PEPFAR Quality Control and Method Validation Activity 14: Part 1

Meets Play • Establisnmnel —cana Establisnrnel FDA-appr manufacturet manufactl manufact demonstrate experimental data for 'the following Pilroose for the following experimental data for the following noun method validation Pxpercments: Con 5.5.1.1 General once Experirnentsl Candidat d n st What Will you do Working In Vour assigned grouv Purpose Working In your assigned groug Studies Purposl a. exfte exft error: exte EQA Summary Report for Chloride Constant Collect experimental data • Collect experimental data exper demonstrate ho' Activity: Collect Experimental Data Role Co lect Experimental Data Role What you doo Precision: resul Precision Studies Validation Plan (1405) Handout 3: AST Validation Plan 1405 Handout 3: AST Validation Plan 1405) Handout 3: AST Validation Plan (1405) Linearit Handout: Linearity Studies Process for Introducing a r,l Method at Process for Introducing a New Method at Handout: dation Plan (1405) (1405) Linearity Handout: Linearit Linearit) Linearity Studies I_inearity What will you Non-standard method The Purpose of Method Evaluation The Purpose of Melcthod Evaluation Activity -14: to Method Evaluation Puruose 5.5.1.1 Genera Modified va scatter Ing of demonstrate hou* Pre-sele Ca Random Error- Learn how to collect the necessary demonstrate hou. demonstrate hov. Candida demonstrate performancf SASTL; ASTL: ASTL Candid(t method validation experiments: wnat will you do? method validat'öl experi cobas' cobas cobas Apply a experit Candi( Replication Experiments Documentatio Doncumentration Linearity Ex; Design a minute rol 1) 406 umma 1406 alidation Summa 1406 Handout 4: AST Validation Summa 1406 Handout 3: AST Validation Plmman (1405) Purpose ISO 15189:2012 - 5.5.1.2 Verification of for your Why is ucrification important? Why is verification important? Ition Learn how to collect t} Working Punjose Pulrpose Linearity Learn how to Method Validation/Verification, TE < TEA Learn ho •t how jnoun Site's Laboratory methods can be subject to Learn how intended 'Select the appropriate types of Learn • Pre-purchase Assessment Candidat be data for the following .>ltets Method Validation Plan Method Evaluation method Evalidation experinoental data for the following Worktng In your group, vou Do ALL re Working in your in your group, you in group, Apply a cl 'B' Installation and Calibration Apply Chemistry Validation Plan 3. Linearity nown Validation Plan Chemistry Validation Plan Method Validation Plan RDRULE8"— ISO 15189:2012 - 5.5 Examination processes ISO 15189:2012+.5 Examination processes 15189:2012 - 5.5 Examination processes i.earn how to the becomes • thew nce •C QUALiW'TDOWNLOAOS Existing method with defined performance Linearity Experiment Worksheet Line:' Experiment Worksh STORE - QC APPLICATIONS - DOWNLOADS — ABOUTU8 —RESOURCES -ABOUT UST ABOUTUS U' Candidét Aspartate Aminotransferase acc. to FCC Without pyridoxal phosphate activation Aspartate Aminotransferase acc. to FCC Without Ipy•ridoxal phosphate activation Aspartate Aminotransferase acc. to IFCC Without pyridoxal phosphate activation "WESTGARb RULES"" • Sele- b. —ESSAVS— - _ QUALITY for your grotp's too high, some too high, somne Example Examnlc sxample -'HOME —HOME — 'HOME. HOM Working In your assigned vroup. too high, high, how to collf Slope —ESSAYS — I ESSAYS ESSAYS—- assAYS 'ESSAYS— experimental data for Role Pla) how to Care must be taken to mix each pool thoroughly, and to protect In your group, vo experimental d, Chemistry Linearity Guidelines Chemistry Guidelines lab( is said to be LINEAR when measured n measured A quantitative analytical method is said to be LINEAR when measured •Define quality requirement 'Define quality requirement how to collect the necessary how collect the by defining Laboratory developed test (LDT) Laboratorv developed test (LDT) learn how to collect the' for your group 's a Expenrimnental Learn ho ac • Familiarization Period for your group's c for your group's a The laboratory The labor ate ( how the demonstrate how to colle 'If method is acceptable, then perform rnethod validation experiment •s: method su a minute play minute role play t' • a minute a minuto role Learn how to the Linearity Experimnent L_inearity Experirnent 'n Summary Report Report Validation Summary Report ikmmarx heport Limitations • interferences Linearity Experirnent Linearity Replication Application for serum and plasma scattering of points Limvtations • c he becon c on reagents can be 'Sed • Indicates c systems on can used • c systems can be •sed • hdicales c systems or, be used • indicates cobas c systems on which reaqents can be used • Indicates c systems on which reagents can be used • Indicates cobas c systems on which reagents can be used nt accepta e, t en per orm ( ments becomes becor€s 13. Zanta B. G. Babbk W. in der 13. Zawta B. Klei G. Bablok W. Temperatururnrechnung in der 13. Zawta B. Klein G. Babbok W. Temperatururnrechnung in der the pools from evaporation or other deterioration. the pools from evaporation or Other deterioration. •oportionai to the are directly proportional to the results from a series of sample solutions are directly proportional to the Select the a errors error: error f error use Error Assessment error present What's New Method on-going monitoring with Method On-going monitorine with for the following, Modified Obas Chemistry Cobas CSO I Chemistry Analyzer Validation Plan for Roche Cobas c501 Chemistry Analyzer Validation Plan for Roche o •s c Intended So here's the with the using OCA Vantage Bias % V 2.51% Re i for for the The perfcr The perfor • a role PI, • a role enlistry na er Criterion: % Of initial value at an AST Criterion: within to % Of value at an AST Criterion: Recovery within to % Of initial value at an AST within % Of initial value at an AST Merrmer Logjn • Seven Vitamin O • ARCHITECT for group's assigned method validation rnethod validc Precision was determined using human samples and controls in an human Samples and in klinischen Enzymonlog•e? Klin Lab klinischen Enzyrrdlogie? Klin Lab Completing instruments, go a ot the • Second method vall method v method. AST cobas c test definition Oetermnine quality requirements at the critical decision levels for your uroup's become Glucose for following: Seven O Order information Order Roche;HItachi cobas c svs'errts information Here's a comparative table of the goals RO±ejHdachi cobas c svs!ems Rcche/Hitachi cobas c svs:erns Ro:he/Hitachi cobas c svs:erns Rcche'Hitachi cobas c svs:erns Roche'Hflachi cobas c svs:erns RocheJHitachi cobas c svs:erns Roche/HiIachi cobas c svs:erns cobas c sys.temns cobas c systemns 2.51"" 5.60 0.06 nens. This means