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Performance Characteristics

Availability

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  • Entire test performed in-house

Analytical Validity

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KIT: The assay identified 1 mutation from the FFPE specimens and give 100% sensitivity and 100% specificity of the assay. Sensitivity=TP/(TP+FN)x100=1/(1+0)x100=100% Specificity=TN/(TN+FP)x100=1/(1+0)x100=100% BRAF: The assay identified 1 mutation from the FFPE specimens and give 100% sensitivity and 100% specificity of the assay. Sensitivity=TP/(TP+FN)x100=1/(1+0)x100=100% Specificity=TN/(TN+FP)x100=1/(1+0)x100=100% PDGFR: The assay identified 1mutations from all 2 DNA specimens and give 100% sensitivity and 100% specificity of the assay. Sensitivity=TP/(TP+FN)x100=1/(1+0)x100=100% Specificity=TN/(TN+FP)x100=1/(1+0)x100=100%

Citations

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Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
No
PT ProviderHelp
N/A

FDA Regulatory Clearances of the Test

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Not provided

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