PEPFAR Quality Control and Method Validation Activity 14: Part 4

50 Set- 56 50 60 vari, k 1 50 Regression line can clearly be defined when 90 50 55 S Correlation Coefficient Correlation Coefficient (r) Correlation k 1 60 Passed AST Performed on the wa AST Performed on the Which Regression Line is the Correct One? 35 Which Regrcssion Linc 50 tnfendd Intended 'Collect ex erimental data •Collect ex erimental data Collect 55 - ASTL ASTL Random Error- Random Error 50 Y = mX +b Y' = mXc + b rte 60 cobas =rnx+ To Use Linear Regression to Estimate SE To Use Rccvesson to Estimate SE Comparison of Methods Experiment Comoarisow L; to SE To Use Linear de To Ust - scattering of Abs N eeås loc co 205 SELECT 2 [00 100 05 120 2 (00 loo Accuracy lob S use wid( Judging Acceptability Worksheet Linear Regression uinear Regression Regression Worksheet 60 55 In Percent Q/ Constant SE Absolute Aspartate Aminotransferase acc. to IFCC Without pyridoxal phosphate activation Aspartate Aminotransferase acc. to FCC Without pyridoxal phosphate activation Aspartate Aminotransferase to FCC Without What is Linear Regression? 60 Compares 60 50 vari points around the Predict the Y-values that Predict the Predict the 'I-valuer 55 select Limitations • interferences zoo Application for serum and plasma Applicat01n for serum and plasma ApplicatO1n for serum and plasma scattering of points Regresision Pegrecision" Precision 13. Zawta B. Klein G. Babbok W. Temperaturumnrechnung in der 13. Zanta B. Klein G. Babbok W. Temperaturumrechnung in der 13. Zanta B. Klei G. Babiok W. Temperatururnrechnung in der 13. Zawta B. Klein G. Bablok W. Temperaturumrechnung in der 13. Zawta B. Klein G. Babbok W. Temperaturumrechnung in der 13. Zawta B. G. in eer 13. Zawta B. Klein G. Bablok W. Ternperatururnrechnung in der 13. Zanta B. Klein G. Babok W. Temperaturumrechmng der 13. 8. AST at Long- %Bias or Total Error Sigma Metric Sigma Acceptability the range of collected data encompasses as zoo 1 60 Correlation Coefficient (r) Correlation Coelilctenl (rl Critverion: Recovery within to % Of initial value at an AST Criterion: Recovery within 10 % Of initial value at an AST Criterion: Recovery within to % Of initial value at an AST 45 AST Performed on the XYZ Analyzer Precision determined samples and controls in an Precision was determined using human samples and controls in an Precision MSs determined using human samples and controls in an human samples and controls in an samples controls an Prosicn determined using samples and in an klinischen Enzyrrdogie? Klin Lab klinischen Enzyrrdlogie? Klin Lab klinischen Enzyrralogie? Kin Lab klinischen Enzyrrdog•e? Klin Lab klinischen Enzymnologie? Klin Lab klinischen Enzyrnolog•e? Kin Lab 19944023-32. klinischen Enzymologie? Klin Lab klinischen Enzyrnologie? Klin Lab 50 EnzyroZve? Lab 19944023-32. Preciession Defines the strength of a relatil cobas c test definition Comparison ot Methods Exoeniment Random Error,• Random Error • Random Error• Y = mX 9b Comparison ot Methods Expeniment Comparison ot Methods Exoenment Y = mX •b Y=mX •b Y = •b Y = mX mX •b zoo points around the regression line clearly define the regression line 0.991X +1.22U/L +1.22U/L Random Error- 205 205 Random Error, Accuracy actvity of 30 ukavL). acbivity of 30 (0.50 peat'L). acbvity of 30 (0.50 ukavL). of 30 (0.50 of 30 pet'L). of 30 ukavL). of 30 of 30 (0.50 pet'L). of 30 (0.50 ukavL). activity of 30 (0.50 Error, 2 100 zoc Directions: Passing H, Bab!ok W, Bender R, A General Regression Passing H, Ban W, Bender R, A General Regression Passing H, Ban W, Bender R, al A General Regression 14, Passing H, Ban W, Bender R, al A General Regres%ion Passing H, W, A General 14, Passing H, Ban W, Bender R, A General Regression Passing H, Ban W, Bender R, A General Passing H, Site's internal protocol Kith repeatabilitv• (n 21) and internal protocol with repeatabilitv• (n 21) and intemnal protocol Kith repeatabilitv• (n 21) and intema( with (n 2' 21 anc internal with (n 21) and Passing H, W, Bender R, A Regres%n Passing H, W, Bender R, A Regression Passing H, Bank W, Bender R, al A Gene.'al Regression (n and interferenal Constant SE Example IQCP for IQCP for L •near Regression Linear Regression Assay type Rate A Rate A % Difference laboratory of Xc concentration Concentration term %Difference + 3 Performance Predict the Y-values (Y) that 205 S aes that 55 loo Set- loc) loc) 2 loc) H', ammurphy Hi, ammurphy ammurphy ompa Transformation, Con Cnem Cun (3 aliquots per run, run per day, 20 days), (3 aliquots per run, t run per day, 20 days), aliquots per run, t run per day, 20 days), aliquots per run. per aliquots per run, run per day, 20 days), (3 20 (3 aliquots pet run, per day. 20 (3 day. 20 Procedure for Method Transformation, J Clin Chem Clin Procedure for Method Transformation, Chem Clin Procedure for Method Transformation, J Chem Clin for Method Transformation, Clin Chem for Method Transformation, Chem Clin Procedure Method Transformation, Clin Chem Clin Procedure Method Transformation, J Clin Chem Clin Method Transformation, Clin Chem Clin Method Transformation, J Chem Clin Method Transformation, Clin Chem for J Clin Chem Clin (3 aligns per 20! TOOI$, Healthcare Tools, Technologies and Train)in for Healthcare Laboratories Tools, Technologies and Trait)in foA Healthcare Laboratories TOOIS, Technolo and for Healthcareuabotatorios Tools, Technologies and Trainling for HealthcaretLaboratorios Tools, Technologies and Trait)in 'for+iealthcare Laboratories Tools, Technologies and Trainling for Healthcare L-ab)oratories Icterus:• NC interference up to an I index of 60 for conjugated Icterus:g NC significant interference up to an I index Of 60 for conjugated NC interference up an I index Of 60 for conjugated Icterus:g NC interference up to an I index Of 60 for conjugated Icterus:g NC interference up an I index Of 60 for conjugated WES Reaction time/Assaypoints 10/ 12-31 10/ 12-31 (STAT 7/12-31) Abs zoo (00 zoo +1 22U/L +1 22U,'L 22U/L 220/1 22U/'L 22U,'L Westgard QC Y = mX +b 205 Defines the strength of a relationship between two Defines the strength of a relati Defines the ofren$,th of a relations3hip between two QC ompQ€lSon o nsh 0 +1 To access the private area of •1 50B The following results were obtained: results The results were obtained: The results wee citaine& Biochem 198B 198B The resuts were loo around the IQCP and ISO Defines the stren$,th of a between two Dhefsthes ahe of relationship between two Defines the strength of a between two Defines the strens:th of between two Defines the stren*th of a relationship between two Defines the strength of a relationship two Defines the strength of relationship between two the of relationship between two the strength a relationship between tv. Q the stren$,th of a between two the af relationship between two the a relationship between the ofrength af relationship between two bilirubin and 60 uncanjugated t,ilirubin (approximate bilirubin bilirubin and 60 unconjugated (approximate bilirubin bilirubin and 60 unconjugated bilirubin (approximate bilirubin and 60 unconjugated (appiroximate bilirubin bilirubin and 60 unconjugated bilirubin and 60 unconjugated t.ilirubin (approximate bilirubin and 60 unconjugated bilirubin (approximate conjugated bilirubin bilirubin and 60 unconjugated t,ilirubin biirubin • The rélåtionship IQCP ane Defines between two Deftnes strength relationship between two Defines the strength of between two Defines; the of relationship twa Deftnes the between two Defines the strens:th of relationship between two Defines the relationship between and ISO the strength of a between two the strength a the strength of relationship between two the strength between two the strength relationship between two a between to Wavelength Wavelength (sub/main) Wavelmgth nm Use statistical tools on the data to estimate size Precision with (See Sigma table • Use statistical tools on 205 S Use tatistic ize comparison Determine your Medical Decision Point (Xc). Ornpafison o zoo )int (Xc effhods 205 Get Unable to clearly define the regréssio ompafison o rhvn Determined by one of the following- Determnined by one of the following' Determined by one of the following,• Determined by one of the following• Determined by one of the following. +ffods loo FOUNDER Re-pea t abdty• SD concentration: or 1026 approximate unconjugated concentration: rrWdL or 1026 approximate unconjugated The relationship between X and Y must be linear • The relationship between X and Y must be linear and Y must e linear zoo Unable to clearly define the regres •ion line because Unable to clearly define the regression line because lox) loo Determined by one of the following: Determined by one of the following:• Reaction direction A pint (period'stop) atwayS used in this Method Sheet as the decimal A *int (per-offstop) atwayS used in this Method Sheet as the decimal A *int (period'stop) awayS used in this Method Sheet as the decimal A *int (period'stop) atwayS used in this Method Sheet as the decimal A *int (per-od'stop) atwayS used in this Method Sheet as the decimal A *int (period.'stop) aways used in this Method Sheet as the decimal A point in this Method Sheet as decimal A *int (periodlstop) is awayS used in this Method Sheet as the decimal A *int (period'stop) is awayS used in this Method Sheet as the decimal correspond to critical X-values correspond to critical X-values (Kc) 205 DFFecence When you plan for When plan this site. please log inj SEC has re loo zoo Bbs At a medical concentration of (X ) At a ot ) At a medical concentration of 30 (X ) At a medical ot 30 At a medical concentratten of IX ) At a medical concentration )f (X ) At a medic el of ) At a medical concentration of (X ) (X At a medical concentration of (X J At a medical concentration ot (X At a medical concentration (X ) used for the patient te>tlng used for the current patient testing used the current testing used for the currtent patient testing used for the cur rtent patient testing used the current patient used for the cur rent patient testing used for the used for the patient Used for the current testing used for the current pat'ent 205 zoo At a medical concentration of (X At a medical concentration of U/ L (X ) At a medical concentration of 30 L (X ) At 3 medical concentratvon of U/ L (X ) At a concentration of U/ L (X ) At a medical concentratu-nn ot U/L (X At a medical concentrat•en -zoo Abs 205 At medical concentration (X At a medical concentration (X At medical concentration zoo loc) much of the AMR as possible. Abs At medical co At concentration ) Known bilirubin concentraticn: mg/dl_ or 1026 biltrubin concentration: mg/dl_ Or 1026 bilirubin concentration: Or 1026 bilirubin concentration: or 1026 zoo zoo LOL (vkaYL) LOL WL (vkaYL) LOL (vkafL) WL (vkat'L) (vka&'L) BFFecence ence 20. 205 mvn rnwn rtovn 265 the between integral and the parts 60 At a concentration At a concentration of ) I Logout separator to ma" the between the integral and the fractional parts separator to the between the integral and the fractional parts separator to the integral and the parts separator to mark the separator units bs loc) tion (in rnn r•nvn rovn rnvn mnvn loc) 5 Comparative y Avis — y — below) abgout 2 loc) Krovn ELECT corrosooltg to critical correspond to critical K-values 2 (00 (00 N eeå-s Used for the current patient testing Cons Calculate the allowable total error at Xc. N ed-s 10 moo loo At a medical concentration of 30 U/L (Xc) At a medical concentration of 30/ U/L (Xc) NeeE Precirorm Ul Precir•orm UJ Precir•orm Ul Predirorm U 36.6 366 36.6 0611) 366 0611) 3676 36.1 0.5 (0.008) 0.3 (0.005) 0.3 (0.005 (0.005) 0611) 0.3 3676 (0.613) of a decimal numeral, Separators thousands are not used. of a Separators thousands are not used. of a numeral, Separators thousands are not used. of a decimal numeral, Separators fc.• thousands are not used. Of a decimal numeral, Separators thousands are not used. of a num€val. Separators musands are not usea of a decimal numeral, Separators tc.• thousands are not used. ot a decimal numeral, Separators thousands are not used. o' a decimal Separators thousands are At a medicalsoneentration of the future. can you HernoIysis:8 NO up to an H hdex Of 40 (approximate Hernolysis.* NO sigdfcaff interfererce up to an H hdex Of 40 (approximate Hemolys@8 NO significant up to an H hdex Of 40 (approximate HernOIySis:-8 NO significant interfererce up to an H hdex Of 40 (approximate Hemolysis:B NO significant interference up to an H hdex Of 40 (approximate HernoIysis.-8 NO significant interfererce up to an H hdex Of 40 (approximate NO interference up to an H hdex Ot 40 (approximate meets the can you tnfendd zoo Colcrelafion 90 Slope(m) C) Meeks Linear regression is a statistical procedure Risk •Free tisacal A)4s — Claims Reagent dure Ompafison o Incompatible? Operating Ti\ Operating T f Operating T \ Operating pre T f Operating within T? Operat'ng within Ti Operat•ng T f Operet.ng w Ith.n T f Username T { Linear reg Operating within Operating Wi'thin Operating' w 'thin 205 zoo tnfended What the What Operat'ne' Operating Ti Operating Intended 'fended 'nfended Westgard QC Westgard in fended intfended intended infende{ tntended Paired l)ata Calculator l)ata Calculator Coefficient ompa is Data Calculator Calculator tnfende•d Precipath Ll Precipath UJ Precipath LJ Precipath Ul P recipath LJ Precipath U Assaying nnatenials With assigned or Assaying nnaterials With assigned or Assaying mnaterials With assigned or 1 (0.02) regression line variables Assawng tnatenals or (2.14) hernæglobn concentration: 25.6 (40 rr@dL))_ herncglobi,n concentration: 25.6 (40 mrg.'dL))_ hernæglobin concentration: 25.6 (40 mg'dL))_ herncglobn concentration: 25.6 (40 rr@dL))_ concentration: 25.6 (40 rr@dL))_ The experiment is performed to rfo IS hemælobin concentration: 25.6 hemcgJobn concentraticn: 256 use Abs tnlended zoo Method tis per Method e Method (I e Method ( Method Method eO zoo CCns+an+ 40 FOR US CUSTOMERS ONLY: LIMITED WARRANTY FOR US CUSTOMERS ONLY. LIMITED WARRANTY FOR CUST( Qt 51 5. Abs Translalln Clans Y Axis — New +1.22U/L analysis of the 205 Provide the estimate of random error at Xc from your long-term precision experiment. analysts of the UI months Abs 55 Ion -term ex erirnent_ assume that quality that quality Contamination with will elevate results, because the analyte level Contamination with erythrocytes will elevate results, because the analyte Contamination wth will elevate results, because the analyte Human serum 2 Human serum 1 126 (2.10) 126 (210) 1 (0.02) 1 (002) Kill results. of anal tical errors uite's Inspection Tips The SE at a given c one-entratlon The SE at a giv en concentration The Sf at a The SE at a Given concentration The SE at concentration The SE at a The SE at a gr. en concentration The SE at a gr. en c oncentratlon The SE at a gran concentration The SE at a gr. en The SE at The SE at a concentration The Sé at a given concentration SE at a SE at a given concentration SE at a concentration serum Y-in+eccepf Method Coefficienf Clans use Roche Diagnostics warrants that this product will meet the specfcations Roche Diagnostics warrants that this product meet the Roche Diagnostics warrants that this product will meet the Roche Diagnostics warrants that this product meet the specificatiors Roche Diagnostics warrants that this product meet the specffcaticrs Roche Diagnostcs this Roche Diagnostics that meet the Roche Diagnostics warrants that this willuct meet the Roche Diagnostics warrants that this product will meet the specffcaticrs that his mee the 205 17 40 20 VL 3 200 Statistics For Linear the three tests the range of collected data is too narrow. the range of collected data is too narrow. 3 zoo 205 Clans • Passed the • the t • the • the tests • Passed the tests Passed the tests Pas',ed the Pas€,ed the tests Passed the the t the tests the zoo Charodmfisfks Charoda-isfks CharodEfisfcs Charodffisfks Charoda-isfrxs Charoderisfks Charodrrisfts Charoderisfxs Ckarod?fisfkxs CharodETisfrts CharodETisfkxs use I . the tests in is higher in normal sera. The level of may be in erythrc.:ytes is higher than in normal sera. The of maybe in erythrc.:ytes is higher in normal sera The level interference maybe in erythrcc:ytes is higher in normal sera. The level of interference may be in is higher in normal sera. The level of interference may be in erythrcc:ytes is higher in normal sera, The level of interference may be in erythrc.:ytes is higher in normal sera, The of interference maybe 205 S Human senn 2 Baman senn 1 Human serum 1 Human 2 Human Senn 2 Human 3 205 S Human 2 3.1 Human I Hurr.an 2 loc) na Charodensfxs Charodmsf.cs Charodensfrs Charodmsfxs ompa€tson o ethods rr s Human man senn 2 Slope(m) C) About Site's Abs ompa€tson o ompaqlson o 35 U/L 35 35 IJ/L • Visually check your comparison plot Visually check your comparison plot Visually check your Visually check y Calculation r plot stated Ln the labeling "hen used in accordance With such labeling ard stated in the labeling "hen used in acccgdance With such Abelng ard stated in the labeling When used in acco•dance With such Qabeling ard stated in the labeling When used in acccgdance With such labeling ard stated in the labeling When used in accordance With such labeling stated •n tha used n accordance such labelng stated in the labeling When used in acccgdance With such Qbeling slated the labeling When used in accctdance such stated in the labeling When used in acccgdance With such Abelng ard slated in the labeling When used in acccgdance With such stated h the a-hen used in accordame such Bbs Correla±ion slope C at Mineray ac-36cc Éiriso Cotas Cotas CSO I Cobas Cobas CSO I ISO I Abs at no longer matters? no longer loo Samnple •volumes Sample neumes Sample nelumes Sample volumes known values Sample Sample diL'tion Samn-ple Sam-ple 205 -zoo variable depending on he content Of anabate in the lysed erythrocytes. variable depending on co tnnthent Of analyte in the lysed erythrocytes. variable depending on content 01 analyte in the *sed erythrocytes. variable depending on Ofntent Of analyte in the lysed erythrocytes. variable depending on content 01 in the lysed eMhrccytes. variable depending on Of analyte the lysed erythrccytes. Abs Provide the estimate of systematic error (difference) at Xc from your comparison of methods experiment. zoo zoo ystematicc t Xc trom your compari Abs 'Slope(m) C) Correlafion ope Intervtew Westgard Westgardi Slope (X ) can be (X ) can be a. (X can be ) can be will be free defects in material and wcr«manship until he expiraticn will be free detects in material and workmanship until the expiraticn will be free defects in material and workmanship until the expiration will be free detects in material and wor«manship until the expiration will be free detects in material and until the will be free detects in material and workmanship until the expiration Will be free detects material and until he expiraton will be free defects in materia' and workmanship until the expiration be free defects in until the eurabon Reference (X ) be (X ) can ) be ) can Abs 2 loo (X can b"FFerence propor+ional (A search- search-.. 