Status:
TERMINATED
Dräger COVID-19 Antigen Test Clinical Performance Study
Lead Sponsor:
Drägerwerk AG & Co. KGaA
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by...
Detailed Description
The Dräger Antigen Test SARS-CoV-2 is a rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleoprotein directly from less invasive nasal swabs, to be performed at the point o...
Eligibility Criteria
Inclusion
- Participants must require SARS-CoV-2 testing for the following reasons:
- COVID-19 symptoms (Fever, cough and/or sore throat, fatigue/ general feeling of weakness, loss of sense of smell and/or taste, shortness of breath, muscle stiffness/ body aches, head cold/ running nose, etc.) on the day of testing, or
- Known or suspected exposure to SARS-CoV-2 (contact persons etc.), or
- Member of a group of high risk of exposure such as healthcare workers etc., or
- Require screening for any other reason, e.g. doctor's orders, hygiene directive etc.
- Participant must be of legal age and must be able to understand the procedure and letter of consent.
Exclusion
- Patients younger than 18 years old are excluded from the study.
- Pregnant or breastfeeding patients are excluded from the study.
- Patients unable to provide written informed consent are excluded.
- Patients with bleeding disorder are excluded from the study as a precaution.
- Hospitalized patients/inpatients are excluded.
- Application of nasal spray within 15 min prior to testing.
- Participants with symptoms on the day of testing are excluded, if any of their symptoms started more than 14 days prior to testing.
- Asymptomatic participants are excluded, if they experienced any symptoms in the 14 days prior to testing.
Key Trial Info
Start Date :
February 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2021
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT04698993
Start Date
February 12 2021
End Date
March 22 2021
Last Update
July 20 2021
Active Locations (1)
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1
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353