Diagnostic accuracy and feasibility of a rapid SARS-CoV-2 (COVID-19) antigen test in general practice – a prospective multicenter validation and implementation study.
Organizational Data
- DRKS-ID:
- DRKS00023822
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-12-21
- Last update in DRKS:
- 2022-08-18
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
https://www.allgemeinmedizin.uni-wuerzburg.de/forschung/covid-projekte/covid-schnellteststudie/
Brief summary in lay language
The aim of this study is to determine the accuracy of a rapid SARS-CoV-2 test in comparison to laboratory tests (PCR), which have been considered the gold standard. The rapid test is already approved in Germany, but so far it has not been tested in the clinical routine. We would like to find out how well the test is suited for the rapid detection or exclusion of a corona infection in the daily routine of a general practitioner.
Brief summary in scientific language
The diagnostic quality of a new rapid test for an suspected Covid-19 Infection should be evaluated for use the use in general practice. Above all, the sensitivity, but also the specificity of the test should be high. Additional criteria are the positive and negative predictive value. In order to be clinically convincing, the determined sensitivity and specificity should also apply with a high degree of certainty in practice, i.e. show a high degree of precision, which is expressed in a small confidence interval. The study compares the SARS-CoV-2 rapid antigen test with the RT-PCR test (Gold Standard). It is unclear whether the sensitivity and specificity declared by the manufacturer can also be reproduced in everyday clinical practice. A further aim of the study is to investigate the correlation between test accuracy and symptoms in order to be able to estimate the significance of the test in patients with mild or unspecific symptoms.
Health condition or problem studied
- ICD10:
- U07.1 - COVID-19, virus identified
- Free text:
- COVID-19
- Free text:
- SARS-CoV-19 infection
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Nearly simultaneous testing for SARS-CoV-2 by PCR Test and rapid antigen Test.
Endpoints
- Primary outcome:
- -Validation of sensitivity, specificity, positive predictive value, negative predictive value of a rapid SARS-CoV-2 antigen tests in daily clinical routine
- Secondary outcome:
- No Entry
Study Design
- Purpose:
- Diagnostic
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- III
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Institut für Allgemeinmedizin Würzburg
- Doctor's practice Diverse allgemeinmedizinische Praxen im Würzburger Stadt und Landkreis
Recruitment period and number of participants
- Planned study start date:
- 2020-12-20
- Actual study start date:
- 2020-12-16
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2021-06-26
- Target Sample Size:
- 4600
- Final Sample Size:
- 1518
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - respiratory symptoms (e.g. acute bronchitis or pneumonia, respiratory distress or fever) - Acute hypo- or anosmia or hypo- or ageusia
Exclusion Criteria
symptomatic and asymptomatic patients in a nursing home, asymptomatic patients whose testing is done for follow-up reasons (travel history, contact person, etc.)
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Würzburg Institut für AllgemeinmedizinJosef-Schneider-Straße 2/D797080 WürzburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.uni-wuerzburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum WürzburgInstitut für AllgemeinmedizinJörn RohdeJosef-Schneider-Straße 2/D797080 WürzburgGermany
- Telephone:
- 015118513320
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.uni-wuerzburg.de
Contact for Public Queries
- Address:
- Universitätsklinikum Würzburg Institut für AllgemeinmedizinJörn RohdeJosef-Schneider-Straße 2/D797080 WürzburgGermany
- Telephone:
- 015118513320
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.uni-wuerzburg.de
Principal Investigator
- Address:
- Universitätsklinikum WürzburgInstitut für AllgemeinmedizinJörn RohdeJosef-Schneider-Straße 2/D797080 WürzburgGermany
- Telephone:
- 015118513320
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.uni-wuerzburg.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Würzburg Institut für AllgemeinmedizinJosef-Schneider-Straße 2/D797080 WürzburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.uni-wuerzburg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Universität Würzburg, Institut für Pharmakologie und ToxikologieVersbacher Str. 997078 WürzburgGermany
- Telephone:
- +49-931-3148315
- Fax:
- +49-931-3187520
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-11-06
- Ethics committee number:
- 254/20
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-12-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- after request to the principal investigator
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Rohde, J., Himmel, W., Hofinger, C. et al. Diagnostic accuracy and feasibility of a rapid SARS-CoV-2 antigen test in general practice – a prospective multicenter validation and implementation study. BMC Prim. Care 23, 149 (2022). https://doi.org/10.1186/s12875-022-01756-1
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry