The Aegle Coronavirus Ag Rapid Test Cassette (Swab) by LumiraDx is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal or nasal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first ten days of symptom onset.
The Aegle test is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The NEWGENE COVID-19 test is also effective for the detection of viruses with S-protein mutations, in particular the English, Brazilian and South African variants. The certificate regarding the effectiveness against the virus mutations is available on demand.
Negative results from patients with symptom onset beyond ten days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.
This coronavirus Ag Rapid Test is intended for use by healthcare professionals or trained operators who are proficient in performing rapid tests and trained clinical laboratory personnel specifically instructed on in vitro diagnostic procedures and proper infection control procedures or individuals similarly trained in point of care settings.
Rapid : results available within 15 minutes
Facilitates patient treatment decisions quickly
Simple, time-saving procedure
No instrumentation required
High sensitivity and specificity
Reliable : listed on FAGG/AFMPS file
Specimen type : Nasopharyngeal and Nasal swab
Time to result : 15 minutes
Specificity = 99.2%
Limit of Detection of the Coronavirus Ag Rapid Test Cassette (Swab): 1.15 x 10² TCID50 / mL