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Yew KC, Sim ASY, Hawkins R, Acharyya S, Wong GD, Wong SWC, Lim YH, Yang WL, Lim WY, Chow ALP. Real-World Evaluation of Point-of-Care Testing for Hepatitis C Antibodies: Navigating Hepatitis C Elimination Effort. J Viral Hepat 2025; 32:e14039. [PMID: 39575764 DOI: 10.1111/jvh.14039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/24/2024] [Revised: 09/27/2024] [Accepted: 11/05/2024] [Indexed: 04/27/2025]
Abstract
An HCV elimination program aims to diagnose more than 90% of Chronic HCV cases. We critically evaluated the performance of a point-of-care test (POCT) using an HCV Rapid Antibody Test. PWID from 4 Halfway Houses (HWH) in Singapore were recruited from March 2022 to April 2023. Participants were concurrently screened for HCV via venous blood for anti-HCV serology and using fingerstick capillary whole blood (FSWB) and oral mucosal transudates (OMT) for POCT, which were interpreted by trained personnel. A blinded study team member independently assessed images of POCTs. Of 207 participants, 37.3% were anti-HCV positive. Compared to anti-HCV serology, POCT performance on FSWB and OMT were: Sensitivity 81.8 (73.2-90.4), 74.0 (64.2-83.8), p = 0.014; Specificity 100.0 (100.0-100.0), 98.5 (96.3-100), p = 0.157. Sub-group analysis of strict 30-min pre-test nil-by-mouth instruction in 103 subjects reported Sensitivity 77.5 (64.6-90.4), 77.5 (64.6-90.4) and Specificity 100.0 (100.0-100.0) and 98.4 (95.3-100.0). OMT positivity and false-negative outcomes did not correlate with the sample analytical cutoff index signal distribution of anti-HCV Serology. Inter-class correlation between real-time and imaging readings of POCT for FSWB and OMT at 20 and 40 min were Kappa 0.9666, 0.9674; 0.8803, 0.8940. Proper preparation and patient selection enhance test performance. Differences in oral fluid immunoglobulin secretion, oral pathology, age, and sample collection can affect POCT OMT readings. POCT OMT is promising in serial and self-testing, complementing its convenience in testing.
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Affiliation(s)
- Kuo Chao Yew
- Department of Gastroenterology & Hepatology, Tan Tock Seng Hospital, Singapore, Singapore
| | - Alyssa Shin Yee Sim
- Department of Gastroenterology & Hepatology, Tan Tock Seng Hospital, Singapore, Singapore
| | - Robert Hawkins
- Department of Laboratory Medicine, Tan Tock Seng Hospital, Singapore, Singapore
| | - Sanchalika Acharyya
- Clinical Research & Innovation Office, Tan Tock Seng Hospital, Singapore, Singapore
| | - Gerard Daquan Wong
- HCSA Highpoint Halfway House, HCSA Community Services, Singapore, Singapore
| | | | - Yuan Heng Lim
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
| | - Wei Lyn Yang
- Department of Gastroenterology & Hepatology, Tan Tock Seng Hospital, Singapore, Singapore
| | - Wei-Yen Lim
- Department of Preventive and Population Medicine, Tan Tock Seng Hospital, Singapore, Singapore
| | - Angela Li Ping Chow
- Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
- Department of Preventive and Population Medicine, Tan Tock Seng Hospital, Singapore, Singapore
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Moonen CPB, Brouwers EEHG, Hoebe CJPA, Dukers-Muijrers NHTM, Bouchaara J, van Loo IHM, den Heijer CDJ. Reaching Syrian migrants through Dutch municipal registries for hepatitis B and C point-of-care testing. PLoS One 2025; 20:e0316726. [PMID: 39823486 PMCID: PMC11741604 DOI: 10.1371/journal.pone.0316726] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2023] [Accepted: 12/13/2024] [Indexed: 01/19/2025] Open
Abstract
Undetected chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections can lead to cirrhosis and liver cancer. Syrian migrants are the largest non-European migrant group in the Netherlands with HBV and HCV prevalence rates above 2%. This study aimed to reach Syrian migrants for HBV and HCV testing using point-of-care tests (POCT). A multifaceted strategy was employed to reach Syrian migrants aged ≥16 years from two Dutch municipalities for free-of-charge HBsAg and anti-HCV POCT using finger prick blood at the regional Public Health Service. All were personally invited by the Public Health Service by postal mail, based on municipal registry data. Respondents' medical history data were analysed descriptively and data on age, sex, and municipality were compared with non-participating invitees, using Pearson's Chi-square test. Of the study population (N = 832), 32.3% (n = 269) attended the testing. The mean age of participants was 36 years (range 16-70), 59.1% were men, and 66.5% were unemployed. Non-participation was higher in the younger age groups (<30 years) (p < .001). The POCT using finger prick blood was well received. None tested HBsAg or anti-HCV positive. With approximately one-third of participation, this study demonstrated relatively high reach of Syrian migrants for testing, compared to studies with similar recruitment methods. However, while the reach could be considered successful, testing failed to demonstrate new infection in this key population. Thereby, other methods may be preferred to identify new HBV and HCV infections, such as opportunistic testing within existing care processes.
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Affiliation(s)
- Chrissy P. B. Moonen
- Department of Sexual Health, Infectious Diseases and Environmental Health, Living Lab Public Health, South Limburg Public Health Service, Heerlen, The Netherlands
- Department of Social Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
| | - Elfi E. H. G. Brouwers
- Department of Sexual Health, Infectious Diseases and Environmental Health, Living Lab Public Health, South Limburg Public Health Service, Heerlen, The Netherlands
- Department of Social Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
| | - Christian J. P. A. Hoebe
- Department of Sexual Health, Infectious Diseases and Environmental Health, Living Lab Public Health, South Limburg Public Health Service, Heerlen, The Netherlands
- Department of Social Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
- Department of Medical Microbiology, Infectious Diseases and Infection Prevention, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Center (MUMC+), Maastricht, The Netherlands
| | - Nicole H. T. M. Dukers-Muijrers
- Department of Sexual Health, Infectious Diseases and Environmental Health, Living Lab Public Health, South Limburg Public Health Service, Heerlen, The Netherlands
- Department of Health Promotion, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
| | - Jamila Bouchaara
- Department of Sexual Health, Infectious Diseases and Environmental Health, Living Lab Public Health, South Limburg Public Health Service, Heerlen, The Netherlands
| | - Inge H. M. van Loo
- Department of Medical Microbiology, Infectious Diseases and Infection Prevention, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Center (MUMC+), Maastricht, The Netherlands
| | - Casper D. J. den Heijer
- Department of Sexual Health, Infectious Diseases and Environmental Health, Living Lab Public Health, South Limburg Public Health Service, Heerlen, The Netherlands
- Department of Social Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands
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Simão M, Gonçalves C. Hepatitis C Virus Infection in Europe. Pathogens 2024; 13:841. [PMID: 39452713 PMCID: PMC11510056 DOI: 10.3390/pathogens13100841] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/09/2024] [Revised: 09/24/2024] [Accepted: 09/27/2024] [Indexed: 10/26/2024] Open
Abstract
The Hepatitis C Virus (HCV) is a significant public health challenge in European countries. Historically, healthcare-related procedures were the primary source of HCV infection in Europe. However, with the implementation of blood safety programs, injection drug use has become the main transmission route. The infection's distribution and genotype prevalence vary widely across the continent. Even with the availability of highly effective direct-acting antiviral (DAA) therapies, HCV infection is far from being controlled. A significant proportion of patients remain undiagnosed, contributing to the ongoing transmission of the virus. Additionally, several barriers hinder the widespread use of DAAs, including high treatment costs, stigma, poor linkage to care, and considerable geographical variations in prevalence and transmission routes. The World Health Organization has set ambitious targets to reduce liver-related deaths, decrease new viral hepatitis infections, and ensure that 90% of infected individuals are diagnosed by 2030. However, most European countries face challenges, highlighting the need for screening programs, funding mechanisms, and public health strategies to effectively control HCV infection in Europe.
