HCV Rapid Test Research Articles

Evaluation of the Sensitivity, Specificity and Accuracy of the HCV Rapid Test Cassette for Detecting HCV Antibodies in Serum or Plasma Specimens

Evaluation of the Sensitivity, Specificity and Accuracy of the HCV Rapid Test Cassette for Detecting HCV Antibodies in Serum or Plasma Specimens

Acceptability and usability of oral fluid HCV self-testing for hepatitis C diagnosis: A systematic review and meta-analysis.

Data on the acceptability and usability of hepatitis C virus self-testing (HCVST) remain scarce. We estimated the pooled rates of acceptability/feasibility and re-reading/re-testing agreement of HCVST using oral fluid tests (PROSPERO-CRD42022349874). We searched online databases for studies that evaluated acceptability, usability and inter-reader/operator variability for HCVST using oral fluid tests. Pooled estimates of feasibility, agreement and post-testing perspectives were analysed. Sensitivity analyses were performed in men who have sex with men (MSM) and people who inject drugs (PWID). Heterogeneity was assessed using the I2 statistics. A total of six studies comprising 870 participants were identified: USA (n = 95 with liver disease), Kenya (n = 150 PWID), Egypt (n = 116 from the general population), Vietnam (n = 104 MSM and n = 105 PWID), China (n = 100 MSM) and Georgia (n = 100 MSM and n = 100 PWID)]. All studies used OraQuick® HCV Rapid Antibody Test. The pooled overall estimates for correct sample collection and for people who performed HCVST without needing assistance in any step (95% confidence interval [CI]) were 87.2% [76.0-95.3] (n = 755; I2 = 93.7%) and 62.6% [37.2-84.8] (n = 755; I2 = 98.0%), respectively. The pooled estimate of agreement for re-reading was 95.0% [95% CI 91.5-97.6] (n = 831; I2 = 74.0%) and for re-testing was 94.4% [90.3-97.5] (n = 726; I2 = 77.1%). The pooled estimate of those who would recommend HCVST was 94.4% [84.7-99.6] (n = 625; I2 = 93.7%). Pooled estimates (95% CI) of correct sample collection (72.8% [63.3-81.5] vs. 90.8% [85.9-94.8]) and performance of HCVST without needing assistance (44.1% [14.1-76.7] vs. 78.1% [53.4-95.3]) was lower in PWID compared to MSM. In summary, HCV testing with oral fluid HCVST was feasible and well-accepted. Oral fluid HCVST should be considered in key populations for uptake HCV testing.

Hepatitis C screening and detection program in a large population: Epidemiological transition and characterization of the disease.

Chronic hepatitis C (CHC) is considered an important public health challenge. Traditionally identified risk factors have undergone an epidemiological transition where other risk factors have become the main cause of new infections. To describe risk factors associated to hepatitis C positivity through the evaluation of the epidemiological profile in hepatitis-C high-risk populations. Cross-sectional study was conducted as part of an HCV screening program in Mexican population. All participants answered an HCV risk-factor questionnaire and took a rapid test (RT). All patients reactive to the test were subject to HCV PCR (polymerase chain reaction) confirmation. A logistic regression model was used to examine associations between HCV infection and risk factors. The study included 297 631 participants that completed a risk factor questionnaire and underwent an HCV rapid test (RT). In total, 12 840 (4.5%) were reactive to RT and 9257 (3.2% of participants) were confirmed as positives by PCR test. Of these, 72.9% had at least one risk factor and 10.8% were in prison. Most common risk factors were history of acupuncture/tattooing/piercing (21%), intravenous drug use (15%) and high-risk sexual practices (12%). Logistic regressions found that having at least one risk factor increased the probability of having an HCV-positive result by 20% (OR = 1.20, 95% CI: 1.15-1.26), compared to the population without risk factors. We identified 3.2% of HCV-viremic subjects, all associated with risk factors and older age. Screening and diagnosis of HCV in high-risk populations (including underserved populations) should be more efficient.

HCV Self-Testing to Expand Testing: A Pilot Among Men Who Have Sex With Men in China.

