SARS-CoV-2 Rapid Antigen TestNCT04716088
Rapid Antigen Testing for SARS-CoV-2 Among Healthcare Workers to Prevent Spread of COVID-19
An observational study of SARS-CoV-2 Rapid Antigen Test, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
Trial summary
Physicians, nurses and hospital attendants currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to participate in the pilot study. Nasopharyngeal swabs were obtained three times per week for two consecutive weeks and tested with a point-of-care rapid antigen test and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Rapid Antigen Test
- What is being tested?
- Rapid antigen test for SARS CoV2
- How many people
- 36 participants
- Where
- 1 siteSlovenia
- Study dates
- 18 Nov 2020to 22 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physicians, nurses and hospital attendants currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to enroll in the pilot study.
Who may be able to join
- health care worker
Who cannot join
- previous known COVID 19 infection
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Universitiy Clinic for respiratory and allergic diseases
Golnik, 4204
About this study
Official title: Usefulness of Rapid Antigen Testing for SARS-CoV-2 Among Healthcare Workers to Prevent Spread of COVID-19 in the Hospital: a Pilot Study
Physicians, nurses and hospital attendants currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to participate in the pilot study. Nasopharyngeal swabs were obtained three times per week for two consecutive weeks and tested with a point-of-care rapid antigen test and reverse transcription polymerase chain reaction (RT-PCR). In addition, serum samples were obtained at the beginning of the study and 2 weeks after last swab was obtained in order to evaluate the serological status of participating health care workers.
Read the detailed description
Health care workers (HCW) currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to enroll in the pilot study. HCW directly involved in COVID-19 patient care and those who had a previous laboratory confirmed SARS-CoV-2 infection were not eligible for inclusion in the study. For each participating HCW, nasopharyngeal swabs were obtained. Swabs were collected on Mondays, Wednesdays and Fridays for two consecutive weeks with a maximum of six samplings per person scheduled.
Swabs were inserted into universal transport medium (UTM) and tested with SARS-CoV-2 Rapid Antigen test (Roche Diagnostics GmbH, Mannheim, Germany), in accordance with the manufacturer's instructions. Briefly, samples were thoroughly vortexed and 350 μL of UTM were mixed with the extraction buffer included in the testing kit. Three drops of the mixture were applied to the specimen well of the lateral flow test device and results were visually read after a 15 min incubation at room temperature.
Nasopharyngeal swab samples were subsequently tested for the presence of SARS-CoV-2 RNA without intermitting freeze-thaw cycle. Viral RNA was isolated from the specimens using the QIAamp Viral RNA Mini Kit (QIAGEN GmbH, Hilden, Germany). PCR amplification was set up on CFX96 Touch Real-Time PCR Detection System (Bio-Rad Laboratories - Dubai Branch, Dubai, United Arab Emirates) and a commercially available PCR kit Allplex™2019-nCoV (Seegene, Seoul, South Korea) was used. Allplex™2019-nCoV assay enables simultaneous detection and identification of three target genes, specific for SARS-CoV-2 (e.g. the E, RdRp, and N gene). Samples were considered positive for SARS-CoV-2 only if all three targeted genes were amplified.
In addition, serum samples were collected at the beginning of the study and 14 days after the last nasopharyngeal swab was obtained. The presence of antibodies against SARS-CoV-2 were evaluated using IDK anti-SARS-CoV-2 IgM and IgG ELISA Kit (Immundiagnostik AG, Bensheim, Germany), following manufacturer's instructions.
- Conditions
- SARS-CoV-2 Rapid Antigen Test
- Being tested
- Rapid antigen test for SARS CoV2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid antigen test for SARS CoV2Diagnostic test
Defining diagnostic performance of repeated testing regimen in hospital setting
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS CoV2 infection
positive rapid antigen test for SARS CoV2
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start18 Nov 2020
- Primary completion2 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 Rapid Antigen TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases Golnik
- Sponsor type
- University, hospital or other
- Collaborators
- Insitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana
- Responsible party
- Sponsor
- Investigators
- Mihaela Zidarn, MD PhD, Principal investigator, Klinika Golnik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716088
- Sponsor's protocol ID
- RADT for COVID-19 Golnik
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD are available on request from PI.
Publications
Jakobsen KK, Jensen JS, Todsen T, Tolsgaard MG, Kirkby N, Lippert F, Vangsted AM, Martel CJ, Klokker M, von Buchwald C. Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection. Dan Med J. 2021 Jun 14;68(7):A03210217.
