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.

Regulatory Status

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.