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Affiliation(s)
| | - Cristina Gonçalves
- Pediatric Gastrenterology and Hepatology Unit, Pediatric Hospital Dona Estefânia, ULS S. José, 1169-045 Lisbon, Portugal
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Romo E, Stopka TJ, Jesdale BM, Wang B, Mazor KM, Friedmann PD. Association of spatial proximity to fixed-site syringe services programs with HCV serostatus and injection equipment sharing practices among people who inject drugs in rural New England, United States. Harm Reduct J 2024; 21:23. [PMID: 38282000 PMCID: PMC10822149 DOI: 10.1186/s12954-023-00916-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2023] [Accepted: 12/10/2023] [Indexed: 01/30/2024] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) disproportionately affects rural communities, where health services are geographically dispersed. It remains unknown whether proximity to a syringe services program (SSP) is associated with HCV infection among rural people who inject drugs (PWID). METHODS Data are from a cross-sectional sample of adults who reported injecting drugs in the past 30 days recruited from rural counties in New Hampshire, Vermont, and Massachusetts (2018-2019). We calculated the road network distance between each participant's address and the nearest fixed-site SSP, categorized as ≤ 1 mile, 1-3 miles, 3-10 miles, and > 10 miles. Staff performed HCV antibody tests and a survey assessed past 30-day injection equipment sharing practices: borrowing used syringes, borrowing other used injection equipment, and backloading. Mixed effects modified Poisson regression estimated prevalence ratios (aPR) and 95% confidence intervals (95% CI). Analyses were also stratified by means of transportation. RESULTS Among 330 PWID, 25% lived ≤ 1 mile of the nearest SSP, 17% lived 1-3 miles of an SSP, 12% lived 3-10 miles of an SSP, and 46% lived > 10 miles from an SSP. In multivariable models, compared to PWID who lived within 1 mile of an SSP, those who lived 3 to 10 miles away had a higher prevalence of HCV seropositivity (aPR: 1.25, 95% CI 1.06-1.46), borrowing other used injection equipment (aPR: 1.23, 95% CI 1.04-1.46), and backloading (aPR: 1.48, 95% CI 1.17-1.88). Similar results were observed for PWID living > 10 miles from an SSP: aPR [HCV]: 1.19, 95% CI 1.01-1.40; aPR [borrowing other used equipment]:1.45, 95% CI 1.29-1.63; and aPR [backloading]: 1.59, 95% CI 1.13-2.24. Associations between living 1 to 3 miles of an SSP and each outcome did not reach statistical significance. When stratified by means of transportation, associations between distance to SSP and each outcome (except borrowing other used injection equipment) were only observed among PWID who traveled by other means (versus traveled by automobile). CONCLUSIONS Among PWID in rural New England, living farther from a fixed-site SSP was associated with a higher prevalence of HCV seropositivity, borrowing other used injection equipment, and backloading, reinforcing the need to increase SSP accessibility in rural areas. Means of transportation may modify this relationship.
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Affiliation(s)
- Eric Romo
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
| | - Thomas J Stopka
- Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA
| | - Bill M Jesdale
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA
| | - Bo Wang
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA
| | - Kathleen M Mazor
- Department of Medicine, University of Massachusetts Chan Medical, Worcester, MA, USA
| | - Peter D Friedmann
- Office of Research, University of MA Chan Medical School - Baystate, Springfield, MA, USA
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Mandel E, Underwood K, Masterman C, Kozak RA, Dale CH, Hassall M, Capraru C, Shah H, Janssen HLA, Feld JJ, Biondi MJ. Province-to-province variability in hepatitis C testing, care, and treatment across Canada. CANADIAN LIVER JOURNAL 2023; 6:234-248. [PMID: 37503520 PMCID: PMC10370727 DOI: 10.3138/canlivj-2022-0029] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/15/2022] [Accepted: 09/19/2022] [Indexed: 07/29/2023]
Abstract
Background Few countries have implemented the necessary policy changes to reduce the number of steps in the cascade of care to achieve hepatitis C virus (HCV) elimination, including Canada. The aim of this study was to describe and compare legislation, scope of practice, and policy as it relates to the provision of HCV care in each province. Methods We reviewed grey literature and regulatory and legislative documents which affect various aspects of the HCV cascade of care. Findings were verified by content experts. Results HCV RNA reflex testing ensures those that are antibody positive get an HCV RNA test; however only 80% of provinces have reflex test. Point-of-care antibody testing can be offered in most community non-health care settings, yet many types of health care providers are unable to do this independently. Following a positive test, it may not be feasible to complete venipuncture; however only a single province processes HCV RNA dried blood spot cards. In many provinces, training and verification are required for novice prescribers, and in some provinces prescribing continues to be restricted to specialists. Only a single province has task-shifted treatment to a non-physician non-nurse practitioner model, where pharmacists can prescribe treatment. Finally, 80% of provinces require authorization forms, and 30% require proof of investigations for treatment. Conclusions No single province is optimizing the use of diagnostic tools and task shifting and decreasing paperwork to expedite treatment initiation. Collaboration between provinces is needed to streamline practice, update policy, and promote equity in HCV diagnosis, care, and treatment.
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Affiliation(s)
- Erin Mandel
- Viral Hepatitis Care Network (VIRCAN) Study Group, Toronto Centre for Liver Disease, Toronto, Ontario, Canada
| | | | - Chelsea Masterman
- Arthur Labatt Family School of Nursing, Western University, London, Ontario, Canada
| | | | - Cheryl H Dale
- Arthur Labatt Family School of Nursing, Western University, London, Ontario, Canada
| | - Melinda Hassall
- The Australasian Society for HIV Medicine, Brisbane, Australia
| | - Camelia Capraru
- Viral Hepatitis Care Network (VIRCAN) Study Group, Toronto Centre for Liver Disease, Toronto, Ontario, Canada
| | - Hemant Shah
- Viral Hepatitis Care Network (VIRCAN) Study Group, Toronto Centre for Liver Disease, Toronto, Ontario, Canada
| | - Harry LA Janssen
- Viral Hepatitis Care Network (VIRCAN) Study Group, Toronto Centre for Liver Disease, Toronto, Ontario, Canada
- Erasmus Medical Centre, Erasmus University, Rotterdam, Netherlands
| | - Jordan J Feld
- Viral Hepatitis Care Network (VIRCAN) Study Group, Toronto Centre for Liver Disease, Toronto, Ontario, Canada
- Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada
| | - Mia J Biondi
- Viral Hepatitis Care Network (VIRCAN) Study Group, Toronto Centre for Liver Disease, Toronto, Ontario, Canada
- Arthur Labatt Family School of Nursing, Western University, London, Ontario, Canada
- School of Nursing, York University, Toronto, Ontario, Canada
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Taha G, Ezra L, Abu-Freha N. Hepatitis C Elimination: Opportunities and Challenges in 2023. Viruses 2023; 15:1413. [PMID: 37515101 PMCID: PMC10386528 DOI: 10.3390/v15071413] [Citation(s) in RCA: 17] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2023] [Revised: 06/08/2023] [Accepted: 06/20/2023] [Indexed: 07/30/2023] Open
Abstract
Hepatitis C Virus (HCV) infection is a leading etiology of liver cirrhosis and its associated complications, namely, decompensated cirrhosis. As such, hepatitis C potentially necessitates liver transplantation and may result in death. Recently, HCV treatment has evolved. Current HCV treatment is effective in curing HCV; some of the agents are pan-genotypic. Numerous countries have adopted an initiative to eliminate HCV. Achieving elimination poses many challenges; it requires improved availability and accessibility of pan-genotypic therapy. Barriers exist at the level of the collective healthcare system and at the level of the individual healthcare providers and patients. Therefore, organized national and local efforts are needed. Surmounting these barriers calls for interventions concerning screening, linkage to care, and treatment delivery. Pertinent barriers include inadequate availability of screening, ill-equipped laboratory testing before treatment, and insufficient access to treatment. Interventions should seek to decentralize laboratory testing and treatment provision, increase funding for resources and personnel, and spread awareness. Special consideration should be allocated to at-risk populations, such as intravenous drug users, refugees, and prisoners. Computerized medical filing and telemedicine have the potential to refine HCV management by enhancing detection, availability, accessibility, and cost-effectiveness.
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Affiliation(s)
- Gadeer Taha
- Department of Gastroenterology, Rambam Health Care Campus, Haifa 31096, Israel
| | - Levy Ezra
- Medical School for International Health, Ben-Gurion University of the Negev, Beer-Sheva 84101, Israel
| | - Naim Abu-Freha
- Institute of Gastroenterology and Hepatology, Soroka University Medical Center, Beer-Sheva 84101, Israel
- Faculty of Health Sciences, Ben Gurion University of the Negev, Beer-Sheva 84105, Israel
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7
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Duah E, Mathebula EM, Mashamba-Thompson T. Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa. Diagnostics (Basel) 2023; 13:684. [PMID: 36832172 PMCID: PMC9955859 DOI: 10.3390/diagnostics13040684] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/01/2022] [Revised: 02/06/2023] [Accepted: 02/10/2023] [Indexed: 02/15/2023] Open
Abstract
As part of a multinational study to evaluate the Bioline Hepatitis C virus (HCV) point-of-care (POC) testing in sub-Saharan Africa (SSA), this narrative review summarises regulatory standards and quality indicators for validating and approving HCV clinical diagnostics. In addition, this review also provides a summary of their diagnostic evaluations using the REASSURED criteria as the benchmark and its implications on the WHO HCV elimination goals 2030.
