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 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
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
388
Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
Charité - Universitätsmedizin Berlin
Berlin, Germany
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)
Time frame: 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)
Time frame: Through study completion, an average of 1 1/2 month
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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: Through study completion, an average of 1 1/2 month