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.
Detection of the ORF1ab and N regions of the SARS-CoV-2 genome in one reaction.
1h 30min turnaround time after RNA extraction.
High sensitivity and specificity. Zero cross-reactivity with 30 different respiratory tract-associated organisms. 100% match with over 200,000 SARS-CoV-2 sequences.
Compatible with current industry-standard RT-PCR instruments and data analysis software without any additional installations.
End-to-end process validated.
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.
Detects all variants of concern, as of 6 August 2021.
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.
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.
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