The MiRXES Fortitude Kit 2.1 is a real-time Reverse Transcription PCR in vitro diagnostic test kit for the qualitative detection of RNA specific to SARS-CoV-2 in nasopharyngeal swabs from patients suspected of COVID-19 by their healthcare provider.
MiRXES Fortitude Kit 2.1 is is a multiplex real-time PCR assay targeting the conserved regions ORF1ab region 1 (FAM) and ORF1ab region 2 (HEX) coupled with an internal spike-in plasmid control.
Limit of detection (LoD): 10 copies per reaction
No cross-reactivity with:
- SARS-CoV-1 (SARS, identified in 2003)
- Influenza A H1N1
- Influenza A H3N2
- Influenza B
- MERS-CoV or EMC/2012 (MERS, identified in 2012)
More than 5 million Fortitude COVID-19 tests have been shipped to 13 hospitals and clinical labs in Singapore, and to more than 45 countries worldwide. Fortitude Kit 2.1 has received CE Mark and regulatory approval in Singapore, Philippines, Panama, Peru, Colombia, and Honduras.
Fortitude Kit 2.1
Primers-Probes Mix, Reverse Transcriptase, Universal Probes Reaction Mix, Positive Control, Negative Control
4480002 (IVD), 4480002R (RUO)
The test is only provided for use by clinical laboratories.