Rapid Antigen Testing for SARS-CoV-2 Among Healthcare Workers to Prevent Spread of COVID-19

NCT ID: NCT04716088

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-18
• Study Completion Date: 2020-12-22

Brief 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 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.

Conditions

SARS-CoV-2 Rapid Antigen Test

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Rapid antigen test for SARS CoV2

Defining diagnostic performance of repeated testing regimen in hospital setting

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• health care worker

Exclusion Criteria

• previous known COVID 19 infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana

UNKNOWN

Sponsor Role: collaborator

The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mihaela Zidarn, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Klinika Golnik

Locations

Universitiy Clinic for respiratory and allergic diseases

Golnik, , Slovenia

Countries

Slovenia

References

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.

Reference Type: DERIVED

PMID: 34169830 (View on PubMed)

Sterbenc 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.

Reference Type: DERIVED

PMID: 34021827 (View on PubMed)

Other Identifiers

RADT for COVID-19 Golnik

Identifier Type: -

Identifier Source: org_study_id