Dräger COVID-19 Antigen Test Clinical Performance Study

Dräger Antigen Test SARS-CoV-2 Clinical Performance Study

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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Dräger Antigen Test SARS-CoV-2

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.

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Symptomatic; Collection of specimens from symptomatic COVID-19 positive participants	Diagnostic test: Dräger Antigen Test SARS-CoV-2; Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Other: Asymptomatic; Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2	Diagnostic test: Dräger Antigen Test SARS-CoV-2; Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Through study completion, an average of 1 1/2 month
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)	Through study completion, an average of 1 1/2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 1 1/2 month
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	Through study completion, an average of 1 1/2 month
Specificity in Asymptomatic Participants	Specificity of the antigen test in at least 100 asymptomatic participants	Through study completion, an average of 1 1/2 month
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	Through study completion, an average of 1 1/2 month

Collaborators and Investigators

• Sponsor: Drägerwerk AG & Co. KGaA
• Investigators: Principal Investigator: Daniel Zickler, Dr, Charite University, Berlin, Germany

Publications and helpful links

Helpful Links

• Results publication - Accuracy of a Novel SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Test from Standardized Self-Collected Anterior Nasal Swabs

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): March 22, 2021
• Study Completion (Actual): March 22, 2021

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: antigen test
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Dräger Antigen Test SARS-CoV-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No