Dräger COVID-19 Antigen Test Clinical Performance Study
Primary Purpose
Covid19
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dräger Antigen Test SARS-CoV-2
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19 focused on measuring antigen test
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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.
Sites / Locations
- Charité - Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Symptomatic
Asymptomatic
Arm Description
Collection of specimens from symptomatic COVID-19 positive participants
Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2
Outcomes
Primary Outcome Measures
Sensitivity
Sensitivity (true positive rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of >=10^6 RNA copies/ml for positive PCR results)
Specificity
Specificity (true negative rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of >=10^6 RNA copies/ml for positive PCR results)
Secondary Outcome Measures
Sensitivity in Relation to the Cycle Threshold Value of the Reference RT-PCR (in the Symptomatic Group)
Description of relationship between cycle threshold value of the reference RT-PCR and Dräger test performance.
Presented is the sensitivity(true positive rate) in the symptomatic group at a cycle threshold of <22
Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)
Description of relationship between days since symptom onset and Dräger test performance.
Presented is the sensitivity(true positive rate) in the symptomatic group at days since symptom onset <5
Specificity in Asymptomatic Participants
Specificity of the antigen test in at least 100 asymptomatic participants
Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection
Record of occurrence of lasting nosebleed or unbearable pain during or immediately after specimen collection
Full Information
NCT ID
NCT04698993
First Posted
January 5, 2021
Last Updated
July 19, 2021
Sponsor
Drägerwerk AG & Co. KGaA
1. Study Identification
Unique Protocol Identification Number
NCT04698993
Brief Title
Dräger COVID-19 Antigen Test Clinical Performance Study
Official Title
Dräger Antigen Test SARS-CoV-2 Clinical Performance Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
March 22, 2021 (Actual)
Study Completion Date
March 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drägerwerk AG & Co. KGaA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 pharyngeal swabs serves as a reference method.
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 of care. The test kit contains all components required to carry out a test detecting SARS-CoV-2 nucleoprotein.
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 pharyngeal swabs serves as a reference method.
The goal of the study is to compare Dräger test results to the corresponding PCR data for overall sensitivity and specificity. Specimens are collected from patients showing COVID-19 symptoms as well as asymptomatic participants. Participants are recruited across all genders and eligible age groups. Study staff records participants' information such as symptoms and time since symptom onset. For each study participant, the specimen for RT-PCR is collected first, then the Dräger test specimen. The Dräger test result is read after 15 min to 20 min.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
antigen test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
388 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Symptomatic
Arm Type
Other
Arm Description
Collection of specimens from symptomatic COVID-19 positive participants
Arm Title
Asymptomatic
Arm Type
Other
Arm Description
Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2
Intervention Type
Diagnostic Test
Intervention Name(s)
Dräger Antigen Test SARS-CoV-2
Intervention Description
Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Primary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity (true positive rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of >=10^6 RNA copies/ml for positive PCR results)
Time Frame
Through study completion, an average of 1 1/2 month
Title
Specificity
Description
Specificity (true negative rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of >=10^6 RNA copies/ml for positive PCR results)
Time Frame
Through study completion, an average of 1 1/2 month
Secondary Outcome Measure Information:
Title
Sensitivity in Relation to the Cycle Threshold Value of the Reference RT-PCR (in the Symptomatic Group)
Description
Description of relationship between cycle threshold value of the reference RT-PCR and Dräger test performance.
Presented is the sensitivity(true positive rate) in the symptomatic group at a cycle threshold of <22
Time Frame
Through study completion, an average of 1 1/2 month
Title
Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)
Description
Description of relationship between days since symptom onset and Dräger test performance.
Presented is the sensitivity(true positive rate) in the symptomatic group at days since symptom onset <5
Time Frame
Through study completion, an average of 1 1/2 month
Title
Specificity in Asymptomatic Participants
Description
Specificity of the antigen test in at least 100 asymptomatic participants
Time Frame
Through study completion, an average of 1 1/2 month
Title
Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection
Description
Record of occurrence of lasting nosebleed or unbearable pain during or immediately after specimen collection
Time Frame
Through study completion, an average of 1 1/2 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Zickler, Dr
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mdpi.com/2077-0383/10/10/2099
Description
Results publication - Accuracy of a Novel SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Test from Standardized Self-Collected Anterior Nasal Swabs
Learn more about this trial
Dräger COVID-19 Antigen Test Clinical Performance Study
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