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Assessment of an artificial intelligence method for determining the result of a COVID-19 lateral flow test

Machine learning for determining lateral flow device results for COVID-19 in an asymptomatic population: A diagnostic accuracy study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN30075312
Enrollment
100000
Registered
2021-06-16
Start date
2021-03-12
Completion date
Unknown
Last updated
2023-08-02

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

Conditions

Detection of SARS-CoV-2 infection using a lateral flow device Infections and Infestations COVID-19 (SARS-CoV-2 infection)

Interventions

1. Participants decide to take a lateral flow test 2. They take the COVID-19 lateral flow test as per the manufacturer’s instructions for use 3. They then log onto the

Sponsors

Department of Health and Social Care
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Any health care worker invited by NHS Test and trace who is willing to participate in the study 2. Aged 18 years or above or adolescents aged 12 - 17 years (self-test and report with adult supervision) or children under 12 years (should be tested and reported by an adult) 3. Without any common COVID-19 symptoms 4. Able (in the Investigators’ opinion) and willing to comply with all study requirements

Exclusion criteria

Exclusion criteria: 1. Did not agree with privacy statement 2. Any common COVID-19 symptoms 3. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study

Design outcomes

Primary

MeasureTime frame
Accuracy of AI reader compared to human readers measured using the test result (i.e COVID lateral flow device) as reported by the user of the test and as determined by the machine learning algorithm at a single time point

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

England, United Kingdom

Outcome results

None listed

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