Bio Spec Overview
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Last Modification Date:
2025-12-25 @ 1:33 AM
Retention:
SAMPLES_WITH_DNA
Description:
A minimum of 1000 qualified specimens shall be collected, including at least 350 anti-HCV seropositive specimens.
To further evaluate RIBA test specificity in HAV IgG positive, HBsAg positive, HEV IgG positive and anti-HIV positive specimens, approximately 30 specimens of each viral infection will be included in the study.
A minimum of 60 matched plasma and serum specimens will be collected to evaluate the applicability of the investigational product on different types of samples, including at least 30% of anti-HCV seropositive specimens.
To further evaluate RIBA test specificity in HAV IgG positive, HBsAg positive, HEV IgG positive and anti-HIV positive specimens, approximately 30 specimens of each viral infection will be included in the study.
A minimum of 60 matched plasma and serum specimens will be collected to evaluate the applicability of the investigational product on different types of samples, including at least 30% of anti-HCV seropositive specimens.
Section:
A minimum of 1000 qualified specimens shall be collected, including at least 350 anti-HCV seropositive specimens.
To further evaluate RIBA test specificity in HAV IgG positive, HBsAg positive, HEV IgG positive and anti-HIV positive specimens, approximately 30 specimens of each viral infection will be included in the study.
A minimum of 60 matched plasma and serum specimens will be collected to evaluate the applicability of the investigational product on different types of samples, including at least 30% of anti-HCV seropositive specimens.