Hepatitis C Virus Rapid Test Research Articles

Chronic hepatitis C elimination prison initiative: HCV-intensive test and treat, a whole prisoner population HCV test-and-treat program in England.

Prison residents are at high risk for hepatitis C virus (HCV) infection. HCV test-and-treat initiatives within prisons provide an opportunity to engage with prison residents and achieve HCV micro-elimination. The aim of the prison HCV-intensive test and treat initiative was to screen over 95% of all prison residents for HCV infection within a defined number of days determined by the size of the prison population and to initiate treatment within 7-14 days of a positive HCV RNA diagnosis. An HCV-intensive test and treat toolkit was developed based on learnings from pilot HCV-intensive test and treat events. From January 2020 to September 2021, 13 HCV-intensive test and treat events took place at prisons in England selected based on high levels of reception blood-borne virus testing and good access to peers from The Hepatitis C Trust. Among a total of 8487 residents, 8139 (95.9%) underwent testing for HCV. Across the 13 prisons included, HCV antibody and RNA prevalence was 8.2% and 1.5%, respectively. The treatment initiation rate among HCV RNA-positive individuals (n = 124) was 79.0%. The HCV-intensive test and treat initiative presented here provides a feasible and rapid test-and-treat process to achieve HCV elimination within individual prisons. The HCV-intensive test and treat toolkit can be adapted for rapid HCV testing and treatment events at other prisons in the United Kingdom and worldwide.

HCV, HIV AND HBV rapid test diagnosis in non-clinical outreach settings can be as accurate as conventional laboratory tests

Point of care rapid diagnostic tests (POC-RDT) for Hepatitis C virus (HCV), Human Immunodeficiency virus (HIV) and Hepatitis B virus (HBV), are ideal for screening in non-clinical outreach settings as they can provide immediate results and facilitate diagnosis, allowing high risk population screening. The aim of this study was to compare POC-RDT with laboratory conventional tests. A total of 301 vulnerable evaluable subjects (drug users, migrants and homeless population) were recruited at a mobile screening unit in outreach settings in Madrid. Fingerprick whole blood capillary samples were tested using the SD BIOLINE HCV POC-RDT, Determine HIV Early Detect and Determine HBsAg 2, and the results were assessed against the LIAISON XL HCV, HIV and Murex-HBsAg-Quant, reference assays, respectively. The feasibility and user satisfaction of the POC-RDT were evaluated through a questionnaire. The resolved sensitivity and resolved specificity and their 95% confidence intervals (95% CI) were as follows, respectively: SD-BIOLINE-HCV: 98.8% (95% CI 93.4, 100.0) and 100.0% (95% CI 98.3, 100.0); Determine HIV Early Detect: 100% (95% CI 85.2, 100.0) and 100% (95% CI 98.7, 100); and Determine HBsAg 2: 66.7% (95% CI 9.4, 99.2) and 100.0% (95% CI 98.7, 100.0). As expected, the number of subjects with a confirmed positive result for HBsAg was very low (n = 4). Therefore, the analytical sensitivity has been evaluated in addition: The Determine HBsAg 2 test demonstrated 100% sensitivity for standard concentrations ≥ 0.125 IU/mL. The subject questionnaire yielded positive feedback for most subjects. The POC-RDT fingerprick blood collection method was well received, and the tests demonstrated a comparable clinical performance with conventional tests in outreach settings and vulnerable high-risk populations.

Behavioural survey and street-based HIV and HCV rapid testing programme among transgender sex workers

BackgroundTransgender women sex workers (TGW-SW) are disproportionally affected by HIV and have reduced access to testing. Moreover, information regarding their behaviours and health needs is scarce.MethodsA behavioural survey and a...

A Feasibility Study to Increase Chronic Hepatitis C Virus RNA Testing and Linkage to Care among Clients Attending Homeless Services in Amsterdam, The Netherlands.

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.

