Hepatitis C is an inflammation of the liver caused by the hepatitis C virus (HCV). HCV is transmitted through blood, for example through drug use. Hepatitis C is often chronic, but can almost always be cured in a maximum of three months. Without treatment, hepatitis C can lead to liver failure or liver cancer.
Conditions
Interventions
Group 1: Test device: Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
This is a cross-sectional, observational design study with retrospective/leftover blood
Sponsors
Sansure Biotech Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -HBV negative Specificity: -HBV Antigen positive/ negative samples Interference: HBV negative Proben with -Hepatitis A virus (HAV) positive -Human Immunodeficiency Virus (HIV) positive -Hepatitis C virus (HCV) positive -Influenza A virus (IAV) positive -Human Cytomegalovirus (CMV) positive -Candida albicans positive -Epstein-Barr virus (EBV) positive -Treponema pallidum positive -Herpes simplex virus 2 (HHV-2) positive -Staphylococcus aureus positive
Exclusion criteria
Exclusion criteria: -Sample was not frozen -Tube was damaged -No blinding ID
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diagnostic specificity (DSpec) represented by negative percentage agreement, NPA) Diagnostic Specificity=NPA=B2/((B1+B2)=TN/((FP+TN) )) | — |
Secondary
| Measure | Time frame |
|---|---|
| crossreactivity tested against genomes of: -Hepatitis A virus (HAV) -Human Immunodeficiency Virus (HIV) -Hepatitis C virus (HCV) -Influenza A virus (IAV) -Human Cytomegalovirus (CMV) -Candida albicans -Epstein-Barr virus (EBV) -Treponema pallidum -Herpes simplex virus 2 (HHV-2) -Staphylococcus aureus interference tested in: - Women who have had more than one pregnancy - Rheumatoid factor positive samples - anti- E. coli antibodies - anti-Candida albicans antibodies | — |
Countries
Germany
Contacts
Public ContactHakan Inan
Requalite GmbH
Outcome results
None listed