Clinical Performance Evaluation of Sansure Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Recruiting
- Conditions
- 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
- Registration Number
- DRKS00034136
- Lead Sponsor
- Sansure Biotech Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 144
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
-Sample was not frozen
-Tube was damaged
-No blinding ID
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method diagnostic specificity (DSpec) represented by negative percentage agreement, NPA) <br>Diagnostic Specificity=NPA=B2/((B1+B2)=TN/((FP+TN) ))
- Secondary Outcome Measures
Name Time Method crossreactivity tested against genomes of:<br>-Hepatitis A virus (HAV)<br>-Human Immunodeficiency Virus (HIV)<br>-Hepatitis C virus (HCV)<br>-Influenza A virus (IAV)<br>-Human Cytomegalovirus (CMV)<br>-Candida albicans<br>-Epstein-Barr virus (EBV)<br>-Treponema pallidum<br>-Herpes simplex virus 2 (HHV-2)<br>-Staphylococcus aureus<br><br>interference tested in:<br>- Women who have had more than one pregnancy<br>- Rheumatoid factor positive samples<br>- anti- E. coli antibodies <br>- anti-Candida albicans antibodies<br>