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)

NCT05787444 | Unknown FDA Device

• 2 other identifiers: CS-1489-0113379
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SARS-CoV-2; Influenza A; Influenza B; Asymptomatic COVID-19

Keywords

LumiraDx Diagnostic tests; Multiplex SARS-CoV-2; Influenza A; Influenza B; Asymptomatic; COVID-19 Infections; Coronavirus Lung disease

Outcome Measures

Primary Outcomes (1)

• Performance evaluation of the LumiraDx SARS-CoV-2 & Flu A/B in point of care settings

  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 Outcomes (1)

• Validation of the LumiraDx SARS-CoV-2 & Flu A/B for use by intended users

  2 months

Study Arms (1)

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

Interventions

LumiraDx SARS-CoV-2 & Flu A/B DIAGNOSTIC_TEST

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.

symptomatic

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Written informed consent obtained prior to study enrollment.
• Male or female aged 2 years of age or older
• 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.

You may not qualify if:

• Subject does not understand or is not able and willing to sign the study informed consent or be verbally assented.
• Subject has had the seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
• Subject is not able to tolerate sample collection.
• Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
• 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.
• Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days.
• 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.
• Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (1)

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Anterior Nasal Swabs

Study Officials

• Randall Quinn, MD

  Cullman Clinical Trials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip Estes

CONTACT

858-355-7143; Philip.Estes@lumiradx.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 28, 2023
• Study Start: May 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 20, 2023
• Last Updated: May 8, 2023

Record last verified: 2023-05

Locations

US (1)