LumiraDx – SARS-CoV-2 Ag

LumiraDx is a portable instrument for point-of-care testing of SARS-CoV-2 Antigen in sample material from the nasal cavity (vestibulum nasi) or using a deep nasal sample (nasapharynx). The instrument is intended for use by healthcare professionals.

The report provides a vendor-independent evaluation of the analysis quality and user-friendliness of the instrument when used under real life conditions by users in a COVID-19 test center.

The diagnostic sensitivity was 87 % for the nasal samples and 90 % for the nasopharynx samples.
The diagnostic specificity was 99,5 % for the nasal samples and 97,8 % for the nasopharynx samples.
The user-friendliness was rated as satisfactory.

SKUP thanks Marie Lien, Sina Årdal Kvidal, Karina Mjeldheim, Marta H. Mjeldheim and Suong Vo at Bergen Emergency Room for good help with the implementation of the pracitcal work, laboaratory consultant Stein Binder at Noklus and bioengineer Randi Monsen Nygaard at the Department of Microbiology, Haukeland University Hospital, for guidance.

On SKUP’s website www.skup.org you can find the evaluation report.

Here you will also find an overview of ongoing evaluations and published SKUP reports.