Usability and acceptability of self-testing for hepatitis C virus infection among the general population in the Nile Delta region of Egypt

BackgroundSelf-testing for hepatitis C virus antibodies (HCVST) may be an additional strategy to expand access to hepatitis C virus (HCV) testing and support elimination efforts. We conducted a study to assess the usability and acceptability of HCVST among the general population in a semi-rural, high-HCV prevalence region in Egypt.MethodsAn observational study was conducted in two hospitals in the Nile Delta region. A trained provider gave an in-person demonstration on how to use the oral fluid HCVST followed by observation of the participant performing the test. Usability was assessed by observing errors made and difficulties faced by participants. Acceptability of HCV self-testing was assessed using an interviewer-administered semi-structured questionnaire.ResultsOf 116 participants enrolled, 17 (14.6%) had received no formal education. The majority (72%) of participants completed all testing steps without any assistance and interpreted the test results correctly. Agreement between participant-reported HCVST results and interpretation by a trained user was 86%, with a Cohen’s kappa of 0.6. Agreement between participant-reported HCVST results and provider-administered oral fluid HCV rapid test results was 97.2%, with a Cohen’s kappa of 0.75. The majority of participants rated the HCVST process as easy (53%) or very easy (44%), and 96% indicated they would be willing to use HCVST again and recommend it to their family and friends.ConclusionOur study demonstrates the high usability and acceptability of oral fluid HCVST in a general population. Further studies are needed to establish the optimal positioning of self-testing alongside facility-based testing to expand access to HCV diagnosis in both general and high-risk populations.

Seroprevalence of hepatitis C virus (HCV) antibodies and associated factors based on voluntary screening data collection in the general population in Benin in 2016

Introductionl´hépatite C est un problème de santé publique dans le monde, et plus particulièrement en Afrique subsaharienne. L´objectif de ce travail était de déterminer la séroprévalence des anticorps anti-virus de l´hépatite C ainsi que les facteurs associés, à l´occasion d´un dépistage volontaire en population générale au Bénin.Méthodesil s´agissait d´une étude transversale descriptive et analytique qui s´était déroulée en juillet 2016 dans 4 grandes villes de 4 différents départements du Bénin. Etaient inclus tous les volontaires résidents dans ces villes ciblées, de tous âges, ayant donné leur consentement éclairé. Pour cette recherche, le test de diagnostic rapide HCV ImuMed (Healgen Scientific LLC, USA) avait été utilisé. Une analyse par régression logistique avait été utilisée afin d´identifier les facteurs associés à l´infection par le virus de l´hépatite C.Résultatsau total, 2809 volontaires étaient inclus avec une moyenne d´âge de 25,9± 16,5 ans (les extrêmes: 0 et 86 ans), constitués de 53,9% (1514/2809) d´hommes et de 46,1% (1295/2809) de femmes. Plus de la moitié de la population d´étude était constituée de célibataires 59,1% (1612/2726). Il s´agissait principalement de 41,3% (1074/2809) d´élèves ou étudiants. La séroprévalence du VHC était de 1,5% (42/2809). En analyse multivariée, les variables significativement associées au portage des anti-VHC étaient: l´âge de 60 ans et plus (aOR: 46,9, IC 95% 10,2-216,0; p < 0,0001) et l´antécédent d´alcoolisme (aOR: 6,3, IC 95% 3,3-12,1; p < 0,0001).Conclusionla séroprévalence des anticorps anti-VHC était de 1,5% dans la population étudiée. L´infection par le VHC touchait volontiers les sujets âgés (de 60 ans et plus) et ceux ayant un antécédent d´alcoolisme.

Bundling Rapid Human Immunodeficiency Virus and Hepatitis C Virus Testing to Increase Receipt of Test Results: A Randomized Trial.