BackgroundHepatitis C virus self-testing (HCVST) may increase test uptake especially among marginalized key populations such as men who have sex with men (MSM). We conducted an observational study to assess the usability, acceptability and feasibility of HCVST among MSM in China.MethodsAn observational study with convenience sampling was performed among MSM in Guangzhou, China in 2019. The OraQuick® HCV Rapid Antibody Test kits were used in this study. Participants performed all 12 HCVST steps and interpreted the results in the presence of a trained observer. Usability was defined as the number and percentage of participants who completed all testing steps correctly without assistance and interpreted the results correctly. Inter-reader concordance was calculated as the percentage agreement between the results interpreted by the participant and those interpreted by a trained staff member. The same process was used to estimate inter-operator agreement between the self-testing and professional use test results. Acceptability was assessed using an interviewer-administered semi-structured questionnaire.ResultsAmong 100 participants with median age 27 (interquartile range 23–30) years, 4% reported prior history of HCV testing, 41% reported using blood-based HIV self-testing in the past, 54% (95%CI: 43.7–64.0%) completed all self-testing steps correctly without assistance and interpreted the results correctly. Both the inter-reader and inter-operator concordance were excellent at 97% (95%CI: 91.5–99.4%) and 98% (95%CI: 93.0–99.8%), respectively. The majority rated the HCVST process as very easy (52%, 95%CI: 41.8–62.1%) or easy (41%, 95%CI: 31.3–51.3%), 76% (95%CI: 66.4–84.0%) were willing to use HCVST again, and 75% (95%CI: 65.3–83.1%) would recommend it to their family and friends.ConclusionsOur findings demonstrate that oral fluid HCVST has high usability and acceptability among Chinese MSM. More implementation research is needed to plan how best to position and scale-up HCVST alongside other facility-and community-based testing approaches and ensure data linkage into health systems.

Results of a Hepatitis C Micro-Elimination Program in Two Addiction Centers Among Subjects With Substance Use Disorder.

Objectives:We aimed to evaluate a hepatitis C (HCV) micro-elimination program in 2 addiction centers among subjects with substance use disorders (SUD).Methods:The program was based on simplifying the diagnosis of HCV infections by avoiding referral to primary care for the diagnosis and performing the necessary tests at the point of care (ie, the addition center) and simplifying the patient pathway by directly referring patients to the specialized care for treatment. Descriptive and multivariate analyses are presented.Results:Of the 1497 subjects included in the program, 327 reported that they were anti-HCV-positive. Among the 1170 patients who were offered the HCV rapid antibody test, 180 (15.4%) did not perform the test. Performing the HCV rapid antibody test only contributed ten patients (3%) to the 337 who were anti-HCV-positive. A high proportion (147 out of 327 [45%]) of subjects who reported being anti-HCV-positive also reported that they had not been treated for HCV. Among the 67 subjects who were HCV-RNA-positive and were referred for treatment, 53 (79%) ultimately received and completed antiviral treatment. Unfortunately, we did not find any factors associated with not performing dry blood testing, and the factors associated with not performing the HCV rapid antibody test were difficult to interpret, and the model showed low goodness of fit.Conclusions:Our results suggest that a micro-elimination program focused on patients with SUD attending an addiction center is not effective for screening the presence of hepatitis C but is successful for linking patients with hepatitis C to antiviral treatment.

Performance of rapid diagnostic tests for HCVinfection in serum or plasma.

Aim: HCV diagnosis will become the bottleneck in eliminating hepatitis C. Simple, accurateand cost-effective testing strategies are urgently needed to improve hepatitis C screening and diagnosis. Materials & methods: Performance of sevenrapid diagnostic tests (RDT) have been assessed in a large series (n = 498) of serum or plasma specimenscollected in France and in Cameroon. Results: Specificity varied from 96.1to 100%. The clinical sensitivity, compared with immunoassays as the reference, was high for all seven RDT (97.2-100%). The Multisure HCV antibody assay and OraQuick HCV rapid antibody test reached sensitivity ≥99%. Conclusion: A number of RDTmay be suitable for WHO prequalification and may be implemented in the framework of large-scale low-cost treatment programs to achieve the WHO viral hepatitis objectives by 2030.