lalyte in the test specimens. This means concentration or activity of an analyte in the test specimens. This means concentration or activity or an analyte in the test specimens. This means following shifted rre intended how to collect the d, how to collect t}e d Candidat ac for group's Role Plays Performance a POC Method Being Evaluated: actvity of 30 pet'L). actvity of 30 (0.50 pet'L). actvity of 30 (0.50 ot 30 of 30 pkavL). of 30 30 uL Molecular Diagnostic methods? We came Constant wec on a 9500 Cobas c501 Date: a-Nov-13 a point-of-care device is compared to Date: 4-Nov-13 Testing i e sting Reportable Rar reportable Reportable Ra thi on 14, Passing H, W, R, A General Tools, Technologies and Training for Healthcare Laboratories Existing method used after repair of a major component Passing H, Baük W, Bender R, A General Regression 14. Passing H, Ban W, Bender R, al A General Regression Diagnostic. We camc than a the M tm internal protocol Kith repeatabilitv• (n 211 and precÉion" internal protocol Kith repeatability' (n 211 and precSion" Play your Site on and XE-.?IOD " The were performed hematology analyzer Of Apply a Assay type Cat. Rate A Fate A and 573 analytical Aspa.•tatc to 'FCC Aspantate Amnhnotransterase n. to 'FCC Aspartate Arninotransferase to FCC Aspartate Arninotransferase to 'FCC Aspartate to FCC Aspartate to IFCC acc. to FCC 10 FCC cobas C went data characteri/j• characterinM charactery MA •Use Tools, Technologies and Training Ior Healthcare L-ab)oratories cobas c cobas c cobasc cobas c 311 cobasc5CI/5C2 cobas c cobasc5CI/5C2 cobas c cobasc501/5C2 cobas c 311 cobasc 1.96% 3.84% 3.29 method Validation (10 = 1.65 Lovel Validation Plan for Vitros 250 Chemistry Analyzer don't agree how Tools, Technologies and Trajnjng Ior Healthcare Laboratories performance of tour point-of-care (POO) chemist'} analyzers one POC HbA 'c deuce: tionship between c characterize the reiationship between that a straight line can be used to characterize the relationship bebwveen that a straight line can be used to characterize the relationship beb.veen that a straight line can be used to characterize the relationship bebween Tools, Technologies and Training tor Healthcare Laboratories -e method va Linearity studies are performed to determine the linear reportable range for an analyte. 10 delermine linear reportablo an cgcoc Evaluation 5 POC POPULAR 5.5.1 Selection, verification and validation of examination Now the pieces are in place. Remember the equation for Sigma metric is (T Ea - bias) I CV, Now the pteces are in place. Remember the equation for Sigma metric is (T Ea - bias) C.V. Now the pieces are In place. Remember the equation for Sigma metric is (T EO - bias) f CV, Now the pteces are in place. [Remember the equation for Sigma metric is (TEa - bias) C.V, Now the pieces are in place. Remember the equation for Sigma metric is (TEa - bias) / C.V. Now the pteces are in place. Remember the equation for Sigma metric is (T Ea - bias) / C.V. BC•3b00. study concluded this is "satisfactory." Doos a c gocc Now the pieces are In place. Remember the equation for Sigma metric •s (T Ea • bias) 1' CV. veur Determine (3 aliquots per run, per day, 20 days), (3 aliquots per run, t run per day, 20 days), Method Chem CLn Dispersicn Calculat0i and Procedure Method Transformation, Clin Chem Clin Procedure Transformation, Clin Chem Procedure Method Transformation, J Chem Clin Method Transformation, Clin Chem Standard method used outside of intended scope by Standard method used outside of Intended scope by des have been valid Icterus:g NC significant interference up to an I index Of 60 for conjugated No mntetference up to an I Index Of 60 for conjugated NC significant interference up an I index Of 60 for conjugated i index of ED . A set of linearity standards will be tested in the same manner as A set of linearity standards will be tested in the same manner as A set of li A direct enzymatic NEW l. Overview Overview 10/ 12-31 10/12-31 10/ 12-31 (STAT 7/12-31) Experirnents on oi 500 'c; an Experirnents E-ßxp€uirnents ßxpcwirnents [Ape: irnents Role Play g 322 SOC tests 500 tests cat. No, 20754949 322 cat NC, 20754949 322 cat NC, 322 cat NC. 20754949 322 cat. NC, 20754949 322 cat. NC. 20754949 322 cat 20750949 322 cat. 322 system-ID 07 6494 9 system-ID 07 6494 g system-ID 07 g 07 3 07 6494 9 07 6494 g I Des. Dos. Bias Rep cc L_inearity use Qd?fisfrs roun mvn N ee+3 experiments to reveal analytical Sigma-metnc.G for L I near lty Determine th roÅf or examination procedures across an early example Of applying to reveal analyti- Comparison ot When the POC and the for group's ntrations or activity levels of an analyte of an analyte measured results and the concentrations or activity levels of an analyte across an early example of applying Sigrna- a core laboratory analyzer. we assume tho rize Hi, ammutphy once it once i the actors Linear It Performance characteristics. Sigma-metrics of a Mindray BC-3600 hematology analyzer across an example of apply.ng Sigma-metrics of a Mindray BC-3600) hematology analyzer I Ricos 1. Summarize Data Documentauon Oocumemtauon Ootumentauon Documemtauon 00tumentauoo oocumentanon Documentation Glqmna•metncs of Six Deterrnine the actors once it a The foll-owing results were obtained: The following results were obtained: Bochern 198B lg8B 198B When the POC and the Core Lab If Methods 1. st tor Vour Creatinune Creattm•ne Creatinjne 3.37%k, 3.37% POC lipid glucose VERIFICA ion Verification Of Manufacturer's Verification Of Manufacturer's Purpose: CIRe-Validation Verification Of Manufacturer's Purpose: C]Re-Validation Verification Of Manufacturer's Purpose: Verification Of Manufacturer's Purpo*?: Verification Purpose: OValidation C]Re-Validation Verification Of Manufacturer's Purpose: CJRe-Validation Verification Of Manufacturer's The linearity for each analyte is assessed by checking the performance of recovery around the in is assessed by checking Lactate 1.96%, jmparison of re ethods Gucose on Juse errors in: bilirubin and 60 (approximate bilirubin and 60 unconjugated t.ilirubin (app.oxirnate conßgated bilirubin and 60 unconjugated bilirubin and 60 unconjugated (approximate conßgated and 60 (approximate 360 R Icos Ricos I Ricos Rlcos Ricos:, LOGN SIGN LOGIN SIGNUP Group 4 group This is an at the of is an 1 at level your LOGIN UP LOGIN SIGN UP Examne LOGIN LOGIN SIGN UP LOGIN UP LOGN SIGN UP LOGIN SIGN th Wavelength Wavelength (sublmain) Slope Acceptable Acceptability Linearity • the actc Precision Calibrator t as. Calibrator f a.s. (12 Calibrator (12 Calibrator f.a.s. (12 Calibrator (12 3 ml) Calibrator f.a.s. (12 3 f.a.s. (12 (12 cat 10753350 lgc cat 10753350 WC cat 10753350 10759350 190 19C