Comparison of Two Point-of-Care CYP2C19 Genotyping Assays for Genotype-Guided Antiplatelet Therapy
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A Method to Study the C924T Polymorphism of the Thromboxane A2 Receptor Gene
Published on: April 1, 2019
Yaolin Zhou1, Alicia R Armstead1, Gina M Coshatt1
1Department of Pathology, University of Alabama at Birmingham, Birmingham AL, USA.
Insights
Point-of-care CYP2C19 genotyping is crucial for clopidogrel therapy. The Spartan RX system offers accurate and rapid results for patients undergoing percutaneous coronary intervention, unlike the Verigene test which had a high no-call rate.
Area of Science:
- Pharmacogenomics
- Clinical Diagnostics
- Cardiovascular Medicine
Background:
- CYP2C19 genetic variations significantly impact clopidogrel's antiplatelet efficacy, affecting approximately 12% of treatment variability.
- Patients undergoing percutaneous coronary intervention (PCI) often require clopidogrel, making rapid CYP2C19 genotyping critical for personalized therapy.
Purpose of the Study:
- To validate and compare the performance of two point-of-care CYP2C19 genotyping tests: Nanosphere Verigene and Spartan RX.
- To assess the clinical utility of rapid CYP2C19 genotyping in guiding treatment decisions for post-PCI patients.
Main Methods:
- A CLIA-certified laboratory performed 99 Verigene and 108 Spartan RX CYP2C19 assays.
- Performance metrics including accuracy, no-call rates, and turnaround times were compared between the two platforms.
- A new clinical workflow utilizing the Spartan RX assay was implemented for post-PCI patients.
Main Results:
- Both assays demonstrated 100% accuracy when results were generated.
- The Verigene CYP2C19 assay exhibited a 33% no-call rate, whereas the Spartan RX system provided consistent results.
- The Spartan RX assay, integrated into a new workflow, delivered clinically significant results to physicians within one hour for 342 post-PCI patients.
Conclusions:
- The Spartan RX CYP2C19 test provides accurate and rapid point-of-care genotyping results, essential for acute cardiac care workflows.
- Implementation of the Spartan RX system facilitates timely clinical decision-making for patients requiring clopidogrel therapy.
- Ongoing prospective studies aim to evaluate the long-term outcomes and effectiveness of CYP2C19 testing in this patient population.
Background:
CYP2C19 polymorphisms contribute about 12% of the variability in the antiplatelet effect of clopidogrel, which is commonly prescribed for patients undergoing percutaneous coronary intervention. For these patients, rapid turnaround time of CYP2C19 genotyping may be critical. We validated and compared the performance of two point-of-care CYP2C19 genotype tests, Nanosphere Verigene CYP2C19 Nucleic Acid Test and Spartan RX CYP2C19 System.
Materials And Methods:
Our CLIA certified Molecular Diagnostic Laboratory performed 99 Verigene tests and 108 Spartan RX CYP2C19 assays. We compared performance and genotype results between the two platforms, across runs, and among technologists. Based on our validation results, we started offering CYP2C19 genotyping using the Spartan RX CYP2C19 assay for post-percutaneous coronary intervention patients.
Results:
Laboratory validation genotype results were consistent between both assays when the assays produced results (100% accuracy); however, the Verigene CYP2C19 had a 33% no call rate. In contrast, Spartan consistently showed accurate results. Using a newly established clinical workflow, we assayed 342 post-percutaneous coronary intervention patients with the Spartan test. Within one hour of submitting patient samples, ordering physicians were notified of any clinically significant results and provided clinical decision support.
Conclusions:
Every approach has its limitations, but our practice of using the Spartan RX CYP2C19 test in our acute cardiac workflow provides accurate and rapid results to guide clinical decision-making at the point-of-care. Prospective follow-up is ongoing to evaluate outcomes and effectiveness of CYP2C19 testing.
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