Falck pilot of COVID-19 antibody test

Methodology

The methodology has been approved by the Danish National Committee on health research ethics (NVK)

Research design

  • Large-scale, multicentre, observational study over 6 months
  • Research cohort of ~4,000 Danish and Swedish employees
  • Bi-weekly testing, data collection and registration
  • 100% voluntary participation

Participants are grouped along different sets of criteria. Key demographic indicators are age, gender, geography and primary and secondary employment. Furthermore, they are grouped in different levels of exposure, such as:

  • High – Ambulance staff with frequent patient interaction
  • Medium – Healthcare staff with direct physical contact with clients
  • Low – Roadside assistance and other field staff
  • Low – Office-based staff
  • Unknown – Firefighters who might have roles outside of Falck

Testing procedure

Point-of-care test kits allow for testing while staying safe at home.

The test consists of a finger prick test and participants receive test kit with instructions at their home address.

On a biweekly basis they prick their finger and insert a drop of blood into the two separate IgM and IgG testing cassettes. After 15 min they review the results and fill out a questionnaire online. Besides the results they are also asked key questions on symptoms, recent patient contact and employment roles.

Academic research partners

The COVID-19 antibody research project in Falck is made in collaboration with key partners to ensure test & research validity. Our partners are:

Henrik Ullum, Professor and Chief Consultant

  • Department of Clinical Immunology at Rigshospitalet
  • Professor at Institute for Clinical Medicine, University of Copenhagen
  • Head of the Biobank and the Virology Section

Kaspar Karmark Iversen, Professor and Chief Consultant

  • Department of Clinical Medicine, Herlev-Gentofte Hospital

Test validation

The test being used is a LivZon test, whuich has been validated in collaboration with Blodbanken, Region Hovedstaden. The test performance is close to 100% accuracy in terms of sensitivity (~93%) and specificity (~97%). This means the test is highly unlikely to give a false-negative or false-positive result

Health authority approval

Test kits are approved under European CE-act indicating conformity with EU health, safety and environmental protection standards. The test supplier is ISO-certified (ISO 13485:2012; ISO 9001:2008)

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About the research study

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