55 o &hods • Compares the the • well the ot the Inter • the ot the Inter • Compares well the the • Compares well tht: the • Compares well the the Inter • Compares well the the inter • the the • the inter Abs • Compares the the I • the • Compares well • well the • well the Inter • well ; • Compares well ; Intermediate precisiorr• Mean Intermediate Intermediate precisiom• Intermediate precisiarr• Mean Intermediate precisian"• Mean Medn Mean Mean Mean SD Mean Operating within pre-defined TEA • Compares • Compares ; ompa€tson o effods Calibraticr 205 EA date on the label. THIS LIMITED WAAAAUTY LIS IN LIEU OF ANY date on label. THIS LIMITED W,VAAAAUTY IS IN OF ANY date on the label. THIS LIMITED W,VAAAAUTY IS IN OF ANY date on label. THIS WAAAAUTY IS IN OF ANY date printed on THIS S OF date on label. THIS LIMITED W,VAAAAUTY IS IN LIEU OF ANY date on label. THIS LIMITED IS IN OF ANY date on the label. THIS LIMITED ',VAAAAUTY IS IN LIEU OF ANY Lipemia No significant interference up an L index Lipemia NC significant interference up an L index Lipemia No significant interference up to an L index date on the label. THIS LIMITED ',VAAAAUTY IS IN OF ANY on THIS LIMITED WAAAAUTY IS IN LIEU OF ANY on label. THIS LIMITED IS IN OF ANY on label. THIS LIMITED WAAAAUTY IS IN OF ANY on THIS IS LIEU OF on label. THIS LIMITED WAAAAUTY IS OF ANY date on label. THIS is OF Voc Coefficierlß • ; date prated on zoo What is the Yc'?? PEPFAR QC Workshop If quality If quality does About 0b Coefficienf Slope be data a expel to the Site's Site's I Sirte's eis Can re•ati Cons Judy designed to show a linear relationship between designed eine the strength of a relationship between two Defines the strength of a relationship between two CorrelaGion in The WL WL (pkatL) WL WL (gkat'L) WL fgkat'L) (vkaV/L) (vka&'L) (pkatL) (gkaYL) at Corte's in The Patholcgje.,t in Pathologist p between •LOL ompafison 50 Calculate the total error and the sigma-metric. Slope(m) C). Slope(m) C) q mpe 51 K site's Of 150. There is cor c.•relation between the L index (corresponds Of 150. There is nor correlation between the L index (corresponds Of There is between the L index (corresponds Of 150. There is cor cc-relation between the L index (corresponds Of 150. There is nor cc-relation between the L index (corresponds Of 150 There s cc-relation bet•een the L index .com r-scc OTHER WARRANTY, EXPRESS ANY OTHER WARRANTY, OR ANY IMPLIED OTHER WARRANTY, ANY OTHER WARRANTY, EXPRESS ANY IMPLIED OTHER WARRANTY, EXPRESS OTHER WARRANTY. EXPRESS ANY IMPLIED OTHER WARRANTY, EXPRESS IMPLIED, ANY OTHER WARRANTY, EXPRESS OR ANY WARRANTY. EXPRESS WARRANTY, OR seqoo aq: Assaying materials with assigned or Assaying mnaterials with assigned or Assaying (materials With assigned or Slope Abs DFFerence ompafison o loc Set-up on an r-scale that ranges from +1.00 to -1.00 Set-up on an r-scale that ranges Set-up on an r-scale that ranges from 01.00 2o -1.00 • Set-up on an r-scale that ranges from +1.00 to -1.00 on an c-sca/e that ranges !rom +1.00 to -1.00 e resslon ence 2 loo ccnsfon+ DIFFecence Jud3i Y-mnfeccep+ rom +1.00 to -1.00 Method (i.e. Method (K) Method (X) method (O Method ( line Comparing patient spec imnen results Comparing patient spec innen results Comparing patient spec Innen re•sults Comparing patient spec linnen results Comparing patient spec innern results Comnparing patient spec Innen results 40 135 P, •ecinorm IJ Precir•orm Ul Precinorrn IJ Precir•orm UJ Precirorm UJ Precinorm Ll PreciT3rrn Ll IJ 367 (0.613) 36 7 36.6 0611) 36.6 36.7 (0.613) 36.7 0613) 36.76 (0.613) 367 0613) 36.6 (0.611) 0.5 (0.008) 0.5 0.3 (0.008) (0.005) 1.3 0.5 (0.008' 36.710.613) 0.5 (0008) 36 7 to turbidlty) and triglycerides a3ncentraticn to turbidity) and triglycerides concentration. to and triglycerides a3ncentraticn. to turbidity) and triglycerides concent.ration to tutoidity) and triglycerides concen:raticn to turbidity) arc trigl>Cendes Corcentra:icn Site's Site with laboratcrv on laboratory laboratory on laboratory report on laboratcrv on a laboratorv report on laboratorv on a laboratcrv report on laboratory on a Comparing patient speenwn OF MERCHANTABILITY OR FITNESS FOR PARTICULAR O; OR FITNESS FOR PARTICULAR OF OR FITNESS FOR PARTICULAR OR FITNESS FOR PARTICULAR OF OR FITNESS FOR omparison o Jud3i A 0 matter. how are you range ol'a It provides a plot of the averatge of a of replicate test Coefficienß 120 IJ/L 120 U/L Y-mfeccep+ Abs zoo propofrional SlQe(m) Correla\ion ce€resston exe estimate the amount of systematic Coefficienf O I nc:reased I roeased Intended Increased I neeased Abs Slope Ligemt specimens may cause > Abs flagging. Choose diluted Ligemic specimens may cause > Abs flagging. Choose diluted Livemtc specimens may cause > Abs flagging. Choose diluted specimens tause Abs flaggirg. Choose Precipath P recipath 130 (2.17) 130 P recipath PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS 8E LIABLE FOR PURPCSé. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR NO SHALL ROCHE NO EVENT SHALL be to 2 loo CCnsfan+ Ct.bhn«rs Ct.rhn€rs Abs Slope Determine the Sigma performance for each Xc using the Sigma table located on the following page. r each Xc using the Sigma table located n [he following page ence N/f •Compare the observed erro (D Ctßhn«s f.ical d Y-mn+eccepf van: ran s (yes or No) ence Proportional SE Constant SE (yes c 35 • Outliers, especially at the ends, can significantly ' Outliers, especial' Outliers, especially at the ends, can significantly Outliers ' Outliers, especially at the ends, can significantly at the ends, cen significantly ( yes The SE at a given medical decision concentration iven medical oncentration loo Y' = mXc + b Y' = + b /00 Y' = sample treatment tor automatic rerun. sample treatment automatic rerun. INCIDENTAL, INDIRECT, SPECIAL ON CONSEQUENTIAL DAMAGES. INCIDENTAL, INDIRECT, SPECIAL CONSEQUENTIAL DAMAGES. treatment automatic rerun. treatment tor automatic rerun. INDIRECT. SPECIAL CONSEQUENTIAL SPECIAL CONSEQUENTIAL results the y-axis the assigned value (111 01 concentliitioti on the x-axis, results on y-axis the (itt 0/0 or on x-axis. going to assure It? Human serum 1 30.0 0501) 30.0 (0.501) 30t0 0501) 30.0 (0501) Human 30.0 (0.501) 0.7 (0.012) 135 23 0.7 (0.012) Abs 0.qq4 SEC stable tor the last 6 SEC staåle for the last 6 SEC remmned the last 6 SEC the 6 SEC stable the last 6 SEC has the 6 SEC has remwne± the last 6 SEC ha} remwne± Stable the 6 SEC has remained tor the last 6 stable the last 6 the 6 SEC the SEC remmned the SEC has tor the last SEC has the SEC has the last SEC has tot the lost SEC has stable tot the last SEC remmned tor the lost SEC has remained tot the SEC has tot the SEC has stable tor the SEC has tot the last SEC has remmned the stable tor the last to' the .Com are he 0 he defin d Compare the observed errors with the defined SEC has SEC ence Judy Y-in+eccepf Correlafion 2 (00 Slope(m) Coefficienf O 2 IOC) of the of of by r will be high Slope by mpaq•tson Judy cobes c 50 "502 test definition cobas c 5011502 test definition with an accurate noethod in long- with an accurate niethod in long- With an accurate mnoethod In longe cobes c 5011502 test definition c 5011502 test definition cobas c test definition What's New with an accurate nnethod in long- with an accurate nnethod In longw ompafison Abs €tson Yin+ercet'+(b) %gias Human 121 (202) 12t (202) 121 (2,02) (2.14) (2.102) (2.02) 1.9 2 rum 4 (202) 85 55 Drugs: NO interference was found at therapeutic concentrations Drugs: NO interference was found at therapeutt concentrations Drugs: NO interference was found at therapeuttc concentrations Drugs: NO interference was found at thera*eutt concentrations found at HOW •WES TOARDRULES" HOME — HOME Can LESSONS, — — STORE , STORE STORE us_ _ -'HOME. rHOME. r HOME" —HOME. Evaluate acceptability at each Medical Decision Point using the pre-defined quality requirement for the new method. Coo e new method. /OØ ccns+on+ 1. 5. I. Passed the previous three proficiency tests • Passed the previous three proficiency tests ompacison o ompafison o ompaqison Assay V' Tvansia\, The regression Linear Regression Regression • I he regression Lhear regression regression mpafison o ompaqitson o ?eéorrrnnce ompa€tson . Slope(m) C) Slope(m) S (syJ perfect pbsit;verelationship using common drug panels:"' using common drug panels:" using common drug panels"' two variables (i.e. X and Y) +1.00 means a perfect positi« réjåii S using common drug using drug 2 100 s (syr) Jud Usef C) m Qnths ence two varia Lirear months 50 ompafison o S(syr) ran: linear tegresston Reaction time/ Assay •points 10/ 1846 (STAT 7/18-46) 10/ 1846 (STAT 7,' 1+46) 10/ (STAT 7,'1846) 10/ 1846 (STAT 7/18-46) 1846 (STAT 7/ 18-46) 10/ 1846 (STAT 7/1846) 1846 (STAT 7/1846) 10/ (STAT 7/1+46) - In 45 •8-46 Can mpa€vson c Can Can ('alculator can be with data a replication to calculate the Incan, can bc a replication to calculate the Incan, will bt Y-tn+eccep+ Exceptions: can cause artificially and Furcsemide artificially Exceptions: can cause artificially and Furosemide artificially Exceptions: can cause artificially low and Furosemide artificially Exceptions: can cause artificially low Furosemide artificially 90 A +1.00 means a perfect positive relationship A +1.00 means a perfect posi +1.00 meaosva perfect Yinferceff(b) iye relationship 2 loo li,leac Y-tnfeccepf 3 200 /OØ can cause r will be low Cobés c501 A +1.00 means a åffecöt[ eac iÅtfbns SlQe(m) (J Cobas Clans standing use CALCULATORS CAn Can Sigma-metrics for HBV Sigma-metrlcs for HBV eeuseå (yes " d" " d' • ALL test method Magnitude of ompafison SE- SE=Y X Wavelength (sub/main) Wavelength (suWmain) S19e(m) C) Neéorrnance ompa€tson o ompa 90 cceas C, cons C, coeas c, cons c, coeas C, conas C, meas c, C, c, cans c, known values used (yes cobas high AST results a: therapeutic concentrations. high AST results at therapeutic high AST results at therapeutic cconcentrations. high AST results at therapeutic concentrations. (Yes or No) 2 loo A ctn Judy Slope(m) (Yes Y-in+ercep+ Y-.n+ercep+ Y-in+eccep+ Y-tn+e€cep+ Y-.n+eccep+ Rentember me om biFerence Re8ression veåorrrnnce linear regression • Calibration acceptable • Calibration verification Calibration acceptable Calibration verification acceptable 2 100 acceptable Acc' f • In ?eéorrmnce (Sl) of vat (C V). A display Regresston (SD and of vat (C V). A histogtatti display or • Calibration Validration • Caltbrat•on Calibration Reaction direction Method comparison Method comparison comparison comparison Obtun (yes 2 loo Quality requirement 02 Quality Requirement Site Cyanokit (Hydroxocobalamin) may cause interfererce with results. Cyanokit (Hydroxocoba'amin) may cause interfererce with results. Cyanokit (Hydroxocoba'amin) may cause interfererce With results. Cyanokjt ( may cause interfererce With n Acct 3 zoo allowable error Site's affect the calculations Slcoe(m) SIC9e(m) Slcpe(m) ompa€tson o SlQe(m) ompa€tson reeresslon Slope (Xc) can be determined as follows: C) e determined as f Clans can be determined as follow ined as follo used (yes or No) useJ ional bc a to 3 2<90 ( yes or NO) 3 2Öo me AST values human serum and plasma samples obtained on a AST values human serum and plasma samples obtained on a Roche,Hitachi AST values human serum and plasma samples on a AST values fot a AST plasma a 3 2ÖO AST and U/L (gkat'L) Slope(m) Slcpe(m) C) Sl.e(m) C) (Yes or No) ional serum on a QC Tools SGJ statistic that na ow eerr r ompafison o 0.997 1.002 be useå ropo«tonal 2.19 120 Tools Slope (m) mpa€tson •e SICQe(m) C) Sigma Performance Table Judy Cons+an s: 2016 Linda 2016 Westgard Award) Linda 2016 Westgard Award] Linda 2016 Award] Linda In very rare cases. gamrncoathy. in partjcutar type Igu (Waldenstråm•s In very rare cases. gamrncoathy. in particular type IgM (Waldenstråm's In very rare cases. gammncoahy. in particular type IgM (Waldenstråm's In very rare cases. gammcpahy. in particular type IgM (Waldenstråm's [n rare cases. In particular type IgM (Wa SlQe(m) C) van: SlQe(m) co (yes cons±on+ cons+on+ ons±on+ ompaqison o cobas c 501 analyzer were compat&d With those determined using the cobas c 501 analyzer were compared With those determined using the cobas c 501 analyzer were compared With those using the cobas c 501 analyzer were compared with those detenrmned using the cobas c 501 analyzer were compared the cobas c 501 analyzer were compared With those dele.