Dräger COVID-19 Antigen Test Clinical Performance Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dräger Antigen Test SARS-CoV-2 Clinical Performance Study

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Dräger Antigen Test SARS-CoV-2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antigen test