Impact of routine opt-out HIV/HCV screening on testing uptake at a syringe services program: An interrupted time series analysis

BackgroundHepatitis C (HCV) is the most common infectious disease among people who inject drugs (PWID). Engaging PWID in harm reduction services, such as syringe service programs (SSPs), is critical to reduce HCV and HIV transmission. Additionally, testing for HIV and HCV among PWID is important to improve diagnosis and linkage to care. On March 1, 2018, Florida's only legal SSP implemented bundled opt-out HIV/HCV testing at enrollment. We aimed to examine the differences in HIV/HCV testing uptake before and after the implementation of the opt-out testing policy. MethodsMultivariable logistic regression was used to assess predictors of accepting HIV/HCV tests, controlling for opt-in and opt-out policy. Monthly estimates of the percent of participants accepting an HIV test, HCV test, or both were generated. Interrupted Time Series (ITS) analysis evaluated the immediate policy impact on level of uptake and trend in uptake over time for bundled HIV/HCV testing before and after the opt-out testing policy. ResultsThe total study period was 37 months between December 2016–January 2020 with 512 SSP participants 15 months prior and 547 SSP participants 22 months after implementation of bundled HIV/HCV opt-out testing. Significant predictors of accepting both HIV/HCV tests were cocaine injection (aOR = 2.36), self-reported HIV positive status (aOR = 0.39) and self-reported HCV positive status (aOR = 0.27). Based on the ITS results, there was a significant increase in uptake of HIV/HCV testing by 42.4% (95% CI: 26.2%–58.5%, p < 0.001) immediately after the policy change to opt-out testing. ConclusionBundled opt-out HIV/HCV testing substantially increased the percentage of SSP clients who received HIV and HCV rapid tests at enrollment into the program, and the effect remained stable across the 22 months post opt-out testing policy. Future investigation must assess PWID-level perspective of testing preferences and examine whether this testing approach improves HIV/HCV detection among PWID previously unaware of their status.

Challenges in adopting in-vitro diagnostic tests in the national health insurance coverage: Korean experience of HCV rapid antibody test

체외진단의료기기는 시장규모가 급속하게 ì„±ìž¥í•˜ê³ ìžˆìœ¼ë©°, 기기의 가격이 ë†’ì•„ì§€ê³ , 이를 이용한 검사에 대한 건강보험 ì ìš© 요구가 ì¦ê°€í•˜ê³ ìžˆë‹¤. 본 연구에서는 한국에서의 HCV 항체간이검사의 의료현장 ë„ìž ë¶€í„° 건강보험 급여 ì ìš©ê¹Œì§€ì˜ ê³¼ì •ê³¼ 국내외 검사 시행현황을 ì‚´íŽ´ë³´ê³ , 이에 기반하여 체외진단기기의 건강보험 ë„ìž ì‹œ ê³ ë ¤í•´ì•¼ í• ì‚¬í•­ë“¤ì„ 도출하였다.이를 위해 ê´€ë ¨ ë²•ë ¹ 및 ê·œì •, ë³´ê³ ì„œì™€ 외국의 ê´€ë ¨ 기관 홈페이지 게재 자료 등을 ê³ ì°°í•˜ì˜€ìœ¼ë©°, 건강보험심사평가원에 공개된 2016ë „ë¶€í„° 2018ë „ê¹Œì§€ì˜ 비급여 진료비용 자료를 분석하였다.오라퀵 체외진단키트를 이용한 HCV 항체 간이검사는 2012ë „ 7월 의료인의 감염예방 등 ì‚¬ìš©ëª©ì ì´ ì œí•œì ì´ê³ ë¹„ìš©íš¨ê³¼ì„±ì´ 낮은 ì  등의 ì´ìœ ë¡œ 건강보험 비급여 행위로 분류되어 시행되었다. 이후 ê±´ê°•ë³´í—˜ë³´ìž¥ì„±í™•ëŒ€ì •ì± ì— 따라 2019ë „ 7월 24일 건강보험 의료행위 급여목록으로 등재되었다. 비급여 진료 시 비용은 약 4만 5천원이었으며, 비급여 진료비용 ì‹ ê³ ê¸°ê´€ ì „ì²´ì˜ 73~75%가 병원급 의료기관으로 조사되었다. HCV항체 간이검사의 수가는 2019ë „ë„ ì„ ë³„ê¸‰ì—¬ 등재 시 약 2만 2천원으로 등재되었으며, 이는 기존 급여등재 ìœ ì‚¬ê¸°ìˆ ìˆ˜ê°€ì˜ 약 6배에 해당된다. 미국, 일본, 대만, 호주, 프랑스, 캐나다의 급여등재여부를 조사한 ê²°ê³¼ 미국에서만 의료보장 급여를 í•˜ê³ ìžˆì—ˆìœ¼ë©°, 1945ë „~1965ë „ 출생 성인을 대상으로 1회만 ì¸ì •í•˜ì˜€ë‹¤.HCV 항체 간이검사의 급여 ì „í™˜ 사례를 통해 향후 체외진단검사에 대한 건강보험 급여 ì ìš©ì„ 위한 ê³¼ì œë¡œ ì‹ ì˜ë£Œê¸°ìˆ ê±´ê°•ë³´í—˜ ê¸‰ì—¬ì ì •ì„± 평가 기준에 대한 ìž¬ê²€í† , ì ì ˆí•œ ê°€ê²©ì‚°ì •ì²´ê³„ 모색 및 건강보험 ìž¬ì •ì— 미치는 영향을 ê³ ë ¤í• í•„ìš”ì„±ì„ ì œì‹œí• ìˆ˜ 있다. 또한 건강보험 ìž¬ì • ê±´ì „ì„± 확보와 ì‚°ì— í™œì„±í™”ë¼ëŠ” 상충하는 ëª©ì ì„ 충족시키기 위해 향후 ì ì ˆí•œ ì œë„ì˜ 모색이 필요하다. Keywords: 건강보험, 급여, 체외진단검사, HCV 항체 간이검사