•mined using the cobas c 501 analyzer (y) were compared with those dele.•mned using the cobas c 501 analyzer were compared with those determined using the • Comparing results across laboratories Comparing results across laboratories consfon+ cobas c 501 analyze' cc-roared those *ermined usirg the 205 cobas c 501 Y-'n+ercep+ 2 loo were compared usng c 501 were compared those determined using the tobas c (y) were compared d "Peåorrnance Clans Can propoq+ional Cons±on+ prop«fional Cons±on+ provnåional Cons±on+ pm±ional cons±on+ Cons±on+ Consfon+ conston+ Cons+on+ Consta. ac ac Tools • Compares well with the peer group of the inter- ' Compares well with the peer group of the inter- Compares well with the peer group of the inter- S (syr) error Acce 2 loo (.61) 01 01 • V) A at Reagent pipetting Reagent nipetting Reagent Reagent pipe fig Diluent Diluent (820) Diluent (HO0) sed on a s(raighl ine Judy pre Ional prye Ional cc ropoq±lonal ropoqttonal ropoq±ional •tonal mal wide the slope wide to of the slope wade enoui'h the wide to the slope wide enough to the slope enough to the slope to the slope to of the slope —Reference or Old -Reference or Old macroglobulinemia). may cause unreliable results. macroglobulinemia). may cause unreiable results. macroglobulinemia). may cause results or Old the Slope the rop«fional ropoqåional oropoqåional ropoqåtonal ropocfional rop«+ional *ional Ional wide to the wade to the to the may cause results The Cobas c501 Chemistry Analyzer may be judged acceptable for the AST analyte if one of the follow,'ing conditions is met: The Cobas c501 Chemistry Analyzer may be judged acceptable for the AST analyte if one of the following conditions is met: of the Io —3 wide wide to corresponding reagent on a RccheYitachi 917 analyzer corresponding reagent on a RccheYitachi 917 anatyzer corresponding reagent on a NccheHitachi 917 analyzer correspcrding reagent on a NccheYitachi 917 anatyzer correspcrding reagent on a RcchevYitachi 917 analyzer corresponding reagent on a 917 analyzer corresponding reagent on a RccheYHitachi 917 anatyzer corresponding reagent on a NccheYitachi 917 anatyzer corresponding reagent on a NccheÆ*itachi 917 analyzer reagent On a 917 analyzer corresponding reagent on a RccheHitachi 917 analyzer reagent on a 917 analyzer re.nt on a 317 Lirear Linear gent on a to hange e. the error results change prop«+ional leéorrmnce tonal s (syr) - In Correla\ion HOME / TOOLS HOME / METHOD TOOLS / TOOLS c, 35 regression line Regression y) regression Thienpcnt Pharm, Ph.D. Thienpont Ph.D. Thienpcnt Ph.D. Cons Pharr, Ph.D. Slope(m) C) (yes LOGIN SIGN UP Slope(m) proportional floral 90 ao 2 loo Slpe(m) S (syr) X increases, Y always increases aivvays increases const'. S(syr) Resresion 2 loo s (syr) Can 00 For diagnostic purposes, the results should assessed in conjurdion For diagnostic purposes, the results should always assessed in For diagrostic purposes, the results should al•ways assessed in conjunction For diagnostic purposes, the results should al•ways assessed in conjunction For purposes. the results asses Clans S (syJ Can Sample size (n) = 192 Sa&ple size (n) 192 Sample size (n) 192 Sampee size (n) Sam*le size (n) = 192 size = 192 size (n) = 192 Analyzer) Based on the equation for a straight line zoo QC Calculators IQCP ac OC Calculators Lirear will be used as the comparative Login Linear ompafison o S19e(m) C) SlQe(m) C) Xc 2 100 Judy ora Can 35 lo Slcpe (m) 0m 120 and Y -intercept by splitting specjnnens with another by splitting specitnens with another by splitting with another by splitting specilnens with another by splitting specirnens with another by splitting specimnens with another Consfon+ Regression and and Y-•nter.-ept and Vi -Interccpt and "'-•nterceo)t and "'-untercept and 'Y -intercept and V-tntert:cot and Y'-untercept and "'-tnteru•pt and "'-•ntcru_vt Method e Analyzer) Method Analv,'er) Method e XYZ Analy,'er) Method e Analv,'er) Method e ÅY,? Analyzer) Hitachi 91 7(X) e Analyzer) Slcpe(m) (J Method e XYZ Method XY,? Hitachi 91 ao 51 The Era Mindray BC- be used with data a co:nparison of Now on On the Blog Hitachi 917(X) Hitachi 91700 917(X) With the patients medical history. clinical examination and Other findings. With the patients medical history. clinical examination and Other find•ngs. 91 120 with the patient's medal history. clinical examination and 1. Manufacturer's claims for linearity, precision and accuracy have been verified. C) Slope (m) Calculator be used clata a of Hitachi -in Slope (m) C) Slcpe(m) C) ompaqlson o Slope(m) C) jneamty, ore-aslan an accuracy ave een ver; Passing'BabIok Lhnear regression Linear Regression Lhnea_r regression Lhear regression regression C) If Then Jud' 2 loo describes the 2 (00 o mpafison o nas Jud üt)da a\usi HOME Can Sarnple •o/umes Sarnple volumes vol1umes 90 San* Sample diL'tion Sarnple 50 Riochem Roche s (s yr) 91 Visually inspect your data using the • Visually check your comparison plot Visually inspect y 'i S (Cyr) Lirear. y'-Xc. Sty) 1.CCOx-O.1CU/L 1.COOx-O.14gU/L F 122WL 122U/L +1.22U/L 12 U,'L 122WL Quality in the Spotlight:An Quality tshe Spotlighti An Quality in An Quality in the Spotlight ACTION S(syJ I-coon Y; 10 C) to calculate (slope. the ompa«son o same 3 2<30 The Sigma metric less Used Begins YouTube: method (K) method (KJ 2. The total error calculation (bias + 3 Sd or %bias + 3CV) for the test method is less than the CLIA total allowable error for each Medical Decision Point The, methöd häSunacceptäbIe performanee notmeetyourreqüirement for quäIity,eVenn The method has unacceptable performance and does not meet your requirement for quality, even BC-3600 consfon+ WHAT'S POPULAR 3 2Öc Method Validation Tools Clans error for each Medical cision Poi, edit:al Derision Point Special Wash programming; The use Of special wash Steps is mandatory Special Wash programming; The use Of spe-cial wash Steps is mandatory Special Wash programming: The use Of spe-cial wash Steps mandatory 91 Special Wash programming; The use Of special by the same increases as the 35 , zo.9gg r: 0.999 us US JS YS use US Judy 35 2 1004 Activity 14: Comparing patient specimen results ' Comparing patient spec limen results ' Comparing patient speciInnen results Con s n -A laboratory laboratorv laboratory report on a monthly basis Q.) S(sy) å-hods S(sy) % c ompa€tson o The laboratory must demonstrate CAn Accep • Forgot iogin? ao S (syr) METHOD VALIDATION TOOLS Can Lirear Antwerp Accord? MOthod Validation Toots when Certain test combinations are run tcgether on Rcche•Hitachi cobas c when certain test are run tcgether on Fcche•Hitachi cobas c w%en Certain test are run tcgether on cobas c w%en Certain test combinations are run tcgethe,• on cobas c when certain test combinations are run tnether cn FCChe'Hitachi cobas c wren certain test are run tcgether Cn cobas c when certain test are run tcgether cn Rcche•Hitachi cobas c when certain test are run tcgether cobas c Human regression the cot relation regression sy/O, and the Peatson product cottelation atio Can AST A 0.00 means there is NO relationship at all A means there is NO relations?" AO.OO means there is NO Re8ression there is NO is relationship 2.8531 Acceptable Accep 90 35 than 2.9 than 2.0 35 mpqrison Antwerp Limnerick Antwerp Limerick Acct? S (syr) when the method is working properly. •e The sample activities were between 30.4 and 674 U/L_ 3 The Sample activities were 30.4 and 674 (0-508 The activities were 30.4 and 574 J/L08 Il _ 3 The activities were 30.4 and 674 (0508 Il _ 3 The activities were between 30.4 and 674 (0±08 Il _ 3 The activities were 30.4 and 674 (0508 The activities were between 30.4 and 674 J/L (0508 Il _ 3 The activities were between 30.4 and 574 J/L (0.508 Il _ 3 The sample activities were between 30.4 and 674 (0.508 pkaVL) The sample activities were between 30.4 and 674 (0508 11 _ 3 pkaVL), The activities were between 30.4 and 674 The activities 30.4 and 674 (0.508 The activities were 30.4 and 674 U/L (0508 Il _ 3 pkaVL) The activities were 30.4 and 674 J/L The activities were between 30.4 and 674 U/L (0508 11 _ 3 The activities were 30.4 and 674 J/L (0608 The activities were 30.4 and 574 J/L (0508 Il _ 3 The were W4 674 3 The 574 mpaqÅson o SGI) activities were 304 10 3 2<90 and 674 Reoression S(syr) s (syr) 110' Decreased 135 pc 2 loo C) Rearess'xon o? % Q the c. IS(syr) Correla\ion Great 90 systems. The Latest versaon the carryover evasion list can be found with systems. The latest versan the evasion list can be found with systems. The latest vhersan thver evasion list can found with systems. The the evasion list can found with systems. The lateston the carry-over evasion list can be found with The latest the evasion list can found with and