Comparison of assay systems for warfarin-related CYP2C9 and VKORC1 genotyping.
BACKGROUND
A variety of commercial genotyping assays is available to detect variants in the CYP2C9 and VKORC1 genes. The assay results are used in genotype-based warfarin dosing algorithms. We compared the performance of four such assay systems: Verigene, eSensor, Invader, and Luminex.


METHODS
Result concordance and no call rates were determined on patient specimens tested on all four instruments. Turnaround times (TAT), hands-on time (HOT), pipetting steps and cost were obtained for runs of 1, 8 and 24 samples.


RESULTS
The four assays were 100% concordant for the common CYP2C9 and VKORC1 alleles (n=100). Verigene had the shortest TAT and HOT for 1 and 8 samples. Verigene had the fewest pipetting steps for all sample sizes, while Invader had the most. Luminex had the longest TAT and highest cost for all sample run sizes. Verigene had the lowest cost for 1 and 8 samples and Invader the lowest for 24 samples. The no call rates for Verigene, Luminex, eSensor, and Invader were 10%, 4%, 1% and 0%, respectively.


CONCLUSIONS
All assays gave comparable results for common variants. Each system offered unique advantages and disadvantages, whose relative importance depends on the needs of the adopting clinical laboratory.
Pathology and Laboratory Medicine Service, VA Connecticut Healthcare System, West Haven, CT 06516, USA.
Carleta B
CB
Maurice
Pankaj K
PK
Barua
Diane
D
Simses
Penny
P
Smith
John G
JG
Howe
Gary
G
Stack
D000465:Algorithms; D001189:Aryl Hydrocarbon Hydroxylases / Q000235:genetics*; D065729:Cytochrome P-450 CYP2C9; D004247:DNA / Q000032:analysis / Q000235:genetics / Q000302:isolation & purification; D030541:Databases, Genetic; D004305:Dose-Response Relationship, Drug; D000431:Ethanol / Q000737:chemistry; D005821:Genetic Techniques / Q000191:economics; D005838:Genotype; D006801:Humans; D006899:Mixed Function Oxygenases / Q000235:genetics*; D020641:Polymorphism, Single Nucleotide / Q000187:drug effects; D013997:Time Factors; D064417:Vitamin K Epoxide Reductases; D014859:Warfarin / Q000009:adverse effects*
D000431:Ethanol; D014859:Warfarin; D004247:DNA; D006899:Mixed Function Oxygenases; C450260:CYP2C9 protein, human; D065729:Cytochrome P-450 CYP2C9; D001189:Aryl Hydrocarbon Hydroxylases; C578523:VKORC1 protein, human; D064417:Vitamin K Epoxide Reductases