Proof Diagnostics Okuyucusu ve COVID-19 Testini İçeren Proof Diagnostics Test Sisteminin Klinik Değerlendirmesi

Sade dilde özet

Bu çalışma, SARS-CoV-2 (COVID-19) tespiti için Proof Diagnostics test sisteminin (Proof Lab Test System) klinik performansını değerlendirmektedir. Çalışmaya, son 5 gün içinde belirti gösteren ya da bilinen bir pozitif kişiyle temas etmiş, 2 yaş ve üzeri kişiler alınmıştır. Faz uygulanmayan bir çalışma olup tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Tamamlandı

Sponsor

Proof Diagnostics

Müdahale

Proof Lab Test System

Başlangıç

09.02.2022

Tahmini bitiş

21.03.2022

Ülkeler

United States

İlgili genler

Merkezler

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

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.