Clinical trial NCT04557046: Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test
Official title: A Multicenter COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag Test at Point of Care Testing Sites
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Covid19
Keywords: POC
SARS-CoV-2
Antigen
Lead sponsor: LumiraDx UK Limited
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 1134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subject are asked to provide nasal swab or nasopharyngeal swab and saliva samples
Primary purpose: DIAGNOSTIC

Brief summary: Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.

Detailed description: The study is a prospective, multi-center study. One (1) reference laboratory and approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician office laboratories, urgent cares, emergency departments, outpatient clinics, drive through testing sites or research centers) in the U.S. will participate in the study. Testing in the reference laboratory will be performed by trained laboratory personnel. Testing at the POC sites will be performed by non-laboratory health professionals who are representative of typical intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol.

A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number.

Subjects will have nasopharyngeal or nasal or throat swabs collected. Capillary blood may be collected alongside nasal swabs. Saliva samples may also be collected. Specimens will be obtained from each subject enrolled using standard collection methods.

The LumiraDx SARS-CoV-2 Ag Test will be performed at POC sites by intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol.

The LumiraDx SARS-CoV-2 Ag Test will be performed at the site on the same day as the date of collection using one swab for each subject enrolled. A central laboratory will perform reference testing.

Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be estimated for the LumiraDx SARS-CoV-2 Ag Test results as compared with the reference Test.

A minimum of thirty (30) positive SARS-CoV-2 are required, but it is likely because of the prevalence of SARS-CoV-2 in the population, that a greater number of negatives will be obtained during the prospective collection of positive samples; therefore, approximately four-hundred (400) subjects will be enrolled. A minimum of thirty (30) negative samples are required.

Eligibility criteria: Inclusion Criteria:

* 1. The subject may be of any age and either sex.
* 2. Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 at the time of the study visit. The subject must present as symptomatic, meaning they have exhibited one or more of the following signs and symptoms for eligibility: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell. The onset of these symptoms will be recorded.

or The subject must have a documented SARS-CoV-2 PCR test in the past 48 hours.

* 3. Written informed consent must be obtained prior to study enrollment.

  1. A subject who is eighteen (18) years or older must be willing to give written informed consent and must agree to comply with study procedures.
  2. The Legal Guardian or Legal Authorized Representative of a subject who is under the age of eighteen (18) 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 defined by the IRB).

Exclusion Criteria:

* 1. The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
* 2. The subject 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.
* 3. The subject has previously participated in this research study

Primary outcomes:
measure: Performance Evaluation
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Altamonte Springs
country: United States
facility: Children's Pediatric Associates of Altamonte Springs
state: Florida
city: Kissimmee
country: United States
facility: Chappel Group
state: Florida
city: Atlanta
country: United States
facility: Good Samaritan Minute Clinic, Georgia Tech
state: Georgia
city: Millersville
country: United States
facility: Gvozden Pediatrics
state: Maryland
city: Winston-Salem
country: United States
facility: Ardmore Family Practice
state: North Carolina
city: Jackson
country: United States
facility: Physicians Quality Care of Jackson
state: Tennessee
city: Plano
country: United States
facility: Village Health Partners
state: Texas
Study officials:
affiliation: Chappel Group
name: Christopher Chappel
role: PRINCIPAL_INVESTIGATOR
affiliation: Ardmore Family Practice
name: Robert Rosen
role: PRINCIPAL_INVESTIGATOR
affiliation: Gvozden Pediatrics
name: Andre Gvozden
role: PRINCIPAL_INVESTIGATOR
affiliation: Village Health Partners
name: Madhavi Ampajwala
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Associates of Altamonte Springs
name: Edward Zissman
role: PRINCIPAL_INVESTIGATOR
affiliation: Physicians Quality Care of Jackson
name: Melanie Hoppers
role: PRINCIPAL_INVESTIGATOR
affiliation: Good Samaritan Minute Clinic
name: Kimberley Henderson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellis JE, Guest P, Lawson V, Loecherbach J, Lindner N, McCulloch A. Performance Evaluation of the Microfluidic Antigen LumiraDx SARS-CoV-2 and Flu A/B Test in Diagnosing COVID-19 and Influenza in Patients with Respiratory Symptoms. Infect Dis Ther. 2022 Dec;11(6):2099-2109. doi: 10.1007/s40121-022-00696-8. Epub 2022 Sep 24.
citation: Drain PK, Ampajwala M, Chappel C, Gvozden AB, Hoppers M, Wang M, Rosen R, Young S, Zissman E, Montano M. A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid Diagnosis of Acute COVID-19 at the Point of Care: A Clinical Performance Study. Infect Dis Ther. 2021 Jun;10(2):753-761. doi: 10.1007/s40121-021-00413-x. Epub 2021 Feb 24.