Siqma• Sigma. Sigma- Dote patient samp es. patient samples. patient samp patient once acc( use CRP QC Calculators rovn SIGMA ANAL • taco • Sigma Estimates: High accl Analyzer Analyte: AST Critical of Test Of Test Analyst: Lisa Johnson . Lisa Johns Member Login Soven far values. for some stated range of analyte values, for some stated range Of analyte values, Lisa J previouslV deter AST bias% Blas% Bias%/o AST Even though manufacturers test their methods n Even though manufacturers test their methods concentration: rrWdL or 1026 approximate unccnjugaled concentration: rn$dL or 1026 approximate unconjugated reference interval experiment or approximate untonjug•aled 384% assay for 'YoHbA lc reviously deter ALL res nown range without I_inearlt Completing trilogy Of Mindray go back to a 2013 study Of the Site's A s atways used in this Method Sheet as the decrnal Claims Claims2. Accuracy The throughout the manufacturer's stated range of the testing system. This is done using a A *int (pefodlstop) atwayS used in this Method Sheet as the decimal A *oint (period'stop) atwayS used in this Method Sheet as the decimal tntend€ Intended tnfendd tntendd stated rangr. system. ins tone using a VERIFICATU Love I Lovel Bias% Bias Yo Select the apl magnitude 0 380 Caiibætct (12 3 Calibratct (12 3 LISA) Calib.•attv (12 x 3 ml, for USA) Calibvatcv [a.s. (12 x 3 USA) Calibvatc.• f.a.s. (12 x 3 for USA) Calib.•atcv f.a.s. (12 x 3 USA) Calib.•atcv f.a.s. (12 x 3 ml, for USA) Calib.•atcv (12 x 3 USA) Calibr•ator f.a.s. (12 x 3 mL. for USA) Calibvatcv• [.a.s. (12 x 3 for USA) Calib.•atcv f.a.s. (12 x 3 rnC. for USA) Calibrator f.a.s. (12 x 3 rnL, for USA) Calibrator [.as. (12 x 3 ml, LIr USA) [as. (12 x 3 for USA) cat 360 Cat. No, 360 cal. 360 tat. 360 tat. 10759350 360 cat. No. 360 cat No. 360 tat. No. 10759350 360 360 Now we have and bias data. ready to calculate our Sigma-metncs We're Now On Now on TO reveal the To reveal the On On Blog On the Blog Linearity Studies Validation Studies Linearit Handout: Documentauoo pac CBC VERIFI Accuracy Validation Verification metrics to the evaluation of an HBV mothod. poc automated CBC Core Lab don't agree metrtcs to the evaluation of an HBV method. cote laboratory analyzer is always "fright". core laboratory analyzer is always Now Now 011 On the Blog On Blog on Select the ap Coli BC BC • BC- On On the Sigma Estimates; Liner of Existing method relocated to another part of the facility Y-inåeccep+ : Des. Mindray BC- Now on Now 0 n VERII The lay BC- NOW Oji Now Ott Now O n Testing should be performed in triplicate and performed within a Testing shou d be performed in triplicate and performed within a VanaatJ0t in a of an Y-måeccep+ Dos. Des. The P Dos. Bias 2.3 23 the actors and the actors and Replication and billrubin concentration: or 1026 bilirubin concentration: or 1026 "ethods • the actors and rmined using a patient samples previously samples previously a. v. a. 5. Linearity verification will be determined using a patient samples previously WL LOL 60 mg•dl_ or 1026 Assay Level Replica Replic Can we calculate Sigma•motrics for So the c 1 good for 270% | Cotoparison 01 Comparison Nee+s Multi Point or Care Instrument Evaluation tor use in Anti-retroviral Clinics in South Africa. Cornparison Repll" Units to the the integral and parts separate.' ma" the the integral and the fractional parts separator to ma" the between the integral and the fractional parts metric Do no Comp Slope slope Slop. Methods An Architect c IGOOC An c Evaluation of a Volume Hematology Westgard Do no LJ plus LJ LJ 3 plus 3 plus plus mg Cat 12149435 cat 12149435 assay Example calculation: for the Cobas cit I, the goal for cholesterol 10%. We also Know from the Example calculation: for the Cobas cl tlI, the goal for cholesterol 10%. We aiso know from the Example calculation: for the Cobas cit I, the goal for cholesiterol 10%. We also know from the Example ca;culatiory for the Cobas c 1 Il, the goal 10%. We also Know from the Example caiculatiotY for the Cobas c 111, the goal for choles,terol 10%. We also know from the Example caiculation: for the Cobas Cltl, the goal 10%, We also know from the Example cavculation: for the Cobas cltl, the goal for cholesterol 10%. We also know from the Example calculation: for the Cobas cttl, the goal We also Know from the Example calculation. for the Cobas the goal for cholesterol We also know from the Example calculation: for the Cobas cltl1, the goal for cholesterol 10%, We also know from the • of perform e Perform intended ALT 250% 270% f Methods of Methods [Vlethods perform Rand or' 3. Linearity set of standards containlng varying levels of an analyte in high enough and low enough set of standards containing varying levels of an analyte in high enough and low enough set of standards containlng varying levels of an analyte In high enough and low enough of standards varying levels ot an analyte in high enough Group 1 — Linearity Experiment Linearity Experiment Creatinjne MVIethods Linearity Samp'es manufacturer ( i.e. urine sample with serum validated method) manufacturer ( I.e. urine sample with sequin validätod method) tnter&d •f Methods .e urine -;atpple-with serum validated m roles lab( use ABC Laboratory Abbott ARCHITECT Westgard QC Candidate instrument selected and purchased Tho study this instrument's portormanco is "satisfactory." Does a CLIA Determines • Determines Meets What will you do? Random Precirorm U 36.6 (0.611) 36.6 0.3 (0.005) (0.005) single run. If one value deviates greatly from the others due to One value devio popuuAR POP'OLAR slightly above the A known high near or shghtly above the analyzed on the XYZ analyzer. A known high near or slightly above the Begins ot a de5imal numeral, Separators thousands are not used. of a de:imal numeral, Separators thousands are not used. Plan Ptan • the actors and HemolyssB NO significant interference up to an H hdex Of 40 (approximate Hemolysis:8 NO significant interference up to an H hdex Of 40 (approximate 3600 NO sigmlican' irredererce up to an k Ot (approximate POPULAR TEaYo Work/h What happens when wc look at one component; the analytical quality requirement. In examp/e, we're going 'o Verification You Tub e: analyzers WHAT'S POPULAR POPULAR popuLAR popuL-AR What happens when we look at What happens 100k at You T ('be: You Logout Precinorm mL,for USA) Precinorm Ll (10 3 mL, for LISA) Precinorm Ll 3 ml, for LISA) Precinorm (10 3 ml, for LISA) Precinorm for LISA) Precinorm 3l (10 ml, for LISA) Precinorm 3 for LISA) Precinorm (10 3 ml, for UISA) U 10 3 mL. LISA) Ll 3 USA) Ll (10 3 for USA) Ll mL, for LISA) (10 3 ml, for LISA) cat No. 12149435 160 cat,No. 121494435 cat 12149435 NC. 12149435 160 121494435 12149435 