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CompletedNCT04782336INFORMUpdated Jun 15, 2026

Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test

An observational study in Covid19, RSV Infection and Influenza Type A, sponsored by LumiraDx UK Limited. Completed at 6 sites in United Kingdom. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by LumiraDx UK Limited · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
79
Sex
All
01

Study summary

Collection of Nasal Swabs, Throat Swabs and Saliva Samples from patients presenting at their designated care or testing facility displaying symptoms of either Influenza, Respiratory Syncytial Virus (RSV), SARS-CoV-2 or those who have been in recent contact with SARS-CoV-2 positive patients. Collected samples will aid the development, calibration and performance evaluation of the LumiraDx POC Test.

Read the detailed description

INFORM is a sample collection study targeting a population of patients attending their designated care or testing facility, suspected of having a respiratory illness typical of Influenza, RSV or COVID-19 and undergoing a Standard of Care (SOC) test on the day. Or those who have been in recent contact with SARS-CoV-2 positive patients. Participants may be of any age, there is no upper or lower age limit.

Depending on the facility's viability and agreed contracting, the following study samples will be collected per patient:

Adult Population: Two (2) Nasal, AND/OR Two (2) Throat Swabs AND/OR, One (1) Saliva Sample

Paediatric Population: Two (2) Nasal, OR Two (2) Throat Swabs AND/OR, One (1) Saliva Sample

Once required samples and data have been collected, participation is complete. No follow-up or subsequent patient involvement is required.

02

Conditions studied

  • Covid19
  • RSV Infection
  • Influenza Type A
  • Influenza Type B

Keywords

  • POC
  • SARS-CoV-2
  • Antigen
  • Paediatric
  • Flu
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 79 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

LumiraDx UK Limited is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Influenza or RSV or SARS-CoV-2 suspected adult and paediatric patients. Participants should be suspected of either Influenza A/B, RSV or COVID-19 when presenting at their designated care or testing facility. Participants may be of any age, there will be no upper or lower age limit.

Inclusion criteria

  • Preliminary assessment of the patient by the Investigator/Designee should be suggestive of Influenza and/or COVID-19 and/or RSV at the time of the study visit. This may include referral to a testing facility.
  • The patient will be completing or has completed a Standard of Care (SOC) Influenza A/B, COVID-19 and/or an RSV test on the day of study. This SOC sampling can be conducted prior or post the patient consenting to this study.

  • Written Informed Consent must be obtained prior to study enrolment:

    • A participant who is 16 years or older must be willing to give written informed consent and must agree to comply with study procedures.
    • The Legal Guardian or Legal Authorised Representative of a participant who is under the age of 16 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as determined by the consent taker in accordance with GCP).

Exclusion criteria

Exclusion Criteria:

  • The patient underwent a nasal wash/aspirate as part of standard of care testing during their current visit.
  • The patient is undergoing treatment currently and/or within the past 14 days of the study visit with an inhaled influenza vaccine (FluMist®) or anti-viral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil (Xofluza™).
  • The patient is undergoing treatment currently or had undergone within the past 14 days of the study visit with RSV-related medication which may include but is not limited to Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
  • The patient is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
  • The patient does not have the capacity to consent as determined by the Research Team.
  • The patient is deemed to be unsuitable for research at the Research Team's discretion.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
79 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Sample Collection - Symptomatic Patients-Suspected Influenza/RSV

    The participant must have a fever of 38°C (or greater), with the onset of the fever being within the past three (3) days and/or present at the time the visit. The participant must have presented with respiratory symptoms and a documented positive Flu or RSV Test in the past forty-eight (48) hours.

    Other: Sample Collection

  • Sample Collection - Symptomatic Patients-Suspected COVID-19

    The participant must have a fever of 38°C (or greater), with the onset of the fever being within the past three (3) days and/or present at the time the visit. The participant must have presented with respiratory symptoms and a documented positive Flu or RSV Test in the past forty-eight (48) hours.

    Other: Sample Collection

Interventions

  • OtherSample Collection

    Sample Collection - Adult Population: * Two (2) Nasal AND/OR * Two (2) Throat Swabs AND/OR * One (1) Saliva Sample Sample Collection - Paediatric Population: * Two (2) Nasal OR * Two (2) Throat Swabs AND/OR * One (1) Saliva Sample

06

What researchers measure

Primary outcomes

  1. Collection of Nasal Swabs, Throat Swabs and Saliva Samples across a range of demographics.

    The collection of Nasal Swabs, Throat Swabs and Saliva Samples positive for Influenza A, Influenza B, RSV or SARS-CoV-2 across a range of demographics to help determine the accuracy of the LumiraDx Point of Care (POC) Influenza A/B + RSV and SARS-CoV-2 tests.

    Time frame: 1-3 Years

07

Study locations

6 sites
  • Cambridge University Hospitals NHS Foundation Trust
    Cambridge, CB2 0QQ, United Kingdom
  • NHS Lothian - Royal Hospital for Children & Young People
    Edinburgh, United Kingdom
  • Leicester Royal Infirmary
    Leicester, LE1 5WW, United Kingdom
  • Barts Health NHS Trust
    London, E1 1BB, United Kingdom
  • University College London Hospitals NHS Foundation Trust
    London, NW1 2PG, United Kingdom
  • St George's University Hospitals NHS Foundation
    London, SW17 0QT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04782336
Lead sponsor
LumiraDx UK Limited
Responsible party
Sponsor
First posted
Mar 4, 2021
Start date
Jun 30, 2021
Primary completion
Aug 10, 2021
Completion
Aug 10, 2021
Last update
Jun 15, 2026

Study contacts

Samer Elkhodair
principal investigator · University College London Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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