Reducing Read Time of Point-of-Care Test Does Not Affect Detection of Hepatitis C Virus and Reduces Need for Reflex RNA.

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.

Early identification and linkage to care of persons with chronic hepatitis B virus infection--three U.S. sites, 2012-2014.

In the United States, an estimated 0.8-1.4 million persons are living with chronic hepatitis B virus (HBV) infection. Among these persons, as many as 70% were born in countries of Asia, Africa, or other regions where HBV is moderately or highly endemic (hepatitis B surface antigen [HBsAg] prevalence ≥2%). HBV-associated cirrhosis and liver cancer are major health problems for these populations. Most persons with HBV were infected at birth or during early childhood and are asymptomatic until advanced liver disease develops. To address these concerns, CDC recommends HBsAg testing for all persons born in these areas and linkage to medical care and preventive services for those who are infected. In 2012, CDC awarded funds to nine sites to implement this recommendation. This report describes programs at three sites (New York, New York; Minneapolis-St. Paul, Minnesota; and San Diego, California) that conducted HBV testing, in clinical or community settings, and referred for medical evaluation and care those persons whose HBsAg test results were positive. During October 2012-March 2014, the three sites tested 4,727 persons for HBV infection; 310 (6.6%) were HBsAg-positive. Among the HBsAg-positive persons, 94% were informed of their results, 90% were counseled, 86% were referred for care, and 66% attended their scheduled first medical visit. These projects demonstrate that community-based programs can identify infected persons among populations with a high prevalence of HBV infection and refer HBsAg-positive persons for care. Individualized efforts to assist patients with accessing and receiving health-care services ("patient navigation services") can increase the number of persons who follow up on referrals and receive recommended care.

Evaluation of Hepatitis C Screening and Treatment Among Psychiatry Inpatients.

Objective: To evaluate uptake of hepatitis C virus (HCV) testing and treatment among psychiatry inpatients at Canada's largest mental health institution, the Centre for Addiction and Mental Health (CAMH).Methods: We reviewed medical records for all forensic and long-stay mental health patients from January 2017 to May 2021 to examine rates of HCV testing (antibody and RNA), treatment, and follow-up and completed a logistical regression to identify predictors associated with HCV antibody (Ab) screening among inpatients.Results: Of 1,031 patients, 73% (n = 753) were male, mean age was 44 years (range: 20-92), and mean length of stay was 7.1 months (range: 0 days-24 years). Most, 83% (n = 856), were diagnosed with schizophrenia spectrum disorders. In total, 652/1,031 (63%) of individuals in this cohort received HCV Ab screening. When broken down by admission rather than individual, 570/1,303 (44%) forensic admissions had an associated HCV Ab screening, and 318/1,450 (22%) non-forensic admissions had an associated HCV Ab screening. Individuals admitted to a forensic unit and those diagnosed with schizophrenia or substance use disorders were more likely to undergo HCV Ab screening, while individuals of Asian ethnicity were less likely (all P < .05). HCV Ab positivity was 4.9%, and most (84%, n = 27) HCV Ab-positive individuals had subsequent RNA testing, of whom 56% (n = 15) tested HCV RNA positive. Of 15 RNA-positive individuals, 10 initiated treatments, 7 on-site at CAMH and 3 at a local hepatology center. A total of 7 individuals (1 treated by specialists and 6 on-site) achieved sustained virological response or cure. The remaining 3 were lost to follow-up, 2 of whom were treated at the hepatology clinic.Conclusions: Based on the high prevalence of HCV, mental health inpatients should be included in groups for whom universal screening is recommended. Since on-site treatment was more successful than referral to external hepatology specialists, utilizing inpatient admission as an opportunity for HCV screening and treatment should receive more consideration.

Leveraging COVID-19 vaccination to promote hepatitis C screening.

Health care initiatives, such as hepatitis C virus (HCV) screening, have been greatly overshadowed by the corona virus disease 2019 (COVID-19) pandemic. However, COVID-19 vaccination programs also provide an opportunity to engage with a high volume of people in a health care setting. We collaborated with a large COVID vaccination center to offer HCV point-of-care testing followed by dried blood spot collection for HCV RNA. Additionally, this opportunity was used to evaluate the practical significance of a 5-minute version of the OraQuick HCV antibody test in lieu of the standard 20-minute test. We tested 2317 individuals; 31 were HCV antibody positive and six were RNA positive of which four were treated and reached sustained virological response. Over a third of those surveyed said they would not have participated had the test required 20 minutes. Conclusion : Colocalizing HCV testing and linkage to care at a COVID vaccination clinic was found to be highly feasible; furthermore, a shortened antibody test greatly improves the acceptance of testing.

Birth cohort hepatitis C antibody prevalence in real-world screening settings in Ontario.

Background: Widespread screening and treatment of hepatitis C virus (HCV) is required to decrease late-stage liver disease and liver cancer. Clinical practice guidelines and Canadian Task Force on Preventative Health Care recommendations differ on the value of one-time birth cohort (1945-75) HCV screening in Canada. To assess the utility of this approach, we conducted a real-world analysis of HCV antibody (Ab) prevalence among birth cohort individuals seen in different clinical contexts. Methods: Cross-sectional study of individuals born between 1945 and 1975 who completed HCV Ab testing at multiple participating centres in Ontario, Canada between January 2016 and December 2020. Differences in prevalence were compared by year of birth, gender, and setting. Results: Among 16,672 birth cohort individuals tested, HCV Ab prevalence was 3.2%. Prevalence was higher among younger individuals which increased from 0.9% among those born between 1945 and 1956 to 4.6% among those born between 1966 and 1975. Prevalence was higher among males (4.4%) compared with females (2.0%) and differed by test site. In primary care, the prevalence was 0.5%, whereas the prevalence was highest among those tested at drug treatment centres (28.7%) and through community outreach (14.0%). Conclusions: HCV Ab prevalence remains high in the 1945-1975 birth cohort. These data highlight the need to re-evaluate existing Canadian Preventative Task Force recommendations, to consider incorporating one-time birth cohort and/or other population-based approaches to HCV screening into the clinical workflow as a preventative health measure, and to increase training among community providers to screen for and treat HCV.