Clinical trial NCT04698993: Dräger COVID-19 Antigen Test Clinical Performance Study
Official title: Dräger Antigen Test SARS-CoV-2 Clinical Performance Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Covid19
Keywords: antigen test
Lead sponsor: Drägerwerk AG & Co. KGaA
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 1 1/2 month
measure: Specificity
timeFrame: Through study completion, an average of 1 1/2 month
Secondary outcomes:
measure: Sensitivity in Relation to the Cycle Threshold Value of the Reference RT-PCR (in the Symptomatic Group)
timeFrame: Through study completion, an average of 1 1/2 month
measure: Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)
timeFrame: Through study completion, an average of 1 1/2 month
measure: Specificity in Asymptomatic Participants
timeFrame: Through study completion, an average of 1 1/2 month
measure: Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection
timeFrame: Through study completion, an average of 1 1/2 month
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Daniel Zickler, Dr
role: PRINCIPAL_INVESTIGATOR
References: