An observational study in SARS-CoV-2 Rapid Antigen Test, sponsored by The University Clinic of Pulmonary and Allergic Diseases Golnik. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by The University Clinic of Pulmonary and Allergic Diseases Golnik · Observational
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.
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.
The University Clinic of Pulmonary and Allergic Diseases Golnik is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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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.
Exclusion Criteria:
Defining diagnostic performance of repeated testing regimen in hospital setting
SARS CoV2 infection
positive rapid antigen test for SARS CoV2
Time frame: 14 days
Plan to share: Undecided — IPD are available on request from PI.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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The University Clinic of Pulmonary and Allergic Diseases Golnik