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Fortitude SARS-CoV-2

& FluA/B Test

The MiRXES Fortitude SARS-CoV-2 & Flu A/B Kit is a real-time Reverse Transcription PCR in vitro diagnostic test kit for the qualitative detection of RNA specific to SARS-CoV-2, Influenza A and Influenza B in nasopharyngeal and oropharyngeal swabs, washes and aspirates from patients suspected of COVID-19 or Influenza by their healthcare provider.

Key

features

Multi-target
detection

Detection of SARS-CoV-2, Influenza A and Influenza B in one reaction.

Fast
results

1h 30min turnaround time after RNA extraction.

Reliable
performance

High sensitivity and specificity. Zero cross-reactivity with 45 different respiratory tract-associated organisms.

Lab
ready

Compatible with current industry-standard RT-PCR instruments and data analysis software without any additional installations.

Quality
assured

End-to-end process validated.

Detailed description

MiRXES Fortitude SARS-CoV-2 & FluA/B Test is a real-time RT-PCR intended for the qualitative detection of RNA from SARS-CoV-2, Influenza A, and/or Influenza B in nasopharyngeal/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, Influenza A, and Influenza B is generally detectable in upper respiratory during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, Influenza, and/or Influenza B 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, Influenza A and/or Influenza B 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 SARS-CoV-2 & FluA/B Test 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 10 May 2021.

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.

MiRXES Fortitude
SARS-CoV-2 & FluA/B Test

Detection Target
Channel
1
SARS-CoV-2
(ORF 1ab and N genes)
FAM
2
Influenza (Flu) A
HEX/VIC
3
Influenza (Flu) B
Texas Red
4
Human RNase P gene
Cy5
Specifications
Values
Limit of Detection
SARS-CoV-2 (0.25 GE/µL); FluA (1 GE/µL); FluB (8 GE/µL)
Inclusivity
100% match to 89,410 SARS-CoV-2 sequences
Cross reactivity
No cross-reactivity with 45 respiratory tract-associated organism
Clinical sensitivity
SARS-CoV-2: 100% (N=50)
Flu A: 100% (N=60)
Flu B: 100% (N=29)
Clinical specificity
SARS-CoV-2: 100% (N=38)
Flu A: 100% (N=55)
Flu B: 100% (N=86)

Ordering

information

Product
Pack size
Contents
Catalogue No.
Fortitude SARS-CoV-2 & FluA/B Test
200 reactions/kit
Primers-Probes Mix, Reverse Transcriptase, Probes Reaction Mix, Positive Control, Negative Control
FGS0022

Contact us

Singapore (Global HQ)
T: +65 6816 2931
E: sales@mirxes.com

Note

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.