What is required from HCV point-of-care tests to reduce the burden of hepatitis C infection? ‘Development and clinical validation of the genedrive point-of-care test for qualitative detection of hepatitis C virus’

Gut ◽  
2018 ◽  
Vol 67 (11) ◽  
pp. 1916-1917 ◽  
Author(s):  
Maud Lemoine ◽  
Hans L Tillmann
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Point Of Care ◽  
Clinical Validation ◽  
Hepatitis C Infection ◽  
Point Of Care Test ◽  
Qualitative Detection ◽  
Point Of Care Tests

scholarly journals Development and clinical validation of the Genedrive point-of-care test for qualitative detection of hepatitis C virus

Gut ◽  
2018 ◽  
Vol 67 (11) ◽  
pp. 2017-2024 ◽  
Author(s):  
Alba Llibre ◽  
Yusuke Shimakawa ◽  
Estelle Mottez ◽  
Shaun Ainsworth ◽  
Tan-Phuc Buivan ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Low Income ◽  
Limit Of Detection ◽  
Point Of Care ◽  
Hcv Rna ◽  
Middle Income ◽  
Middle Income Countries ◽  
Point Of Care Test ◽  
Qualitative Detection

ObjectiveRecently approved direct acting antivirals provide transformative therapies for chronic hepatitis C virus (HCV) infection. The major clinical challenge remains to identify the undiagnosed patients worldwide, many of whom live in low-income and middle-income countries, where access to nucleic acid testing remains limited. The aim of this study was to develop and validate a point-of-care (PoC) assay for the qualitative detection of HCV RNA.DesignWe developed a PoC assay for the qualitative detection of HCV RNA on the PCR Genedrive instrument. We validated the Genedrive HCV assay through a case–control study comparing results with those obtained with the Abbott RealTime HCV test.ResultsThe PoC assay identified all major HCV genotypes, with a limit of detection of 2362 IU/mL (95% CI 1966 to 2788). Using 422 patients chronically infected with HCV and 503 controls negative for anti-HCV and HCV RNA, the Genedrive HCV assay showed 98.6% sensitivity (95% CI 96.9% to 99.5%) and 100% specificity (95% CI 99.3% to 100%) to detect HCV. In addition, melting peak ratiometric analysis demonstrated proof-of-principle for semiquantification of HCV. The test was further validated in a real clinical setting in a resource-limited country.ConclusionWe report a rapid, simple, portable and accurate PoC molecular test for HCV, with sensitivity and specificity that fulfils the recent FIND/WHO Target Product Profile for HCV decentralised testing in low-income and middle-income countries. This Genedrive HCV assay may positively impact the continuum of HCV care from screening to cure by supporting real-time treatment decisions.Trial registration numberNCT02992184.

Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection

2010 ◽  
Vol 48 (1) ◽  
pp. 15-17 ◽  
Author(s):  
S.R. Lee ◽  
G.D. Yearwood ◽  
G.B. Guillon ◽  
L.A. Kurtz ◽  
M. Fischl ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Point Of Care ◽  
Hepatitis C Infection ◽  
Test Device ◽  
Point Of Care Test

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 ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Hepatitis B ◽  
Whole Blood ◽  
Point Of Care ◽  
Antibody Test ◽  
The United States ◽  
Blood Tests ◽  
Hcv Antibody ◽  
Point Of Care Tests

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.

scholarly journals P3-S5.03 Conflict of interest and point of care tests: an exploration of accuracy in Hepatitis C infection

2011 ◽  
Vol 87 (Suppl 1) ◽  
pp. A293-A294
Author(s):  
S. Shivkumar ◽  
Y. Jafari ◽  
G. Lambert ◽  
C. Claessens ◽  
M. Klein ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Conflict Of Interest ◽  
Point Of Care ◽  
Hepatitis C Infection ◽  
Point Of Care Tests

scholarly journals Successful Integration of Hepatitis C Virus Point-of-Care Tests into the Denver Metro Health Clinic

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
A. Jewett ◽  
A. A. Al-Tayyib ◽  
L. Ginnett ◽  
B. D. Smith
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Point Of Care ◽  
Linkage To Care ◽  
Antibody Test ◽  
Care Program ◽  
Ease Of Use ◽  
Return Of Results ◽  
Health Clinic ◽  
Hepatitis C Infection

Background. The Centers for Disease Control and Prevention (CDC) recommends testing and linkage to care for persons most likely infected with hepatitis C virus (HCV), including persons with human immunodeficiency virus. We explored facilitators and barriers to integrating HCV point-of-care (POC) testing into standard operations at an urban STD clinic.Methods. The OraQuick HCV rapid antibody test was integrated at the Denver Metro Health Clinic (DMHC). All clients with at least one risk factor were offered the POC test. Research staff conducted interviews with clients (three HCV positive and nine HCV negative). Focus groups were conducted with triage staff, providers, and linkage-to-care counselors.Results. Clients were pleased with the ease of use and rapid return of results from the HCV POC test. Integrating the test into this setting required more time but was not overly burdensome. While counseling messages were clear to staff, clients retained little knowledge of hepatitis C infection or factors related to risk. Barriers to integrating the HCV POC test into clinic operations were loss to follow-up and access to care.Conclusion. DMHC successfully integrated HCV POC testing and piloted a HCV linkage-to-care program. Providing testing opportunities at STD clinics could increase identification of persons with HCV infection.

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