Evaluation of three commercialized rapid point-of-care tests for detection of anti-hepatitis C virus antibodies in Burkina Faso

This study aimed to evaluate the diagnostic performance of commercially rapid point-of-care (POC) tests used for HCV antibodies detection. This is a case-control study conducted in Ouagadougou between December 2014 and January 2015. Three POC for HCV antibodies detection (SD Bioline HCV test®, Anti-HCV dipstick® and First response® HCV card test) marketed in Burkina Faso were evaluated. Architect anti-HCV assay and ImmunoComb® II HCV were combined and used as a reference test. All three tests were evaluated with a panel of 62 anti-HCV positive sera and 62 anti-HCV negative sera. The tests performance was calculated using the software OpenEpi. The three rapid POC tests had a specificity of 100% (95% CI: 94.17-100). However, the sensitivities were 33.87% (95% CI: 23.34-46.28) for the SD Bioline HCV test®, 41.94% (95% CI: 30.48-54.33%) for Anti-HCV dipstick® and 45.16% (95%CI: 33.42-57.47%) for First response® HCV card test. The tests evaluated in this study had good specificity but poor sensitivity for the HCV antibodies detection in Burkina Faso. The surveillance of HCV rapid POC tests through the validation of their accuracy in the local context before their approval must be strengthened. Key words: Hepatitis C virus, point-of-care, diagnostic test.

300. Drug Use Characteristics and Hepatitis C Antibody Prevalence in Southern Illinois

BackgroundHepatitis C virus (HCV) infection rates have increased among younger, rural persons nationally. We report on a preliminary sample of a study examining HCV acquisition risk factors among rural persons who inject drugs (PWID) or person who use opioids (PWUO) non-medically.MethodsWe used respondent-driven sampling (RDS) to recruit PWID/PWUO in southern, rural Illinois as part of a larger study on infectious disease rates among social networks of PWID and illicit opioid users. Participants were surveyed regarding drug and sexual risk behavior, healthcare access, stigma, and social networks, and underwent rapid screening for HCV (OraQuickÒ HCV Rapid Antibody Test) and other infections. Using R software, we generated descriptive statistics to characterize HCV prevalence.ResultsBetween July 2018 and April 2019,135 current PWID/PWUO were recruited, screened, and surveyed (58.5% male; 82.2% white; mean age 40.1 years). HCV rapid tests detected antibodies (HCV+) among 53 of 112 screened (47.3%). HCV+ participants were more likely to be white (96.2% vs. 83.1%, P = 0.006) than HCV antibody negative (HCV-) participants and showed a bimodal age distribution with peaks in the 25–30 and 45–50 age ranges. Reported injection drug use and heroin use in the past 30 days was significantly more common among HCV+ participants (96.2% vs. 72.9%, P = 0.001, and 12.9 vs. 7.9 days, P = 0.024) While HCV+ participants less frequently used methamphetamine compared with HCV -participants, the use of that drug was still high in both groups (11.9 vs. 18.4 days of use in the past 30 days, P = 0.01). HCV+ participants reported fewer social network members than HCV- participants (2.2 vs. 3.0, P = 0.048).ConclusionIn this analysis of a preliminary sample, HCV exposure was high; with those positive for HCV antibody showing a bimodal age distribution, high frequency of multiple drug use, and smaller social network size compared with HCV negative counterparts. Upon RDS-based enrollment completion and pending analysis we will further examine HIV RNA status as well as the specific associations between network size and other risk factors that may inform disease screening and treatment interventions.Disclosures All authors: No reported disclosures.