The overlapping human immunodeficiency virus (HIV) and hepatitis C virus (HCV) epidemics disproportionately affect people with substance use disorders. However, many people who use substances remain unaware of their infection(s). The objective of this study was to examine the efficacy of an on-site bundled rapid HIV and HCV testing strategy in increasing receipt of both HIV and HCV test results. Two-armed randomized controlled trial in substance use disorder treatment programs (SUDTP) in New York City. Participants in the treatment arm were offered bundled rapid HIV and HCV tests with immediate results on-site. Participants in the control arm were offered the standard of care, that is, referrals to on-site or off-site laboratory-based HIV and HCV testing with delayed results. A total of 162 clients with unknown or negative HIV and HCV status. The primary outcome was the percentage of participants with self-reported receipt of HIV and HCV test results at 1-month postrandomization. Over half of participants were Hispanic (51.2%), with 25.3% being non-Hispanic black and 17.9% non-Hispanic white. Two thirds were male, and 54.9% reported injection as method of drug use. One hundred thirty-four participants (82.7%) completed the 1-month assessment. Participants in the treatment arm were more likely to report having received both test results than those in the control arm (69% vs. 19%, P<0.001). Seven participants in the treatment arm received a preliminary new HCV diagnosis, versus 1 in the control arm (P=0.029). Offering bundled rapid HIV and HCV testing with immediate results on-site in SUDTPs may increase awareness of HIV and HCV infection among people with substance use disorders.

Routine screening for hepatitis C viral infection in patients undergoing elective cranial neurosurgery.

Undiagnosed hepatitis C virus (HCV) and HIV in patients present risks of transmission of bloodborne infections to surgeons intraoperatively. Presurgical screening has been suggested as a protocol to protect surgical staff from these pathogens. The authors sought to determine the incidence of HCV and HIV infection in elective craniotomy patients and analyze the cost-effectiveness of universal and risk factor-specific screening for protection of the surgical staff. All patients undergoing elective craniotomy between July 2009 and July 2016 at the National Brain Aneurysm Center who did not refuse screening were included in this study. The authors utilized rapid HCV and HIV tests to screen patients prior to elective surgery, and for each patient who tested positive using the rapid HCV or HIV test, qualitative nucleic acid testing was used to confirm active viral load, and risk factor information was collected. Patients scheduled for nonurgent surgery who were found to be HCV positive were referred to a hepatologist for preoperative treatment. The authors compared risk factors between patients who tested positive on rapid tests, patients with active viral loads, and a random sample of patients who tested negative. The authors also tracked the clinical and material costs of HCV and HIV rapid test screening per patient for cost-effectiveness analysis and calculated the cost per positive result of screening all patients and of screening based on all patient risk factors that differed significantly between patients with and those without positive HCV test results. The study population of patients scheduled for elective craniotomy included 1461 patients, of whom 22 (1.5%) refused the screening. Of the 1439 patients screened, 15 (1.0%) tested positive for HCV using rapid HCV screening; 9 (60%) of these patients had active viral loads. No patient (0%) tested positive for HIV. Seven (77.8%) of the 9 patients with active viral loads underwent treatment with a hepatologist and were referred back for surgery 3-6 months after sustained virologic response to treatment, but the remaining 2 patients (22.2%) required urgent surgery. Of the 9 patients with active viral loads, 1 patient (11%) had a history of both intravenous drug abuse and tattoos. Two of the 9 patients (22%) had tattoos, and 3 (33%) were born within the age-screening bracket (born 1945-1965) recommended by the Centers for Disease Control and Prevention. Rates of smoking differed significantly (p < 0.001) between patients who had active viral loads of HCV and patients who were HCV negative, and rates of smoking (p < 0.001) and IV drug abuse (p < 0.01) differed significantly between patients who were HCV rapid-test positive and those who were HCV negative. Total screening costs (95% CI) per positive result were $3,877.33 ($2,348.05-$11,119.28) for all patients undergoing HCV rapid screening, $226.29 ($93.54-$312.68) for patients with a history of smoking, and $72.00 ($29.15-$619.39) for patients with a history of IV drug abuse. The rate of undiagnosed HCV infection in this patient population was commensurate with national levels. While the cost of universal screening was considerable, screening patients based on a history of smoking or IV drug abuse would likely reduce costs per positive result greatly and potentially provide cost-effective identification and treatment of HCV patients and surgical staff protection. HIV screening found no infected patients and was not cost-effective.

Comparative evaluation of three rapid immunochromatographic test assays with chemiluminescent microparticle immunoassay for the detection of hepatitis C virus antibody.