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Affiliation(s)
- Evans Duah
- Faculty of Health Science, School of Health Systems and Public Health, University of Pretoria, Pretoria 0002, South Africa
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Romo E, Rudolph AE, Stopka TJ, Wang B, Jesdale BM, Friedmann PD. HCV serostatus and injection sharing practices among those who obtain syringes from pharmacies and directly and indirectly from syringe services programs in rural New England. Addict Sci Clin Pract 2023; 18:2. [PMID: 36597153 PMCID: PMC9809047 DOI: 10.1186/s13722-022-00358-7] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2022] [Accepted: 12/14/2022] [Indexed: 01/04/2023] Open
Abstract
BACKGROUND Among people who inject drugs (PWID), obtaining syringes via syringe services programs (SSPs) and pharmacies reduces injection sharing practices associated with hepatitis C virus (HCV). Whether indirect use of SSPs via secondary exchange confers a similar benefit remains unknown, particularly in rural settings. We compared HCV serostatus and injection sharing practices by primary syringe source among a sample of rural PWID. METHODS Data are from a cross-sectional study of adults who use drugs recruited from eleven rural counties in New Hampshire, Vermont, and Massachusetts using respondent-driven sampling (2018-2019). Study staff performed HCV antibody testing. An audio computer-assisted self-interview assessed sociodemographic characteristics, past 30-day injection practices, and past 30-day primary syringe source. Primary syringe source was classified as direct SSP, pharmacy, indirect SSP (secondary exchange), or "other" (friend/acquaintance, street seller, partner/relative, found them). Mixed effects modified Poisson models assessed the association of primary syringe source with HCV seroprevalence and injection sharing practices. RESULTS Among 397 PWID, the most common primary syringe source was "other" (33%), then pharmacies (27%), SSPs (22%), and secondary exchange (18%). In multivariable models, compared with those obtaining most syringes from "other" sources, those obtaining most syringes from pharmacies had a lower HCV seroprevalence [adjusted prevalence ratio (APR):0.85, 95% confidence interval (CI) 0.73-0.9985]; however, the upper bound of the 95% CI was close to 1.0. Compared with those obtaining most syringes from other sources, PWID obtaining most syringes directly from SSPs or pharmacies were less likely to report borrowing used syringes [APR(SSP):0.60, 95% CI 0.43-0.85 and APR(Pharmacies):0.70, 95% CI 0.52-0.93], borrowing used injection equipment [APR(SSP):0.59, 95% CI 0.50-0.69 and APR (Pharmacies):0.81, 95% CI 0.68-0.98], and backloading [APR(SSP):0.65, 95% CI 0.48-0.88 and APR(Pharmacies):0.78, 95% CI 0.67-0.91]. Potential inverse associations between obtaining most syringes via secondary exchange and injection sharing practices did not reach the threshold for statistical significance. CONCLUSIONS PWID in rural New England largely relied on informal syringe sources (i.e., secondary exchange or sources besides SSPs/pharmacies). Those obtaining most syringes from an SSP or pharmacy were less likely to share injection equipment/syringes and had a lower HCV seroprevalence, which suggests using these sources reduces the risk of new HCV infections or serves as proxy for past injection behavior.
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Affiliation(s)
- Eric Romo
- grid.168645.80000 0001 0742 0364Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA USA
| | - Abby E. Rudolph
- grid.264727.20000 0001 2248 3398Department of Epidemiology and Biostatistics, Temple University College of Public Health, Philadelphia, PA USA
| | - Thomas J. Stopka
- grid.67033.310000 0000 8934 4045Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA USA
| | - Bo Wang
- grid.168645.80000 0001 0742 0364Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA USA
| | - Bill M. Jesdale
- grid.168645.80000 0001 0742 0364Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA USA
| | - Peter D. Friedmann
- grid.266683.f0000 0001 2166 5835Office of Research, University of Massachusetts Chan Medical School-Baystate, Springfield, MA USA
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Chellamuthu P, Angel AN, MacMullan MA, Denny N, Mades A, Santacruz M, Lopez R, Bagos C, Casian JG, Trettner K, Lopez L, Nirema N, Brobeck M, Kojima N, Klausner JD, Turner F, Slepnev V, Ibrayeva A. SARS-CoV-2 Specific IgG Antibodies Persist Over a 12-Month Period in Oral Mucosal Fluid Collected From Previously Infected Individuals. Front Immunol 2021; 12:777858. [PMID: 34956206 PMCID: PMC8697108 DOI: 10.3389/fimmu.2021.777858] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/15/2021] [Accepted: 11/22/2021] [Indexed: 01/12/2023] Open
Abstract
Background Developing an understanding of the antibody response, seroprevalence, and seroconversion from natural infection and vaccination against SARS-CoV-2 will give way to a critical epidemiological tool to predict reinfection rates, identify vulnerable communities, and manage future viral outbreaks. To monitor the antibody response on a larger scale, we need an inexpensive, less invasive, and high throughput method. Methods Here we investigate the use of oral mucosal fluids from individuals recovered from SARS-CoV-2 infection to monitor antibody response and persistence over a 12-month period. For this cohort study, enzyme-linked immunosorbent assays (ELISAs) were used to quantify anti-Spike(S) protein IgG antibodies in participants who had prior SARS-CoV-2 infection and regularly (every 2-4 weeks) provided both serum and oral fluid mucosal fluid samples for longitudinal antibody titer analysis. Results In our study cohort (n=42) with 17 males and 25 females with an average age of 45.6 +/- 19.3 years, we observed no significant change in oral mucosal fluid IgG levels across the time course of antibody monitoring. In oral mucosal fluids, all the participants who initially had detectable antibodies continued to have detectable antibodies throughout the study. Conclusions Based on the results presented here, we have shown that oral mucosal fluid-based assays are an effective, less invasive tool for monitoring seroprevalence and seroconversion, which offers an alternative to serum-based assays for understanding the protective ability conferred by the adaptive immune response from viral infection and vaccination against future reinfections.
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Affiliation(s)
- Prithivi Chellamuthu
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Aaron N. Angel
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Melanie A. MacMullan
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
- Mork Family Department of Chemical Engineering and Materials Science, Viterbi School of Engineering, University of Southern California, Los Angeles, CA, United States
| | - Nicholas Denny
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Aubree Mades
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Marilisa Santacruz
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Ronell Lopez
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Cedie Bagos
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Joseph G. Casian
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Kylie Trettner
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
- Mork Family Department of Chemical Engineering and Materials Science, Viterbi School of Engineering, University of Southern California, Los Angeles, CA, United States
| | - Lauren Lopez
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Nina Nirema
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Matthew Brobeck
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Noah Kojima
- Department of Medicine, University of California, Los Angeles, Los Angeles, CA, United States
| | - Jeffrey D. Klausner
- Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States
| | - Fred Turner
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Vladimir Slepnev
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
| | - Albina Ibrayeva
- Department of Serology Research and Development, Curative, Monrovia, CA, United States
- Eli and Edythe Broad Center for Regenerative Medicine at the University of Southern California, William Myron Keck School of Medicine, Los Angeles, CA, United States
- Davis School of Gerontology, University of Southern California, Los Angeles, CA, United States
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10
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Shenge JA, Osiowy C. Rapid Diagnostics for Hepatitis B and C Viruses in Low- and Middle-Income Countries. FRONTIERS IN VIROLOGY 2021; 1. [DOI: 10.3389/fviro.2021.742722] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/05/2025]
Abstract
The global health challenge posed by hepatitis B virus (HBV) and hepatitis C virus (HCV) persists, especially in low-and-middle-income countries (LMICs), where underdiagnosis of these viral infections remains a barrier to the elimination target of 2030. HBV and HCV infections are responsible for most liver-related mortality worldwide. Infected individuals are often unaware of their condition and as a result, continue to transmit these viruses. Although conventional diagnostic tests exist, in LMIC they are largely inaccessible due to high costs or a lack of trained personnel, resulting in poor linkage to care and increased infections. Timely and accurate diagnosis is needed to achieve elimination of hepatitis B and C by the year 2030 as set out by the World Health Organization Global Health Sector Strategy. In this review rapid diagnostic tests allowing for quick and cost-effective screening and diagnosis of HBV and HCV, are discussed, as are their features, including suitability, reliability, and applicability in LMIC, particularly those within Africa.
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Shahid I, Alzahrani AR, Al-Ghamdi SS, Alanazi IM, Rehman S, Hassan S. Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises. Diagnostics (Basel) 2021; 11:1253. [PMID: 34359335 PMCID: PMC8305142 DOI: 10.3390/diagnostics11071253] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2021] [Revised: 07/02/2021] [Accepted: 07/05/2021] [Indexed: 12/14/2022] Open
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 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.
