scholarly journals The performance of hepatitis C virus ( HCV ) antibody point‐of‐care tests on oral fluid or whole blood and dried blood spot testing for HCV serology and viral load among individuals at higher risk for HCV in South Africa

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Nishi Prabdial‐Sing ◽  
Lucinda Gaelejwe ◽  
Lillian Makhathini ◽  
Jayendrie Thaver ◽  
Morubula Jack Manamela ◽  
...  
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.


2020 ◽  
Vol 7 (6) ◽  
Author(s):  
Stéphane Chevaliez ◽  
Mélanie Wlassow ◽  
Johann Volant ◽  
Françoise Roudot-Thoraval ◽  
Antoine Bachelard ◽  
...  

Abstract Background Injecting drug use is a major driver of hepatitis C virus (HCV) spread worldwide, and the World Health Organization (WHO) has identified people who inject drugs (PWID) as a key population to target for HCV screening and care. Point-of-care (POC) hepatitis C tests and dried blood spot (DBS) sampling offer benefits for the management of patients with HCV infection by increasing HCV testing and linkage to care in different nonclinical settings. The aims of this prospective study were to evaluate the feasibility and the acceptability of use HCV ribonucleic acid (RNA) POC and fingerstick DBS testing in social-medical risk-reduction centers and to describe the cascade of care among PWID in France. Methods Between June 2018 and February 2019, 89 consecutive HCV-seropositive PWID attending 2 drug treatment services and 1 supervised consumption room in inner Paris were invited to participate in further evaluation, undergoing a clinical review with a liver assessment and blood tests including fingerstick capillary whole blood POC HCV RNA testing and fingerstick DBS sampling. Results Of the 89 participants enrolled, HCV RNA was detected in 34 (38.6%) participants. Fingerstick whole blood POC RNA testing and HCV RNA detection from DBS sample were feasible and acceptable among PWID with no major difference in terms of HCV RNA detection rate. Overall, 16 participants received pan-genotypic antiviral treatment. The proportion of PWID with sustained virologic response at 12 weeks was 81.2%, with data for 3 patients still pending. Conclusions One-step screening strategy based on the detection of HCV RNA would engage people in care for treatment scale-up and HCV elimination.


2017 ◽  
Vol 4 (5) ◽  
pp. 1871 ◽  
Author(s):  
Sheesham Agrawal ◽  
Pawan Kumar Sulaniya ◽  
Kapil Garg ◽  
Ramesh Choudhary ◽  
Chandrakanta Sulaniya

Background: To study the prevalence of hepatitis-C virus infection in multi-transfused thalassemic children and to correlate these patients with age, number of transfusion, serum ferritin levels and transaminases levels.Methods: This study was conducted in the Department of Pediatrics of a Teaching Institute of Rajasthan. It was a hospital based cross sectional study, conducted over a period of 12 months (April 2016- March 2017). Blood sample for Ant-HCV antibody detection was taken at time of follow-up visit in the subspeciality clinic. These samples were processed in central laboratory for hep-C antibody, serum ferritin and transaminases levels. Anti-HCV antibody detection was done by BI-DOT machine. HCV RNA PCR was done to access viral load in all positive cases.Results: A total of 300 patients were enrolled in the study. There were 219 (73%) males and 81 (27%) females. The mean age of the study group was 7.59±3.6 years (range 1.5-18years). At the time of our study 277 (92.4%) cases were on one or the other chelating agent whereas 23 (7.6%) cases were not taking any kind of chelation therapy. Out of 300 patients, 72(24%) cases tested positive for anti HCV antibody. Out of 72 patients only 36(12%) patients had detectable viral load in RNA PCR.  Mean age of the HCV positive cases (9.58±3.28) years was higher as compared to HCV negative cases (6.98±3.54). Maximum HCV positivity 20/38 (52.6%) was seen in 12-18 year age group; followed by 33/76 (43.4%) in 9-12yr age group. Significant association was observed between advancing age and prevalence of hepatitis C in thalassemia major patients (p=0.002). The number of blood transfusions received by anti-HCV positive children (Avg. Transfusion 185±98.40 ml/kg/year) was significantly higher than that by anti-HCV negative patients (Avg. Transfusion 102.8±71.20) (p value<0.001). Maximum HCV positive cases 33 (45.83%) had total transfusions >200 in a year followed by 15 (20.83%) cases with 151-200 transfusions (p<0.001).Conclusions: Despite ELISA screening of blood donors, our study demonstrated high (24%) prevalence of transfusion transmitted hepatitis-C virus in thalassemic children which increases with increasing number of transfusions, it also correlates with rising serum ferritin level and SGPT level. 


2018 ◽  
Vol 5 (4) ◽  
Author(s):  
Julia Kang Cornett ◽  
Vimal Bodiwala ◽  
Victor Razuk ◽  
Devangi Shukla ◽  
Navaneeth Narayanan

Abstract Background Persons born between 1945 and 1965 account for an estimated 81% of those infected with hepatitis C virus (HCV) in the United States. However, up to 60% remain undiagnosed. Prior studies have reported HCV screening results from large urban emergency departments. Methods This is a retrospective cohort study of patients in the 1945–1965 birth cohort tested for HCV in a large emergency department (ED) in New Jersey from June 1, 2016, through December 31, 2016. The purpose was to report HCV antibody and viral load results of this testing program located in a small urban/suburban area and to analyze specific characteristics associated with positive results, such as race/ethnicity and insurance status. Descriptive statistics were performed, and, using a multivariate logistic regression model, adjusted odds ratios and 95% confidence intervals were calculated. Results A total of 3046 patients were screened: 55.8% were white, and 17.9% were black; 52.1% had private insurance, 33.4% Medicare, 3.9% Medicaid. One hundred ninety-two were antibody positive (6.3%). Of 167 with HCV viral load testing results, 43% had a positive viral load. On multivariate analysis, black race and Medicaid were independently associated with a positive HCV viral load. Conclusions HCV antibody seropositivity was above 6% and twice as high as the Centers for Disease Control and Prevention estimated prevalence in this birth cohort. These results indicate that EDs outside of large urban cities are also important sites for routine HCV screening. Other findings of interest include 43% with chronic HCV infection and the persistent association between black race and positive HCV viral load even when adjusted for insurance status.


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