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Clin Chim Acta. 2009 Aug;406(1-2):143-7. doi: 10.1016/j.cca.2009.06.015. Epub 2009 Jun 21.

Comparison of performance of three commercial platforms for warfarin sensitivity genotyping.

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1
Department of Pathology, Pritzker School of Medicine, The University of Chicago, 5481 S. Maryland Avenue, Chicago, IL 60637, United States.

Abstract

BACKGROUND:

We performed a 3-way comparison on the Osmetech eSensor, AutoGenomics INFINITI, and a real-time PCR method (Paragonx reagents/Stratagene RT-PCR platform) for their FDA-cleared warfarin panels, and additional polymorphisms (CYP2C9*5, *6, and 11 and extended VKORC1 panels) where available.

METHODS:

One hundred de-identified DNA samples were used in this IRB-approved study. Accuracy was determined by comparison of genotyping results across three platforms. Any discrepancy was resolved by bi-directional sequencing. The CYP4F2 on Osmetech was validated by bi-directional sequencing.

RESULTS:

Accuracies for CYP2C9*2 and *3 were 100% for all 3 platforms. VKORC1 3673 genotyping accuracies were 100% on eSensor and 97% on Infiniti. CYP2C9*5, *6 and *11 showed 100% concordance between eSensor and Infiniti. VKORC1 6484 and 9041 variants compared between ParagonDx and Infiniti analyzer were 100% (6484) and 99% (9041) concordant. CYP4F2 was 100% concordant with sequencing results. The time required to generate the results from automated DNA extraction-to-result was approximately 8h on Infiniti, and 4h on eSensor and ParagonDx, respectively.

CONCLUSIONS:

Overall, we observed excellent CYP2C9*2 and *3 genotyping accuracy for all three platforms. For VKORC1 3673 genotyping, eSensor demonstrated a slightly higher accuracy than the Infiniti, and CYP4F2 on Osmetech was 100% accurate.

PMID:
19545555
DOI:
10.1016/j.cca.2009.06.015
[Indexed for MEDLINE]
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