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Affiliation(s)
- Imran Shahid
- Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University, Al-Abidiyah, P.O. Box 13578, Makkah 21955, Saudi Arabia; (A.R.A.); (S.S.A.-G.); (I.M.A.)
| | - Abdullah R. Alzahrani
- Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University, Al-Abidiyah, P.O. Box 13578, Makkah 21955, Saudi Arabia; (A.R.A.); (S.S.A.-G.); (I.M.A.)
| | - Saeed S. Al-Ghamdi
- Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University, Al-Abidiyah, P.O. Box 13578, Makkah 21955, Saudi Arabia; (A.R.A.); (S.S.A.-G.); (I.M.A.)
| | - Ibrahim M. Alanazi
- Department of Pharmacology and Toxicology, Faculty of Medicine, Umm Al-Qura University, Al-Abidiyah, P.O. Box 13578, Makkah 21955, Saudi Arabia; (A.R.A.); (S.S.A.-G.); (I.M.A.)
| | - Sidra Rehman
- Functional Genomics Laboratory, Department of Biosciences, COMSATS University Islamabad (CUI), Islamabad 45550, Pakistan;
| | - Sajida Hassan
- Viral Hepatitis Program, Laboratory of Medicine, University of Washington, Seattle, WA 98195, USA;
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12
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Smookler D, Vanderhoff A, Biondi MJ, Valencia J, Ryan P, Karkada J, Hong R, Sattar I, Mandel E, Gjevori M, Casey J, Fletcher D, Shah H, Hansen BE, Capraru C, Janssen HLA, Lazarus JV, Feld JJ. Reducing Read Time of Point-of-Care Test Does Not Affect Detection of Hepatitis C Virus and Reduces Need for Reflex RNA. Clin Gastroenterol Hepatol 2021; 19:1451-1458.e4. [PMID: 32763480 DOI: 10.1016/j.cgh.2020.07.058] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/28/2020] [Revised: 07/28/2020] [Accepted: 07/29/2020] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Global elimination of hepatitis C virus (HCV) will require increases in diagnosis. Point of care (POC) tests that detect antibodies against HCV can be useful for testing large and difficult to reach populations. The most accurate POC test requires a 20 min read time to identify antibody-positive samples. We investigated whether viremic patients could be identified using a shorter read time, to increase efficiency and reduce the need for reflex tests (a follow-up test for HCV RNA on the same specimen to confirm viremia). METHODS Patients with past or current HCV infections provided samples at 2 clinics in Canada for evaluation by the OraQuick HCV Rapid antibody POC test. A community HCV-screening program in Madrid, Spain (real-world cohort) invited people to be tested for HCV with the same OraQuick test. Patients provided samples of whole blood, via finger prick. Fingerprick samples were tested immediately after collection. In the clinic cohort, photographs of the developing test were taken at 15 second intervals, and blinded readers recorded the time to positivity. In the real-world cohort, readers recorded the OraQuick result at 5 minutes, and each minute after, up to 10 minutes, and then again at 20 minutes; viremia was then evaluated using a POC HCV RNA test (GeneXpert HCV Viral Load Assay). Sera from viremic and non-viremic clinic patients were used to quantify antibody titers to investigate the relationship between the time of band appearance and antibody concentration. Fisher's exact test and exact logistic regression were used to determine factors associated with a positive result at 5 minutes. RESULTS Blood from all viremic patients produced a positive result in the antibody POC test by 5 min. Median time to a positive result for 171 viremic patients was 2.6 min (range, 1.8-4.6 min), vs 4.1 min (range, 2.3-14.4 min) for 108 patients with resolved infection (P < .001). The 5-min threshold identified all viremic cases among 176 HCV antibody-positive patients in the real-world cohort, confirmed by testing for HCV RNA. In the pooled cohorts, antibody positivity at 5 min identified viremic patients with 100% sensitivity (95% CI, 98.4%-100%); the negative predictive value was 100% (95% CI, 94.9%-100%). The positive predictive value at 5 min was 62.0% (95% CI, 56.7%-67.0%) and therefore insufficient alone to detect viremia; an HCV RNA test would still be necessary to confirm active infection. CONCLUSIONS The wait time for the OraQuick HCV Rapid antibody POC blood test can be reduced from 20 min to 5 min and continue to reliably identify patients with HCV infection. Shortening the test time could increase high-throughput screening, reduce loss to follow up, and reduce the need for reflex HCV RNA testing.
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Affiliation(s)
- David Smookler
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Aaron Vanderhoff
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Mia J Biondi
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Jorge Valencia
- Harm Reduction Unit (SMASD), Subdireccion General de Adicciones, Madrid, Spain
| | - Pablo Ryan
- Internal Medicine/HIV Unit, Infanta Leonor Hospital, Madrid, Spain
| | - Joel Karkada
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Rachel Hong
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Izza Sattar
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Erin Mandel
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Martina Gjevori
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Julia Casey
- Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | | | - Hemant Shah
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Bettina E Hansen
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada; Institute of Health, Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
| | - Camelia Capraru
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Harry L A Janssen
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | | | - Jordan J Feld
- Viral Hepatitis Care Network (VIRCAN), Toronto, Ontario, Canada; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada.
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Akiyama MJ, Kronfli N, Cabezas J, Sheehan Y, Thurairajah PH, Lines R, Lloyd AR. Hepatitis C elimination among people incarcerated in prisons: challenges and recommendations for action within a health systems framework. Lancet Gastroenterol Hepatol 2021; 6:391-400. [PMID: 33857445 DOI: 10.1016/s2468-1253(20)30365-4] [Citation(s) in RCA: 47] [Impact Index Per Article: 11.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/23/2020] [Revised: 11/10/2020] [Accepted: 11/16/2020] [Indexed: 12/13/2022]
Abstract
Hepatitis C virus (HCV) is a global public health problem in correctional settings. The International Network on Health and Hepatitis in Substance Users-Prisons Network is a special interest group committed to advancing scientific knowledge exchange and advocacy for HCV prevention and care in correctional settings. In this Review, we highlight seven priority areas and best practices for improving HCV care in correctional settings: changing political will, ensuring access to HCV diagnosis and testing, promoting optimal models of HCV care and treatment, improving surveillance and monitoring of the HCV care cascade, reducing stigma and tackling the social determinants of health inequalities, implementing HCV prevention and harm reduction programmes, and advancing prison-based research.
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Affiliation(s)
- Matthew J Akiyama
- Department of Medicine, Divisions of General Internal Medicine and Infectious Disease, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, New York, NY, USA.
| | - Nadine Kronfli
- Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, QC, Canada; Research Institute of the McGill University Health Centre, Montreal, QC, Canada
| | - Joaquin Cabezas
- Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, Santander, Spain; Marques de Valdecilla Research Institute, Santander, Spain
| | - Yumi Sheehan
- Viral Immunology Systems Program, Kirby Institute for Infection and Immunity, University of New South Wales, Sydney, NSW, Australia
| | - Prem H Thurairajah
- Department of Gastroenterology and Hepatology, Yong Loo Lin School of Medicine, National University Hospital, Singapore, Singapore
| | | | - Andrew R Lloyd
- Viral Immunology Systems Program, Kirby Institute for Infection and Immunity, University of New South Wales, Sydney, NSW, Australia
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Farnsworth CW, Lloyd M, Jean S. Opioid Use Disorder and Associated Infectious Disease: The Role of the Laboratory in Addressing Health Disparities. J Appl Lab Med 2020; 6:180-193. [PMID: 33438735 DOI: 10.1093/jalm/jfaa150] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/16/2020] [Accepted: 08/07/2020] [Indexed: 11/12/2022]
Abstract
BACKGROUND Opioid use disorder, defined as a pattern of problematic opioid use leading to clinically significant impairment, has resulted in considerable morbidity and mortality throughout the world. This is due, at least in part, to the marginalized status of patients with opioid use disorder, limiting their access to appropriate laboratory testing, diagnosis, and treatment. Infections have long been associated with illicit drug use and contribute considerably to morbidity and mortality. However, barriers to testing and negative stigmas associated with opioid use disorder present unique challenges to infectious disease testing in this patient population. CONTENT This review addresses the associations between opioid use disorder and infectious organisms, highlighting the health disparities encountered by patients with opioid use disorder, and the important role of laboratory testing for diagnosing and managing these patients. SUMMARY Infections are among the most frequent and adverse complications among patients with opioid use disorder. As a result of health disparities and systemic biases, patients that misuse opioids are less likely to receive laboratory testing and treatment. However, laboratories play a crucial in identifying patients that use drugs illicitly and infections associated with illicit drug use.
