ALINITY m MPXV ASSAY (EUA)*

*For Use Under an Emergency Use Authorization (EUA) Only. For In Vitro Diagnostic Use. Rx Only.

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ABBOTT'S PANDEMIC RESPONSE IN ACTION

ALINITY m MPXV IS THE FIRST COMMERCIAL TEST KIT TO BE EMERGENCY USE AUTHORIZED BY THE FDA FOR THE DETECTION OF MONKEYPOX.

Harness the power of ReadiFlex to easily manage varying testing volumes and consolidation of assays on Alinity m.

ReadiFlex on Alinity m provides the flexibility to integrate EUA monkeypox virus (MPXV) testing into your established workflows and adapt to varying testing volumes, while maintaining your regular service commitments.

ALINITY m DELIVERS OPERATIONAL EFFICIENCIES ACROSS HEALTHCARE
  • Alinity m is a continuous and random-access molecular analyzer with a time-to-first result of less than 115 minutes enabling you to eliminate batching procedures and improve laboratory workflow.
  • All steps of the Alinity m MPXV (EUA) assay procedure are performed automatically by the Alinity m system with no intermediate processing or transfer steps performed by the user.

UNIQUE ASSAY DESIGN DELIVERS CONFIDENCE IN RESULTS

  • Dual target assay design for current and future viral evolution
  • Internal control for assessment of amplification efficiency and potential PCR inhibition
  • Cellular control for assessment of sample adequacy to potentially reduce patient recall due to inadequate sample collection

The Alinity m MPXV assay is a real-time polymerase chain reaction (PCR) test intended for the qualitative detection of DNA from monkeypox virus in human skin lesion material specimens from individuals suspected of monkeypox infection by their healthcare provider.

ABBOTT ALINITY m MONKEYPOX ASSAY (EUA) SPECIFICATIONS1-4
TechnologyReal-time PCR
Time to First Result< 115 minutes
ThroughputUp to 1,080 samples in 24 hours*
Probe DesignSingle-stranded probes
Target RegionDual Target: B7R and J2R
Result ReportingMPXV Negative / MPXV Positive XX.XX CN
Sample TypesHuman lesion swab specimens collected in VTM
Sample Input Volume400 μL
Internal Control (IC)Exogenous plasmid DNA
Cellular Control (CC)Human ß-globin gene (DNA)

*Number of actual samples per 24-hour period may vary based on laboratory practice and workflow.
1. Abbott. Alinity m MPXV AMP Kit Package Insert 53-608429/R2.
2. Abbott. Alinity m MPXV CTRL Kit Package Insert 53-608428/R1.
3. Abbott. Data on File.
4. Abbott. Alinity m Operations Manual 54-605001/R13.

 

ORDERING INFO

Alinity m MPXV AMP Kit (EUA)(US-IVD)
UNITORDER #GTIN
4 packs of 48 tests ea, 192 tests total09R06-09500884999050792
Alinity m MPXV CTRL Kit (EUA)(US-IVD)
UNITORDER #GTIN
24 Tubes Total09R06-08500884999050785
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