COVID-19 and other infectious diseases Infections and Infestations
Conditions
Interventions
This framework incorporates both prospective observational cohort studies and performance evaluation studies of in-vitro diagnostic devices (IVDDs), methodologies or testing regimens for SARS-CoV-2 an
Sponsors
UK Health Security Agency
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals able to give consent to participate in the evaluation, or in the case of an adult who lacks capacity or a minor (< 16 years), their identified personal or professional consultee, who is willing and able to give consent. 2. Individuals who are known, or suspected, to have an infectious disease which is the subject of a UKHSA National Testing Programme, contacts of such individuals, or any individual who is at risk of contracting the disease in question (e.g. healthcare workers, hospital inpatients, etc)
Exclusion criteria
Exclusion criteria: 1. Participants who cannot provide informed consent and do not have an identified caregiver who can provide consent on their behalf. 2. Individuals for whom the caregiver, healthcare worker, or physician stipulates the process of sample collection is clinically unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard Diagnostic Accuracy is calculated using PCR CT (Cycle Threshold) values at sub-study completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at sub-study completion for each new arm: 1. Sensitivity is calculated using PCR CT (Cycle Threshold) values 2. Usability is demonstrated using the MHRA Guidance on applying human factors to medical devices | — |
Countries
England, United Kingdom
Outcome results
None listed