HCV-FiS (HEpatitis C Virus Finger-stick Study): HCV RNA point-of-care testing by GeneXpert in the setting of DAA therapy

2018 ◽  
Vol 68 ◽  
pp. S255-S256
Author(s):  
V. Calvaruso ◽  
F. Bronte ◽  
D. Ferraro ◽  
M.G. Bavetta ◽  
S. Petta ◽  
...  
2018 ◽  
Vol 50 (1) ◽  
pp. 58
Author(s):  
F. Bronte ◽  
V. Calvaruso ◽  
D. Ferraro ◽  
S. Petta ◽  
B. Magro ◽  
...  

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.


2019 ◽  
Vol 39 (12) ◽  
pp. 2240-2243
Author(s):  
Vincenza Calvaruso ◽  
Fabrizio Bronte ◽  
Donatella Ferraro ◽  
Giada Reina ◽  
Elisabetta Conte ◽  
...  

Gut ◽  
2018 ◽  
Vol 67 (11) ◽  
pp. 2017-2024 ◽  
Author(s):  
Alba Llibre ◽  
Yusuke Shimakawa ◽  
Estelle Mottez ◽  
Shaun Ainsworth ◽  
Tan-Phuc Buivan ◽  
...  

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.


2018 ◽  
Vol 9 (06) ◽  
pp. 20251-20256
Author(s):  
Mudassir Khan ◽  
Shahrukh Khan ◽  
Shohra Haider ◽  
Fazal Jalil ◽  
Muhsin Jamal ◽  
...  

Background: Prevalence of Hepatitis C viral infection and its major risk factors has been found out in population of Batkhela, Khyber Pakhtunkhwa, Pakistan by taking number of volunteers from the interested area. HCV prevalence has not been researched in recent time here in this area, so that’s why we contributed. Materials and Methods: Ab rapid test cassette serum/plasma (USA) kit has been used for the mentioned purpose following by ELISA and finally PCR to find out active infection of virus. ICT positive individuals were reconfirmed by ELISA and then ELISA positive samples were carefully investigated by RT-PCR for Hepatitis C Virus. Results: The study population was of 770 volunteers belonging to the mentioned area of research, 453 males and 317 females. The overall prevalence was found to be 5.32% of HCV in Batkhela. This prevalence ratio was 3.12% in males and 2.20 % in females. 3rd generation ELISA was used to refine ICT positive samples which showed that 37 of the ICT positive samples had antibodies detected by ELISA. To find out active HCV infection, ELISA positive samples were refined by real time PCR which showed 2.98% of prevalence of active HCV infection in Batkhela based on HCV RNA in their blood. Principle Conclusion: Overall prevalence was found 5.32%, contaminated reused syringes and blades at Barbour’s shop, blood transfusion, surgical operations and unhygienic food in stalls etc were found significant risk factors for acquiring HCV infection. Body weakness and pale yellow skin color was common symptom in HCV positive volunteers. Safe sexual activities, blood screening before donation and sterilizing surgical equipment’s can protect us from Hepatitis C Virus.


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