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Performance Characteristics

Availability

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  • Entire test performed in-house

Analytical Validity

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Plasmids containing the target sequence for each pathogen represented the panel were run at serial dilutions across multiple runs to calculate repeatability, reproducibility, limit of detection, inclusivity and exclusivity. Analytical sensitivity and specificity inferred from the validation data are >99%.

Citations

Not provided

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
Yes
Method used for proficiency testingHelp
Formal PT program
PT ProviderHelp
College of American Pathologists, CAP

FDA Regulatory Clearances of the Test

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Not provided

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