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Affiliation(s)
- Christopher W Farnsworth
- Division of Laboratory and Genomic Medicine, Department of Pathology and Immunology, Washington University, St. Louis, MO
| | - Matthew Lloyd
- Division of Laboratory and Genomic Medicine, Department of Pathology and Immunology, Washington University, St. Louis, MO
| | - Sophonie Jean
- Department of Pathology and Laboratory Medicine, Nationwide Children's Hospital, Columbus, OH
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Pawlotsky JM, Negro F, Aghemo A, Berenguer M, Dalgard O, Dusheiko G, Marra F, Puoti M, Wedemeyer H. EASL recommendations on treatment of hepatitis C: Final update of the series ☆. J Hepatol 2020; 73:1170-1218. [PMID: 32956768 DOI: 10.1016/j.jhep.2020.08.018] [Citation(s) in RCA: 758] [Impact Index Per Article: 151.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/18/2020] [Accepted: 08/18/2020] [Indexed: 02/08/2023]
Abstract
Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Clinical care for patients with HCV-related liver disease has advanced considerably thanks to an enhanced understanding of the pathophysiology of the disease, as well as developments in diagnostic procedures and improvements in therapy and prevention. These therapies make it possible to eliminate hepatitis C as a major public health threat, as per the World Health Organization target, although the timeline and feasibility vary from region to region. These European Association for the Study of the Liver recommendations on treatment of hepatitis C describe the optimal management of patients with recently acquired and chronic HCV infections in 2020 and onwards.
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Evaluation of dried blood spot testing using the Abbott Alinity i. J Clin Virol 2020; 132:104638. [PMID: 33049642 DOI: 10.1016/j.jcv.2020.104638] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2020] [Revised: 09/03/2020] [Accepted: 09/06/2020] [Indexed: 11/23/2022]
Abstract
BACKGROUND The West of Scotland Specialist Virology Centre currently uses the Abbott Architect for DBS serology. The new Abbott Alinity i will replace the Architect in our laboratory. In this study, mock and stored patient DBS samples were tested on both platforms and results compared. STUDY DESIGN Mock DBS were made from whole blood where patient results were known (38 negative samples and 141 positive samples; 39 HIV Antigen/Antibody (Ag/Ab), 35 HCV IgG antibody (HCVG), 34 HBV core IgG (HBCG) and 33 HBsAg). Mock DBS were tested on both Abbott platforms. Stored patient DBS samples (132 negative and 263 positive: 9 HIVAg/Ab, 10 HBsAg, 52 HBCG and 60 HCVG) previously tested on the Architect were retested on the Alinity i. RESULTS Mock DBS showed good correlation between the Architect and Alinity i for the HIV Ag/Ab,HBCG and HCVG assays. A poorer correlation occurred with HBsAg, the Alinity i reported HBsAg positives at a lower value compared to the Architect. The coefficient of variation for intra-assay variation was 1.69 % (HIVAg/Ab), 3.25 % (HCVG), 1.68 % (HBsAg) and 1.95 % (HBCG). The sensitivity and specificity was determined based on results from the mock and patient samples. At S/Co cut-off 1.0 both HIV and HBsAg had a sensitivity of 100 %. A cut-off 0.8 gave a sensitivity of 95.83 % (95 % CI 89.67%-98.85%) for HCVG and 0.3 gave a sensitivity of 98.8 % (CI 93.69%-99.97%) for HBCG. DISCUSSION The alinity i compared well against the architect and can be used to test DBS samples.
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[Rapid diagnosis of sexually transmitted infections : Joint statement of DSTIG, RKI, and PEI, as well as the reference centers for HIV, HBV, and HCV and consulting laboratories for Chlamydia, gonococci, and Treponema pallidum]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2020; 63:1271-1286. [PMID: 32930821 DOI: 10.1007/s00103-020-03218-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
Abstract
In February 2019, the fourth expert meeting on rapid diagnostic tests (RDTs) for sexually transmitted infections (STI) was held at the Robert Koch Institute (RKI) in Berlin. Novel technical developments and new aspects of RDT applications were discussed by representatives from the German STI Society (DSTIG); RKI; the Paul Ehrlich Institute; national reference centers for HIV, HBV, and HCV; and reference laboratories for Chlamydia, gonococci, and Treponema pallidum.As a result of this meeting, we present a revision of the joint statement on STI diagnostics with RDTs from 2017. The Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices became effective in May 2017 and includes more stringent regulatory requirements for RDTs, mainly concerning conformity of manufacturing processes and performance characteristics of class D in vitro diagnostics (detection of HIV, HBV, HCV, and T. pallidum). Some RDTs for HIV, HCV, and T. pallidum have been evaluated in clinical studies and/or were WHO prequalified and may be used in low-threshold services. Among them are some HIV RDTs available and approved for self-testing. In addition, some HBV RDTs based on detection of HBs antigen (HBsAg) received WHO prequalification. However, false negative results may occur in samples with low HBsAg levels, as for instance in HIV-coinfected patients receiving antiretroviral therapy. For Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), antigen-based RDTs still do not allow reliable detection of infection. Only PCR-based CT/NG RDTs possess sufficient diagnostic accuracy to be used as point-of-care tests. Rapid PCR tests for NG, however, do not provide any information about antimicrobial resistance.
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HEPCARE EUROPE- A case study of a service innovation project aiming at improving the elimination of HCV in vulnerable populations in four European cities. Int J Infect Dis 2020; 101:374-379. [PMID: 32992012 DOI: 10.1016/j.ijid.2020.09.1445] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/08/2020] [Revised: 09/18/2020] [Accepted: 09/22/2020] [Indexed: 12/11/2022] Open
Abstract
OBJECTIVES Hepatitis C Virus (HCV) is a significant cause of chronic liver disease. Among at-risk populations, access to diagnosis and treatment is challenging. We describe an integrated model of care, Hepcare Europe, developed to address this challenge. METHODS Using a case-study approach, we describe the cascade of care outcomes at all sites. Cost analyses estimated the cost per person screened and linked to care. RESULTS A total of 2608 participants were recruited across 218 clinical sites. HCV antibody test results were obtained for 2568(98•5%); 1074(41•8%) were antibody-positive, 687(60•5%) tested positive for HCV-RNA, 650(60•5%) were linked to care, and 319(43•5%) started treatment. 196(61•4%) of treatment initiates achieved a Sustained Viral Response (SVR) at dataset closure, 108(33•9%) were still on treatment, eight (2•7%) defaulted from treatment, and seven (2•6%) had virologic failure or died. The cost per person screened varied from €194 to €635, while the cost per person linked to care varied from €364 to €2035. CONCLUSIONS Hepcare enhanced access to HCV treatment and cure, and costs were affordable in all settings, offering a framework for scale-up and reproducibility.
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Houri I, Horowitz N, Katchman H, Weksler Y, Miller O, Deutsch L, Shibolet O. Emergency department targeted screening for hepatitis C does not improve linkage to care. World J Gastroenterol 2020; 26:4878-4888. [PMID: 32921964 PMCID: PMC7459203 DOI: 10.3748/wjg.v26.i32.4878] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/20/2020] [Revised: 06/13/2020] [Accepted: 08/09/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) infection is a leading cause of chronic liver disease worldwide. New treatments for HCV revolutionized management and prompted the world health organization to set the goal of viral elimination by 2030. These developments strengthen the need for HCV screening in order to identify asymptomatic carriers prior to development of chronic liver disease and its complications. Different screening strategies have been attempted, most targeting high-risk populations. Previous studies focusing on patients arriving at emergency departments showed a higher prevalence of HCV compared to the general population.
AIM To identify previously undiagnosed HCV carriers among high risk emergency room attendees and link them to care for anti-viral treatment.
METHODS In this single center prospective study, persons visiting the emergency department in an urban hospital were screened by a risk factor-specific questionnaire. The risk factors screened for were exposure to blood products or organ transplantation before 1992; origins from countries with high prevalence of HCV; intravenous drug use; human immunodeficiency virus carriers; men who have sex with men; those born to HCV-infected mothers; prior prison time; and chronic kidney disease. Those with at least one risk factor were tested for HCV by serum for HCV antibodies, a novel oral test from saliva (OraQuick®) or both.
RESULTS Five hundred and forty-one participants had at least one risk factor and were tested for HCV. Eighty four percent of all study participants had only one risk factor. Eighty five percent of participants underwent OraQuick® testing, 34% were tested for serum anti-HCV antibodies, and 25% had both tests. 3.1% of patients (17/541) had a positive result, compared to local population incidence of 1.96%. Of these, 82% were people who inject drugs (current or former), and 64% served time in prison. One patient had a negative HCV-RNA, and two patients died from non-HCV related reasons. On review of past medical records, 12 patients were found to have been previously diagnosed with HCV but were unaware of their carrier state. At 1-year follow-up none of the remaining 14 patients had completed HCV-RNA testing, visited a hepatology clinic or received anti-viral treatment.