PubMed 34169830Sterbenc A, Tomic V, Bidovec Stojkovic U, Vrankar K, Rozman A, Zidarn M. Usefulness of rapid antigen testing for SARS-CoV-2 screening of healthcare workers: a pilot study. Clin Exp Med. 2022 Feb;22(1):157-160. doi: 10.1007/s10238-021-00722-y. Epub 2021 May 22.
PubMed 34021827
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Rapid Antigen Testing for SARS-CoV-2 Among Healthcare Workers to Prevent Spread of COVID-19 in the Hospital: a Pilot Study
- ClinicalTrials.gov ID
- NCT04716088
- Acronym / sponsor ID
- RADT for COVID-19 Golnik
- Conditions
- SARS-CoV-2 Rapid Antigen Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases GolnikUniversity, hospital or other
- Collaborators
- Insitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physicians, nurses and hospital attendants currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to participate in the pilot study. Nasopharyngeal swabs were obtained three times per week for two consecutive weeks and tested with a point-of-care rapid antigen test and reverse transcription polymerase chain reaction (RT-PCR). In addition, serum samples were obtained at the beginning of the study and 2 weeks after last swab was obtained in order to evaluate the serological status of participating health care workers.
Detailed description
Health care workers (HCW) currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to enroll in the pilot study. HCW directly involved in COVID-19 patient care and those who had a previous laboratory confirmed SARS-CoV-2 infection were not eligible for inclusion in the study. For each participating HCW, nasopharyngeal swabs were obtained. Swabs were collected on Mondays, Wednesdays and Fridays for two consecutive weeks with a maximum of six samplings per person scheduled.
Swabs were inserted into universal transport medium (UTM) and tested with SARS-CoV-2 Rapid Antigen test (Roche Diagnostics GmbH, Mannheim, Germany), in accordance with the manufacturer's instructions. Briefly, samples were thoroughly vortexed and 350 μL of UTM were mixed with the extraction buffer included in the testing kit. Three drops of the mixture were applied to the specimen well of the lateral flow test device and results were visually read after a 15 min incubation at room temperature.
Nasopharyngeal swab samples were subsequently tested for the presence of SARS-CoV-2 RNA without intermitting freeze-thaw cycle. Viral RNA was isolated from the specimens using the QIAamp Viral RNA Mini Kit (QIAGEN GmbH, Hilden, Germany). PCR amplification was set up on CFX96 Touch Real-Time PCR Detection System (Bio-Rad Laboratories - Dubai Branch, Dubai, United Arab Emirates) and a commercially available PCR kit Allplex™2019-nCoV (Seegene, Seoul, South Korea) was used. Allplex™2019-nCoV assay enables simultaneous detection and identification of three target genes, specific for SARS-CoV-2 (e.g. the E, RdRp, and N gene). Samples were considered positive for SARS-CoV-2 only if all three targeted genes were amplified.
In addition, serum samples were collected at the beginning of the study and 14 days after the last nasopharyngeal swab was obtained. The presence of antibodies against SARS-CoV-2 were evaluated using IDK anti-SARS-CoV-2 IgM and IgG ELISA Kit (Immundiagnostik AG, Bensheim, Germany), following manufacturer's instructions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians, nurses and hospital attendants currently working at the University Clinic of Respiratory and Allergic Diseases Golnik were invited to enroll in the pilot study.
Key inclusion criteria (1 listed)
- health care worker
Key exclusion criteria (1 listed)
- previous known COVID 19 infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid antigen test for SARS CoV2Defining diagnostic performance of repeated testing regimen in hospital setting | Diagnostic test | – |
Primary outcome
SARS CoV2 infection
Time frame: 14 days
positive rapid antigen test for SARS CoV2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 34169830Jakobsen KK, Jensen JS, Todsen T, Tolsgaard MG, Kirkby N, Lippert F, Vangsted AM, Martel CJ, Klokker M, von Buchwald C. Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection. Dan Med J. 2021 Jun 14;68(7):A03210217.
- Derived from this study: PubMed 34021827Sterbenc A, Tomic V, Bidovec Stojkovic U, Vrankar K, Rozman A, Zidarn M. Usefulness of rapid antigen testing for SARS-CoV-2 screening of healthcare workers: a pilot study. Clin Exp Med. 2022 Feb;22(1):157-160. doi: 10.1007/s10238-021-00722-y. Epub 2021 May 22.
- Individual participant dataSharing planned: Undecided. IPD are available on request from PI.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihaela Zidarn, MD PhD principal investigator
Klinika Golnik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Rapid Antigen Test, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS CoV2 infection (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04716088, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.