Total Error Allowable

CLIA Waiver, Demonstrating "Accuracy"

26 Allowable Total Error Zone, Limits for Erroneous Results Zones Allowable Total Error Zone (at least 95% of subjects) Limits for Erroneous Results Zones (0% of subjects).

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In EP Evaluator®, allowable instability is specified as a percent of Total Allowable Error (TEa). This Instability Budget is typically 50%. Example: Based on CLIA limits, TEa for AST is 20%.

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Recent Advances in in Method Evaluation

... tolerated without invalidating the medical usefulness of the analytical result" (Carey and Garber -1989). z Definition 2 : An administratively acceptable error (i.e. CLIA '88 PT limit) z In essence, it defines what constitutes acceptable laboratory performance. 15 Allowable Total Error Allowable Total Error z ...

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External Quality Assessment The main methods for assessing allowable error limits in external quality assessment are: #{149} deletion of the results beyond ± 3SD from the mean, followed by recalculation of the ±3SD range; #{149} variation(V) ± 5% range; #{149} the Variance Index Score (VIS ...

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Thus, as a first approximation, analytical goals for medical tests are best defined as the total allowable analytical error, to include both the bias and imprecision components.

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CLIA Waiver

23 Allowable Total Error Zone, (CLSI EP21-A) Limits for Erroneous Results Zones Allowable Total Error Zone (at least 95% of subjects) Limits for Erroneous Results Zones (0% of subjects).

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REVISION OF ALLOWABLE LIMITS OF PERFORMANCE

These goals, called Allowable Limits of Performance (ALP's) were largely a choice between total error goals of ±5%, ±10% or ±20%. They were initially established and maintained by advisory expert groups based on expert opinion and peer based capability.

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GSC Revision of allowable limits August 2010

These goals, called Allowable Limits of Performance (ALP’s) were largely a choice between total error goals of ±5%, ±10% or ±20%. They were initially

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CLIA Waiver Statistical Issues for CBC/ADCC Devices

23 23 Allowable Total Error Allowable Total Error White Blood Cell (WBC) differentials White Blood Cell (WBC) differentials CLIA88 : CLIA88 : +3SD for Proficiency Testing +3SD for Proficiency Testing Criteria not appropriate for an ATE Criteria not appropriate for an ATE

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Desirable Specifications for Total Error, Imprecision, and ...

http://www.westgard.com/biological-variation-database-specifica. Biological Variation Database specifications Updated for 2010! Desirable Specifications for imprecision, inaccuracy, and total allowable error, calculated from data on within-subject and between-subject biologic variation.

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