IBO 12149435 12149435 160 code 300 code 401 code 391 But what if we can't tell whether either the But what if can't tell either tho YouTube: YourTube: • Four Gluccse Methods Reagent procedures As we have a of number-., We have average imptecisiøn ane average keep •n only to WBC, RBC. Overview S.'SG 3600 Y Ou Begins Total Allowable Error (TEa): Allowa Description Of Equipment/Process: DescriéticSenStiüitY'ipment/Process: Units: U/L QC Tools Units: Method Method Validation Now In all the biases.. Now we'll •n all the biases.._ Experiment consfon+ -v Hi, ammurphy suitabi/, amount Cre Site concentrations so as to span the entire range of the test system. Therefore, the (185 SE When a device is compared to simple VERII • Define quality requirement Define quality requirement George, Hi, P ræipath J Precipath LJ (2.14) 1 (0.02) Evaluation Evaludation regression line hn*eccep+ herncgobn concentrator,: 25.6 herncglob•n concentration: 25.6 rr@dL)). herncslobin concentration: 25.6 (40 rr@dL))_ nt Thenpcnt Pharm, Sigma•metnics for HBV concentrator: 25.6 mg'dLjj 3.36% 2.6% Hospital Complex glucose device Specificity: hig Specificity imit Of detection will a known low near the limit Of detection will upper measurement range and a known low near the limit of detection will Lactate compatison study that there is a bias and an Imprecision of comparison Study that there is a hiae., and an imprecision of t .6S'Yo. compatison Study that there is a bias and an imprecision of t f3S'Yo: comparison that is a bias and an imprecision of comparison Study that there is a bias., and an Imprecision of .6S'Yo. comparison study that is a bias and an imprecision of 1 ,6S'Yo. Study that is a bias and an imprecision of comparison Study that there is a bias and an imprecjslon of .6S'Yo. study that there is a bias and an Imprecision of .6S'Yo. study that there is a bias and an imprecision of Experimnent device for HBV previously Do Chloride compatison study there is a and an imprecision of 1 companison study that there is a bias and an imprecision of comparison study that there is a bias and an Imprecision of comparison study is a bias and an impreci510n ot 185 ' 299% analytical er Comparison ot Do Do not Compari ' 209% 6.05 6.605 random error, it may be removed from the data analysis and cvo/o analytical eri Create the r Corn p. Co Ptecceih Ll plus x 3 rnLl Precipath U Pius x 3 rnLl Precipath U plus x 3 Precipath U x 3 ml) Precipath U plus x 3 ml) Precipath U $lus x 3 ml) Precipath U $us x g ml) Precipath U (10 x 3 ml) Precipath U plus (10 x 3 ml) ccnsfon+ Cat 121494435 cat. 12149443 '22 cat. NC. 10171743 122 cat. No. 121494435122 cat No, 12149443 122 cat NC. 12149443 122 Cat No. 12149443 122 cat No. 121494435122 cat NC, 12149443 122 cat No. 12149443 122 12149443 122 12149443 '22 cade code 401 Code 40' wac WBC t .95 SD Range HBV previously d'eta examinati( Create the needed pr Create the needed p increas 40 N ee+3 FOR US CUSTOMERS ONLY: LIMITED WARRANTY TE present Experiment previously deter previousl\ previoushy Comnpa, Corn pa 51 JAMES Oevjce VALID intended Purpose VALID, nown N ee±3 c8C00 Spensitivity a. Error Assessment error present I .85 1 85 1.85% 85 273% 299% the verifia (final 50 5% 5. Specificity Specific data at Constant 40K, 6851) +2 SD ALL consfon+ Experiment su Contamination with will elevate results, because the analyte Matters st Human serum 3 128 (2.10) 126 (2.10) 1 (0.02) use elevate because analyte poc Experim€ demonstration of the linear range requires a series of known concentrations or know demonstration of the linecar range requires a series of known concentrations or know on the logarithmnic scale? On the . or sets ot quality to judge the method. just by using the point-of-caro method or tho coro lab method Sigma Sigma Matters Signtna Matters Matter G AST method • Determines Site Completing our trilogy or Mindtay hontatology instruments, we go back to a 2013 study of the method or tho lab method Completing our trilogy of Mindray hematology we go back to a 2013 study of Completing trilogy Of hematology instruments, wo go back to a 2013 study Of the Completing our trilogy Of Mindray hematology go to a 2013 study Of the Siggna Matters Matters blood-gas ane blood-gas devices and rneth be used._ be used, FDA-approved method or instrument & EQA & QA Sigmna Matters once it a Precipath U p(uS 3 for USA) Precipath plus 3 for USA) Prccipath plus 3 for USA) U plus ( 10 3 mL, for USA) plus 3 mL, for USA) plus for USA) plus 3 for USA) plus mL, for USA) 3 USA) cat, 121494435 Cat. 12149443 Cat. No. 12149443 cat, 12149435 cat 121494435 code mind that the nught be better or worse at the upper and/or lower parts of the canoe these IQC & EQA Diagmstics warrants this will meet the 121494435 Roche Diagnostics warrants th,at this product will meet the specifc.ations Roche Diagnostics warrants that this willuct meet the Can wo calculate for WHAT'S NEW use me 37 1.7 20 VL that healthcare. 3.0 Sigma the performance for 123 Big Road S NEW NEW insference of Reference NEW AST Transference of repeated. Reference propm+lonal Factors that demonstrate how well a method performs Hemogiobtn 59.8 NBC a core c501 Chemistry Analyzer regarding AST only Reference Range ICCP in is higher in normal sera.The of interference maybe in erythrccytes is higher in normal sera, The of interference maybe is higher Ihan in normal sera maybe Lymphocytes 58 5 Sigma-metrjcs of aix Qoche Cobas c501 Chemistry Analyzer regarding AST only Human ser-um I Human serum 1 Equipment/Process: Roche Cobas c501 Chemistry Analyzer regarding AST only Cobag Cher•ugtry Analyzer regarding AST only Of Stgma•metncs Of a Slope Cons+an+ Experirv • ComF 20 Simc extensively, there are many factors in an individual Modified validated method Corte's Pre-purchase Assessment .JIå Experime ;lope Site stated •n the labeling when used in accordance WJth such Qabeling ard stated in the labeling When used in accctdance With such labeling lacp props Experimen Prectrorm x 5 ml.) Precirorm U (20 5 ml.) Precinorm U (20 5 ml.) 120 5 U (20 5 ml.) 5 ml.) Car 10171743 122 Samples will be run in triplicate. cal. NC. 10171743 122 Cat. 10171778 122 Cat 10171743 122 Cat NC, 10171743 122 Cat. NC, 10171743 122 relationships established by dilution. -l dilution FOUNDER Code 300 lac Perform n triplicate. oce Y-infeccep+ Y-tnfeccepf Concentration: th Slope Six Sigmta Calculators Six Sigma Calculators Percent: per 20% search data abou Transt Six Calculators WHERE WE data The pen Do no errors Perrors precision Sample •.o/ütnes Sample volumes Sarnple volumes Sample diL'tion sample The time period when the analytical staff learns or ALT variable depending on he content analyte the tysed variable depending on content 01 analyte in the *ysed erythrocytes. variable depending on tnntent 01 analyte in the lysed erythrocytes. he o! 