S(sy) Sigma Matters can SGJ (Xc). Slpe(m) 35 •n 's (syr) Claims 2<30 Regression C) standard deviation 120 Claims Register regression line St.e(m) , Slope (m) Xc (00 eéorrrnnce % C WHAT'S NEW WHATS NEW the the asccs the 2,SCCS the or the coefficient); statistics between two 01 btas Six Sigma Calculators Can 120 90 leéorrnance Claims WESTGARD WEB 110 References It is n t accept ble for routine o eration. It is not acce table for routine o eration. It is not acceptable for routine operation. Winner 2016 120 wid€ lacp Regression y) (Yes or or gees i - rnnce loc) AS (1, 3 -acc gas Xc (-S€/XC x 10 Compantng Verdicts from Companing Verdicts from Claims Can Reares50on (Yes Avers Method Sheets. For further instructons refer the operator's manual. Method Sheets. For tutther instructions the cperator's manual. Method Sheets. For tutther instructions 'c the operator's manual. Method Sheets, For further instructions the cperator's manual, Clans keoresston 's O? % ;asa c Xc % lasa % c ias cobas ae Xc Q) 2 loo test results get esults ge Can % as Nagy Muscle disease. In: Kaplan LA, Ad,. eds. Clinical Chemistry, Nagy Buscle disease. In: Kaplan LA, Ad, eds. Clinical Chemistry, Nagy Muscle disease. In: Kaplan LA, Ad, eds. Clinical Chemistry, Nagy disease. In: Kaplan LA, AdJ, eds. Clinical Chemistry, Nagy disease. In: Kaplan LA, A,J, eds. Clinical Chemistry, Nagy Muscle disease. In: Kaplan LA, Pesce Ad, eds. Clinical Chemistry; Nagy Muscle disease Kaplan LA, Clinical Chemistry. Nagy disease. In: Kaplan LA, Ad, Clinical Chemistry; Nagy disease. 1m: Kaplan LA, Pesce Ad, eds. Clinical Chemistry, Nagy disease. In: Kaplan LA, Pesce Ad, eds Chemistry, Nagy disease. 1m Kaplan LA, Pesce Ad, eds. Clinical Chemistry, Nagy B. In: Kaplan LA Pesce AJ, eds. Nagy disease. In: Kaplan LA. pesce ao Nagy E _ Pen AJ '6ecum y'-xe 3. The Sigma-metric is > 3.0 for each Medical Decision Point (Xc). Sty) 3.0 for Medical Decision Point keg resston Redress\on The Sigma-metric I comparison or difference plots •om difference plots Human Human Xc test.r, amount Regresston y deviatton of the the two It be used to 120 cobas• cobas c 502 analyzer All wash necessary for avoidirg cobas c 502 analyzer All speeal wash programming necessary for avoiding cobas c 502 analyzer All special wash programming necessary for avoiding cobas c 502 analyzer All wash necessary avoiding cobas c 502 anawyzer All wash necessary for avoidirg cobas c 502 anawzer All wash necessary for avoidirg standat@i deviation of the the two It can also be used to at Xc Xc codas C, ?eéorrnance Clans TheSig å etr s 'Stsy) ASTL 120 at Xc % a 120 •Z s (syr) Secum The method has marginal performance and provides the necessary quality when everything is working keg reson theory, analysis, correlation, St, Louis: theory, analysis, correlation, St Louis: theory, analysis, Sr theory, analysis, correlation, Sr theory, analysis, correlation, St Lcuis: theory, analysis, Sr Louis: theory, analysis, correlation, Sr Louis: theory, anatysis, Sr Louis: theory, anatysis, correlation, St thecty, S Mcsbv theory, analysis, correlation S. Louis: theory, anatysis, correlation, theory, analysis, correlation, St Iwuis: theory, analysis. S Lcuis: analysis, and correlation, St Most" analysis, correlation, Sr Louis: Most" and St. Louis: theory. analysis, and St Y' Lira r Xc loo SlQe(m) C) Cal i bratc•rs s (syr) Rearession y) -TEA y'-xc ser 120 Different Goals IS (syr) = mX Regression Resresslon y) % c 2 100 Human carryover is available via the cobas 'inc manual is not required carryover is available via the cobas Iinoal manpual is not required carryover is available via the cobas Line manual input is not required carryover is a-Wilable via the cobas Iino manual not required is codas is S (s yr) between X and Y; betweerO( and Y; Sec um Regression v'-Xe. y'-xc y'-Xe Normalized OPSpecs OPSpecs SEC has remained relatively stable for the last 6 Reg resSon Lhe regression Regresston Regresston r urnan 2, MOs: DW. •n; 2 Moss DWI Henderson AR, JF. Enzymes. In: NW, . Moss DWI Henderson AR, JF Entymes. In:tz NW, . Moss DW Henderson AH. JF Entymes. In: NW, . Moss DW. Henderson AR, JF Enzymes. In: NW, . Moss DW Hende•son AR. Entymes. In: NW, . Moss DWI Henderson AR, JF. Entymes, In: NW, . Moss DWI Henderson AR, JF. Entymes. In: NW, Moss DW Henderson AR, JF Entymes. In: NW, Moss DWI Henderson AR, Kachm,ar Enzymes, In: NW, Moss DWI AR NW, Moss DW, Henderson AR, JF Enzymes. In. NW, Moss OW Henderson AR. Kachrnar Irr Voss DW, Henderson AR. Kachmat Enzymes in; T•etz NW, DW Henderson AR, JF. Moss OW. AR S BAS x ICOX 2 loo C) SGI) regression Method Validation Data Analysis 1001 Kit S 3. A 55 C) provide a plot" that shows test on the y•a.vas the ptovide a "comparison plot" that shows the test on the y•axts the urnan about the regression In Units of U/ L In Units of U/L Ideally, X=Y where at Xc Accel y'-Xe Xc In Units of Xc Human 12. Where required, special wash/carry•over evasion programming must Slope(m) C) correctly. Seam y'-xc Serum and Wks Can Resres.S10n 120 Another Thing ed. Furdamentals Of Clinical Chemistry. 3M ed. Philadelphia: ed. Furdamentals Of Clinical Chemistry 3M ed. Philadelphia: ed. Fur-damentals Of Clinical Chemistry 3M ed. Philadelphia. ed. Furdamentals Of Clinical Chemistry. 3M ed. Philadelphia. ed. Fur-damentats Of Clinical Chemistry 3M ed. Philadelphia: ed. Fundamentals Of Clinical Chemistry 3M ed. Philadelphia ed. Furdamentals Of Clinical Chemistry 3M" ed. Philadelphia. Ed o: Cherpstry P eff F urdämf Reoresslon lietween the with an accurate method in long- with an accurate mnethod in long- with an accurate nnethod in long- Regression 120 AST Human Xc -infercef+(b) Mean sq lox Securn Method that a new method performs 22. CalibtatOn mode Calibrate' rode Calibrate' node Linear implemented to With this to With this that ödqs search- keg resston Quality Goals at the Crossroads: Growing, Going, or Gone? Quality Goals at the Crossroads: Growing, Going. or Gone? Y'-xc y'—Xc. af Xc Human y'-Xc um Saunders co:npa:ative on the x-ax:s. as well as a plot" that displays the fum rzÖc WB Saunders Member Login we ao Lirear Secum 120 RearesS\on OOZ 45 Can Human Human • Remains the • Remainsåthe higher regression line at Xc sot) Sigma-metncs a undray Sigma•metncs a Sigma-metocs of a Mjnd±ray of a Mlndray a Mindray 90 C S (syr) Accep Secum Thisrpethod will require: This method will require: Calibratrn frequercy Calibrators Calibrate' frequency 2-point 2•point Concentration AST TEA at . Human Reoresston Bopa+iona/_ Long- Bias or % c Total Error Sigma Metric Sigma Acceptability -in AST 201 S %Bias or about Theranos„. about Theranos„ at apos. kearesston plot" the Regresston f) M, R, Approved 3.1 35 aergmeyer HLJ, Herder M, Rej R, Apprwed (1985) 30.0 HLJ, Herder M, Rej R, Apprwed (1985) HU, Herder M, Rej R, Apprwed (1985) HI], Herder M, Rej R, Apprwed HLJ, Herder M, Rej R, Apprwved (1985) HLJ, M, Rej R, Apprwed recommendation (1985) HI], Herder M, Rej R, Apprwed (1985) Harder M, R, Apprcued (1985) Herder M, Rej R, Apprwed (1985) Herder M, Rej R, Apprwed recommendation (1385) HUJ, Herder M, Rej R, Apprwed (1985) Herder M, Rej R, Apprwed recommendation (1985) Herder M, Rej R, Apprc.•ed M, Rej R. (1985) HLJ. Herder M, R, Apprwed 1.2 2 A/c - M, Rej R Approved HIJ M. Rej 120 130 10 f) ecu m Human af Xc %ias AST Limits and ranges Xc Can 90 ser sq Accep 120 f) ecu m after reagent lot change between the test on the y-axts versus tlic between the test co:nparative results on the y-ax:s versus thc 35 120 120 • Identify and remove outlier points Identify and remove outlier points Identify and remove ou and remove outlier points on IFCC methods for the measurement Of catalytic concentration on IFCC methods for the m,easurement Of catalytic concentration on FCC methods the on IFCC methods for the measurement 01 catalytic concentration or, IFCC methods for the measurement Ot catalytic concentration IFCC methods he o' on FCC he cd cataMic cottentration [FCC metros the of • plotter Regression y resston Reyresston 0 4-8 controls per run 4-8 run ec-gccc hematology ec.36C0 hematology BC-36CO hematology ec-gcco hematology Regress s€/r AVC hematology Introduction to Method Evaluation cobaS• %Bias at Measuring range Measuring y'-Ye at Xc Secum Xc displays the range Grear Example IQCP for IQCP for IQCP Human line. as required quality as required follow•ng quality as required fallow•ng quality Quality Control Grid of Xc concentration 35 %Difference DFffecence Difference (bias + 3sd) ([TEA - bias]/sd) - biaslisd) Performance termn term Of enzymes. Part 2. 'FCC method aspartate aminotransferase. Of enzymes. Part 2. •FCC method aspartate aminotransferase. Of enzymes. Part 2, 'FCC method aspartate aminotransferase. Of enzymes. Part 2. 'FCC method tv aspartate aminotransferase. Of enzymes. Part 2. 'FCC methCd aspartate aminctransferase. Of Part 2 FCC aspartate amirttransferase. Part 2 FCC 8: 35 RegressÅon Sh the uill scatter randomly Hi. ammurphy Hi. ammurpny To access the pnivate area ot all the points will scatter, randomly all the points will scatter randomly 35 • f) HI, arnrnurphy 5-700 -in Human 'I Human method result on the sq 120 the slop the slope is 1.00 and on the x-ax:s. Can o months to the at Xc S(syJ ptccedures procedures y'-Ye 35 JAMES o well-trained operators J them J Clin Chern J Clin Clin Clin Chem 35 Xc (Yes . SI) calculator SSI) QC Secum 35 analyzer 3 -abc n; Human c yes S(syr) BC. C. IQCP and ISO IQCP ane ISO and ISO 001 z -In • Changes as yes or G ism a. %gias Cabculatory Calculator Determine samples having higher activities via the rerun Dilution ot Determine samples having higher activities via the rerun turction Dilution ot Determine samples having higher activities via the rerun turcticn Dilution ot having higher via the 3. ECCS Lirear. 