS. Among 80 samples with plasma HCV viral loads between 61.5 and 2.2 × 108 IU/mL, 74 were RNA-positive in DPS. The mean viral load difference between plasma and DPS was 2.65 log10 IU/mL. The performance of DPS for detection of serological and virological markers of hepatitis C virus infection was comparable to that of the conventional specimen types. However, the limits of detection were higher for DPS. Full article
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
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14 pages, 272 KiB  
Article
A Lay-User Assessment of Hepatitis C Virus Self-Testing Device Usability and Interpretation in Johannesburg, South Africa
by Mohammed Majam, Alex Fischer, Elena Ivanova Reipold, Naleni Rhagnath, Vanessa Msolomba and Samanta T. Lalla-Edward
Diagnostics 2021, 11(3), 463; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11030463 - 07 Mar 2021
Cited by 10 | Viewed by 2137
Abstract
Only 20% of people with hepatitis C virus (HCV) know their status. In low-income countries diagnosis is under 10%. Self-testing for HCV antibodies (HCVST) could expand the coverage of HCV testing services. Currently, there are no stringent regulatory authority (SRA) approved HCVSTs, therefore [...] Read more.
Only 20% of people with hepatitis C virus (HCV) know their status. In low-income countries diagnosis is under 10%. Self-testing for HCV antibodies (HCVST) could expand the coverage of HCV testing services. Currently, there are no stringent regulatory authority (SRA) approved HCVSTs, therefore lay-user usability of three prototype kits was assessed. This was a cross-sectional observational study conducted with 171 (CareStart n = 60, Bioline n = 52, First Response n = 59) participants. Participants were given one of the three HCVST kits with only instructions for use (IFU) and asked to perform the test in front of a professional trained in rapid diagnostic tests (RDT). Usability indices were calculated based on the correctness of performing each step of the product-specific process followed by contrived results interpretation and a post-test interview. The usability index was 93.9% for CareStart, 90.7% for Bioline and 94.9% for First Response. Most errors were on incorrect handwashing, sample collection and transfer to the test device. An average of 93.1% of contrived results were correctly interpreted, with most errors related to interpreting invalid results. Most participants (n = 167) stated they would visit a clinic after a positive result. With negative results, nearly half (28/60 (46.7%)) stated they should condomize, while just over two-thirds of participants that used Bioline (35/52 (67.3%)) and First Response (38/59 (64.4%)) said they should re-test. Most participants (n = 162) found the devices easy to use. Participants liked that self-testing was fast, private and convenient, however there were some confusion with IFU steps and pictures, finger-pricking with the lancet, collecting blood after the finger-prick, and transferring the sample/buffer. Prototype HCVST kits exhibit high usability and result interpretation by lay-users, and should be considered for SRA approval. Full article
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
16 pages, 1248 KiB  
Article
Acceptability and Usability of HCV Self-Testing in High Risk Populations in Vietnam
by Linh Thuy Nguyen, Van Thi Thuy Nguyen, Kim Anh Le Ai, Minh Binh Truong, Tam Thi Minh Tran, Muhammad S. Jamil, Cheryl Johnson, Elena Ivanova Reipold, Philippa Easterbrook and Kidong Park
Diagnostics 2021, 11(2), 377; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11020377 - 23 Feb 2021
Cited by 21 | Viewed by 3190
Abstract
HIV self-testing has emerged as a safe and effective approach to increase the access to and uptake of HIV testing and treatment, especially for key populations. Applying self-testing to hepatitis C virus (HCV) may also offer an additional way to address low coverage [...] Read more.
