NCT04698993

Dräger COVID-19 Antigen Test Clinical Performance Study

Dräger Antigen Test SARS-CoV-2 Clinical Performance Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 388 (actual)
• Sponsor: Drägerwerk AG & Co. KGaA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-12
• Primary completion: 2021-03-22
• Completion: 2021-03-22
• First posted: 2021-01-07
• Last updated: 2021-07-20
• Results posted: 2021-06-25

Locations

1 site across 1 country: Germany