Dräger COVID-19 Antigen Test Clinical Performance Study

NCT ID: NCT04698993

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-12
• Study Completion Date: 2021-03-22

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.

Conditions

Covid19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Symptomatic

Collection of specimens from symptomatic COVID-19 positive participants

Group Type: OTHER

Dräger Antigen Test SARS-CoV-2

Intervention Type: DIAGNOSTIC_TEST

Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test

Asymptomatic

Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2

Group Type: OTHER

Dräger Antigen Test SARS-CoV-2

Intervention Type: DIAGNOSTIC_TEST

Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test

Interventions

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

Intervention Type: DIAGNOSTIC_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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Drägerwerk AG & Co. KGaA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Zickler, Dr

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Dräger Antigen Test SARS-CoV-2

Identifier Type: -

Identifier Source: org_study_id