Rapid Antigen Testing for SARS-CoV-2 Among Healthcare Workers to Prevent Spread of COVID-19
Condition: SARS-CoV-2 Rapid Antigen Test
Study type: Observational

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.
    

Intervention name(s): Rapid antigen test for SARS CoV2
Intervention type(s): Diagnostic Test
Intervention description(s): Defining diagnostic performance of repeated testing regimen in hospital setting
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
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.