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GTR Home > Tests > UBE3A Gene Sequencing

Performance Characteristics

Availability

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  • Entire test performed in-house

Analytical Validity

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Analytical Sensitivity 99-100% Accuracy 100% Precision 100%

Citations

Not provided

Assay Limitation(s)

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Does not detect large deletions in the UBE3A gene or deep intronic mutations.

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
Yes
Method used for proficiency testingHelp
Intra-Laboratory

FDA Regulatory Clearances of the Test

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FDA Category Designation
FDA exercises enforcement discretion

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