Rapid diagnostic tests (RDTs) can serve as good alternatives to standard serological assays for hepatitis C virus (HCV) detection in limited resource settings. Aim of this study was to evaluate performance of three Indian manufactured RDTs with chemiluminescent microparticle immunoassay (CLIA) for screening of HCV infection with further evaluation using HCV RNA. Serum samples tested for anti-HCV by CLIA (Architect i1000SR, Abbott Diagnostics, IL, USA) were retrieved from -80°C and retested for anti-HCV by three RDTs: Alere Trueline (SD Bioline; Haryana, India) (RDT 1), Benesphera HCV Rapid card test (Avantor Performance Materials India Limited; Uttarakhand, India) (RDT 2), AccuTest HCV (Accurex Biomedical Pvt. Ltd.; Mumbai, India) (RDT 3). HCV RNA results were obtained from hospital information system and anti-HCV reactive but RNA negative cases without treatment were considered as either 'false positives' or 'spontaneous clearance of HCV RNA'. Among 86 samples, 75 (87.2%), 49 (57%), 58 (67.4%) and 51 (59.3%) were reactive by CLIA, RDT1, RDT2 and RDT3, respectively. Taking CLIA as reference standard, RDT 1, 2 and 3 demonstrated sensitivity of 65.30%, 77.33% and 68% respectively. Specificity of all three RDTs was 100% with sensitivity of 97.6-100% above signal/cut-off ratio (S/Co) of 6 by CLIA and 88-100% in all HCV RNA positive cases. Sensitivity of RDTs increased from 65.30-77.33 to 72-82.4% when RNA negative/anti-HCV reactive results were considered as non-reactive. The three RDTs have acceptable sensitivity and specificity in anti-HCV detection especially in RNA positive patients that would require treatment for HCV.

Diagnosis and treatment of hepatitis C virus infection: a tool for engagement with people who inject drugs in Vancouver's Downtown Eastside.

Vancouver's Downtown Eastside (DTES) faces the interrelated challenges of poverty, homelessness, mental health, addiction, and medical issues such as hepatitis C virus (HCV). This study evaluates a new model of engagement with people who inject drugs (PWID) in the DTES. Our centre has developed the community pop-up clinic (CPC) to engage vulnerable populations such as PWID. Rapid HCV testing is offered using the OraQuick saliva assay. If a test is positive, immediate medical consultation and an incentivized clinic appointment are offered. At this appointment, an HCV treatment plan is developed, along with a plan for engagement in multidisciplinary care. In 12 months, 1,283 OraQuick tests were performed at 44 CPCs; 21% of individuals were found to be positive for HCV (68% of whom were PWID). Of individuals positive for HCV antibodies who consulted with the on-site doctor, 50% engaged in care in our clinic-61% of whom have initiated interferon-free directly acting antiviral (DAA) HCV therapy with 100% cured of HCV (per protocol). Individuals who did not engage in care were significantly more likely to be homeless (P < .0001). CPCs paired with a multidisciplinary model of care address the needs of vulnerable populations such as PWID, particularly in the management of HCV with interferon-free DAA therapies.

Performance of the OraQuick Hepatitis C virus antibody test in oral fluid and fingerstick blood before and after treatment-induced viral clearance

BackgroundA reliable population screening strategy for hepatitis C virus (HCV) infection may be based in easy-to-use point-of-care (POC) tests for HCV antibodies, but validation data is needed before their potential widespread use in primary care or outreach practice. Besides, the sensitivity of these POC tests in patients with spontaneous or treatment-induced viral clearance is unknown. ObjectivesTo test the performance of a non-invasive POC anti-HCV test (OraQuick HCV rapid test) in oral mucosal transudate (OMT) and fingerstick blood from patients with known anti-HCV serostatus and with or without active viremia (after treatment-induced clearance). Study designA risk factor questionnaire was collected from 317 consecutive patients (anti-HCV positive/HCV-RNA positive n = 107; anti-HCV positive/HCV-RNA negative after antiviral treatment n = 107; anti-HCV negative with other liver diseases n = 109) before performing the OraQuick HCV rapid test in OMT (n = 317) and fingerstick blood (n = 251). We calculated the sensitivity and specificity of the test by using anti-HCV serostatus as the reference gold-standard. ResultsAmong all anti-HCV seropositive patients, the clinical sensitivity and specificity of the OraQuick HCV rapid test in OMT was 89.9% and 100%, respectively. In fingerstick blood, the sensitivity improved to 98.8%. The sensitivity was higher in OMT (97.2%) in anti-HCV seropositive patients who were viremic as compared to that in non-viremic individuals (82.2%). In contrast, there were no significant differences in sensitivity between viremic and non-viremic individuals when testing fingerstick blood. Finally, extension of the read time to 40 min enhanced the sensitivity, especially in OMT (up to 94.7%) and in the subgroup of non-viremic, anti-HCV-positive patients (up to 90.1%). ConclusionsThe OraQuick HCV rapid test in OMT has a high sensitivity and specificity for detecting active HCV infection that decreases substantially in anti-HCV positive/HCV-RNA negative patients with treatment-induced viral clearance. For these individuals, extension of read times and testing fingerstick blood showed improved sensitivity.

