Diagnostic accuracy of a novel COVID-19 test

A prospective study to evaluate the real-world diagnostic accuracy and potential clinical impact of the Veros COVID-19 test in adults presenting to the Emergency Department with suspected COVID-19: ED-POC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN66255490

Enrollment

400

Registered

2023-02-10

Start date

2023-01-09

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

The real-world diagnostic accuracy of the Veros COVID-19 test Infections and Infestations

Interventions

This study will consist of a diagnostic accuracy study of the Veros COVID-19 test, in the form of a prospectively recruited study. Adult patients presenting to the ED with suspected COVID-19 and/or sy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Is a patient in the ED or AMU at Southampton General Hospital, UHS 2. Aged =18 years old 3. Can be recruited into the study on arrival to the hospital at the time of/prior to routine point-of-care testing for COVID-19, and 3.1. Has an acute respiratory illness, or 3.2. Does not have an acute respiratory illness but is a suspected case of COVID-19 according to the current PHE case definition 4. Has the capacity to consent to the study

Exclusion criteria

Exclusion criteria: 1. Not fulfilling all inclusion criteria 2. Declines nasal/pharyngeal swabbing

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of the Veros COVID-19 test measured using the GeneXpert SARS-CoV-2 result as the reference standard as defined by the manufacturer's instructions at comparable timepoints	—

Secondary

Measure	Time frame
1. Time to result for the Veros COVID-19 test compared to the reference standard assessed at comparable timepoints at the point of care 2. Proportionate failure rate of the Veros COVID-19 test (with the failure to provide a valid result after the use of a test denoting a failed test) assessed at one timepoint at the point of care 3. Ease-of-use measured using quantitative data from the ‘Veros COVID-19 Test Kits – Ease of Use’ Questionnaire provided to users assessed at one timepoint at the point of care 4. Proportion of positive discordant results measured using viral culture of the stored sample at one timepoint after the final physical interaction with the participant 5. The performance of the Veros COVID-19 test across high, medium and low viral loads as determined by cycle threshold (Ct) value bins (with a Ct value of 2530 low levels of virus) as calculated by the GeneXpert SARS-CoV-2 test at one timepoint	—

Measure

Time frame

1. Time to result for the Veros COVID-19 test compared to the reference standard assessed at comparable timepoints at the point of care 2. Proportionate failure rate of the Veros COVID-19 test (with the failure to provide a valid result after the use of a test denoting a failed test) assessed at one timepoint at the point of care 3. Ease-of-use measured using quantitative data from the ‘Veros COVID-19 Test Kits – Ease of Use’ Questionnaire provided to users assessed at one timepoint at the point of care 4. Proportion of positive discordant results measured using viral culture of the stored sample at one timepoint after the final physical interaction with the participant 5. The performance of the Veros COVID-19 test across high, medium and low viral loads as determined by cycle threshold (Ct) value bins (with a Ct value of 2530 low levels of virus) as calculated by the GeneXpert SARS-CoV-2 test at one timepoint

—

Countries

England, United Kingdom

Contacts

Public ContactTristan Clark

t.w.clark@soton.ac.uk+44 (0)2381 208410

Outcome results

None listed

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