Detection of sexually transmitted infections Infections and Infestations
Conditions
Interventions
A retrospective clinical performance study will be conducted to demonstrate that, under the anticipated conditions of use, the STI-fleX qPCR device family will meet the intended use and labelling clai
Sponsors
Randox (United Kingdom)
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Persons aged =18 years 2. Persons who are suspected of having an STI infection, at increased risk of STI, have a known exposure to any STI, contact tracing.
Exclusion criteria
Exclusion criteria: 1. Subjects under the age of 18 2. Contamination and/or deterioration of the specimen that, in the investigator’s opinion, may impact its handling and/or analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome variables will be used to correlate STI-fleX qPCR device results with the reference method measured using the Randox STI Multiplex Array II at one timepoint: 1. Percentage difference 2. Diagnostic sensitivity 3. Diagnostic specificity 4. Positive Predictive Value (PPV) 5. Negative Predictive Value (NPV) 6. Positive Likelihood Ratio 7. Negative Likelihood Ratio Clinical Performance Study acceptance criteria will be as follows: Sensitivity =90% Specificity =95% | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures. | — |
Countries
Northern Ireland, United Kingdom
Contacts
Public ContactHelena Murray
Outcome results
None listed