CONCLUSION Targeted high-risk screening in the emergency department identified undiagnosed and untreated HCV carriers, but did not improve treatment rates. Other strategies need to be developed to improve linkage to care in high risk populations.
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Affiliation(s)
- Inbal Houri
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Noya Horowitz
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
| | - Helena Katchman
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Yael Weksler
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Ofer Miller
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Liat Deutsch
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
| | - Oren Shibolet
- Department of Gastroenterology and Hepatology, Tel-Aviv Medical Center, Tel-Aviv 6423906, Israel
- Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6997801, Israel
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Hsiang JC, Sinnaswami P, Lee MY, Zhang MM, Quek KE, Tan KH, Wong YM, Thurairajah PH. Point-of-care hepatitis C screening with direct access referral to improve linkage of care among people with substance misuse: a pilot randomised study. Singapore Med J 2020; 63:86-92. [PMID: 32729280 DOI: 10.11622/smedj.2020116] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/18/2022]
Abstract
INTRODUCTION Linkage to care among people with substance misuse remains a barrier to the elimination of the hepatitis C virus (HCV). We aimed to determine if point-of-care (PoC) education, screening and staging for liver disease with direct access to hospitals would improve linkage to care among this group. METHODS All participants were offered PoC education and HCV screening. HCV-positive participants were randomised to standard care (controls) or direct access, which provided a direct pathway to hospitals. Linkage to care was determined by reviewing electronic medical records. Linkage of care cascade was defined as attendance at the specialist clinic, confirmation of viraemia by HCV RNA testing, discussion about HCV treatment and initiation of treatment. RESULTS 351 halfway house residents were screened. The overall HCV prevalence was 30.5% (n = 107), with 69 residents in the control group and 38 in the direct access group. The direct access group had a significantly higher percentage of cases linked to specialist review for confirmatory RNA testing (63.2% vs. 40.6%, p = 0.025), HCV treatment discussion (p = 0.009) and treatment initiation (p = 0.01) compared to the controls. Overall, only 12.6% (n = 13) had treatment initiation during follow-up. PoC HCV screening with direct access referral had significantly higher linkage to HCV treatment initiation (adjusted odds ratio 9.13, p = 0.005) in multivariate analysis. CONCLUSION PoC HCV screening with direct access improves linkage to care and simplifies the HCV care cascade, leading to improved treatment uptake. PoC education, screening, diagnosis and treatment may be an effective strategy to achieving HCV micro-elimination in this population.
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Affiliation(s)
- John Chen Hsiang
- Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.,Department of Gastroenterology, Sengkang General Hospital, Singapore.,Yong Loo Lin School of Medicine, National University of Singapore, Singapore
| | - Pream Sinnaswami
- Saw Swee Hock School of Public Health, National University of Singapore, Singapore
| | - Mui Yok Lee
- Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore
| | - Meng Meng Zhang
- Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore
| | - Kwang Ee Quek
- Clinical Trials and Research Unit, Changi General Hospital, Singapore
| | - Keng Hwee Tan
- Clinical Trials and Research Unit, Changi General Hospital, Singapore
| | - Yew Meng Wong
- Clinical Trials and Research Unit, Changi General Hospital, Singapore
| | - Prem Harichander Thurairajah
- Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.,Yong Loo Lin School of Medicine, National University of Singapore, Singapore.,National University Hospital, Singapore
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21
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Evaluación de la precisión diagnóstica del sistema Cobas 6800 para la detección de los niveles de viremia del virus de la hepatitis C a partir de muestras de gotas de sangre seca en papel de filtro. Enferm Infecc Microbiol Clin 2020; 38:267-274. [DOI: 10.1016/j.eimc.2019.10.009] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2019] [Revised: 10/01/2019] [Accepted: 10/03/2019] [Indexed: 01/22/2023]
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Antezack A, Chaudet H, Tissot-Dupont H, Brouqui P, Monnet-Corti V. Rapid diagnosis of periodontitis, a feasibility study using MALDI-TOF mass spectrometry. PLoS One 2020; 15:e0230334. [PMID: 32168352 PMCID: PMC7069628 DOI: 10.1371/journal.pone.0230334] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2019] [Accepted: 02/26/2020] [Indexed: 12/24/2022] Open
Abstract
AIM The aim of the present study was to assess the feasibility and diagnostic contribution of protein profiling using MALDI-TOF mass spectrometry applied to saliva, gingival crevicular fluid (GCF) and dental plaque from periodontitis and healthy subjects. We hypothesized that rapid routine and blinded MALDI-TOF analysis could accurately classify these three types of samples according to periodontal state. MATERIALS AND METHODS Unstimulated saliva, GCF and dental plaque, collected from periodontitis subjects and healthy controls, were analyzed by MALDI-TOF MS. Based on the differentially expressed peaks between the two groups, diagnostic decision trees were built for each sample. RESULTS Among 141 patients (67 periodontitis and 74 healthy controls), the decision trees diagnosed periodontitis with a sensitivity = 70.3% (± 0.211) and a specificity = 77.8% (± 0.165) for saliva, a sensitivity = 79.6% (± 0.188) and a specificity = 75.7% (± 0.195) for GCF, and a sensitivity = 72.1% (± 0.202) and a specificity = 72.2% (± 0.195) for dental plaque. The sensitivity and specificity of the tests were improved to 100% (CI 95% = [0.91;1]) and 100% (CI 95% = [0.92;1]), respectively, when two samples were tested. CONCLUSION We developed, for the first time, diagnostic tests based on protein profiles of saliva, GCF and dental plaque between periodontitis patients and healthy subjects. When at least 2 of these samples were tested, the best results were obtained.
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Affiliation(s)
- Angéline Antezack
- Department of Periodontology, Service of Odontology, AP-HM, UFR of Odontology, Aix-Marseille University, Marseille, France
- AP-HM, IHU-Méditerranée Infection, Institut de Recherche pour le Développement, Institut Hospitalo-Universitaire Méditerranée Infection, MEPHI, Aix Marseille University, Marseille, France
| | - Hervé Chaudet
- AP-HM, IHU-Méditerranée Infection, Institut de Recherche pour le Développement, Institut Hospitalo-Universitaire Méditerranée Infection, MEPHI, Aix Marseille University, Marseille, France
| | - Hervé Tissot-Dupont
- AP-HM, IHU-Méditerranée Infection, Institut de Recherche pour le Développement, Institut Hospitalo-Universitaire Méditerranée Infection, MEPHI, Aix Marseille University, Marseille, France
| | - Philippe Brouqui
- AP-HM, IHU-Méditerranée Infection, Institut de Recherche pour le Développement, Institut Hospitalo-Universitaire Méditerranée Infection, MEPHI, Aix Marseille University, Marseille, France
| | - Virginie Monnet-Corti
- Department of Periodontology, Service of Odontology, AP-HM, UFR of Odontology, Aix-Marseille University, Marseille, France
- AP-HM, IHU-Méditerranée Infection, Institut de Recherche pour le Développement, Institut Hospitalo-Universitaire Méditerranée Infection, MEPHI, Aix Marseille University, Marseille, France
- * E-mail:
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Carvalho-Gomes Â, Cubells A, Pallarés C, Hontangas V, Conde I, Di Maira T, Peiró S, Sanfélix-Gimeno G, López-Labrador FX, Berenguer M. A population-based screening for hepatitis C antibodies and active infection using a point-of-care test in a low prevalence area. PLoS One 2020; 15:e0228351. [PMID: 32045417 PMCID: PMC7012430 DOI: 10.1371/journal.pone.0228351] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/27/2019] [Accepted: 01/13/2020] [Indexed: 12/14/2022] Open
Abstract
Background Data on the true prevalence of hepatitis C virus (HCV) infection in the general population is essential. We evaluated a program implementing free universal HCV screening using a non-invasive point-of-care test (POCT) (OraQuick-HCV rapid test) in oral fluid in an urban area in Valencia, South-Eastern Spain. Methods A cross-sectional study was performed during 2015–2017. Free HCV screening was offered by regular mail to 11,500 individuals aged 18 and over, randomly selected from all census residents in the Health Department. All responding participants filled in a questionnaire about HCV infection risk factors and were tested in their tertiary Hospital. In those with a positive POCT, results were confirmed by enzyme-immunoassay and HCV-RNA. Results 1,206 persons agreed to participate (response rate: 11.16%). HCV antibodies were detected in 19 (1.60%) cases (age-sex standardized rate: 1.31%; 95%CI: 0.82–2.07), but only 8 showed positive HCV-RNA (age-sex standardized rate: 0.56%; 95%CI: 0.28–1.14). The majority (89%) of the cases were born before 1965 and 74% had at least one known risk factor for HCV infection. All anti-HCV positive individuals were already aware of their infection, and no undiagnosed cases were detected. The performance of the POCT was excellent for detecting active infection. Conclusions These preliminary data suggest that HCV population screening with a POCT is feasible but, in our setting, mailing recruiting is not effective (11% response rate). The low prevalence of HCV antibodies and active infection in the participant population (with no new diagnoses made) suggests that, in our setting, underdiagnosis may be uncommon.
