ZandCell Flu/COVID-19 Nasal Swab Antigen Combo Test

ZandCell Flu/COVID-19 Nasal Swab Antigen Combo Test

The assay is an in vitro diagnostic medical device that diagnoses Influenza type A, B and SARS-CoV-2 antigen by qualitatively testing Influenza type A, B and SARS-CoV-2 virus antigen in nasal (nasopharyngeal, anterior Nares and/or Mid-turbinate) secretions by chromatographic immunoassay.

Facts:

The limit of detection has been evaluated at 0.5 ng/mL.

Sensitivity: 98,4%
Specificity: 98,2%
Accuracy: 98.2%

Sample size:

SARS-CoV-2: 350
Influenza virus A: 100
Influenza virus B: 120