Clinical Evaluation of Xpert® HCV Test on the GeneXpert® Xpress System in a CLIA-Waived Environment

HCV

 

Brief Background

This study evaluates an investigational rapid fingerstick blood test for Hepatitis C viral load in comparison to standard FDA approved HCV viral load testing through a blood draw.  Study will enroll participants 18 or over with a risk factor for hepatitis C infection including history of injection drug use, living with HIV, born between 1945-1965, or man who is sexually active with men.  Known untreated HCV or previous HCV infection are not exclusionary, however, cannot be taking active HCV treatment. Results from standard FDA approved testing for HCV viral load will be shared with participants. Results from the experimental fingerstick will not be shared.  $100 compensation for one-time visit.

 

Purpose of Study

This study evaluates an investigational rapid fingerstick blood test for Hepatitis C viral load in comparison to standard FDA approved HCV viral load testing through a blood draw.

 

Major requirements for entering the study (things that must be true for you):

  • 18 years or older
  • Participant is not currently on HCV treatment based on review of medical records or self-reported. Prior treatment is not exclusionary
  • Participant has signs or symptoms and/or is considered at risk of HCV infection based on factors outlined above.
  • Participant is able to and agrees to provide the following specimens for study purposes:
  • Finger stick
  • Three to four (3-4) blood samples, as 3 required and 4th is optional.

 

Duration of study: One-time blood draw

 

Contact information:

Phone number: 415-806-8554

Email: [email protected]