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poor recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic | Other | Collection of specimens from symptomatic COVID-19 positive participants |
|
| Asymptomatic | Other | Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dräger Antigen Test SARS-CoV-2 | Diagnostic Test | Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test |
| 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 |
| 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 |
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Inclusion Criteria:
Participants must require SARS-CoV-2 testing for the following reasons:
Participant must be of legal age and must be able to understand the procedure and letter of consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Zickler, Dr | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Symptomatic | Collection of specimens from symptomatic COVID-19 positive participants 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 |
| FG001 | Asymptomatic | Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Symptomatic | Collection of specimens from symptomatic COVID-19 positive participants 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 |
| BG001 | Asymptomatic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 8 symptomatic participants with low RNA copy number were excluded for the calculation of the primary endpoint As this endpoint only considers the sensitivity in symptomatic participants, no numbers are shown for the asymptomatic group | Posted | Number | 95% Confidence Interval | percentage of true cases | Through study completion, an average of 1 1/2 month |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symptomatic | Collection of specimens from symptomatic COVID-19 positive participants 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Rainer Polzius | Draegerwerk AG & Co. KGaA | +498824514429 | rainer.polzius@draeger.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2021 | Jul 19, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Asymptomatic |
Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 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 |
|
|
| Primary | 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) | 8 symptomatic participants were excluded due to low RNA copy number As this endpoint only considers the specificity in symptomatic participants, no numbers are shown for the asymptomatic group | Posted | Number | 95% Confidence Interval | percentage of true negative cases | Through study completion, an average of 1 1/2 month |
|
|
|
| Secondary | 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 | For the calculation of this endpoint only the PCR-positive participants from the symptomatic group were counted. | Posted | Number | 95% Confidence Interval | percentage of true positive cases | Through study completion, an average of 1 1/2 month |
|
|
|
| Secondary | 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 | For the calculation of this endpoint only the PCR-positive participants from the symptomatic group were counted. | Posted | Number | 95% Confidence Interval | percentage of true positive cases | Through study completion, an average of 1 1/2 month |
|
|
|
| Secondary | Specificity in Asymptomatic Participants | Specificity of the antigen test in at least 100 asymptomatic participants | For the calculation of this endpoint only the PCR-negative participants from the asymptomatic group were counted. | Posted | Number | 95% Confidence Interval | percentage of true negative cases | Through study completion, an average of 1 1/2 month |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Through study completion, an average of 1 1/2 month |
|
|
|
| 0 |
| 275 |
| 0 |
| 275 |
| 0 |
| 275 |
| EG001 | Asymptomatic | Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 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 | 0 | 113 | 0 | 113 | 0 | 113 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |