The MiRXES Fortitude Kit 3.0 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 and oropharyngeal swabs, washes and aspirates from patients suspected of COVID-19 by their healthcare provider.
The MiRXES Fortitude Kit 3.0 contains the assays and controls, based on real-time Reverse Transcriptase-Polymerase Chain Reaction workflow, for the qualitative detection of SARS-CoV-2 specific RNA in nasopharyngeal / oropharyngeal swabs, nasopharyngeal wash/aspirate, nasal wash/aspirate and anterior/mid-turbinate nasal swabs specimens 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 RNA. 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.
The MiRXES Fortitude Kit 3.0 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.
The test has obtained Provisional Authorisation from the Health Sciences Authority, Singapore and has CE-mark.
This test has not been reviewed by the Food and Drug Administration.
SARS-CoV-2 ORF 1ab gene
SARS-CoV-2 N gene
Human RNase P gene
Limit of Detection
100% match to 207,417 SARS-CoV-2 sequences
No cross-reactivity with 30 respiratory tract-associated organism
Fortitude Kit 3.0
Primers-Probes Mix, Reverse Transcriptase, Universal Probes Reaction Mix, Positive Control, Negative Control
FGS0025-1 (CE-IVD), FGS0025R (RUO)
This test has been validated but FDA’s independent review of this validation is pending.
The test is only provided for use by clinical laboratories covered by a laboratory’s CLIA certification for high-complexity testing, and not for at home testing including at-home specimen collection.