Clinical evaluation of a hepatitis C antibody rapid immunoassay on self-collected oral fluid specimens

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.

CV diagnosis and direct-acting antiviral agents -based treatment for HIV/HCV co-infected patients in a primary care setting in Maputo, Mozambique

Background: Direct-acting antiviral agents (DAAs) treatment has been associated with high rates of sustained virological response at week 12 after treatment completion (SVR12) and a good safety profile in HIV + /HCV + individuals in clinical trials. We aimed to assess the HCV diagnosis and DAA-based treatment feasibility in a Minister of Health (MoH) primary care setting in Maputo, Mozambique. Methods & Materials: We included for analysis the active cohort of HIV-positive adults enrolled for HIV care between March 2015-July 2017 in MSF supported MoH HIV clinic in a primary health centre in Maputo, Mozambique. Results: Among 1486 active patients enrolled between March 2015-July 2017, 1334 (90%) were screened for HCV antibodies (OraQuick HCV Rapid Antibody Test, OraSure Technologies, Bethlehem, USA): 81 (6%) patients tested antibodies positive, among them 83% had viral load (VL) detectable. GNT 1a was detected in 90% of cases, 8% were GNT 4, and 2% were GNT 3. Among patiens with HCV VL detectable, 87% were men, with a mean age of 37 years old, and 90% had a history of injectable drugs abuse. The fibrosis score by Fibroscan® was F0-F1 for 82% of patients, F2-F3 for 10%, F3-F4 for 8%. A total of 21 HIV/HCV patients were initiated on DAAs from December 2016 up to October 2017 and 15 of them completed treatment. All patients were on antiretroviral treatment at HCV treatment initiation, 35% on second line regimen (with Lopinavir/ritonavir). No severe side effects were reported. No defaulters or treatment discontinuation in this cohort. VL follow-up 12 weeks after the end of treatment was done for 4 patients: 3 patients with SVR12 achieved and one failure. Conclusion: This is the first experience of HCV treatment with DAAs in the primary care setting in public health sector in Mozambique. Injectable drugs use appears as main risk factor for HCV infection. A more comprehensive package of care with targeted testing, harm reduction interventions and treatment need to be offered to most at risk population. Inclusion of HCV routine diagnosis followed by access to treatment by new DAAs in primary HIV care setting in Maputo, mozambique, is feasible.

Prevalence of hepatitis C in people who inject drugs in the cities of Rawalpindi and Islamabad, Pakistan

