Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test (ASPIRE-2)

NCT05506618 | Unknown FDA Device

• 1 other identifier: S-CLIN-PROT-00053
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 6

Brief Summary

Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Performance Evaluation

  Evaluation of performance of the device versus a reference method using standard qualitative comparison techniques (Percent Agreement)

  4 months

Study Arms (4)

Group A: Sample Collection

OTHER

2x Nasopharyngeal Swab Sample Collection

Diagnostic Test: Nasopharyngeal swab

Group B: Sample Collection

OTHER

1x Nasopharyngeal Swab and 2x Nasal Swab Sample Collection

Diagnostic Test: Nasal Swab; Diagnostic Test: Nasopharyngeal swab

Group C: Sample Collection

OTHER

1x Nasopharyngeal Swab and 2x Nasal Swab Sample Collection for sample pooling

Diagnostic Test: Nasal Swab; Diagnostic Test: Nasopharyngeal swab

Group D: Sample Collection

OTHER

2x Nasal Swab Sample Collection

Diagnostic Test: Nasal Swab

Interventions

Nasal Swab DIAGNOSTIC_TEST

Collection of one more nasal swabs

Group B: Sample Collection; Group C: Sample Collection; Group D: Sample Collection

Nasopharyngeal swab DIAGNOSTIC_TEST

Collection of one more nasopharyngeal swabs

Group A: Sample Collection; Group B: Sample Collection; Group C: Sample Collection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject may be of any age or gender.
• 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 congestion or runny nose, diarrhea, nausea or vomiting. The onset of these symptoms will be recorded and will be within the last twelve (12) days.
• or The subject is asymptomatic and is neither currently exhibiting signs or symptoms of SARS-CoV-2 nor has experienced signs or symptoms within the past fourteen (14) days, and has not knowingly been exposed to someone with a positive test result within the last fourteen (14) days
• Participant (or parent/legal guardian) capable and willing to give informed consent/assent.

You may not qualify if:

• The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
• 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.
• Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with medication to treat novel Coronavirus SARS-CoV-2 like illness symptoms, which may include but is not limited to Remdesivir or convalescent plasma therapy for SARS-CoV-2.
• The subject has previously participated in this research study.

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (6)

Cahaba Research, Inc.

Birmingham, Alabama, 35242, United States

Location

Advanced Investigative Medicine

Hawthorne, California, 90250, United States

Location

Healthy Life Research, Inc.

Miami, Florida, 33175, United States

Location

The Machuca Foundation, Inc.

Las Vegas, Nevada, 89104, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

Zion Urgent Care

Katy, Texas, 77494, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Christine Girgis, MD

  Advanced Investigative Medicine

  PRINCIPAL INVESTIGATOR

• Michael Vaughn, MD

  Cahaba Research, Inc.

  PRINCIPAL INVESTIGATOR

• Frank Calcagno, MD

  Cyn3rgy Research

  PRINCIPAL INVESTIGATOR

• Hilda Brito, MD

  Healthy Life Research, Inc.

  PRINCIPAL INVESTIGATOR

• Rogelio Machuca, MD

  The Machuca Foundation, Inc.

  PRINCIPAL INVESTIGATOR

• Tewodros Teketel, MD

  Zion Urgent Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subject are asked to provide nasal swab or nasopharyngeal swab samples

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 18, 2022
• Study Start: June 30, 2022
• Primary Completion: October 4, 2022
• Study Completion: April 30, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)