A Clinical Evaluation of Proof Diagnostics Test System Including the Proof Diagnostics Reader and COVID-19 Test

NCT05331976 | Completed

• 1 other identifier: PDx-2233-01
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 3

Brief Summary

To determine the accuracy of Proof Diagnostics COVID-19 Test in the intended, symptomatic and suspected/at-risk asymptomatic population and point-of-care use as compared to a standard molecular comparator, Quidel Lyra SARS-CoV-2 Assay for diagnosing SARS-CoV-2 infection.

Conditions

COVID-19; Asymptomatic COVID-19

Keywords

COVID-19; CRISPR; Diagnostics; Medical Device

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Percent Agreement

  The primary outcome measure will be positive and negative percent agreement (PPA and NPA) of the candidate device in a point-of-care setting to the authorized molecular comparator.

  Two weeks

Secondary Outcomes (1)

• Ratio of Positive Predictive Value to Negative Predictive Value

  Two Weeks

Study Arms (2)

Symptomatic subjects

* Subjects must present with 1 or more signs or symptoms of COVID-19 infection\*. * Subjects must have experienced symptom onset within the previous 5 days. * Subject or Subject's legally authorized representative (LAR) is willing and able to provide informed consent. Adult subjects unable to consent will provide assent in addition to LAR's consent. * Subject is ≥ 2 years of age. Subjects 2 ≥ x ≤ 17 will provide assent in addition to parent/legal guardian's consent.

Diagnostic Test: Proof Lab Test System

Asymptomatic Subjects

* Subject must have been exposed to known SARS-CoV-2 positive or suspected SARS-CoV-2 symptomatic individuals within the previous 5 days. * Subject or Subject's legally authorized representative (LAR) is willing and able to provide informed consent. Adult subjects unable to consent will provide assent in addition to LAR's consent. * Subject is ≥ 2 years of age. Subjects 2 ≥ x ≤ 17 will provide assent in addition to parent/legal guardian's consent.

Diagnostic Test: Proof Lab Test System

Interventions

Proof Lab Test System DIAGNOSTIC_TEST

Includes the Proof Lab Reader and the Proof Lab COVID-19 Test Kit containing: Proof Lab COVID-19 Test Cartridge, Sample Vial, Sample Swab, Exact Volume Transfer Pipette

Asymptomatic Subjects; Symptomatic subjects

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

Individuals exhibiting signs and symptoms of respiratory infection as well as those individuals who are asymptomatic and are suspected of having SARS-CoV-2 or at risk due to exposure to individuals with SARS-CoV-2.

You may qualify if:

• For Symptomatic Subjects:
• Subjects must present with 1 or more of the following signs or symptoms:
• Fever Cough Shortness of Breath Difficulty Breathing Muscle Pain Headache Sore Throat Chills New Loss of Taste or Smell Congestion Runny Nose Diarrhea Nausea or vomiting
• Subjects must have experienced symptom onset within the previous 5 days.
• Subject or Subject's legally authorized representative (LAR) is willing and able to provide informed consent. Adult subjects unable to consent will provide assent in addition to LAR's consent.
• Subject is ≥ 2 years of age. Subjects ages 2 ≥ x ≤ 17 will provide assent in addition to parent/legal guardian's consent.
• For Asymptomatic Subjects:
• Asymptomatic subjects must have been exposed to known SARS-CoV-2 positive or suspected SARS-CoV-2 symptomatic individuals within the previous 5 days.
• Subject or Subject's legally authorized representative (LAR) is willing and able to provide informed consent. Adult subjects unable to consent will provide assent in addition to LAR's consent.
• Subject is ≥ 2 years of age. Subjects ages 2 ≥ x ≤ 17 will provide assent in addition to parent/legal guardian's consent.
• Note that subjects in recognized vulnerable populations, such as pregnant women and the cognitively impaired, will not be specifically targeted for recruitment, however individual subjects within vulnerable populations may be enrolled. The Human Subject's Protections procedures employed in this protocol are sufficient to protect the rights and welfare of any subject within an eligible vulnerable population and no additional measures are necessary.

You may not qualify if:

• The subject is not able to tolerate sample collection.
• The subject has been positive for SARS-CoV-2 previously.
• The subject underwent a nasal wash/aspirate as part of standard of care within 24 hours prior to the 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.
• The subject has previously participated in this research study.

Sponsors & Collaborators

• Proof Diagnostics: lead
• ICON Clinical Research: collaborator
• MRI Global: collaborator
• ASCLEPES Research Center: collaborator
• Eastside Research Associates: collaborator
• PMG Research of Piedmont Healthcare: collaborator

Study Sites (3)

Asclepes Research Center

Spring Hill, Florida, 34609, United States

Location

PMG Research of Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

Eastside Research Associates

Redmond, Washington, 98052, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dry anterior nares swabs with self-collected nasal material.

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 Design

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

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 18, 2022
• Study Start: February 9, 2022
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)