Fortitude 3.0

Fortitude 3.0

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.

Key Features

Two-target
multiplex RT-PCR

Detection of the ORF1ab and N regions of the SARS-CoV-2 genome in one reaction.

Fast
results

1h 30min turnaround time after RNA extraction.

Reliable
performance

High sensitivity and specificity. Zero cross-reactivity with 30 different respiratory tract-associated organisms. 100% match with over 200,000 SARS-CoV-2 sequences.

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.

Details

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.

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.

Detection Target
Channel
1
SARS-CoV-2 ORF 1ab gene
FAM
2
SARS-CoV-2 N gene
HEX/VIC
3
Human RNase P gene
Cy5
Specifications
Values
Limit of Detection
0.25 GE/µL
Inclusivity
100% match to 207,417 SARS-CoV-2 sequences
Cross reactivity
No cross-reactivity with 30 respiratory tract-associated organism
Clinical sensitivity
100% (N=50)
Clinical specificity
100% (N=37)

Ordering Information

Product
Pack Size
Contents
Catalogue No.
Fortitude Kit 3.0
200 reactions/kit
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.

Contact Us

Singapore (Global HQ)
Tel: +65 6816 2931
Email: sales@mirxes.com

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