Clinical Performance Evaluation of Sansure Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Recruiting

• Conditions: 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.

• Registration Number: DRKS00034144
• Lead Sponsor: Sansure Biotech Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 144

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

-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