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Affiliation(s)
- Ângela Carvalho-Gomes
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
- CIBERehd, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain
| | - Almudena Cubells
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
| | - Carmina Pallarés
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
- CIBERehd, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain
| | - Vanessa Hontangas
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
| | - Isabel Conde
- Liver Transplantation and Hepatology Unit, Hospital Universitario y Politécnico La Fe, València, Spain
| | - Tomasso Di Maira
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
| | - Salvador Peiró
- Health Services Research Area, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO Public Health), València, Spain
| | - Gabriel Sanfélix-Gimeno
- Health Services Research Area, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO Public Health), València, Spain
| | - F. Xavier López-Labrador
- Virology Laboratory, Joint Units in Genomics and Health and Infection and Health, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO Public Health) / Universitat de València, València, Spain
- CIBEResp, Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública, Instituto de Salud Carlos III, Madrid, Spain
- * E-mail:
| | - Marina Berenguer
- Liver Transplantation and Hepatology Laboratory, Instituto de Investigación Sanitaria La Fe, València, Spain
- CIBERehd, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain
- Liver Transplantation and Hepatology Unit, Hospital Universitario y Politécnico La Fe, València, Spain
- Department of Medicine, Universitat de València, València, Spain
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24
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Evaluation of a new point-of-care oral anti-HCV test for screening of hepatitis C virus infection. Virol J 2020; 17:14. [PMID: 32005264 PMCID: PMC6995050 DOI: 10.1186/s12985-020-1293-7] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/16/2019] [Accepted: 01/27/2020] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) infection is a public health issue for which an effective universal screening method is urgently needed. An oral anti-HCV test could provide a noninvasive and rapid screening strategy for HCV infection. This study evaluated the performance of a new point-of-care oral assay developed by Well for the detection of HCV antibody. METHODS Individuals from three centers with and without HCV infection were enrolled. All participants were tested for oral HCV antibody using the Well assay and for serum HCV antibody using established tests (ARCHITECT i2000 anti-HCV assay and InTec serum anti-HCV assay). For participants who obtained positive results, HCV RNA was tested for verification. Some patients underwent the OraQuick HCV test at the same time, and some self-tested with the Well assay during the same period. RESULTS A total of 1179 participants, including 486 patients with chronic HCV infection, 108 patients with other liver diseases, and 585 individuals who underwent physical examination, were enrolled. The Well anti-HCV test had a sensitivity of 91.88% (95% confidence interval [CI]: 88.97-94.09%) and a specificity of 98.00% (96.58-98.86%) for oral HCV antibody detection. The consistency between the Well and InTec assays was 97.02% (1138/1179). The consistency between the Well and OraQuick assays was 98.50% (197/200). Furthermore, the results of self-testing were highly consistent with those of researcher-administered tests (Kappa = 0.979). In addition, the HCV RNA results also showed that HCV RNA could only be detected on 1 of the 39 false-negative samples, and for 172 positive HCV RNA results, 171 could be detected by the Well oral anti-HCV assay. CONCLUSIONS The Well oral anti-HCV test offers high sensitivity and specificity and performed comparably to both the OraQuick assay and InTec assay for HCV diagnosis. Thus, the Well test represents a new tool for universal HCV screening to identify infected patients, particularly in regions with limited medical resources.
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25
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Chionne P, Madonna E, Villano U, Tritarelli E, Pisani G, Costantino A, Equestre M, Marcantonio C, Bruni R, Ciccaglione AR. Sensitivity of hepatitis C virus rapid tests in detecting antibodies in general population. Panminerva Med 2019; 62:125-130. [PMID: 31692308 DOI: 10.23736/s0031-0808.19.03678-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
BACKGROUND Evaluation of clinical performance of the anti-hepatitis C virus (HCV) rapid tests were carried out mostly in chronic hepatitis C patients and in individuals at high risk of HCV infection. METHODS The aim of this study was to evaluate the performance of OraQuick and Wantai rapid tests on archived serum samples from 1408 individuals (mean age 46, range 18-90; 65% female) recruited with a systematic sampling procedure during a general population survey. RESULTS The analysis of samples by Ortho HCV 3.0 ELISA and Cobas Taqman HCV RNA assays resulted in 69 anti-HCV antibody positive sera, including 42 HCV RNA positive (group 1) and 27 HCV RNA negative (group 2) samples. The performance of rapid tests was evaluated on the 69 anti-HCV positive (group 1+2) and 206 (OraQuick) and 198 (Wantai) anti-HCV negative sera, randomly selected from the 1339 anti-HCV negative samples. The OraQuick and Wantai rapid assays showed a sensitivity in group 1 of 92.9% and 90.5%, respectively. The sensitivity in group 2 was 40.7% and 51.9%, respectively. The anti-HCV antibodies signal/cutoff mean value was the only parameter that statistically differed between group 1 and group 2 individuals (P<0.0001). Further, 3 (OraQuick) and 4 samples (Wantai) from group 1, with very low HCV RNA level (<25 UI/mL), were misdiagnosed by rapid assays as false negative. CONCLUSIONS The proportion of infections with low level of viremia and the risk associated with rapid assay failure remained to be carefully estimated in general population.
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Affiliation(s)
- Paola Chionne
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Elisabetta Madonna
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Umbertina Villano
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Elena Tritarelli
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Giulio Pisani
- Center for Immunobiologicals Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy
| | - Angela Costantino
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Michele Equestre
- Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, Rome, Italy
| | - Cinzia Marcantonio
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Roberto Bruni
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy
| | - Anna R Ciccaglione
- Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy -
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26
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Crespo J, Albillos A, Buti M, Calleja JL, Garcia-Samaniego J, Hernández-Guerra M, Serrano T, Turnes J, Acín E, Berenguer J, Berenguer M, Colom J, Fernández I, Fernández Rodríguez C, Forns X, García F, Granados R, Lazarus J, Molero JM, Molina E, Pérez Escanilla F, Pineda JA, Rodríguez M, Romero M, Roncero C, Saiz de la Hoya P, Sánchez Antolín G. Elimination of hepatitis C. Positioning document of the Spanish Association for the Study of the Liver (AEEH). ACTA ACUST UNITED AC 2019. [DOI: 10.1016/j.gastre.2019.09.002] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
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27
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Crespo J, Albillos A, Buti M, Calleja JL, García-Samaniego J, Hernández-Guerra M, Serrano T, Turnes J, Acín E, Berenguer J, Berenguer M, Colom J, Fernández I, Fernández Rodríguez C, Forns X, García F, Rafael Granados, Lazarus JV, Molero JM, Molina E, Pérez Escanilla F, Pineda JA, Rodríguez M, Romero M, Roncero C, Saiz de la Hoya P, Sánchez Antolín G. Elimination of hepatitis C. Positioning document of the Spanish Association for the Study of the Liver (AEEH). GASTROENTEROLOGIA Y HEPATOLOGIA 2019; 42:579-592. [PMID: 31594683 DOI: 10.1016/j.gastrohep.2019.09.002] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/05/2019] [Accepted: 09/06/2019] [Indexed: 02/07/2023]
Abstract
The Spanish Association for the Study of the Liver (AEEH) is convinced that the elimination of hepatitisC virus (HCV) in Spain is possible as long as we are able to use the resources and tools necessary for it. This document reflects the position of the AEEH regarding the elimination of HCV, establishing a wide range of recommendations that can be grouped into five categories: 1)Screening of HCV according to age, of the existence of classic acquisition risk factors of infection, active search of previously diagnosed patients and development of micro-elimination strategies in vulnerable populations; 2)Simplification of HCV diagnosis (one-step diagnosis and diagnosis at the point of patient care); 3)Simplification of patient treatment and improvement of care circuits; 4)Health policy measures, and, finally, 5)Establishment of HCV elimination indicators.
