scholarly journals Comparison of Rapid Point-of-Care Tests for Detection of Antibodies to Hepatitis C Virus

2015 ◽  
Vol 2 (3) ◽  
Author(s):  
Dennis G. Fisher ◽  
Kristen L. Hess ◽  
Erlyana Erlyana ◽  
Grace L. Reynolds ◽  
Catherine A. Cummins ◽  
...  

Abstract Background.  Hepatitis C is one of the most prevalent blood-borne diseases in the United States. Despite the benefits of early screening, among 3.2 million Americans who are infected with hepatitis C virus (HCV), 50%–70% are unaware of their infection status. Methods.  Data were collected between 2011 and 2014, from 1048 clients who were in the following groups: (1) injection drug users, (2) women at sexual risk, (3) gay and bisexual men, and (4) transgender individuals. The sensitivity and specificity of point-of-care tests included (1) the MedMira rapid human immunodeficiency virus (HIV)/HCV antibody test, (2) MedMira hepatitis B (HBV)/HIV/HCV antibody test, (3) Chembio HCV Screen Assay used with both whole blood and (4) oral specimens, (5) Chembio HIV-HCV Assay also used with both whole blood and (6) oral specimens, (7) Chembio HIV-HCV-Syphilis Assay, and (8) OraSure HCV Rapid Antibody Test used with whole blood. The gold standard for the HCV tests were HCV enzyme immunoassay (EIA) 2.0. Results.  OraSure had the highest sensitivity at 92.7% (95% confidence interval [CI] = 88.8%–96.5%) followed closely by Chembio's 3 blood tests at 92.1% (95% CI = 87.7%–96.4%), 91.5% (95% CI = 87.2%–95.7%), and 92.3% (95% CI = 88.4%–96.2%). The sensitivities of MedMira HIV/HCV and MedMira HIV/HCV/HBV tests were the lowest, at 79.1% (95% CI = 72.6%–85.5%), and 81.5% (95% CI = 75.2%–87.8%), respectively. Specificity for the OraSure was 99.8% (95% CI = 99.4%–100%); specificity for the Chembio blood tests was 99.2% (95% CI = 98.6%–99.9%), 99.4% (95% CI = 98.8%–99.9%), and 99.3% (95% CI = 98.8%–99.9%); and specificity for the MedMira was100% and 100%. False-negative results were associated with HIV and hepatitis B core antibody serostatus. Conclusions.  The OraSure and Chembio blood tests (including those multiplexed with HIV and syphilis) appear to good performance characteristics. This study has identified potential limitations of rapid testing in those testing positive for HIV and HBcAb. There should be discussion of updates to the 2013 CDC guidance.

2015 ◽  
Vol 2 (4) ◽  
Author(s):  
Julie Bottero ◽  
Anders Boyd ◽  
Joel Gozlan ◽  
Fabrice Carrat ◽  
Jean Nau ◽  
...  

Abstract 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.


2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Anneli Uusküla ◽  
Ave Talu ◽  
Jürgen Rannap ◽  
David M. Barnes ◽  
Don Des Jarlais

Abstract Background Between December 2018 and January of 2019, we evaluated the accuracy of the point-of-care Hepatitis C (HCV) antibody test (POC; OraQuick HCV) used at a community-based needle and syringe exchange program serving persons who inject drugs in Tallinn, Estonia. Methods We compared the results of screening for HCV antibodies by OraQuick (oral swab) and enzyme immunoassay (EIA; blood draw) and assessed test results implications in a high prevalence setting. Findings Of the 100 participants, 88 (88%) had reactive POC test results, and 93 were HCV antibody positive on EIA testing. Sensitivity, specificity and negative predictive value (NPV) for the POC assay with EIA as the relevant reference test were as follows: 94.6% (95% CI 90.0–99.2%), 100% and 58.3% (95% CI 30.4–86.2%). Of the 12 testing, HCV-negative with the POC only 7 (58.3%) were true negatives. Conclusions Oral swab rapid testing HCV screening in this nonclinical setting was sensitive and specific but had unacceptably low NPV. In high prevalence settings, POC tests with high sensitivity and that directly measure HCV RNA may be warranted.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S561-S562
Author(s):  
Jehan F Chowdhury ◽  
Anna Winston ◽  
Tanya Zeina ◽  
Hong Gi Shim ◽  
Tine Vindenes

