Panbio™ COVID-19 Ag

panbio-covid19-ag-img

Abbott

Panbio™ COVID-19 Ag

For people suspected of COVID-19 exposure

Panbio™ COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasal swab specimens from individuals who meet COVID-19 clinical and / or epidemiological criteria. Panbio™ COVID-19 Ag Rapid Test Device is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.

PANBIO™ COVID-19 Ag rapid test device offers:
  • High performance compared to nasal PCR
      – Panbio™ vs. Nasal PCR: Sensitivity 98.1%, Specificity 99.8%
  • Patient-friendly nasal* sample collection
      – 2cm insertion depth minimises undesirable reflexes like coughing or sneezing
      – Patient-friendly nasal self-collected swab option minimises health worker exposure
  • Fast identification of contagious individuals
      – Test results in 15 minutes
  • Accessible, large-scale testing that helps contain the virus spread
      – Enabling immediate treatment or isolation measures to minimise transmission
PANBIO™ COVID-19 Ag rapid test device can be used to:
  • Screen Asymptomatic individuals
  • Test in individuals presenting with symptoms in the last 7 days
  • Test individuals suspected of exposure to COVID-19
Sample Type Nasal swab
Test Time 15 minutes
Sensitivity 98.1% [93.2%; 99.8%]
Specificity 99.8% [98.6%; 100.0%]
Overall Percent Agreement 99.4% [98.3%; 99.9%]
Storage 2°–30°C
Shelf Life Indicated on the outer package
Qty per kit 25 tests
Control Procedural control included within the test
Cat No 41FK11 (CE)
Materials Provided:
  • 25 Test devices with desiccant in individual foil pouch
  • Buffer (1 x 9 ml/bottle)
  • 25 Extraction tubes
  • 25 Extraction tube caps
  • 1 Positive control swab
  • 1 Negative control swab
  • 25 Sterilized nasal swabs for sample collection
  • 1 Tube rack
  • 1 Quick Reference Guide
  • 1 Instructions for use
Materials Required but not Provided:
  • Personal Protective Equipment per local recommendations (i.e. gown/lab coat, face mask, face shield/eye goggles and gloves), Timer, Biohazard container
Panbio™ COVID-19 Ag Nasal Swab Procedure Live Action

* For more information about Panbio™ COVID-19 Ag Rapid Test Click Here