Pakistan has the second highest burden of hepatitis C (HCV) in the world. The major route of HCV transmission is contaminated blood or needle sharing. Seventy percent of people who inject drugs (PWIDs) shared needles at some time in their addiction history. The aim of the present study was to estimate the prevalence of HCV in PWIDs in cities of Pakistan. We enrolled 100 PWIDs from the Rawalpindi and Islamabad cities of Pakistan. Blood samples were taken in collection tubes and were subjected to HCV screening by using three rapid HCV screening kits including one step anti-HCV test, onsite HCV Ab rapid test and advance quality rapid anti-HCV test. All 100 blood samples were also subjected to HCV detection by using Elecsys anti-HCV II performed on the Roche Cobas 601 platform based on the ECLIA principle. Seventy-two percent of PWIDs showed the presence of HCV antibodies using the Roche anti-HCV II ECLIA test. We also compared the performance of different rapid kits in comparison with the anti-HCV II by Roche. The sensitivity of CTK kit was 84.72%, which was almost equal to the sensitivity by the SD Bioline HCV and Advanced Quality Rapid HCV tests, which was 83.33%. All three kits showed 100% specificity and positive predictive values. The results showed that the three market competitors of HCV rapid test showed almost equal results. The prevalence of HCV is very high in PWIDs in the capital twin cities of Pakistan. There is dire need to initiate the administration of a hepatitis test and treatment program for both high-risk and the general HCV-positive population. This is the optimal way to achieve HCV control targets established by the United Nations Sustainable Development Goals and Global Health Sector Strategy by WHO.

Hepatitis C virus infection among patients with diabetes mellitus in Dammam, Saudi Arabia.

BackgroundData regarding comorbidities of hepatitis C virus infection (HCV) in the kingdom of Saudi Arabia (KSA) are lacking. The present study aimed to determine the prevalence and risk factors of HCV among Saudi patients with diabetes mellitus (DM) in Dammam, KSA.MethodsIn this cross-sectional study done in 2011, a total of 1054 Saudi DM patients were randomly selected from the Diabetes Center in Dammam Medical Complex, KSA, for interview and HCV screening using the HCV Rapid Test. Positive cases were later confirmed via INNO-LIA HCV score line immune assay.ResultsSeropositivity of HCV was 1.9 %. DM duration of >5 years increased the probability of HCV risk to 3.7 fold while insulin users were 3.2 times more likely to have HCV infection. Increased hospital admission (3–4 times) also increased HCV risk by 11.5 times and 13.6 times among patients with ≥5 admissions. Similarly, having 3–4 surgical procedures increased HCV risk by 8.6 times and 39.3 times with ≥5 procedures. HCV transmission is 4 times more likely by blood transfusion. Those who shared personal items were 8.5 times more likely to have HCV. Tattooing increased HCV risk by 6.7 times. The likelihood of HCV infection was also higher among DM patients with liver diseases and elevated liver enzymes.ConclusionThe study confirmed a significant association between HCV risk and DM. Frequency of HCV among DM Saudis was 1.9 %. Predictors of HCV among DM patients were sharing personal items, occupational exposure to blood or its products, elevated transaminases, tattooing, disease duration > 5 years, increased hospital admission and blood transfusion.

Implementation of baby boomer hepatitis C screening and linking to care in gastroenterology practices: a multi-center pilot study.

BackgroundEstimates suggest that only 20 % of HCV-infected patients have been identified and <10 % treated. However, baby boomers (1945-1965) are identified as having a higher prevalence of HCV which has led the Centers for Disease Control and Prevention to make screening recommendations. The aim of this study was to implement the CDC’s screening recommendations in the unique setting of gastroenterology practices in patients previously unscreened for HCV.MethodsAfter obtaining patient informed consent, demographics, clinical and health-related quality of life (HRQOL) data were collected. A blood sample was screened for HCV antibody (HCV AB) using the OraQuick HCV Rapid Antibody Test. HCV AB-positive patients were tested for presence of HCV RNA and, if HCV RNA positive, patients underwent treatment discussions.ResultsWe screened 2,000 individuals in 5 gastroenterology centers located close to large metropolitan areas on the East Coast (3 Northeast, 1 Mid-Atlantic and 1 Southeast). Of the screened population, 10 individuals (0.5 %) were HCV AB-positive. HCV RNA testing was performed in 90 % (9/10) of HCV AB-positive individuals. Of those, 44.4 % (4/9) were HCV RNA-positive, and all 4 (100 %) were linked to caregiver. Compared to HCV AB negative subjects, HCV AB-positive individuals tended to be black (20.0 vs. 5.2 %, p = 0.09) and reported significantly higher rates of depression: 60.0 vs. 21.5 %, p = 0.009. These individuals also reported a significantly lower HRQOL citing having more fatigue, poorer concentration, and a decreased level of energy (p < 0.05).DiscussionAlthough the prevalence of HCV AB-positive was low in previously unscreened subjects screened in the gastroenterology centers, the linkage to care was very high. The sample of patients used in this study may be biased, so further studies are needed to assess the effectiveness of the CDC screening recommendations.ConclusionImplementation of the Baby Boomer Screening for HCV requires identifying screening environement with high prevalence of HCV+ individuals as well as an efficient process of linking them to care.