Management of hepatitis C in decentralised versus centralised drug substitution programmes and minimally invasive point-of-care tests to close gaps in the HCV cascade.

In Switzerland, intravenous drug use accounts for the majority of hepatitis C virus (HCV) infections. Early HCV treatment prevents further transmissions and reduces morbidity and mortality due to decompensated liver cirrhosis and hepatocellular carcinoma. Nevertheless, patients in drug substitution programmes are often insufficiently screened and treated. The aim was to compare the current state of HCV management in centralised and decentralised drug substitution programmes of the canton Aargau. Objectives were human immunodeficiency virus (HIV) and HCV prevalence, compliance with guidelines and gaps in the HCV cascade, as well as feasibility/acceptance/validity of HIV/HCV rapid tests on finger-prick blood and noninvasive liver fibrosis assessment with Fibroscan®. For the cross-sectional study, in June 2013, questionnaires and free rapid tests for HIV (Determine®) and HCV (OraQuick®) that used capillary blood (finger-stick) were sent to 161 physicians providing drug substitution treatment for 631 patients. Free liver fibrosis assessment with Fibroscan® by a member of the study team was offered to all patients. Additionally, patients were directly recruited by the study team in the heroin substitution programme and several addiction clinics visited every 4-6 months, as well as in the Infectious Diseases Outpatient Clinic (questionnaire, rapid tests and Fibroscan® in the same session). Between July 2013 and July 2015, 205 (32.5%) of the 631 patients receiving opioid substitution in the canton Aargau were enrolled, 192 (93.7%) with HIV/HCV rapid tests and 167 (81.5%) with Fibroscan®. Acceptance of Fibroscan® was higher when offered in the same session (94.1 vs 69.2%). Overall, 77.8% had ever used intravenous drugs. HCV seroprevalence was 53.7% (109/203), HCV RNA prevalence 27.8%. Overall, 7.4% (15/202) were HIV infected, all of whom were HCV co-infected and under antiretroviral treatment. Of the 205 patients included, 104 (50.7%) were recruited in a decentralised setting (family practice / pharmacy) and 101 (49.3%) in a centralised setting (heroin programme, addiction clinic, Infectious Diseases Outpatient Clinic). Compliance with guidelines (regular HIV/HCV screening, workup of HCV-positive patients, availability of HAV/HBV serology) was consistently lower in the decentralised setting, characterised by a higher proportion of females, longer median time in the programme, lower percentage of daily attendance, ever-use of intravenous drugs and HIV and HCV infections. We identified several gaps in the HCV cascade: 23.9% (49/205) had never been HCV screened; 18.9% (18/95) of the HCV positive patients had no HCV RNA test. Of the 61 patients developing chronic HCV infection, 19.7% (12) were not HCV genotyped, 52.5% (32) had no liver fibrosis assessment (liver biopsy) and 54.1% (33) never received treatment; 25.0% (7/28) did not achieve a sustained virological response with interferon-based treatment. The 192 HCV rapid tests showed a sensitivity of 90.4% (94/104; 95% confidence interval 84.7-96.1%) and a specificity of 100% (88/88), and provided 14 new HCV diagnoses. Eight of ten patients with a false-negative HCV rapid test were HCV RNA negative (2 unknown). Among the 88.6% (39/44) currently HCV RNA-positive individuals with valid Fibroscan® results, 24 (61.5%) had a liver stiffness <7.5 kPa. Both HIV co-infection and alcohol overconsumption doubled the risk of severe fibrosis/cirrhosis in HCV positive patients. In contrast to HIV, HCV transmission among intravenous drug users is still ongoing. The management of hepatitis C in drug substitution patients needs improvement, especially in family practices. Minimally invasive "point-of-care" diagnostics such as the HCV antibody rapid test using capillary blood and mobile Fibroscan® can close some of the gaps in the HCV cascade. HCV RNA determination in capillary blood is still an unmet need. A "one-stop strategy" might improve linkage to care. Restricting the new, highly efficient (90-100% sustained virological response for all genotypes) direct-acting antivirals to patients with at least stage F2 fibrosis withholds treatment from two thirds of the chronically infected and prevents us from reaching the WHO goal of 80% treatment uptake necessary to eliminate hepatitis C by 2030.