Abstract Background Hepatitis C virus (HCV) is a leading cause of advanced liver disease and death. In the United States about 3.5 million people are living with HCV, but only 50% are aware of the infection, 16% are prescribed treatment, and only 9% achieve sustained viral response. The World Health Organization published an HCV elimination goal for 2030 that strives to achieve a 65% reduction in HCV-related deaths and 90% reduction in transmission. An important step toward this goal is micro-elimination at local hospitals by addressing care gaps in the HCV care cascade. Figure 1 Methods We created a retrospective cohort of patients who tested positive for HCV antibody (HCV Ab+) between 2016 and 2018 at Tufts Medical Center in Boston, Massachusetts. We assessed achievement of care cascade steps including HCV viral load (VL) testing, linkage to care, treatment initiation, and sustained viral response (SVR). We also assessed patient demographics, clinical factors and HCV risk factors. We used STATA/IC 14.1 to conduct bivariate analysis to identify factors associated with loss to follow-up across each care cascade step. Results A total of 24,308 HCV antibody tests were done during this timeframe, of which 5% (n=1,222) were HCV Ab+. After excluding duplicate tests, 1,041 unique patients with HCV Ab+ were included. This cohort had a mean age of 47 years and were 61% male, 66% white, 72% on public insurance, 12% HIV-positive, 13% HCV treatment-experienced. The most frequent HCV risk factor was injection drug use, occurring in 64% of patients. Of patients with HCV Ab+, 76% (n=791) were tested for an HCV VL, of which 50% (n=393) had detectable VL and 50% (n=398) had undetectable VL. Of the patients with a detectable VL, 58% (n=226) were linked with care. Following care linkage, 69% (n=155) initiated treatment, of which 90% (n=139) completed treatment, of which 97% (n=135) achieved SVR (Figure 1). Factors that were significantly associated with getting a VL test and linking to care included private insurance, HIV co-infection, absence of intravenous drug use and cirrhosis; however, these factors were not significantly associated with achieving subsequent steps. Conclusion Assessment of the HCV care cascade at our hospital allowed us to identify clear care gaps and areas needing improvement towards a local micro-elimination. Disclosures All Authors: No reported disclosures


2017 ◽  
Vol 28 (12) ◽  
pp. 1234-1238 ◽  
Author(s):  
Sophie Candfield ◽  
Mannampallil I Samuel ◽  
David Ritchie ◽  
Candice McDonald ◽  
Michael Brady ◽  
...  

People held in prison are at a high risk of having hepatitis C virus (HCV) and there is a public health drive in the UK to increase HCV testing in prisons and Young Offender Institutions (YOIs), with opt-out testing. There is an oral antibody test for HCV; this project aims to determine its acceptability in an English YOI setting. This project offered HCV oral point-of-care testing (POCT) using the OraQuick® test to 107 male young offenders attending a sexual health service at an English YOI, monitoring HCV positivity and evaluating acceptability. It also investigated young offenders’ histories of sexually transmitted infections (STIs) and drug use. Mean age was 19.1 years. A total of 80.4% reported lifetime drug use and 0.9% reported lifetime drug injection. A total of 19.6% reported previous STIs. One patient (0.9%) was positive for HCV on OraQuick® testing. All patients found the POCT acceptable and one stated he would have refused a fingerprick test had it been the only test available for HCV testing. Salivary rapid HCV testing is acceptable among English YOI inmates. It is not as sensitive or specific as standard HCV tests and is more expensive. In our cohort, HCV positivity was low.


2019 ◽  
Vol 21 (5) ◽  
pp. 780-790 ◽  
Author(s):  
Aaron Plant ◽  
Emerald G. Snow ◽  
Jorge A. Montoya ◽  
Sean Young ◽  
Marjan Javanbakht ◽  
...  

Individuals born between 1945 and 1965 (“baby boomers”) account for an estimated three quarters of all hepatitis C (HCV) infections in the United States. This article describes the evaluation of Test4HepC, a program that uses social media and a website to promote HCV testing to baby boomers in Los Angeles County, California. The first 16 months of Test4HepC were evaluated using an online survey (n = 302), qualitative interviews (n = 20), website and social media analytics, and records of free testing offered though the program. Test4HepC.org had 6,919 visitors; 48 individuals used the free testing offered. Within 1 month of visiting the website, 24.5% (74) of survey participants tested for HCV, 67.6% (50) received a negative HCV antibody test result, 2.7% (2) received a positive HCV antibody test result, and 25.7% (19) had not received their results as of taking the survey. Most of those not tested (60.5%) reported intention to test. In multivariable analysis, male sex and high perceived usefulness of the program website were associated with HCV testing. Qualitative interviews suggested that Test4HepC increased baby boomers’ HCV risk perception and encouraged testing. Social media is a promising strategy for promoting HCV testing to baby boomers. Expanding Test4HepC to other areas and prioritizing the highest risk baby boomers could enable many people with HCV to benefit from new treatments.


2018 ◽  
Vol 154 (3) ◽  
pp. 754-758 ◽  
Author(s):  
Anne C. Moorman ◽  
Jian Xing ◽  
Loralee B. Rupp ◽  
Stuart C. Gordon ◽  
Philip R. Spradling ◽  
...  

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