HIV self-testing has emerged as a safe and effective approach to increase the access to and uptake of HIV testing and treatment, especially for key populations. Applying self-testing to hepatitis C virus (HCV) may also offer an additional way to address low coverage of HCV testing and to accelerate elimination efforts. To understand the potential for HCV self-testing (HCVST), an observational study was conducted to assess the acceptability and usability of the OraQuick® HCV Self-Test (prototype) among people who inject drugs (PWID) and men who have sex with men (MSM) in Thai Nguyen, a province in northern Vietnam. A total of 105 PWID and 104 MSM were eligible and agreed to participate in the study. Acceptability, defined as the proportion of participants among eligible subjects who agreed to participate in the study, was 92.9% in PWID and 98.6% in MSM. Compared to MSM, PWID were older (median age: 45 vs. 22 years; p < 0.0001) and had a lower education level (high school and college: 38.1% vs. 100%; p < 0.0001). HCVST usability was high among MSM with fewer observed mistakes, difficulties, or participants requiring assistance (33.7%, 28.8%, and 17.3%, respectively) compared to PWID (62.9%, 53.3%, and 66.7%, respectively; all p < 0.0001)). Inter-reader and inter-operator agreement were good in both groups (Kappa coefficient range: 0.61–0.99). However, the concordance between HCVST and study staff -read or performed HCV testing was lower among PWID than MSM (inter-reader concordance 88.6% vs. 99.0% and inter-operator concordance 81.9% vs. 99%). Overall, HCVST was highly acceptable with moderate to high usability among PWID and MSM in Thai Nguyen. Efforts to provide support and assistance may be needed to optimize performance, particularly for PWID populations and for those who are older and with lower literacy or education levels. Full article
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
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10 pages, 1480 KiB  
Article
Identifying the Hidden Population: Former Intravenous Drug Users Who Are No Longer in Contact with Services. “Ask a Friend”
by Sarah R. Donaldson, Andrew Radley and John F. Dillon
Diagnostics 2021, 11(2), 170; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11020170 - 25 Jan 2021
Cited by 1 | Viewed by 1761
Abstract
People who, after a period of drug use, have changed their lifestyle and left substance use behind them are a hidden population within our communities. Lack of contact with drug services may mean that they are not tested for hepatitis C (HCV) infection [...] Read more.
People who, after a period of drug use, have changed their lifestyle and left substance use behind them are a hidden population within our communities. Lack of contact with drug services may mean that they are not tested for hepatitis C (HCV) infection through service-led initiatives and, therefore, may be exposed to the chronic morbidity and risk of death inherent with a legacy of HCV infection. This study utilized respondent-driven sampling (RDS) in a novel fashion to find those at historical risk of HCV. The social networks of people with a history of drug use were mapped, and individuals not currently in contact with services were invited to come forward for testing by members of their social network. The study used a reference group to inform study methodology and communication methods to reach out to this hidden population. One hundred and nine individuals received dry blood spot tests for HCV, 17.4% were antibody positive. Fifty one individuals met the inclusion criteria for this study. One hundred and twenty three invite-to-test coupons were issued; however, only one wave of recruitment consisting of one participant resulted from this method. Using RDS in historical social networks was not effective in this study and did not reach this hidden population and increase testing for HCV. This study is registered with clinicaltrials.gov (Ref NCT03697135). Full article
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
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Review

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68 pages, 19689 KiB  
Review
Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises
by Imran Shahid, Abdullah R. Alzahrani, Saeed S. Al-Ghamdi, Ibrahim M. Alanazi, Sidra Rehman and Sajida Hassan
Diagnostics 2021, 11(7), 1253; https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11071253 - 13 Jul 2021
Cited by 13 | Viewed by 8636
Abstract
The simplification of current hepatitis C diagnostic algorithms and the emergence of digital diagnostic devices will be very crucial to achieving the WHO’s set goals of hepatitis C diagnosis (i.e., 90%) by 2030. From the last decade, hepatitis C diagnosis has been revolutionized [...] Read more.
The simplification of current hepatitis C diagnostic algorithms and the emergence of digital diagnostic devices will be very crucial to achieving the WHO’s set goals of hepatitis C diagnosis (i.e., 90%) by 2030. From the last decade, hepatitis C diagnosis has been revolutionized by the advent and approval of state-of-the-art HCV diagnostic platforms which have been efficiently implemented in high-risk HCV populations in developed nations as well as in some low-to-middle income countries (LMICs) to identify millions of undiagnosed hepatitis C-infected individuals. Point-of-care (POC) rapid diagnostic tests (RDTs; POC-RDTs), RNA reflex testing, hepatitis C self-test assays, and dried blood spot (DBS) sample analysis have been proven their diagnostic worth in real-world clinical experiences both at centralized and decentralized diagnostic settings, in mass hepatitis C screening campaigns, and hard-to-reach aboriginal hepatitis C populations in remote areas. The present review article overviews the significance of current and emerging hepatitis C diagnostic packages to subvert the public health care burden of this ‘silent epidemic’ worldwide. We also highlight the challenges that remain to be met about the affordability, accessibility, and health system-related barriers to overcome while modulating the hepatitis C care cascade to adopt a ‘test and treat’ strategy for every hepatitis C-affected individual. We also elaborate some key measures and strategies in terms of policy and progress to be part of hepatitis C care plans to effectively link diagnosis to care cascade for rapid treatment uptake and, consequently, hepatitis C cure. Full article
(This article belongs to the Special Issue New Diagnostics and Testing Strategies for Hepatitis C Virus (HCV))
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