A Clinical Evaluation of Proof Diagnostics Test System Including the Proof Diagnostics Reader and COVID-19 Test
Completed
Conditions studied: COVID-19, Asymptomatic COVID-19
In brief
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.
Key facts
- Study ID
- NCT05331976
- Run by
- Proof Diagnostics
- People needed
- 276
- Starts
- 2022-02-09
- Expected to finish
- 2022-03-21
- Last updated by the study team
- 2022-04-25
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Asclepes Research Center — Spring Hill, Florida, United States
- PMG Research of Piedmont Healthcare — Statesville, North Carolina, United States
- Eastside Research Associates — Redmond, Washington, United States
Full record on ClinicalTrials.gov
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