4 ECCLS_ Determination of activity concentration 4 ECCLS_ Determination of che activityc concentration 4 ECCLS_ Determination of the activity' concentration ECCLS_ Determination of the catalytic activity concentration ECCLS_ Determination of the activity' concentration ECCLS_ Determination of concentration ECCLS. Determination of the catalytic activity concentration ECCLS. Determination of activity' concentration 4 ECCLS_ Determinatbon of the catheytic activity concentration ECCLS_ Determination of activity concentration ECCLS. the 4. ECCLS_ of Re8ressÅon Precision wvith Site with (See Sigma table (SHE (See la±le 2 loo What's New Regression Regresston rnQ„ 15 y'-Xc this please this site. please log 35 y'-xe. 120 Traceability-. This mehc•d has been standardized again•st the original IFCC Traceability-„ This mehc•d has been standardized again•st the original IFCC Traceability-. This meho•d has been standardized agair•st the original IFCC Traceability-. This mehc•d has been standarüed agair•st the original IFCC Roche Cobas Sec um Lirear same AST es as one 35 Xc Roche Cobas Secum o reduced roQation of personnel o reduced rotation of personnel 35 There are days I worry we are debating how many angels can dance on the head Of a Test Method FOUNDER samples via the rerun functis a 1:10 dilution, Results from samples (fluted samples via the rerun function is a 1:10 dilution, Results from samples (fluted samples via the rerun function is a dilution, Results from samples (fluted via the rerun function is a dilution, Results from samples • Calculators at Xc Human 35 in serum Of I-aspartale amnirdransterase (EC 261.1, ASAT). in serum Of I-aspartale amnirdransferase (EC 2.6.1.1. ASAT). in serum Of I-aspartale amirdransterase (EC 261.1, ASAT). in serum Of I-aspartate arnirdransterase (EC 2.6.1.1. ASAT), in serum Of I-aspar•tale amirdransterase (EC 2.6.1.1, ASAT). in serum Of I-aspartate amir•dransterase (EC 2.6.1.1, ASAT). in serum Of amtrdransterase (EC 261.1. in serum Of L-aspartale amirdransterase (EC 261.1. ASAT), in serum Of L-aspa.•tate arnirdranster•ase (EC 2.6.1.1, ASAT). in serum Of I-aspartale amirdransterase (EC ASAT), o' I-aspartate amirdrans±rase (EC ASAT). in serum L-aspaflale amirdra-&ase (EC 2.6.1.1. ASAT). senn Ot in serum of -TEA When you pian for lethod gum an c- 3, Human 35 • Paired-data ('alculator• • Paired ('alculator Paired ata ('alculatot• When you plan for , Human Human formulation •Sing calibrated pipettes together with a manual photometer formulation 'Sing calibrated pipettes tcgether with a manual *Ootometer formulation 'Sing calibrated pipettes with a manual formulation pipettes together with a manual photometer you •Sing calibrated pipettes with a manual photometer calibrated pipettes tcgether with a photometer calibrated pipettes together with a manual photometer formulation calibrated pipettes *ther with a Human 35 Method standing use 15189: . Human 120 35 Method Decision Calculator 'l his, tool has been de-activated. updated tool can be Xc Human 35 keoresslon comparably to or better than the old 'Judge the accept3bility of observed •Judge the acceptability of observed 'Judge the acceptability of observed 35 using the rerun function are automatealty multipied by a factor Of 10. using the rerun function are automatealhy multipied by a factor of 10. using the rerun function are by a factor of 10. using the rerun function are automatealhy multipled by a factor of 10. using the rerun function are multipled by a 10. using the rerun function are multipled by a factor of 10. using a.e a SE=Y' X 55 Lirear. 120 xyz Acce Chemn Chem Chem Mitt Chem crem s (syr) • It quantifies the • Regression is used to show a relationship Regression is used to show a relationship 35 % vas * xc) Comparative on following Cobas (in sd) (in maintenance providing absolute values the substrate•specific aesorpttvity, c.7 providing absolute values the absorptivity, c.7 y'-Xc 55 35 providing absolute values the substrate•specific aOsurptivity, providing absolute values the substratwpecfflc &es.orptivity, providing values the substratwpecific aesuptivity, providing absolute values the substratNpecific absorptivity, prwiding abscUte the o more aggressive preventive maintenance 56 Username Y may increase, decrease, or remain the same as X performance specification. Or that all blind men feeling different parts of a great elephant performance specification. Or that we're all blind mon tooling different parts of a great elephant Clans • A sufficient range of data must be collected to A sufficient range of data must be collected to Test Method Sigma-metric 51 5. Tietz NW. Ctr.ical Gu•de to Tests, ed. Philadebhia, 5. Tietz NW, Gu•de to Laboratory Tests, ed. Philadebhia. 5. 5. Tietz NW. Glide to Tests, ed. Philadebhia. 5. Tietz NW. Gu•de to Tests, ed. Philad#hia. 5. Tietz NW. Gu•de to Tests, ed. Philadebhia, W. 5. Tietz NW. Gu•de Laboratory Tests. ed. Philadebhia. 5. Tietz NW. CMicaI Gu•de Tests. ed. Philadebhia. 5. Tietz NW Gu•de to Tests, ed. Philadebhia, . Tietz NW. Clinical Gu•de to Laboratory Tests, ed. Philadebhia. . Tietz NW, Clinical Gu•de to Laboratory Tests, ed. Philadebhia. Tietz NW. Clinical Guide to Laboratory Tests, ed. Philadebhia. Tietz NW. CEinicaI Glide to Laboratory Tests, ed. Philadebhia. 5. Tietz NW. Cldnical Gu•de to Laboratory Tests, ed. Philadebhia. Tietz NW. Glide to Laboratory Tests, 3'" ed. Phila*hia, Tietz NW. Clinical Gu•de to Laboratory Tests, 3'" ed. Philadebhia. Tietz NW. Clnical Gu•de to Laboratory Tests, 3" ed. Philadebhia. NW Guide to Laboratory Philadebhia, G. to Test. PhiladebhÄ W. Laboratory Tests, NW to Tess, Roche Cobas Control Calculator 121 the future. can you 35 :obas Human 35 • l)ecision Calculai0!1 Se€um Lower of measurement limits of measurement Lofer measurement of measurement measuretnent Lower omits 35 I umun Human 120 35 Sigma-metnics fot HBV Risk-Free 35 regression line accessed at course . those who not to pay access. you 35 Incompatible? f) accessed at kesression 120 the Y-inter ept is 0.0 the Y-intercept is 0.0 Y-int •Y-int Y-int rcept/ f) ecu m Quality control. Qor quality control. Quality control page) rcept Accepy PA: PA: WB PA: WB PA WE Control Limit Calculator over a range of over a range of' of concentration concentrations 23 o careful monitoring of patient test results tool tool can be Lower delecf,bn Of the test Lower Of the test Lower detecf,bn Of the test Jimi: O,' S or S BAS it Method onh.'N• eon' Method 120 85 Calibration verification was acceptable • Calibration verification was acceptable che Cobas of error and uncertainty. But the latest "round" in the debate is depressingly familiar. of error and uncertainty, But tho latest "round" in tho debate is depressingly familiar. Roche Cobas Of Roche over a ra ge 121 analysis of the Sec um fief um For quality control. use control materials as Listed in the For quality control, use control materials as listed in the Test Method 35 roche Cobas assume that quality quality 6 Use of Anticoaguhnts in Diagnostic Investigatons. 6 Use of Anticoaguhnts in Diagnostic Laboratory Investigatbns, 6 use Anticoaguhnts in Diagnostic Laboratory Investigatons, 6 Use of Antaaguhnts in Diagnostic Laboratory Investigations. 6 Use of Anticoaguhnts in Diagnostic Laboratory Investigatons. 6 Use of Anticoaguhnts in Diagnostic Investigatbns, 6 Use of A nticoagÄhnts in Diagnostic Laboratory Investigatbns, 6 use of Anticoaguhnts in Diagnostic Investigatbns. 6 Use of Anticoaguhnts in Diagnostic Laboratory Investigatbns. 6 Use of AntkoagÄnts in Diagnostic Investigations, 6 Use of AntacoagÄhnts in Diagnostic Laboratory Investigatons. 6 use of Anticoaguhnts in Diagnostic Investigations, use Anticoagulants in Diagnostic Laboratory Investigatbns. use of Anticoagulants in Diagnostic use of in Diagnostic Laboratory Investigatons_ use ot in use in In Roche Cobas sec um 'Che Cobas Cobas Regression still download a Six spreadsheet. Roche Cobas Roche Cobas Roche Coba.s Test Method still download a Inspection Tips och 5 u,'L 5 U,'L cobas 'ethod % C Test 'as Roche Cobas 120 IQS Abgout Logout Human 35 Rea resson Human 40 IJ/L •Order section. •Order information" section. •Order Sedicn. •Order Section •Order information' section. •Order Non-nation' Section. 2.3 U/L 35 o continual efforts to im rove method erformance Xc iod WHO Rev,2, WHO Rev,2. Rev,2, Rev2 Reportable Range 120 2016 Westgatci Award: Linda The detection Emit represents the lowest measurable analyte The detection represents the che Cobas The Lower detection Eimit represents the lowest measurable analyte The lower detection Emit represents the lowest measurable analyte The detection Emit represents the measurable analyte regression line Human scatter of points S BAS 55 access. Test Method 35 120 35 U/L xyz Humqn % c Mindray BC.3600 BC-3600 y'-Xc Test Method Roche Cobas XYZ Ana In additOon, other suitable control material can be used. est Method Method 'bas no longer matters? In addition, other suitable control material can be used. In addition, other suitable control uterial can be used. In additOn, other suitable control can be used. Regression y) Test Method no longer . Schumann G. R. al. FCC Primary Reference Schumann G. R. Ceriotti F, et IFCC Primary Reference Schwnann G. Bonc.•a R. h et al. IFCC Prima,"' Reference Schumann G. R. Ceniotti h, et al. IFCC Priman/ Reference Schumann G. Boncta R. Ceriotti h et IFCC Primary Reference Schumann G. Bonc.•a R. Ceriotti F, et IFCC Primary Reference Schumann G. Boncta R. F. et al. IFCC Primary Reference Schumann G. R. Ceriotti h et IFCC Primary Reference Schwnann G. Boncta R. Cenotti h et Il. [FCC Primary' Reference Schwnann G. Boncta R. h et IFCC Reference . Schumann G. R. F, et al. IFCC Reference Schwnann G. Bonc.