Frequency and factors associated with hepatitis C virus infection among patients with diabetes, Dammam, KSA.

Hepatitis C virus (HCV) infection and diabetes mellitus (DM) are main causes of morbidity and mortality worldwide. There is an increasing evidence of association between HCV and type 2 DM. Comorbidity will cause devastating health and financial burdens. Early detection may help proper management and better prognosis. The aim of this study was to examine the frequency and risk factors of HCV among Saudi patients with diabetes. In this cross-sectional study, 1054 Saudi patients with diabetes type 1 and type 2 were randomly selected, interviewed, and tested for HCV in Dammam Medical Complex, KSA (2011), using the HCV Rapid Test. Positive cases were later confirmed using the INNO-LIA HCV score line immunoassay. Seropositivity of HCV was 1.9%. Regression analysis revealed the following independent predictors: sharing articles, elevated liver enzymes, exposure to blood or blood products in occupational setting, disease duration more than 5 years, tattooing, blood transfusion, and hospitalization more than two times. The study confirmed a positive association between HCV and DM. The frequency of HCV among patients with diabetes was 1.9%. Predictors of HCV among DM patients were sharing articles, elevated transaminases, occupational exposure to blood or its products, disease duration more than 5 years, tattooing, blood transfusion, and hospitalization more than two times. We recommend screening for HCV among DM patients with elevated serum transaminases and those having the disease for more than 5 years and education of patients with diabetes as regards their high risk for HCV and how to avoid infection.

A Pilot Study of Rapid Hepatitis C Testing in Probation and Parole Populations in Rhode Island.

Hepatitis C virus (HCV) affects between five and seven million individuals in the United States and chronic infection can lead to liver disease, cirrhosis, and hepatocellular carcinoma. Probation/parole offices are a novel setting for rapid HCV testing, providing outreach to populations at increased risk for HCV infection and/or transmitting HCV to others. While some correctional facilities offer HCV testing, many individuals who present to probation/parole offices are never or briefly incarcerated and may not access medical services. We conducted a rapid HCV testing pilot at probation/parole offices in Rhode Island. Overall, 130 people accepted rapid HCV testing, of whom 12 had reactive tests. Only four of these individuals presented to a community-based clinic for confirmatory testing, despite being offered a monetary incentive. Identifying and addressing barriers to HCV confirmatory testing and follow-up care is critical to increasing the uptake of HCV care and treatment in this vulnerable population.

Acceptability of Rapid Point-of-Care Hepatitis C Tests Among People Who Inject Drugs and Utilize Syringe-Exchange Programs.

People who inject drugs may benefit from point-of-care hepatitis C virus (HCV) testing offered at syringe exchanges. We sought to understand whether this population would be willing to undergo rapid HCV testing. We found that there was broad support for rapid HCV testing, especially among younger people who inject drugs with high perceived risk.

On-site bundled rapid HIV/HCV testing in substance use disorder treatment programs: study protocol for a hybrid design randomized controlled trial.

