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

SARS-CoV-2 Rapid Antigen Test Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716088
• Other study ID #: RADT for COVID-19 Golnik
• Status: Completed
• Start date: November 18, 2020
• Est. completion date: December 22, 2020

Study information

• Verified date: January 2021
• Source: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 22, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• health care worker

Exclusion Criteria:

• previous known COVID 19 infection

Related Conditions & MeSH terms

• SARS-CoV-2 Rapid Antigen Test

Intervention

Diagnostic Test:
• Rapid antigen test for SARS CoV2
Defining diagnostic performance of repeated testing regimen in hospital setting

Locations

Country	Name	City	State
Slovenia	Universitiy Clinic for respiratory and allergic diseases	Golnik

Sponsors (2)

Lead Sponsor	Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik	Insitute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS CoV2 infection	positive rapid antigen test for SARS CoV2	14 days