Hepatitis B is an inflammation of the liver caused by the HBV virus. It is easily transmitted, especially during sex and through contaminated syringes and accessories. The infection can become chronic, i.e. make you permanently ill
Conditions
Interventions
Group 1: Test device: Hepatitis B Virus DNA 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 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