Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Detecting and Differentiating Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (Flu A), and/or Influenza B (Flu B)

May 5, 2023 updated by: LumiraDx UK Limited

Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Anterior Nares Nasal Samples For Point-of-Care (POC) Use

This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 & Flu A/B tests at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing on the device under evaluation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a prospective study at point of care sites in the United States for the clinical validation of the LumiraDx SARS-CoV-2 & Flu A/B test for the differential detection of the SARS-CoV-2, and influenza A & B using anterior nasal samples. Up to 1,500 or more symptomatic subjects who are currently experiencing symptoms associated with COVID-19 and Influenza A & B may be enrolled.

The samples are obtained from each subject using standard collection methods and are processed and tested by untrained operators without laboratory training and with no prior experience using the candidate test.

The primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the LumiraDx SARS-CoV-2 & Flu A/B test for the qualitative and differential detection of SARS-CoV-2, Influenza A & B virus antigen using anterior nares samples collected by a healthcare professional, compared to a 510(k) cleared or Emergency Use Authorized (EUA) high-sensitivity reverse transcription-polymerase chain reaction (RT-PCR) test for COVID-19 and a 510(k) cleared Influenza A/B test.

The secondary objective is to assess the usability and user accuracy/performance around limit of detection (LoD) of the investigational test using a questionnaire and accuracy study.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The entire population that met the eligibility criteria. Symptomatic subjects who are currently exhibiting fever, or one or more symptoms associated with COVID-19 or influenza and present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.

Description

Inclusion Criteria:

  1. Written informed consent obtained prior to study enrollment.
  2. Male or female aged 2 years of age or older
  3. Subject is currently exhibiting fever, or one or more symptoms associated with COVID-19 or influenza (such as, but not limited to, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) and must present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.

Exclusion Criteria:

  1. Subject does not understand or is not able and willing to sign the study informed consent or be verbally assented.
  2. Subject has had the seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
  3. Subject is not able to tolerate sample collection.
  4. Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
  5. Subjects undergoing treatment currently and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
  6. Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days.
  7. Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to study sample collection.
  8. Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
symptomatic
Subject is currently exhibiting fever, or one or more symptoms associated with COVID-19 or influenza (such as, but not limited to, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) and must present within 6 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.
Diagnostic test: LumiraDx SARS-CoV-2 & Flu A/B
The LumiraDx SARS-CoV-2 & Flu A/B test is an automated rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform, for near-patient testing, intended for the qualitative and differential detection of nucleocapsid viral antigens from SARS-CoV-2, influenza A, and influenza B in an anterior nares sample (from both nostrils) collected by a healthcare professional for individuals aged 2 years and older. The test is authorized for individuals with symptoms of COVID-19, influenza A and B within the first 6 days of symptom onset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance evaluation of the LumiraDx SARS-CoV-2 & Flu A/B in point of care settings
Time Frame: 6 months
Evaluate the performance of the LumiraDx SARS-CoV-2 & Flu A/B test in detecting and differentiating SARS-CoV-2, influenza A and influenza B in fresh nasal swab specimens from symptomatic patients. Performance will be evaluated by use of statistical analysis techniques to assess negative and positive percent agreement (NPA, PPA) of the LumiraDx test results versus an FDA-approved method where a result of 100% NPA or PPA would equate to complete agreement with the reference method and 0% would equate to no agreement.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the LumiraDx SARS-CoV-2 & Flu A/B for use by intended users
Time Frame: 2 months
Each site will conduct testing with contrived samples prepared by the Sponsor in a User Accuracy study. Additionally, each operator will complete a usability questionnaire evaluating various features of the investigational test and instructions. Users will use the Likert scale (strongly agree - strongly disagree) to rate their responses. Results will be collated and assessed.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LumiraDx UK Limited

Investigators

  • Principal Investigator: Randall Quinn, MD, Cullman Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 20, 2023

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-1489-01
  • 13379 (Other Identifier: RADx)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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