'ySed for imprecjsjon and bas separatelya Next. we'll use the CLIA proficiency which sets City-Township, Country is When methodology is not the ONLINE STORE STORE Data should be plotted immediately to identify and correct any Quality in Instruments l-ogln Create the ne co, 7.71 is correct? Whten methodology is not the your assigned group, you will: Method Approval 7. Method Approval Sbope Slope BC-3600. The study concluded this instrument's is '"satisfactory," a BC-3600. The study authors concluded this performance is ' 'satisfactory" Does a BC-3600). Tho study authors concluded this instrument's performance is "satisfactory." Does a Working in your assigned group, you will: Working in y'our assigned group, you will: a core lab analyzer core analyzer C.hance Address all procedurv all have been previously Slope Group 2 —Precision Experiment BC-3600. study concluded this instrument's performance is • 'satisfactory" a Accuracy enzymatic, consfon+ ccns+on+ will be free detects in material and workmanship until the expiratictl will be free defects in material and workmanship until the expiraticn Molecular Diagnostic. Wo canto of Reference the verifiG the props tests substances in p, substances in p. Precipath Ll (20 x 5 Precipath LJ (20 x 5 Precipath Ll (20 x 5 ml_) Precipath Ll (20 x 5 mL) Precipath LJ (20 x 5 ml_) Preci;.ath Ll 120 x 5 mL) Precipath LJ x mL) U 120 5 IJ 120 x 5 Cat. No. 10171778 122 Cat. 10171778 122 Code Logout The per engine 122 Ll (20 x 5 ml_) (20 X 5 10171778 '22 10171778 122 simple A e The mean value for each point will be calculated. vals Work Abs hlagging. Choose diluted Ligemic specimens may cause > Abs flagging. Choose diluted *use Abs flagging. Choose diluted all p Laboratory, 111 Main Street, Arusha, Tanzania he graph with zonnect the points cnthe graph with Precipath UJ Location: Cape Clinic Laboratory, 111 Main Street, Arusha, Tanzania NO SHALL BE 130 line will be drawn to connect the points on the graph with line wi be drawn to connect the points on the graph with PURPCSé. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR NO SHALL ROCHE LIABLE FOR Validation Summary Report We'll the table below and all tho a goal upper end of the range Gwen that we working with averages of point-of-care method or the core lab method Compa for troubleshooting purposes when quality control is unacceptable and deviations from for troubleshooting purposes when quality control is unacceptable and dev'ations from qualit,' is and developers once i Calculator AST aockman Coulter HMX Servic€ Service Ser ' Studies Iona Evaluation of Mandray checks PreciCcntroI ClinChem 2 5 for USA) Clinchem 2 5 mL, Clinchem 2 mL, 2 mc, uSA) 5 mL, uSA) Proportional SE Cat No. Cat No. 05947774 experimental data for the following Code 300 Code 392 Comparing Verdicts from Beckman HMX 2 mL, 2 5 5 mL, mL, Cat. cat. No. cat No. No. code 300 c-iata the following So the c 1 1 ' is delivering good cholesterol, So the c 111 is delivering good performance for cholesterol. So the c 1 1 ' is delivering good So the vs delivering good So the good cholesterol, So the is delivering good performance So the is good performance cholesterol. So the delisering good for cholesterol, So the c is good performance for cholesterol, So the is delivering good for cholesterol, So the is good performance for cholesterol, So the is delivenng good for So the c IV is good for So the is good for cholesterol, So the is delivering good performance for cholesterol, So the is good performance for So the is delivering good performance for cholesterol. So the is good for cholesterol. So the c 1 1 1 is delivering good for cholesterol. So the c IV good for cholesterol So the good performance for cholesterol So the c 111 is deltvenng good performance for cholesterol, So the c 1 1 ' is delivenng good for cholesterol. So the c 1 1 1 is detvenng good for u need? outlined Constant SE Ill you need? •n 9-',undout work WANT TO BE examinati( from commercial advertising, published 2) Types of analytical errors 2) 'Types of analytical errors cob" c 502 anatyzer wash necessary for avoiding cobas c 502 analyzer All special wash programming necessary avoiding cobas c 502 analyzer: All special wash programming necessary avoiding 1.03% Detection Limit • Increa Workstant Hemoglobin 1 598 Hemoglobin 59. B Hemoglobin j 59. B HemogiObin 1 598 Hemoglobin j 598 Hemoglobin i 598 characteristics, once developed f e GU U characteristics, once developed 598 developed Absolute A'Eoæcessary An C 160CC H e moglobin Hemoglobin j necessary consfan+ An Architect c 160CC An Architect id A;chiutect Paperwork Reference Interval reference intl reference inti an assay does not perform as expected. the %CV will be theory, analysis, S, Louis: theory, anatysis, correlation, Sr Louis: theory, correlation, St. Louis: In the event that an assay does not perform as expected, the %CV WII' be In the event that an assay does not perform as expected, the %CV Will be In the event that an assay does not perform as expected, the %CV be In the event that an assay does not perform as expected, the %CV will be is When mothodology is not the -ocessary •r •cessary Seven Vitamin O reference In tissue hepatic, cardiac musse, art Elevated in tissue, phincOaIIy hepatic, cardiac. mussle, art kidney. Elevated in tissue, phncOaIIy hepatic, cardiac. muse art kidney. Elevated in tissue, phncOaIIy hepatic, cardiac, musee, art kidney. Elevated in tissue, phncOaIIy hepatic, cardiac, muscle, art kidney. Elevated in tissue, princOaIIy hepatic, cardiac. musee, art kidney. Elevated in tissue, phncOaIIy hepatic, cardiac. musee, art kidney. Elevated in tissue, phncOaIIy hepatic, cardiac. muse'e,e.rt kidney. Elevated tissue, pnm-pally hepatic, cardiac. and kidney. Elovated Specificity: higher or lower results due to interference by 2 loc) re s scary -ecessary Reportable Range art 2 loc) 2 (00 loc) kt•.cessary when called upo WANT WANT TO BE Set up the m WANT TO TO BE Workst, st: qcceef perfc must be less than 50% Of the total error. The systematic error must be less than 50% Of the total error. QC + emogiDbln Farni'iarization Period Familiarization Period 1.93% Create the needed props • Create the needed props • Three POC implementing an analytical quality control • Create the needed props Olympus CaicaIat0/ Shelf •C Shelf Shelf at Shelf 2-8 •C CC CC roo•s cc tools See date See enpiraticn date Ill. analytical error present cC What happens when we look at perfo'rmnance 1270% 27 A 2015 study comnpared the performance Of -known relationship between diiucic:'fi those (/nea (/oear your as carryover is available via tho cobas Line manual input is not required carryover is available via the cobas manual inpu not required 4. 