Implementation of rapid HIV and HCV testing within harm reduction programmes for people who inject drugs: a pilot study

ABSTRACTIncluding HCV and HIV rapid tests in harm reduction programmes (HRP) for people who inject drugs (PWID) can increase detection of these infections in high-risk populations who do not seek conventional health care. Aims: To assess acceptability and feasibility of rapid HIV and HCV tests in HRP; to identify HIV and HCV prevalence rates in HRP; to identify the percentage of PWID with a reactive test that attend hospital for confirmation and follow-up. Rapid oral tests for HCV and HIV were offered to users of 13 HRP from both mobile units and facility-based centres. A total of 172 HCV and 198 HIV tests were performed, with a refusal rate of 1.7% and 10.4%, respectively. Injectors made up 64.9% of all drug users and 35.1% did not inject drugs. Overall, 20.3% of HCV tests and 2.5% of HIV test were reactive. Only 24 of the 35 reactive HCV could be confirmed (68.6%) and one was false-negative. Of the five HIV reactive cases, only two could be confirmed (40%) with 1 false-positive case. Acceptability of rapid HIV and HCV tests among HRP users was high. The usefulness of oral rapid tests in HRP has been demonstrated, especially in mobile HRP.

Hepatitis C virus infection in the 1945-1965 birth cohort (baby boomers) in a large urban ED

IntroductionThe US Preventive Services Task Force recommends one-time screening of the 1945-1965 birth cohort (baby boomers) for hepatitis C (HCV) infection. New York State legislation mandates screening of baby boomers for HCV in most patient care settings except the emergency department (ED). This cross-sectional study explores baby boomer knowledge of HCV, prevalence of HCV infection, and linkage to care from a large urban ED. MethodPatients participated in a researcher-administered structured interview and were offered an HCV screening test. If HCV antibody reactive, a follow-up clinic appointment was made within 6 weeks. Reminder telephone calls were made a week before the appointment. Attendance at the follow-up appointment was considered successful linkage to care. ResultsA total of 915 eligible patients were approached between October 21, 2014, and July 13, 2015. A total of 427 patients participated in the structured interview; 383 agreed to an HCV rapid test. Prevalence of HCV antibody reactivity was 7.3%. Four patients were successfully linked to care. General knowledge about HCV was fair. Misconceptions about transmission were apparent. Beliefs that “if someone is infected with HCV they will most likely carry the virus all their lives unless treated” and that “someone with hepatitis can look and feel fine” were significantly associated with agreement to testing. ConclusionsBetter linkage to care is needed to justify HCV screening in the 1945-1965 birth cohort in this particular ED setting. Linkage to care from the ED is challenging but can potentially be improved with specific measures including simplified screening algorithms and supportive resources.

Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage.

Background. In Europe and the United States, more than two thirds of individuals infected with hepatitis B virus (HBV) or hepatitis C virus (HCV) and 15%-30% of human immunodeficiency virus (HIV)-positive individuals are unaware of their infection status. Simultaneous HIV-, HBV-, and HCV-rapid tests could help improve infection awareness and linkage-to-care in particularly vulnerable populations. Methods. The OptiScreen III study was a single-center, randomized, control trial conducted at a free clinic ("Médecins du Monde", Paris, France). Participants were randomized 1:1 to receive 1 of 2 interventions testing for HIV, HBV, and HCV: standard serology-based testing (S-arm) or point-of-care rapid testing (RT-arm). The main study endpoints were the proportion of participants who became aware of their HIV, HBV, and HCV status and who were linked to care when testing positive. Results. A total of 324 individuals, representing mainly African immigrants, were included. In the S-arm, 115 of 162 (71.0%) participants performed a blood draw and 104 of 162 (64.2%) retrieved their test result. In comparison, 159 of 162 (98.2%) of participants randomized to the RT-arm obtained their results (P < .001). Of the 38 (11.7%) participants testing positive (HIV, n = 7; HBV, n = 23; HCV, n = 8), 15 of 18 (83.3%) in the S-arm and 18 of 20 (90.0%) in the RT-arm were linked-to-care (P = .7). In post hoc analysis assuming the same disease prevalence in those without obtaining test results, difference in linkage-to-care was more pronounced (S-arm = 60.0% vs RT-arm = 90.0%; P = .04). Conclusions. In a highly at-risk population for chronic viral infections, the simultaneous use of HIV, HBV, and HCV point-of-care tests clearly improves the "cascade of screening" and quite possibly linkage-to-care.

