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Clia Allowable Error

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Toxicology Alcohol, blood Target value ± 25% Blood lead Target value ± 10% or ± 4 mcg/dL (greater) Carbamazepine Target value ± 25% Digoxin Target value ± 20% or ± 0.2 Copyright © 2009. lipoproteinCholesterol, totalCholesterol, TotalCholesterol,LDLCholinesteraseCholinesterase, catalitic activityCK, TotalCk-MBCK-MBCK-MB ActivityCK-MB MassCK-MB qualitativeCK2 Isoenzyme (CKMB)CO2CO2 - TotalCoaguChek Prothrombin TimeCocaine MetabCocaine-MetaboliteComplement C3Complement C4Conjugated Bilirubin, NeonatalCopperCortisolcPSACreatine kinaseCreatine KinaseCreatine kinase isoenzymesCreatine kinase MB, %Creatine kinase MB, activityCreatine kinase All rights reserved. http://entrelinks.com/allowable-error/clia-allowable-error-recommendations.php

or neg.) Rheumatoid factor Target value ± 2 dilution or (pos. or neg.) 1 CLIA INR Analyte Fluid Method Limit Source INR 2 SD 2 WLSH Insulin Analyte Fluid Method Limit Source Insulin +/-25% or 3.0 uU/mL 3 NYS Insulin S- 32.9% When two criteria are given, which ever one is greater should be used. The Poor Lab's Guide to the Regulations The tables below contain information on CLIA proficiency testing criteria for acceptable analytical performance, as printed in the Federal Register February 28, 1992;57(40):7002-186. https://www.westgard.com/clia.htm

Clia Regulations

These guidelines for acceptable performance can be used as Analytical Quality Requirements in the Westgard QC Design and Planning process. or neg.) 1 CLIA, 3 NYS Antithrombin III Analyte Fluid Method Limit Source Antithrombin III P- 8.3% 5 BV Apolipoprotein A1 Analyte Fluid Method Limit Source Apolipoprotein A1 BNII 3 SD Some browsers may not display the plus/minus character (it should appear right here, ±. Some browsers may not display the plus/minus character (it should appear right here, ±.

lipoprotein Target value ± 30% Creatine kinase Target value ± 30% Creatine kinase isoenzymes MB elevated (present or absent) or Target value ± 3 SD Creatinine Creatinine Target value ± 0.3 Analyte Fluid Method Limit Source M-Protein Interpr. Hematology Test or Analyte Acceptable Performance Cell identification 90% or greater consensus on identification White cell differentiation Target ± 3 SD based on percentage of different types of white cells Erythrocyte Total Allowable Error Hematology or IQCP-xit?

Some browsers may not display the plus/minus character (it should appear right here, ±. Sebia Hydrasis LS 90% consensus 4 CAP Magnesium Analyte Fluid Method Limit Source Magnesium +/- 25% 1 CLIA, 2 WLSH, 3 NYS, 6 AAB Magnesium AU640 25% 4 CAP Magnesium S- If it does not, your browser does not support this character). http://www.clinlabnavigator.com/clia-acceptable-test-performance-criteria.html or neg.) Antistreptolysin O Target value ± 2 dilution or (pos.

Endocrinology Test or Analyte Acceptable Performance Cortisol Target value ± 25% Free thyroxine Target value ± 3 SD Human chorionic gonadotropin Target value ± 3 SD or (positive or negative) T3 Total Allowable Error Westgard You can skip ahead to specific areas of laboratory tests by clicking on the listed items: Routine Chemistry Toxicology Hematology Endocrinology General Immunology Note: Analytical Quality Requirements are a plus/minus percentage. Interpr, UrineProtein SProtein, concentrationProtein, outputProtein, TotalProtein, totalProtein, Urine (qual)Protein,total - urineProthrombin timeProthrombin Time (PT)PSAPSA - freePTHPyridinoline/creatinine, morning spotPyruvateQualitative hCGQuinidineRBC FolateRBC Total PorphyrinRed cell distribution wideReticulocyte CountReticulocyte highly fluorescent, countReticulocyte low fluorescent, If it does not, your browser does not support this character).

Clia Allowable Limits

These guidelines for acceptable performance can be used as Analytical Quality Requirements in the Westgard QC Design and Planning process. lipoprotein +/- 30% 1 CLIA, 2 WLSH, 3 NYS, 6 AAB Cholesterol, total Analyte Fluid Method Limit Source Cholesterol, total +/- 10% 1 CLIA, 2 WLSH, 3 NYS, 6 AAB Cholesterol, Clia Regulations Tools, Technologies and Training for Healthcare Laboratories My Cart|Check Out|Login Home"Westgard Rules"EssaysBasic QC PracticesCLIAHigh Reliability"Housekeeping"ISOLinksMaryland GeneralMethod ValidationPersonalQC DesignQuality Requirements and StandardsQuality of Laboratory TestingStatisticsSix SigmaToolsTrendsGuest EssayRisk ManagementQC ApplicationsQC DesignBasic QC PracticesMethod Clia Acceptable Performance Some browsers may not display the plus/minus character (it should appear right here, ±.

or neg.) Rubella Target value ± 2 dilution or (pos. Forgot your username? Westgard QC • 7614 Gray Fox Trail • Madison, Wisconsin 53717 Call 608-833-4718 or E-mail [email protected] "Westgard Rules"QuestionsInterviewsLessonsCLIA & QualityEssaysToolsQC ApplicationsPhotosContact WQCSite Map Home"Westgard Rules"EssaysBasic QC PracticesCLIAHigh Reliability"Housekeeping"ISOLinksMaryland GeneralMethod ValidationPersonalQC DesignQuality Some browsers may not display the plus/minus character (it should appear right here, ±. Total Allowable Error In Clinical Laboratory

General immunology Test or Analyte Acceptable Performance Alpha-1 antitrypsin Target value ± 3 SD Alpha-fetoprotein Target value ± 3 SD Antinuclear antibody Target value ± 2 dilution or (pos. Routine Chemistry Test or Analyte Acceptable Performance Alanine aminotransferase Target value ± 20% Albumin Target value ± 10% Alkaline phosphatase Target value ± 30% Amylase Target value ± 30% Aspartate aminotransferase or neg.) 1 CLIA, 3 NYS Antistreptolysin O Analyte Fluid Method Limit Source Antistreptolysin O Target value +/- 2 dilution or (pos. http://entrelinks.com/allowable-error/clia-allowable-error-limits.php Some analytes have different performance criteria at different medical decision levels.

mOsm/kg or 10% 6 AAB Osmolality 8 mmol/kg 7 RCPA Osmolality 3% 8 CFX Osmolality, urine Analyte Fluid Method Limit Source Osmolality, urine U- Freezing point 3 SD 4 CAP Osmolality,serum Clia Requirements For Analytical Quality CLIA allowable error is calculated by multiplying CLIA acceptable performance criteria by the medical decision level.Fraser has independently published what he believes allowable error should be based on medical significance. Jansdal Ziekenhuis Case StudyTrivergent Health Alliance Case StudyUNC Rex Healthcare Case StudyData Innovations North AmericaData Innovations EuropeData Innovations Latin AmericaData Innovations AsiaBusiness PartnersSolutionsOverviewProductsInstrument ManagerConnectivity Quality Management Productivity IM Version HIstory JResultNetUnify

UsernamePassword Remember me Forgot login?Register Other Articles 1999 Stockholm Consensus Statement 2016 State of the Art Hematology Performance Specifications A selection of SEKK-DMax specifications Belgium EQA performance specifications Biological Variation Database

Routine Chemistry CLIA Acceptable Performance Medical Decision Level CLIA Allowable Error Medically Allowable Error Albumin +/-10% 3.5 g/dL 0.35 g/dL 0.24 g/dL Bilirubin +/-20% or 0.4 mg/dL 1.0 mg/dL 0.40 mg/dL mg/dL or 15% 6 AAB Phosphorus 0.4 mg/dL or 15% 6 AAB Phosphorus 12% 8 CFX Phosphorus -urine Analyte Fluid Method Limit Source Phosphorus -urine U- 0.5 mg/dL or 12% 2 Interpr, SerumProtein El. Rcpa Total Allowable Error or neg.) Anti-Human Immunodeficiency virus Reaction or nonreactive Complement C3 Target value ± 3 SD Complement C4 Target value ± 3 SD Hepatitis (HBsAg, anti-HBc, HBeAg) Reactive (positive) or nonreactive (negative)

If it does not, your browser does not support this character). HomeTest InterpretationsTransfusionQualityMethod EvaluationOutcomes of Poor QCProficiency TestingQuality ControlTest Significant ChangeTest UtilizationNewsletterProductsFREE iPhone ApplicationFREE iPad ApplicationBooksBlog HomeQualityMethod EvaluationClinlabMethod EvaluationCLIA Acceptable Test Performance Criteria Advertisement CLIA Acceptable Test Performance Criteria Details Last Update If it does not, your browser does not support this character). RCPA Allowable Limits of Performance for Biochemistry Rilibak - German Guidelines for Quality Spanish Minimum Consensus Performance Specifications What's New Analysis of common cortisol assays RCPA Allowable Limits of Performance for

Interpr, Ur 24Protein El. or neg.) Back to top Joomla SEF URLs by Artio JAMES WESTGARDFOUNDER Blog About Us Reference Materials& Resources CalculatorsQC ToolsQC CalculatorsMethod Validation ToolsSix Sigma CalculatorsNormalized OPSpecs CalculatorQuality Control Grid CalculatorControl Limit lipoprotein Analyte Fluid Method Limit Source Cholesterol, high dens. Create an account Advertisement Mobile Applications Get it for:iPhone /iPad

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