Description
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.
Details
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.
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 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 |
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.