3. Patient specimens may be used if a high value near the Patient specimens may be used a high value near the is via the manual inv not What happens when wc look at performance $3 Lie near [he 205 But what it wo can't tell whether either the known relationship between dilutions as follows: f acceptable when called upor• What happens when we look at What happens when we look at performance 180 But what if we tell whether either tho 180.083 when called upon 177 180 when called upol Use statistical tools on the data to estimate size of analytical errors Phosphorous, Potassium, Sodium, Total Bilirubin, Total Protein, Triglycerides, -zoo Coge consfo resources acceptability 2 'n: 2. Moss DWI Henderson AR. JF. Enty•mes. In: NW, Moss DW. Henderson AR. Enzymes. In: NW, Moss Henderson AR. Enzymes. NW, Horiba Med. (ABX) Pentra 400 devices andi a core lab analyzer protocol method companson for analys•s were from sent protocol for method companison Specimens 'or analysts were from routines sent to study that there a 2 an of Second Chance Charese serum are these tissues. serum levels are found in diseases involving these tissues. Hepatobiliary serum levels are in diseases involving these tissues. Hepatobiliary Method Validation Observed Results allowable random error (33% of Total Allowable Serum are tissues. comppred to ellpwable random 6FCL"A Total Allowable Method Validation Tools Method Tools Tools Third 55 simpler and streamlined process than validation) 93 83 2.3 2.439 a core lab analyzer 2.39 compared to the allowable random error (33% of CLIA Total Allowable Basic QC Practices, Retain • If me patient idenl ident Different shipping and storage conditions that cobas Analytical Evaluation of Zee C. from Zee C. Awesome N' C, C. C. Y ram C. Awesome V' Calculator Quantifying Trtgiycendes •4.2% cobaS c pack 5.17 Analytical of C, Awesome N Where required, special wash/carry•over evasion programming must Triglycerides •42% Triglycerides Trjglycenides Trtg[ycen»des Tniglycenides Trtgiycendes A 205 2.51% Analytical Evaluatcon of Evaluation of Glucose 205 identified fi (00 Transference of Reference ZOO zoo 55 Results Sigma Metric AnGysi5 identifiec ed. Fundamentals Of Clinical Chemistry 3M ed. Philadelphia. ec o' Clint Cherniswv ed expected upper range can be found. expected upper range can be found, Sigmna-metrics of a Mindray BC-3600 hematology analyzer Sigma-metrics of a N'indray BC-36()() hemnatology analyzer Constant SE Constant 205 Another •thing i, Pool 1 = mean of Pool O xo = (Pool 1 i, Pool 1 = mean of Pool 3 xo = (Pool 1 i, Pool 1 = mean of Pool 3xO= (Pool 1 i. Pool 1 = mean of Pool 3 x O = O (Pool 1 idt idi idl Sigma-metrics of a hematology analyzer 1336 Methods diseases such as cirrhosis, metastatic carcinoma. and vital diseases. as cirrhosis. and hepatitis diseases, such as cirrhosis. metasta!ic, carcinoma, and viral hepatits diseases, such as cirrhosis, metastatic carcinoma, and viral hepati1S diseases, such as cirrhosis, metastatic carcinoma, and viral hepatiIS diseases, such as cirrhosis, metastatic carcinoma, and viral hepatitS Refer to the ABC Lab Validation Plan for Vitros 950 Chemistry Analyzer to the ABC Lab for Vitros 960ChemjstryAnatyze Sigma-metrics of a Mindray hematology analyzer zoo loo) | 133.5 205 Calculator Recording *loo Metric Theronos Ste De method. Markers on the SD, companson study that there a 2 and an of 650/" 133.5 two blood gas analyzers with a core Error Limits for between day and 25% Of CLIA Total Allowable Error Limits lrror Limits for between day and 25% of CLIA Total Allowable Error Limits Calib•aticc' rode Calibrate' mode CalibtatOn mode Linearity be to this implemented to With this to With this on the logarithmnic scale? method or tho core lab method ion of an anatyte that can be measured 4. Sensitivity is the lowest concentration of an analyte that can be measured on the scale? 2.1% zoo point-of-caro method 01 the core lab ntothod point-of.care method or the lab method Between Day use and on 12 weeks On-board use and refrigerated on On-board use and on the analyzer: On-board use and on the Between Day and on Creatimjne on the logarithmic scalo? 12 weeks 205 S mothod or the coro lab method poc Materi that will determine the amount of error (SE and RE) teed ceeef Roche Paperwork -up table Qcceef cceef SD, Yocv Saunders reported reportabled reporters Performed 091% MAY (m, abso/( 2.5 our laboratory at Charlotte Academic Hospital. Johannesburg, For a few analytes on certain uric Acid Sigma-met:tcs o' a Member Login HhA on the Six Hcy methods identified f also AST Following serum also AST 'eve's infarction, serum also AST 'eves infarctin serum also in•crease serum AST "eve's Following mpoc.ardial infarction. serum also increase AST levels Following mptardial infarction. serum also ir•crease AST levels Following mpt.ardial infarction. serum also ir•crease serum AST levels Following mpc.ardial infarction. serum also in•crease serum AST levels Following mpc.ardial infarction. serum also in•crease AST levels Following mptardial infarction. serum also ir•crease serum AST •eve's Following myoc.ardial infarcticn, serum 133 s on the ccbas the same Edition higher 55 devices Sufficient volume Of each sample must be available to analyze in Sufficient volume of each sample must be available to analyze in • -icicnt rach sample muså_ vaitable to analyze in • Performed by the must be zero Or near zero, Or else the actual must be zero Or near zero, or else the actual must be zero or near zero, or else the actual Detection L checks and initial calibration. a POC E,'oed Analyss Errors a POC Blood a POC Detection Limit Detecti01 Calibrate' frequency 2•point a POC Analysis a POC Analysts Increcs day). for within day). data about a method's analytical performance eth zoo 635.0 Evaluation of 4 POC instruments iified method, the FDA-approved, unmodified method, the (Lower Llmnlt of Detection). For an FDA-approved, unmodified method, the (Lower Llmlt of Detection). For an FDA-approved, unmodified method, the (Lower Limit of Detection). For an FDA-approved, unmodified method, the (Lower Limilt of Detection). For an FDA-approved, unmodified method, the WHERE WE OCA Vantage Bias % Sigmna •mnetric OCA Vantage Bias % Stmrna•mnetric Vantage Bias % Sigma-metric OCA Vantage CV% Bias % Sigma •metric OCA Vantage Bias % Bias % Sigma-metric Blas %/0 Sigma-metric Bias % Sigma•metric Bias % Bias %/0 Sigma•metric about Theranos _ High 3. HaU, Herder M, Rej R, Apprwed (1985) HU, Harder M, Rej R, Apprwed (1985) 205 OCA Vantage OCA Vantage I DCA Vantage Lactate Sigma High AST vs and teaches peaK 2 days after Onset AST is elevated and reaches a peak 2 days after onset. Abs Resoultes zoo . 