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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

About this trial

This is an interventional diagnostic trial for Covid19 focused on measuring antigen test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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