The Panbio COVID-19 Ag Rapid Test Device is manufactured by Abbott. Health Canada approved the nasal collection method on 2020-12-31 and the nasopharyngeal collection method on 2020-10-05.
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.
The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results don’t preclude SARSCoV-2 infection and they cannot be used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
|Diagnostic Sensitivity||84.2% – 95.6%|
|Diagnostic Specificity||98.6% – 100.0%|
|Shelf Life||6-24 months|
|Time To Result||15 Minutes|
|Sample Collection||Shallow Nasal|
Each box only contains one bottle of buffer solution to share between 25 tests. Extra solution is NOT available.