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

Plain-language summary

This study evaluates the clinical performance of the Proof Diagnostics test system (Proof Lab Test System) for detecting SARS-CoV-2 (COVID-19). It enrolled people aged 2 and over who had symptoms within the past 5 days or had been in contact with a known positive individual. This is a study without a phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Proof Diagnostics

Intervention

Proof Lab Test System

Start date

2/9/2022

Estimated completion

3/21/2022

Countries

United States

Related genes

Locations

• Spring Hill, United States
• Statesville, United States
• Redmond, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.