BackgroundMore than 1.2 million people in the United States are living with human immunodeficiency virus (HIV), and 3.2 million are living with hepatitis C virus (HCV). An estimated 25 % of persons living with HIV also have HCV. It is therefore of great public health importance to ensure the prompt diagnosis of both HIV and HCV in populations that have the highest prevalence of both infections, including individuals with substance use disorders (SUD).Methods/designIn this theory-driven, efficacy-effectiveness-implementation hybrid study, we will develop and test an on-site bundled rapid HIV/HCV testing intervention for SUD treatment programs. Its aim is to increase the receipt of HIV and HCV test results among SUD treatment patients. Using a rigorous process involving patients, providers, and program managers, we will incorporate rapid HCV testing into evidence-based HIV testing and linkage to care interventions. We will then test, in a randomized controlled trial, the extent to which this bundled rapid HIV/HCV testing approach increases receipt of HIV and HCV test results. Lastly, we will conduct formative research to understand the barriers to, and facilitators of, the adoption, implementation, and sustainability of the bundled rapid testing strategy in SUD treatment programs.DiscussionNovel approaches that effectively integrate on-site rapid HIV and rapid HCV testing are needed to address both the HIV and HCV epidemics. If feasible and efficacious, bundled rapid HIV/HCV testing may offer a scalable, potentially cost-effective approach to testing high-risk populations, such as patients of SUD treatment programs. It may ultimately lead to improved linkage to care and progress through the HIV and HCV care and treatment cascades.Trial registrationClinicalTrials.gov: NCT02355080. (30 January 2015)

A pilot study of rapid hepatitis C virus testing in the Rhode Island Department of Corrections.

The correctional population bears a heavy burden of hepatitis C virus (HCV) infection necessitating expansion of HCV testing and treatment opportunities. Rapid HCV testing provides point-of-care antibody results and may be ideal for correctional facilities, particularly jails, where persons are often incarcerated for short periods of time, yet feasibility has not been established. We conducted a pilot study of a rapid HCV testing algorithm among short-term inmates with unknown HCV status. Participants completed a questionnaire, viewed an informational video and underwent rapid HCV testing and confirmatory testing, when indicated. Persons with chronic infection were referred to community care after release. Baseline characteristics, risk behaviors, test results and linkage were examined by descriptive analyses. Two hundred and fifty-two inmates were enrolled and 249 completed all study activities. Twenty-five participants (10%) had reactive rapid tests and 23 (92%) completed confirmatory testing. 15/23 (65%) had detectable HCV RNA, but only 4 linked to care after release. Persons with reactive HCV tests were more likely to be White (P = 0.01) and to have ever injected (P < 0.0001) and/or recently injected (P < 0.0001) drugs. Rapid HCV testing within jails is feasible, identifies previously unrecognized cases of HCV infection, and implementation should be considered. Low rates of linkage to care after release remain a barrier to care.

Cost-effectiveness of rapid hepatitis C virus (HCV) testing and simultaneous rapid HCV and HIV testing in substance abuse treatment programs.

To evaluate the cost-effectiveness of rapid hepatitis C virus (HCV) and simultaneous HCV/HIV antibody testing in substance abuse treatment programs. We used a decision analytic model to compare the cost-effectiveness of no HCV testing referral or offer, off-site HCV testing referral, on-site rapid HCV testing offer and on-site rapid HCV and HIV testing offer. Base case inputs included 11% undetected chronic HCV, 0.4% undetected HIV, 35% HCV co-infection among HIV-infected, 53% linked to HCV care after testing antibody-positive and 67% linked to HIV care. Disease outcomes were estimated from established computer simulation models of HCV [Hepatitis C Cost-Effectiveness (HEP-CE)] and HIV [Cost-Effectiveness of Preventing AIDS Complications (CEPAC)]. Data on test acceptance and costs were from a national randomized trial of HIV testing strategies conducted at 12 substance abuse treatment programs in the United States. Lifetime costs (2011 US$) and quality-adjusted life years (QALYs) discounted at 3% annually; incremental cost-effectiveness ratios (ICERs). On-site rapid HCV testing had an ICER of $18,300/QALY compared with no testing, and was more efficient than (dominated) off-site HCV testing referral. On-site rapid HCV and HIV testing had an ICER of $64,500/QALY compared with on-site rapid HCV testing alone. In one- and two-way sensitivity analyses, the ICER of on-site rapid HCV and HIV testing remained <$100,000/QALY, except when undetected HIV prevalence was <0.1% or when we assumed frequent HIV testing elsewhere. The ICER remained <$100,000/QALY in 91% of probabilistic sensitivity analyses. On-site rapid hepatitis C virus and HIV testing in substance abuse treatment programs is cost-effective at a <$100,000/quality-adjusted life year threshold.