2 so props Six Sogma Calcu:ators Set up the m S»gma Calculators Normal Ann Control 10.89% 0.87 substances in patient samples Limits and ranges working range of the new method HOL 5.35% 3.35%, 525% 5.17 0.87% laboratory instrument. Can wo assume that ccepf identified fc n and and Six Sigma Calculators Specimen and Specimen Specimen and preparation allowable error allowable and preparation Can we that is correct? When methodology is not the is L-actate Address all procedural steps • Add cess all procedural steps after reagent lot change procee Ira' steps Interva Is Intervals IntervalIs triplicate and for possible troubleshooting. Irip!icate far pn.ssihle triplicate and for possible troubleshootlng. value must be taken into account) I Method Roche Cobas —u LIA the verification process shall be 33% of CLIA 33% of CUIA 180.5 CLIA BC•S6CC hematology • Sysmex SE 0500 • SE 0500 on IFCC methods for the measurement Of catalytic concentration on IFCC methods for the treasurernent Of catalytic concentration I-CC POC instruments an EP9 evaluation could net be perfortned as the specimen type reguvred for (to = ".14 1.65 = 4.33 Precision SE 9500 identified fo instruments Pie ill be used. manufacturer's stated sensitivity Will be used. manufacturer's stated sensitivity will be used. Results: All raw data reports and statistical analysis can be found in the Vitros 950 38.87% props f Glucose Abs 133.5 In patients renal diaSSiS Or those with def:ciency. In patien's undergoing renal diatysis Or those with vitamin deficienc•y, In patien's undergoing renal dialysis Or those with vitamin deficiency, In patients undergoing renal dialysis Or those with vitamin deficieney, In patients undergoing renal diaiysis Or those with vitamin deficienc•y, In patients undergoing renal dialysis Or those with vitamin deficienc•y, In patien:s undergoing renal dialysis Or those with vitamin 86 defdcienc•y, Sigma-metrics of a Mindray BC-360() hematology analyzer Sigwua-guetrics of a cobas 8000 specimen preparation. ons' use suitable In patients undergeng dia.'ySiS thcse with vitamin detciency. Introduction to Method Evaluation For collection and preparation. only suitable For specirren collection preparation. onty use suitable For specimen collection preparation. only use suitable Measuring range For specirnen collection preparation, only use suitable For specimen collection and preparation. only use suitable For specirnen collection preparation. only use suitable CV% Abs GAVC H', quality Qua:ity Standards Medica Easylyte Glucose monictoring System use XYZ Analyzer Hemoglobin B 29 Method as required quality as required quality control as required follow•ng quality 5. Linea H e mogi00in Example Abs •gas HI. ammurphy Of enzymes. Part FCC method aspartate aminotransferase. Of enzymes. Part 2. 'FCC method aspartate aminotransferase. Example IQCP for Bbs enzvmes P±rt2 FCC :SO EC Hematology .fg Precision 33% Random Error (RE) Random Error Random Prror (RE) Bbs Analyte 33% of .fg Precision Precision 25% Of TEA Preparation Rreplication 33% of 25% of TEA 25% 25% of [226% ii. Pool mean of Pool 3 x iii. Pool 2 = mean of Pool 3 x 1.5 ii, Pool = mean of Pool 3 x substances. For an he effect Of interfering substances. For an Sorum AST may docreasod roüticn in AST may be serum AST may in may be serum AST may be decreased The apparent reduction in AST may serum AST may be decreased The apparent reduzticn in AST may serum AST may be decreased The apparent redu:ticn in AST may serum AST may be decreased The apparent reduzticn in AST may be Serum AST may be decreased The apparent reduction in AST may be 5. Specificity is the determination of the effect Of interfering substances. For an 5. Specificity is the determination Of the effect of inteffering substances. For an our modem blood gas results match the workload HI, Detection (/oeor Worksta tubes cotLeaicn containers tubes or 5-700 Continue Reading out modern blood gas results will match the our blood gas results match the 356.06 -2.06 Abs Hi, ammurphy HI, ammurphy 100/4 acceptable 100K acceptable Test Mothod onta•ners 354 tubes tubes Or Collection containers. tubes or collection containers. tubes or collecticn con,tainers. 55 (10 - 2.86) J 1.65 = 1.65 = 4.33 354 same. how do you handle the differences cceef -0.58 H'. ammutphy ZOO In the CJS. traditionally 'abs look first to for guidance. study was not conducted the US. It how do you handle the ammurphy same, how do you handle the differences Bbs ccepf pr 205 Controle 2260/0 12.519 1.79 1.19 ptccedures procedures evaluations, or the previous experiences HbA1c 1 c 2.6%/0 Chemistry Validation binder. IQCP and ISO J Chem Clin Chemn Ex.•ALT EX.•ALT EXALT Ex:•ALT Acceptability b,fierence analysts differed from that by the rent these cases sampies 6Wtable a. Precision is re Precision is - the agreement of the measurements of replicate Precision is reproducibility - the agreement of the measurements of replicate A study compared petformanco ot - the agreement of the measurements of replicate analyzer • Sysmex XE • XE 2toc Evaluation of 5 POC Indian Pilct Study in Study In J Chom Eocnom • of 5 POC WES IGARO may affect reagents and _rnaterials may affect reagents and materials 196% 1.91%, 3.36% 1.596%, 2.86%, 3.56%, 3.29 9.19 329 9.79 3,29 JAMES WES Abs Glucose (glucose. Abs Comparative Works related *teased pup AST, related decreased phosphate, the prosthetic group AST, related to decreased phosphate, the group AST, JAMES XE 2 related phosphate, the prosthetic group AST, related decreased phosphate, the prosthetic group for AST, Dtspersion Caicu:atot and Otspersion Calculator Oriy speamens tested and Only the specimens were tested and found acceptable. the below were tested and found acceptable. specimens below were tested acceptable, Calculate Sigma metrics Creatinimne Architect c '6000 An Architect c XYZ Analyzer were tested and acceptable. Normanized OP Specs On-ty the specimens listed below were tested and found acceptable. the specimens isted were tested and acceptable. the specimens isted were tested and tcund acceptable. the specimens below were tested and acceptable. On-ty the specimens isted below were tested and acceptable. the specimens were tested and acceptable. Onty the specimens below were tested and tound acceptable. the specimens isted below tested and acceptable. ated specificity will i the manufactured s stated specificity will FDA-approved, unmodified method the manufacturer's stated specificity will 6.67% AST ASTL 6.67% 2.67% 1.3% 1.33 6.67% 2.67% 25% 5% 55 j 733 devices core xyz Arch'tecte16000 xyz Introdu -1 • Changes as OPSpecs . If using purchased materials, refer to manufacturer's instructions. If using purchased materials, refer to manufacturer's instructions. ufacture'ß .nstruclions. 