Workflow

Sample Type: Cheek swab
Hands-On Time: <4 minutes
Sample Preparation: None
Pipetting Steps: None
Run Time: <60 minutes


Method Comparison

A total of 325 individuals were tested with the Spartan RX CYP2C19 System and compared with bi-directional DNA sequencing.

If the first test result (First Pass) was a “No Call”, the test was repeated (Second Pass).

Number of Samples Tested: 325
Sensitivity: 100%
Specificity: 100%
First Pass Call Rate: 98.8%
Second Pass Call Rate: 100%


Reproducibility

The Spartan RX CYP2C19 System was evaluated at three sites. At each site, operators repeatedly tested eight individuals with the following genotypes: *1/*17, *2/*3, *1/*1, *17/*17, *1/*3, *2/*17, *2/*2, and *1/*2. Genotypes were confirmed with bi-directional DNA sequencing.

If the first test result (First Pass) was a “No Call”, the test was repeated (Second Pass).

Number of Samples Tested: 960
First Pass Call Rate: 98.8%
Second Pass Call Rate: 99.8%

Regulatory

  • FDA-Cleared For In Vitro Diagnostic Use
  • CE IVD Mark Approved
  • Health Canada Medical Device Licence
  • Korean Medical Device Licence

Background

1 in 3 people carry CYP2C19 mutations that can impair drug metabolism.1

15% of all prescribed drugs are metabolized by CYP2C19 enzymes2, including many commonly prescribed medications such as anti-platelet drugs, anti-depressants, anti-epileptics, proton pump inhibitors and more.


Indications for Use

Spartan RX CYP2C19 Assay

The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Assay will be run on the Spartan RX CYP2C19 Platform from the buccal sample collected with a buccal swab. The Spartan RX CYP2C19 Assay is not indicated to be used to predict drug response or non-response.

Spartan RX CYP2C19 Platform

The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Platform will be used to run the Spartan RX CYP2C19 Assay.


Size and Weight

Spartan RX Analyzer

Height: 4.7 inches (12 cm)

Width: 6.7 inches (17 cm)

Depth: 14.2 inches (36 cm)

Weight: 9.3 pounds (4.2 kg)


Electrical Requirements

  • Electrical Compatibility: 100 to 240 V, 50 to 60 Hz
  • Maximum Electrical Power: 150W to 500W
    • Analyzer: 100W peak
    • Netbook: 40W peak
    • Printer: 9W peak
  • Operating Voltage: 12.0V +/-5%
  • Operating Current: 6.5A Maximum

Environmental Requirements

  • Designed for indoor use only
  • Operating Ambient Temperature: 18° to 25° C (64.4° to 77° F)
  • Operating Relative Humidity: 30% to 70% Non-condensing

System Contents

  • Spartan RX Analyzer
    • Power adapter for Spartan RX Analyzer
    • Crossover ethernet cable
  • Netbook computer
    • Power adapter for netbook
  • Printer
    • Power adapter for printer
    • USB Cable
  • Barcode scanner and stand

System Warranty

  • 1 Year

1Damani SB, Topol EJ. (2010). J Am Coll Cardiol. 56:109–111.
2dbSNP Short Genetic Variations. Reference SNP (refSNP) Cluster Report: rs12248560