The MiRXES Fortitude 4.0 Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs, nasopharyngeal wash/aspirate, nasal wash/aspirate and anterior/mid-turbinate nasal swabs samples from patients suspected of COVID-19 by a healthcare provider.
MiRXES Fortitude 4.0 is a real-time RT-PCR intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs, nasopharyngeal wash/aspirate, nasal wash/aspirate and anterior/mid-turbinate nasal swabs samples from patients suspected of COVID-19 by a healthcare provider.
The RNA from SARS-CoV-2 is generally detectable in upper respiratory during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
MiRXES Fortitude 4.0 has received CE Mark and is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
SARS-CoV-2 ORF 1ab gene
SARS-CoV-2 N gene
Human RNase P gene
Limit of Detection
>99.8% have 100% homology to either N or ORF1ab target as of 16th February 2021 including B.1.1.7 lineage and B.1.351 lineage.
No cross-reactivity with 31 respiratory tract-associated organisms
96.8% (CI: 89.0% – 99.1%)
96.2% (CI: 87.0% – 98.9%)
Primers-Probes Mix, Reverse Transcriptase, Universal Probes Reaction Mix, Positive Control, Negative Control
FGS0006R (RUO), FGS0006
The test is only provided for use by clinical laboratories or Research Use Only (RUO).
- IFU for Fortitude 4.0
- MSDS for Fortitude 4.0