Strategies for hepatitis C testing and linkage to care for vulnerable populations: point-of-care and standard HCV testing in a mobile medical clinic.

Despite new Hepatitis C virus (HCV) therapeutic advances, challenges remain for HCV testing and linking patients to care. A point-of-care (POC) HCV antibody testing strategy was compared to traditional serological testing to determine patient preferences for type of testing and linkage to treatment in an innovative mobile medical clinic (MMC). From 2012 to 2013, all 1,345 MMC clients in New Haven, CT underwent a routine health assessment, including for HCV. Based on patient preferences, clients could select between standard phlebotomy or POC HCV testing, with results available in approximately 1 week versus 20 min, respectively. Outcomes included: (1) accepting HCV testing; (2) preference for rapid POC HCV testing; and (3) linkage to HCV care. All clients with reactive test results were referred to a HCV specialty clinic. Among the 438 (32.6 %) clients accepting HCV testing, HCV prevalence was 6.2 % (N = 27), and 209 (47.7 %) preferred POC testing. Significant correlates of accepting HCV testing was lower for the "baby boomer" generation (AOR 0.67; 95 % CI 0.46-0.97) and white race (AOR 0.55; 95 % CI 0.36-0.78) and higher for having had a prior STI diagnosis (AOR 5.03; 95 % CI 1.76-14.26), prior injection drug use (AOR 2.21; 95 % CI 1.12-4.46), and being US-born (AOR 1.76; 95 % CI 1.25-2.46). Those diagnosed with HCV and preferring POC testing (N = 16) were significantly more likely than those choosing standard testing (N = 11) to be linked to HCV care within 30 days (93.8 vs. 18.2 %; p < 0.0001). HCV testing is feasible in MMCs. While patients equally preferred POC and standard HCV testing strategies, HCV-infected patients choosing POC testing were significantly more likely to be linked to HCV treatment. Important differences in risk and background were associated with type of HCV testing strategy selected. HCV testing strategies should be balanced based on costs, convenience, and ability to link to HCV treatment.

Diagnostic accuracy evaluation of the ImmunoFlow HCV rapid immunochromatographic test for the detection of hepatitis C antibodies

2% of the world's population lives with a hepatitis C virus (HCV) infection with highest rates in developing countries. The most common mode of transmission takes place via unsafe blood transfusions and unsafe therapeutic injections.Thus, screening potential blood donors for hepatitis C infection is a must to ensure safe blood transfusions. Rapid immunochromatographic tests are the best suitable test format to be used for screening for blood donors in resource-limited settings.The ImmunoFlow HCV from Core Diagnostics was evaluated at the Paul-Ehrlich-Institute, Germany for its test accuracy on three seropanels. Panel 1 consisted of 26 HCV positive and 55 negative samples, panel 2 of 193 HCV positive samples. Panel 3 contained 116 samples of 10 patients during seroconversion period. 39 of these 116 samples were characterized as HCV positive.The HCV ImmunoFlow had a sensitivity of 100% (95% CI: 93.5–100) and a specificity of 100% (95% CI: 86.8–100) when samples of panel 1 were tested.191 samples of the 193 samples in panel 2 were correctly by the HCV Immunoflow, resulting in a sensitivity of 99.0%.9 of 10 HCV infections were detected by the HCV ImmunoFlow when panel 3 was used.This evaluation revealed good sensitivity of the HCV ImmunoFlow test from and compares favorably with the results from the WHO evaluation and a systematic review conducted of field evaluations of Hepatitis C rapid diagnostic and other point of care tests.