Implementation of Baby Boomer Hepatitis C (HCV) Screening and Linking to Care in Gastroenterology (GE) Practices: A Multicenter Pilot Study

Introduction: Treatment of HCV has been limited by identification of infected patients and by linking them to care. Some estimates suggest that only 20% of HCV-infected patients have been identified and < 10% have been treated. In addition, baby boomers born between 1945 and 1965 have been identified as having higher prevalence of HCV leading to screening recommendations by the Centers for Disease Control and Prevention (CDC). The aim of this study was to implement the CDC's screening recommendations in GE practices. Methods: This was a multi-center study involving 5 GE practices selected by the American College of Gastroenterology and the Chronic Liver Disease Foundation (CLDF). After obtaining patient informed consent, demographics, clinical and quality of life (QoL) data were collected. A blood sample was screened for HCV antibody (HCV AB) using the OraQuick HCV Rapid Antibody Test. HCV ABpositive patients were tested for presence of HCV RNA and, if HCV RNA-positive, linked to a clinician for treatment discussons. Results: We screened 2,000 subjects in 5 GE centers located close to large metropolitan areas on the East Coast (3 Northeast, 1 Mid-Atlantic and 1 Southeast). Of the screened subjects, 39.8% were male, age 59.7±6.0 years, 72% White, 5% Black, and 20% Hispanic. Thirty percent self-reported a history of anxiety, 22% of depression, and 38% of clinically overt fatigue. Additionally, 15.6% had a history of diabetes, 43.4% of hypertension, 47.8% of hyperlipidemia, 27.5% reported drinking alcohol and 10.2% smoked. Of the screened population, 10 patients (0.5%) were HCV AB-positive. HCV RNA testing was performed in 90% (9/10) of HCV AB-positive patients. Of those, 44.4% (4/9) were HCV RNA-positive, and all 4 (100%) were linked to a HCV treater. Compared to HCV AB-negative subjects, in HCV AB-positive patients, there was a trend towards a higher proportion of Blacks (20.0% vs. 5.2%, p=0.09). Also, HCV AB-positive patients more frequently reported a history of depression: 60.0% vs. 21.5%, p=0.009. HCV AB-positive patients also had lower QoL as documented by more fatigue, poor concentration, and more frequently reported decreased level of energy (p < 0.05). Conclusion: Although the prevalence of HCV AB-positive was low in subjects screened in these GE centers (0.5%), linkage to care was high (90% to 100%). HCV AB-positive patients reported more QoL impairment as compared to HCV AB-negative subjects. A history of depression was the only predictor of being HCV AB-positive.

Risk factors for HCV infection among young adults in rural New York who inject prescription opioid analgesics.

We investigated a cluster of new hepatitis C cases in rural New York among a cohort of young people who inject drugs (PWID) and misuse prescription opioid analgesics (POA). We recruited a purposive sample of PWID from Cortland County for an in-person survey and HCV rapid antibody test (March-July 2012). We examined sociodemographics, drugs currently injected, and lifetime and recent injection behaviors to ascertain associations with HCV antibody (anti-HCV) positivity. Of 123 PWID, 76 (61.8%) were younger than 30 years, and 100 (81.3%) received HCV rapid testing. Of those tested, 34 (34.0%) were positive. Participants who reported injecting POA in the past 12 months were 5 times more likely to be anti-HCV positive than those who injected drugs other than POA, and participants who reported sharing injection equipment in the past 12 months were roughly 4 times more likely to be anti-HCV positive than those who did not. Our analysis suggests people injecting POA may be at higher risk for HCV infection than people who inject heroin or other drugs but not POA.