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Affiliation(s)
- Javier Crespo
- Servicio de Digestivo, Hospital Universitario Marqués de Valdecilla, IDIVAL, Facultad de Medicina, UNICAN, Santander, España.
| | - Agustín Albillos
- Servicio de Digestivo, Hospital Universitario Ramón y Cajal, Facultad de Medicina, Universidad de Alcalá, Madrid, España
| | - María Buti
- Servicio de Hepatología, Hospital Universitario Vall d'Hebron y Ciberehd del Instituto Carlos III, Barcelona, España
| | - José Luis Calleja
- Servicio de Digestivo, Hospital Universitario Puerta de Hierro, Facultad de Medicina, Universidad Autónoma, Madrid, España
| | | | | | - Trinidad Serrano
- Hospital Universitario Lozano Blesa, ISS Aragón, Zaragoza, España
| | - Juan Turnes
- Servicio de Digestivo, Hospital Universitario de Pontevedra, Pontevedra, España
| | - Enrique Acín
- Área de Salud Pública, Subdirección General de Sanidad Penitenciaria, Secretaría General de II.PP. Ministerio del Interior, Madrid, España
| | - Juan Berenguer
- Unidad de Enfermedades Infecciosas/VIH, Hospital General Universitario Gregorio Marañón, IiSGM, Madrid, España
| | - Marina Berenguer
- Servicio de Digestivo, Hospital La Fe, Universidad de Valencia, Valencia y Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD) del Instituto Carlos III, Barcelona, España
| | - Joan Colom
- Dirección del Programa de Prevención, Control y Atención al VIH, las ITS y las Hepatitis Víricas, Subdirección general de Drogodependencias, Agencia de Salud Pública de Cataluña, Barcelona, España
| | - Inmaculada Fernández
- Servicio de Aparato Digestivo, Hospital Universitario 12 de Octubre, Madrid, España
| | - Conrado Fernández Rodríguez
- Unidad de Aparato Digestivo, Hospital Universitario Fundación Alcorcón, Comité científico de la SEPD, Alcorcón, Madrid, España
| | - Xavier Forns
- Servicio de Hepatología, Hospital Clínic, IDIBAPS y CIBEREHD, Universidad de Barcelona, Barcelona, España
| | - Federico García
- Servicio de Microbiología Clínica, Hospital Universitario San Cecilio, Instituto de Investigación Ibs Granada, Grupo de estudio de hepatitis de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (GEHEP-SEIMC), Granada, España
| | - Rafael Granados
- Hospital Universitario de Gran Canarias Dr. Negrín, Las Palmas de Gran Canaria, España
| | - Jeffrey V Lazarus
- Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, Universidad de Barcelona, Barcelona, España
| | | | - Esther Molina
- Servicio de Aparato Digestivo, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, La Coruña, España
| | - Fernando Pérez Escanilla
- Centro de Salud San Juan de Salamanca, Facultad de Medicina, USAL, Representante de SEMG, Salamanca, España
| | - Juan A Pineda
- Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valme, Grupo para el Estudio de las Hepatitis Víricas (GEHEP) de la SEIMC, Sevilla, España
| | - Manuel Rodríguez
- Sección de Hepatología, Servicio de Digestivo, Hospital Universitario Central de Asturias, Oviedo, España
| | - Manuel Romero
- Servicio Digestivo, Hospital Universitario Virgen del Rocío, Facultad de Medicina, Universidad de Sevilla, Sevilla, España
| | - Carlos Roncero
- Servicio de Psiquiatría, Complejo Asistencial Universitario de Salamanca, Instituto de Biomedicina de Salamanca, Universidad de Salamanca, Salamanca, España
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Clinical evaluation of a hepatitis C antibody rapid immunoassay on self-collected oral fluid specimens. Diagn Microbiol Infect Dis 2019; 95:149-151. [PMID: 31204109 DOI: 10.1016/j.diagmicrobio.2019.05.010] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/06/2019] [Revised: 05/08/2019] [Accepted: 05/17/2019] [Indexed: 01/30/2023]
Abstract
We evaluated the performance of the OraQuick® HCV Rapid Antibody Test (Orasure Technologies, Inc., Bethlehem, PA) on oral fluid specimens when used by patients for self-testing. Participants used a set of instructions, self-collected their specimens, and interpreted their result. A researcher interpreted the test simultaneously and independently. Participants' true antibody status was determined by reviewing medical records or by a venipuncture blood sample. Sensitivity, specificity, and κ statistic were calculated. The sample included 95 participants (48 male and 47 female). Sensitivity and specificity on self-collected oral fluid samples were 88.4%% (95% CI, 74.9-96.1) and 100% (95% CI, 93-100), respectively, when patients interpreted the test results. Sensitivity and specificity were 97.7% (95% CI, 88-99.9) and 98% (95% CI, 89.6-100), respectively, when trained staff interpreted the result. κ statistic was 0.89 (95% CI 0.80-0.98). The rapid HCV test kit showed good performance when used for self-testing of oral fluid specimens.
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Sharafi H, Poustchi H, Azimian F, Tamadoni B, Ramezani R, Gouya MM, Sheikh M, Hashemi F, Tashakorian M, Alasvand R, Alavian SM, Merat S. Performance of a rapid diagnostic test for screening of hepatitis C in a real-life prison setting. J Clin Virol 2019; 113:20-23. [PMID: 30825832 DOI: 10.1016/j.jcv.2019.02.005] [Citation(s) in RCA: 20] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/05/2018] [Revised: 02/07/2019] [Accepted: 02/25/2019] [Indexed: 12/18/2022]
Abstract
BACKGROUND Hepatitis C virus (HCV) point-of-care testing using rapid diagnostic test (RDT) is the solution for large-scale, feasible, fast and reliable screening of HCV infection. OBJECTIVES The aim of this study was to evaluate the diagnostic performance of HCV RDT for screening of HCV infection in a real-life prison setting. STUDY DESIGN This study was conducted on individuals admitted and incarcerated in the Central Prison of Karaj, 2017-2018. For all inmates, anti-HCV testing using a RDT on finger-stick blood in the prison and ELISA at the laboratory were performed. For evaluation of reproducibility, more than 1000 cases were recruited for re-evaluation of the HCV RDT using anticoagulated blood in the laboratory. RESULTS Among 1788 participants, 76 (4.25%) and 106 (5.93%) were positive for anti-HCV using RDT and ELISA, respectively. Among 34 cases with discordant results using the RDT and ELISA, 17 were the result of testing error in prison, 7 false positive of ELISA and 10 false negative of RDT in individuals with HCV spontaneous clearance. The sensitivity of the RDT with inclusion of testing error in prison for detection of anti-HCV was 75%. However, with exclusion of testing error in prison and considering HCV RNA as the reference method for diagnosis of current HCV infection the sensitivity reached 100%. The RDT was 100% reproducible using both evaluations in prison and the laboratory. CONCLUSIONS The RDT is a reliable and feasible method for screening of anti-HCV in settings such as a prison. However, the testing should be performed in a standard procedure to have the optimal diagnostic performance.
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Affiliation(s)
- Heidar Sharafi
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran; Middle East Liver Diseases (MELD) Center, Tehran, Iran
| | - Hossein Poustchi
- Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
| | - Fatemeh Azimian
- Centre for Communicable Diseases Control, Ministry of Health and Medical Education, Tehran, Iran
| | - Babak Tamadoni
- Health and Treatment Directorate of Prisons and Security and Corrective Measures Organization, Tehran, Iran
| | - Rashid Ramezani
- Centre for Communicable Diseases Control, Ministry of Health and Medical Education, Tehran, Iran
| | - Mohamad Mehdi Gouya
- Centre for Communicable Diseases Control, Ministry of Health and Medical Education, Tehran, Iran
| | - Mahdi Sheikh
- Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
| | - Farnaz Hashemi
- Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
| | - Mehrzad Tashakorian
- Health and Treatment Directorate of Prisons and Security and Corrective Measures Organization, Tehran, Iran
| | - Ramin Alasvand
- Health and Treatment Directorate of Prisons and Security and Corrective Measures Organization, Tehran, Iran
| | - Seyed Moayed Alavian
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran; Middle East Liver Diseases (MELD) Center, Tehran, Iran
| | - Shahin Merat
- Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
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Feld JJ. Hepatitis C Virus Diagnostics: The Road to Simplification. Clin Liver Dis (Hoboken) 2018; 12:125-129. [PMID: 30988927 PMCID: PMC6385922 DOI: 10.1002/cld.760] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/28/2018] [Accepted: 09/08/2018] [Indexed: 02/04/2023] Open
Affiliation(s)
- Jordan J. Feld
- Toronto Centre for Liver Disease, Sandra Rotman Centre for Global HealthUniversity of TorontoTorontoOntarioCanada
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31
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Trapero-Marugán M, Little EC, Berenguer M. Stretching the boundaries for liver transplant in the 21st century. Lancet Gastroenterol Hepatol 2018; 3:803-811. [DOI: 10.1016/s2468-1253(18)30213-9] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/10/2018] [Revised: 06/20/2018] [Accepted: 06/22/2018] [Indexed: 12/12/2022]
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