•a R. Cenotti h et al. IFCC Prima,"' Reference Schwnann G. Boncta h et IFCC Reference Schumann G. Boncta R. Ceriotti F, et al. IFCC Primary Reference Schumann G. Boncta R. Ceroti et al. IFCC Primary Reference Schumann G. Boncta R. Ceriotti F, et al. IFCC Reference Schna,-n G. F. Ceriotti al IFCC G. F. et al FCC Reference (Y) performance characteristics Slope st Method Method Test Method •he Cobas y) XYZ Analyzer 'St Method rest Method that can be distin,guished from C. It is calculated as the value level that can be distinguished from C. It is calculated as the value that can be distinguished from C. It is calculated as the value car. from is as can be distinguished from C. It calculated as kesression Interview: Westgard Regression R" resson Tools tools to tools "popup'. " Interv•ew Westgaf€i Useful for assessing whether the range of data is y'-xc 35 Human 121 (Y) y'-Xec If the Sigma metric is Comparative at Xc obas Reference Xc The method has fair performance and meets your requirement for quality and can be managed in urnan Q search... CA search.. tod Human Reference Materials Reference Mater'a's Reference Matotfalo Reference MaterlaJ4 between the X and Y values, as well as to The intervals and limits should be adapted each The control intervals and limits shcuJd be adapted to each The intervals and limits be adapted to each The intervals and limits should be adapted to each laboratory's intervals and limits be adapted to each 121 35 Procedures for the Measurement of Catalytic Activity Concentratbns Procedures for the Measurement of Catalytic Activity Ccncentratbns P.•æedures for the Measurement Of Catarytic Activity Co•ncentratbns P.•æedures for the Measuremnent of Catalytic Activity Co•ncentrations Procedures for the Measurem,ent of CataMytic Activity Concentratbns Procedures for the Measurement Of Catalytic Activity Ccncentratbons Procedures for the Measurement Of Catatytic Activity Concentrat6ns Prozedures for the Measurement of Catatytic Activity Concentratons Procedures for the Measurement of Catalytic Activity Co•ncentratbns for the Measurement Of Catalytic Activity for the V.easurement of Activty Concentrat6ns 3. the ot Calculator Quantifying Calculat.or Quantifying Quantifying XYZ Analyzer 35 (Y) can be data a ity to assess the qJL Thienpont Ph.D. e Cobas i 110 Ying 3 that the standard Iving 3 the standard Iving 3 thet of the standard lying 3 that the standard Iving 3 that the standard Part 4 Reoresston y changes rest Method Continue Reading 15 concentrations clearly define the regression line Goz If quality does Roche Cobas Y-intercept = 1.22 Y-intercept = XYZ Human individual r&äuirements. Values Obtained smuld fall within the defined individual require.•nents. Values Obtained sm-auld fall Within the defined ind•vidual r&quiret•nents. Values Obtained sm-auld Within the defined individual r&äuirements. Values Obtained smuld Within the defined 1.20 35 Enzymes at 37 'C • i. the ot Enzymes at .37 'C S. of at 37 Pad 5. for the of Enzymes at 37 • Pad 5. for the of Enzvmes at 37 • Part 5. Reference for the of Enzymes at 37 • Part 5. Reference for the of Enzymes at 37 • Pad for the ot at 37 • Part Reference for the of at 37 • Part 5. for the of Enzv,es at 37 Part 5. Reference for the of Enzv,es at 37 Part 5. for the of Enzv,es at 37 • Part 5. for the Enzymes at 37 Part 5. Reference for the of Enzymes at 37 'C • Part 5. Procedure the (Y) Enzymes at 'C • 5 ot Enzymes method of testing. of teo ns 35 Regressxon y) in The Patholog•st in The in The Patholog.st in The Patholog.sit (standard I + 3 SO, repeatability. n 21). (standard 3 SO, repeatability, n 21). (standard 3 SO, repeatabdlity. n 21). (standard 3 SO, repeatabdity. n 21). (Y) Rea ressxon y (Y) Password 50 Comparative hod L XYZ Analyze r) routine operation. hod hod I XYZ Analyzer xyz Analyzer Analyzer XYZ AnalIyzer XYZ Ana S Resources Compp-ative Result (X) 35 Cobas thod , 35 35 limits. Each laboratory *aould establish corrective measures to be limits. Each laboratory establish measures be limits. Each laboratory Should establish corrective measures be limits. Each laboratory Should establish cor•rective measures limits. Each laboratory establish cc.•reeive measures limits. Each laboratory Sr-auld establish measures limits. Each laboratory establish measures to limits. Each laboratory *auld establish cc.•reeive measures as 120 121 121 Comparative Method Result (X) Measurement of of Aspartate Amhotransferase. Measurement of Concentration Aspartale Amhotransferase. Measurement Catalvlic Concentration of Aspartate Measurement Aspartate Amhotransferase. Measurement of Aspartate Measurement Catalvlic Aspartate Measurement Aspartate Annotransterase. Measurement Aspartate Measurement Catalvlic of Aspartate Amhotransferase. Measurement Catalylic of Aspartate Measurement of Aspartate Amnotransferase. of Concentration Aspartate Catalvlic of Aspartate Amhotransferase. Concentration of Aspartate Amhotransferase. Concentration Aspartate of Aspartate Amnotransferase. of Aspartate Amnotransterase, of Aspartate Amhotransferase. Aspartate Measurement of (Y) Method y'-Xc OOZ c SOI Cobas 120 'as Comparing results across ' Comparing results across v'-Xe have a that popup ethod (Y) have have a popujp have pop."' thot popajp 'hot 47 'bas Westgard QC bas Method tas Method xyz Test Method XYZ rest 121 matter. how are you Thienpont Phatm. PhD neth0d about the regression Method f Method (i.e. taken values fall outside the defined "mits. taken if values fall outside the defined limits. taken it values fall outside the defined limits. taken it values tall the defined -b to lethod i 120 Clin Chem Lab Med Clin Chern Lab Med Clin Chemn Lab wed Clin Chem Lab wed Clin Lab Med Chem Lab Med Clin Chern Lab wed Chem Lab ctn Lab Clin Chern Lab cr•ern Lab 725-733 Cin Chem L Roche Cobas Errors wide enough to provjds estimates of the slope— Comparative Compacativ, Sec um Expected values 120 120 IJ/L 120 UJ/L Sec um Quality jn the Spotlight: An Expected values" Roche Cobas Method vas :hod Human AST Method Human (Y) This method will re uire a multirule rocedure with 4-6 control measurements er run. 'thod Zobas rest Method Calculator Quantifying you to graphs. Also. you graphs. the y-axts versus the untts) the x-axis, to graph',. Also. graphs. Also. thod obas (Y) Test Method Cobas X Axis —Reference or Old X Axis —Ref'rence or Old Follow the appli:able regulaticons and Follow the applicable and Follow the applicable government and Follow the applicable and gÆines Follow the applicable regulaticons and the applkable government regulaticons and Follow the applicable regulations and the applicable and the applicable regulations and the appb:able regulaticos IQ Co m pa (X) you 8. E Glick MN, Ryder KW, Jackson SR Graphtal Comparisons of Interferences E Glick MN, Ryder KW, Jackson GraphCaI Cornparisonsof Interferences Glick MN, Ryder KW, Jackson SR G r apneal Comparisons Of Interferences Glick MN, Ryder KW, Jackson SR Comparisons Of Interferences E Glick MN, Ryder KW, Jackson SR GraphCaI Comparisons Of Interferences E Glick MN, Ryder KW, Jackson SR Graphtal Comparisons Of Interferences E Glick MN, Ryder {W, Jackson SR G r aphCaI Comrparisons Of Interferences Glick MN, Ryder KW, Jackson SR GraphCaI Comparisons Of Interferences GIO MN, Ryder KW. Jackson SR Comparisons Of Interferences MN, Ryder KW, Jackson SR Compansons Of Interferences GO Ryder Jackon SA_ Coroansons Of AST Gbck 'IR, KW Jackson SA_ Of Interferences MR. KW J30:scn SA Roche Cobas •obas (Y) Roche ROC h 0 Roc h O cobas Od Acc, the optimized standard method (comparable to the IFCC Acc, standard methcd (comparable to the IFCC Acc, standard (comparable to the IFCC Acc, standard (comparable the IFCC Acc. the standard (comparabie 'o the 110 wide enough to provide good estimates of the slope •wide enough to provide good estimates of the slope 35 Roche Calculator Comparative An IQCP Primer from MU Survey 2015: CLSI EP15-A3: • IncreaséShb9 Method (X) Method (i.e. Method Method OO Method (K) 110 Method Method (X) going to assure it? • Increases by an • Increases by a Increases by an predict the Y-values (Y') that correspond predict the Y-values (Y') that correspond) ses by a Validation el Test Method (A) for quality for quality control. quality for quality in Clinical Chemistry Inslrumentation Clin Chem in Clinical Chemistry Instrumentation Clin Chem in Clinical Chemistry Instrumentation.Clin Chem in Clinical Chemistry Clin Chem in Chemistry Clin Chem in Clinical Chemistry Instrumentation Cfin Chem 1986;32470475_ XYZ 35 Antwerp Accord? method Without pyridcxal phosphate activation 12}. method Without phosphate method Without phosphate activation method Without pyridoxal phosphate activation 12): method pyridcxal phosphate method phosphate activation method Without pyridcxal phosphate activation 12); method Without pyridcxal phosphate activation 12): as 35 OY Opera Or Opera mehod pyridoxa] phosphate Human Roche What's New cobas Cobas ROC The method has good performance and is clearly acceptable and can be well-managed in routine OY or od 35 Test Method 55 Test Method Y = mX+b Analyzer Method (Y) 9 J, Report on the Symposium •Drug in Clinical 9 J, Report on Symposium Effects in Clinical Chemistry 9 J, Report on Symposium •Drug Erects in Clinical Chemistry 9 J, Report on Symposium •Drug in Clinical Chemistry 9 J, Report on the Symposium •Drug Effects in Clinical Chemistry 9 greuerJ, Repon on me Symposium •Drug Effects in 9 J, Report on Svmposium •Drug Effects in Clinical Chemistry 9 J, Report on Symposium •Drug Effects in Clinical Chemistry 9 J, on Symposium •Drug Effects in Clinical Chemistry 91 Report on Symposium •Drug Effects in Clinical Chemistry Report on Symposium •orug Effects in Clinical Chemistry Report on Symposium Effects in Chemistry J. on the Effects in Chemistry J. on the 'Drug in J. Re" on Effects 9 Re (Y) Cobas XYZ r 120 U/L Y = 0.9818 X + 2.8531 Validation Method (X) XYZ Analyzer 110 50% of your samples selected for the • 50% of your samples selected for the verification of verification Of Calculation Calculations Calibrations Test Method the Real World Labs Speak Out ethod 120 urnan Cobas c501 Sol Roche Cobas Cobas XYZ up to 40 (up 2thod Mean Method f SD bc data to calculate the Human Serum between 2.0-3.0 between 3.0-4.0 Method Methods' J Clin Chem Clin Methods'. J Clin Chem Clin 8cchem 1996;34385-386. Methods'. J Clin Chem Clin gcchem 199634;385-386. Methode J Clin Chem Clin 199634385-386. Methods'. J Clin Clin 80:hem 199634385-386. Methods'. J Clin Chem Clin 1996;34385-386. Methods'. J Clin Chem Clin Methods'. J Clin Chem Clin acchem 199634385-386. Methods' J Ct'Æm Clin Methode'. J Clin Chem Clin 8cchem 19g6;34385-386. Methods'. J