Clinical Performance Evaluation of Sansure Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Recruiting
- Conditions
- An untreated HIV infection usually leads to AIDS after a latency phase of varying length, usually lasting several years without symptoms
- Registration Number
- DRKS00034146
- Lead Sponsor
- Sansure Biotech Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 144
Inclusion Criteria
samples positive for:
-Hepatitis A virus (HAV)
-Human herpes virus 4 (HHV-4)
-HIV-2
-Hepatitis B virus (HBV)
-Human herpes virus 6 (HHV-6)
-Rubella virus
-Hepatitis C virus (HCV)
-Influenza A virus
-Candida albicans
-Human herpes virus 1 (HHV-1)
-Treponema pallidum
-Toxoplasma gondii
-Human herpes virus 2 (HHV-2)
-Staphylococcus aureus
-Human T-cell virus type I
-Human herpes virus 5 (HHV-5)
-Adenovirus
-Human T-cell virus type II Virus
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 herpes virus 4 (HHV-4)HIV-2<br>-Hepatitis B virus (HBV)<br>-Human herpes virus 6 (HHV-6)<br>-Rubella virus<br>-Hepatitis C virus (HCV)<br>-Influenza A virus<br>-Candida albicans<br>-Human herpes virus 1 (HHV-1)<br>-Treponema pallidum<br>-Toxoplasma gondii<br>-Human herpes virus 2 (HHV-2)<br>-Staphylococcus aureus<br>-Human T-cell virus type I<br>-Human herpes virus 5 (HHV-5)<br>-Adenovirus<br>-Human T-cell virus type II Virus<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