Clinical Performance Evaluation of Sansure Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Clinical Performance Evaluation of Sansure Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) - REQA_24005_SNSR_HIV

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034146

Enrollment

144

Registered

2024-07-24

Start date

2024-07-22

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

An untreated HIV infection usually leads to AIDS after a latency phase of varying length, usually lasting several years without symptoms

Interventions

Group 1: Test device: Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) This is a cross-sectional, observational design study with retrospecti

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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 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 interference tested in: - Women who have had more than one pregnancy - Rheumatoid factor positive samples - anti- E. coli antibodies - anti-Candida albicans antibodies	—

Measure

Time frame

crossreactivity tested against genomes of: -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 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

info@requalite.com+49 89 32800304

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026