Clin Clin Methode J Clin Clin 19g6;34385-386. Methods'. J Clin Chem Clin 80:hern 199634385-386. Methods'. J Clin Clin 199634385-386. J Clin Chem Clin 199634385-386. J Chern Bb:hern Methods' J Cin 1996:34385-386. Methods' Chem Ctrl : 35 operation with 2-4 control measurements per run, using standard Westgard QC rules. Calculator: Recording line. Met-hods :obas man Roche Cobas (Y) XYZ Analyzer cobas c systems automatically calculate the analyte Roche,Htachi cobas c systems automatically calculate the analyte Aochø,Htachi cobas c systems automatically calculate the analyte 120 Method urnan ooz CALCULATORS Females: up to 32 Females: up Memales: uptc32U't up '.c 32 (up to 0.53 gkat,'L) (up to 0.53 (up 0.53 O, not the not the to the (up to Validation Studios Validation Studies Goa 10. Sonntag O, Scholer Drug interferer-ce in clinical chemistry: Sonntag O, Scholer A. Drug interfererce in Clinical Chemistry. Sonntag O, Scholer A. Drug hterfererce in Clinical Chemistry: Sonntag O, Scholer A. Drug interferer-ce in clinical chemistry: Sonntag O, Scholer A. Drug interfererce in clinical chemistry. Sonntag O, Scholer Drug interferer-ce in Clinical Chemistry. Sonntag O. A intertererce in Clinical chemstry: Sonntag O. Schffer A. Drug interfererce in chemist"': Sonntag O, Scholer A. Drug interferer-ce in Clinical Chemistry. Sonntag O, Sche,er Drug interfererce in Clinical Chemistry: Sonntag O, Scholer A. Drug interferer-ce in clinical chemistry. O, A Drug 'n Chemistry: 10. O. interference to ßZ Comparing Verdicts from Analyzer (Y) Calculator Recording Remilember me Human OZ OOZ Validation Studies precision and concentration each sample. concentration of each sample. 120 135 will be used as the comparative Studies TEA About Uncertainty Sigma-metnics for H3V me deviation (SD or and of vat (C V). A display of cobas Roche Cobas ooz ö+nps rum 35 110 recommerdatjon drugs and their con-centrations to be used in drug recommerdation drugs and their used in drug be used in drug Test Method (Y) recommendation ctugs and their concentrations to be used in drug recommendation ct and their cccentrations to be used in drug recommendation ct drugs and their concentrations to be used in drug recommendation drugs and their co.-centrations to be used in drug recommendation drugs and their ccæ:entrations to be used in drug recommendation dugs and ther be used drug recommerdabion ot drugs and their cconcentrations to be used in drug recommendation ot drugs and their to be used in drug recommendation and their cccentrations to be used in drug ct and their concentrations to be used in drug drugs their in their to in $ug (Y) absolute value Resotts and Y-intercept and Y-antercept XYZ :hod Comparative Y-intercept 120 percentage laboratories by splitting specimens laboratories by sp/itting specimens •thod thod cobas Serum Copyright (0 2003, 2008, 2009. All rights reserved. cum Studies [ Test Method Method (i.e. XYZ Analyzer) Conversion factor Conversion Conversion factor: factor factor: Calculated values: A 'actor Of 2.13 is used 'or the Calculated values: A factor Of 2.13 is used for the conversion Calculated A factor Of 2.13 is used for the Calculated values: A factor Of 2.13 is used for the A 2.13 •s used Caculated A factor Of 2.13 is used Cobas 35 'Method Result (X) Comparative interference Ann Clin Bicchem 200138376-385. interference sludies, Ann Clin Bicchem interference studies, Ann Clin Bicchem 200138376-385. interference Ann Clin Bicchem 200138376-395. interference Ann Clin Bicchem interference sludies, Ann Clin 200138376-385. interference Ann Clin 200138376-385. interference Ann Clin Bicc.hem interference sludies, Ann Clin Bicchem 200138376-385. sludies, Ann Clin Biochem 200138376-385. studies, Ann Clin Bicchem Ann Clin Bicchem Ann Clin 200138376-385. Ann Olin studies. Oifferent Goats Ann Clin Birhe,m 200138376-395. Ann Ann Comparative Method Result (X) Hitachi 917(X) Results Go sum w ocbe 15 Boche to critical X-values (Xc) to critical X-values (X c) Method (X) estimation of bias Validation Studies compa Comparing results across the data also available. Method from 25 from 25 •C to 37 from 25 cc to 37 from 25 •C -C 25 to 37 to 37 23 - Roche Cobas Y = 1.00 1.00 X +0.0 = 1.00 X +0.0 Il, W H, Busch Thefeld W, H. Busch et a'. Referenzwe.•te fir Theleld W. H. Busch et a'. fir Thefeld W. H. Busch et a'. Referenzwet•te fir Thefeld W, H. Busch et a'. fir Thefeld W. H. Busch EW e'. al, Thefeld W. H. Busch EW, et a'. Referenzwe.•te fir Thefeld W. H. Busch et al. Referenzwe.•te fir Thefeld W, Haffmeister H, Busch EW, et a'. Referenzwe.•te fir The'eld W. H, Busch et al Referenzwe.•te fir Thefeld W, H. Busch EW, et al. fir The'eld W. H. Busch et al Thefeld W. H. Busch et a'. Referenzwe.•te fir Thefeld W, H. Busch et al fir The:eld W. H. Busch EW, et al. Referenzwerte fir Il. Thefeld W, Busch et al. Il. W, H. EW. Method (X) QC Tools IQCP ac QC 35 The method has Six Sigma performance and can be managed using a single control rule with wide 35 35 2016 Westgard Award: Method • Reflects the RE from Westgard Award' Linda 2D16 Westgard Award' Award Linda Il Linda JJ'estgard Gray I"o.v Trail, Madison. QC, Trail, C ObaS Roc he thod die Bestirnmungen diet Transaminasen GOT und CPT sowie der die Bestirnmuwngen der' Transaminasen GOT und GPT sowie der die Bestirrnwungen der Transaminasen GOT und CPT SONie der die Bestirnrmungen de," Transaminasen GOT und CPT sowie der die Bestirnmungen tier Transaminasen GOT und CPT sowie der die Bestimnmuwngen de." Transaminasen GOT und GPT sowie der die Bestirnmungen GOT und GPT sowie die Bestirnrmungen de:" Transaminasen GOT und CPT sowie der die Bestirnrnungen de:" Transaminasen GOT und CPT SOKie der die Bestirnmungen de," Transaminasen GOT und CPT sowie der die Bestmmungen de," Transamnasen GO' GPT Some der Besnrnmungen GOT GPT der die Transarrinasen GOT und G.PT der die der GOT und GFT sowie der de de GOT Each laboratory st-auld investigate the transferabiity Of the expected values to Each laboratory st-auld inv'estigate the transferabiity Of the expected values to Each laboratory shoauld investigate the transferablity Of the expected values to Each laboratory should h.'estigate the trarsferabity Of the e Of experiment should be outside the reference Calculator and and to t/w the 2003. 2008. 2009. All Winchester Hospital Of the •spiral Of the )ospital the uospital of the 35 35 (Y) wopues sol alkalischen Phosphatase im Serum mit optimierten Standardmethoden. alkalischen Phosphatase im Serum mit optimie.rten Standardmethoden alkalischen Phosphatase im Serum mit optimierten Standardmethoden alkalischen Phosphatase im Serum mat optimierten Standardmethoden. alkalischen Phosphatase im Serum mit optimie.rten Standardmethoden. Sewn mil Serum fiol Scrum nit alkalischer, 20-0 (l limits i.e. 1:3s, 1:3.5s . limits i.e. 1:3s, 1:3.5s is own patent population and it necessary determde its own reference its Own patient populatOon and if necessary detennr-,e its own reference ranges _ is patient population and if necessary detennr,e its own reference ranges _ its Own patient populatOon and if necessary determi-,e its own reference ranges _ patient populatOn and if necessary its own reference ranges. its patent and if necessary its own Test Method Tost Method 3. qqg(z 35 197499313-351. 901 (DOJ 10. 12. Ken G. Lehmann P. E al der 120 12. Klein G, Lehmann P. Michel E. e! al. Vergleich der IFCC•Methcden Klein G. Lehmann P. Michel e! al. Vergteich der IFCC-MethOden Klein G, Lehmann P. Michel e: al. Vergleich der IFCC-Methcden Klein G. Lehmann P. Michel E. e! al. Vergleich der IFCC-Methcden fir Klein G, Lehmann P. Michel E. e: al. Vergleich der IFCC-Methcden fir Klein G, Lehmann P. Michel E. e! al, Vergteich der IFCC-MethOden fir Gem G, P, E al der IFCC•Methcden Klein G. Lehmann P. Michel E. e! al, Vergteich der IFCC-Methcden Klein G, Lehmann P, Michel E. e' al, Vergleich der IFCC-MethocEen Klein G, Lehmann P, Michel e! al. Vergteich der IFCC-Methcden G, Lehmann P, Michel E al, der tFCC•Methcden 10. G, P. Uichel et al 'FCC-Mehcden 10. G. Lehmann P, e' al Vetgeh data Specific performance data G. P. E. Ill method OO Method (i. Method Method Method (X) both methods (Y) ALAT. ASAT und GGT bei 37 'Ct den einge'ührten Standardrnetroden ALAT. ASAT und GGT bei 37 'C mit den einge'ührten Standardmnetroden ALAT. ASAT und GGT bei 37 'C den einge'ührten Standardretroden ALAT. ASAT und GGT bei 37 'C mit den eingetührten Standardmetroden ALAT. ASAT und GGT bei 37 'C mil den eingeführten Standardrnetroden ALAT. ASAT und GGT bei 37 'C mid den eingetührten Standardrnetrodent ALAI. ASAT und 37 'C den engetüh.'ten Standardmetroden ALAT, ASAT und GGT bei 37 'C mil den einge'ührten Standardretroden ALAT. ASAT und GGT bei 37 -C mil den eingeführten Standardretroden ALAT. ASAT und GGT bei 37 'C mit den eingetührten Standardretroden ALAT, ASAT GCT bei 37 'C mit eingeührten ALAI ASAT und be 37 •C den Standardmetroden AMT. ASAT und GGT bei 37 'C m it den engeführten Representative performarce data c" the analyzers are given below Representative performan•ce data c" the analyzers are given below. Representative performance data c" the analyzers are given below. Representative performarce data me analyzers are given below. Representati•Æ data he analyzers are ALAT ASAT cobas 35 00/ 120 Roche Cobas thod Validation Studio, with another laboratory Activity 14C: Comparison of Methods Experiment 'C 37 und37 •C. Lab •C Med bei25 'C und37 Results obtained in indQviduaI laboratores may differ. Nesults obtained in indQviduaI may differ. Results obtained in indQiduaI laboratorés may differ. Results obtained in indQiduaI may differ. Nesults obtained in may differ. Results obtained individual may differ 'C Lat 25 37 Med be 25 37 Med und37 Med 25 37 Lab 37 Med Cobai CSOI gocbe Test Method interval 35 47 49 45 53 55 56 59 58 50 46 52 57 51 15 Comparative cobas c systems co bas c systems 2011-0B, V g 2011-0B, V g English 2011-08, v g V English 2011-0B, V g English 2011-0B, V g cobas c systems c systems 35 AST Method Test Method (Y) (Y) (Y) Fiona/ / Duo! IAAÅÅ!MÅANIÅAA.