59 50 iii. Pool 4 = mean of Pool 3 x 1.5 iii. Pool 4 = mean Of Pool 3 x 1.5 iii. Pool = mean of Pool 3 x 1.5 iij. Pool 4 = mean of Roche Plate;ets XYZ tQCP ISO and ISO Determine samples having higher activities via the Dilution ot Determine samples having higher activities via the rerun turcticn Dilution ot Cotermine samples having higher activities via the Dilution of Abs Installation for HBV Analytical method validation mainly focuses on evaluation of Completing our trilogy of Mtndray hematology instruments. we go back to a 2013 study of the Completing our trilogy ot Mindtay hematology instr umneonts. we go back to a 2013 study of the ence and 4 ECCLS. of catatytic activity concentration 4 ECCLS. of the activity 4. ECCLS_ Determination of activity concentration ECCLS. Determination of activity concentration amount Completing trilogy of Mindray hematology instruments. we go back to a 2013 study of the Completing trilogy of we go back to a 7013 study Of Completing trilogy Of hematology go back to a 2013 study Of the Set up the m Lactate XE Ptateiets P:ateiets Plateiets Roc he laboratory as part of the • acc acc (Y) and/or and/or- outlined in the Handout —2. Organize & File: 2. Organize & File: xyz Set up the Traceability:, This mehc•d has been standardaed agair•st the original 'FCC Traceability-. This mehc•d has been standarüized agair•st the original IFCC The specified requirements (performance specifications) for bl#ecence coro labs results? resulting an increase in the c' 10 resulting in an increase the ratio cd apoenzyme 10 holcentvne, resulting in an increase the ratio ct apoer•zyme to holcentyme. resulting in an increase the ratio cd apoenzyme 10 holcentyme, resulting in an increase the ratio ct apoenzyme 10 holcentyme, resulting in an increase the ratio ct apoenzyme to holcentyme, resulting in an increase the ratio ct apoen•zyme 10 holcentyme, resutting in an increase in the ratio cd apoen•zyme to holcentymneu XYZ Analyzer resulting an increase in the ratio to holcenzyme and bias between devices? exe xyz Serum, may be advisable to use these goals since we're at the where more error •s 133.5 and bias devices? XYZ Ana not XYZ present in the new method. FOUNDER be used. be used, Sensitivity: false negatives because methods fail to detect very low Abs 573% Comparative Limit Calculator sarnples via is a Results samples via rerun function is a 1:10 diluticn, samples samples via the rerun function is a diluticn, Results from samples (fluted samples via the rerun function is a 1:10 dilution, Results from samples (fluted cceef isthe rocess of determiningthe range of cceef CRP tests Stgma•metntcs in serum Of L-aspa.•tate amrdransterase (EC 261.1, ASAT). in serum Of L-aspa.•tate amirdransterase (EC 2.6.1.1, ASAT). ARE 20 23 If using patient specimens, then perform the dilutions using the for both POC instrument and the were simultaneously twenty So vs defrverwg good perfo•mance for both the POC the current anaiyser were simultaneously obtained twenty both POC instrument and the analyser were simultaneously obtained twenty runs of the same sample. It is the process of determining the range of runs of the sa runs of the sarne sample. It is the process of determining the range of R Ocho iii. Pool 4 = mean of Pool 3 x 1.5 iii. Pool = mean of Pool 3 x 2.0 iv. pool 5 mean of Pool 3 x 2.0 •v. Pool mean of 3 r 2.0 pool 5 mean of Pool 3 x 2.0 iii. pool 4 = mean of Pool 3 x 1.5 ofP0013x2.O 50 XYZ Analyzer • SE Retain all installation and calibration paperwork C. can you • t8COi formulation using calibrated pipettes together Kith a manual photometer formulation •Sing calibrated pipettes tcgether with a manual Photometer Critical Number of %est FOUNOER XYZ Analyzer Comparative Method 2 enzy•nes Ot AST have been detected. *oplasmic and mitochondria' 2 Scoenzymnes Of AST been detected. crtoplasmic and mitochondrial. 2 isoenzymes Of AST been detected. cytoplasmic and mitochondrial. 2 isoenzymes Of AST have been detected. cytoplasmic and mitochct'drial. PHOTO GALLERY Judg.ng on and bias separately, the Ricos desirable maximum allowable spec:ficaticns. xyz Analyzer Method PHOTO When you pian for • Beckman Coulter HMX • Convert data into statistical estimates of errors When you plan Comparative fibs Bias % Sigma-•metric Sigma-metric Sigma Beckman Coulter HMX plusma Plasma' and K2-EDTA plasma 1. Precision- refer to tab A Plasma: Il-heparin and K?-EDTA plasma Plasma: and K?-EDTA plasma Plasma: Li-heparin and K2-EOTA plasma Plasma: Li•heparin and K2-EOTA plasma Plasma: Li•heparin and plasma Plasma: Li•heparin and {a-EDTA plasma Cholestech LOX Cholestech LOX cvo/o Bias % qcceef XYZ Analyzer xyz XYZ • Compare the observed errors with the defined allowable error Compare the observed errors with the defined allowable error An analysis of 4 different (POC)-ot-care (POC) analyzers and one POC device for HbA1c. based on a sd0)d using the rerun furctjon are by factor 10. using the rerun function are mu"tipied by a factor of 10. using the rerun function are multipled by a factor of 10. BC-360(). The study authors concluded this instrumnent's performance is " 'satisfactory." Does a BC-3600. The study authors concluded this is "satisfactory." Does a Logout 1238 1 1238M 15189 Co mparative Chern Chem 6. Reference Ranges developers of the method BC-3600. The study authors concluded this instrument's pectotmance is "satisfactory." Does a BC-3600. The study concluded this instrument's is "satisfactory." Does a BC-3600. The study authors concluded ' 'satisfactory.' Does a 384%, new 2.413 2.43 1.45 XYZ Roche Cobas Method (X) o' a Rocho Cob as Roche Roche Co baa I c 10.89%, 1.591% 0.89%, 3840K, 384% 3.8408, If HbAIC lc 336% 213% 239"", Vitros 5M Roeho Cobas Roche Cobas Evaluation 27 2. Accuracy/Correlation Accuracy/Correlation Method (X) Vitros xyz Analyzer xyz XYZ Analyzer prwviding values the substrate•specific providing absolute values the atsorptivity, G7 1338.1 I Logout On'S' the soenzyme normal serum, while Oney the rsoenzyTne occurs in serum, while he Oney the cytoplasmic isoenzyrne occurs in normal serum. while the Only the cyfoplasmic isc•enzyme in normal serum, while the providing absolute values the substratwpecific ate,orptivity, providing absolute values the &suptivity, providing absolute values the substrate•specific &tsorptivity, Only the cyfoplasmic Éc•enzyme occurs in normal serum, while the Only the cyfoplasmic Goc•enzyme in normal serum, while the Only the cytoplasmic iso•enzyme occurs in normal serum, while the Only the cyfoplasmic goc•enzyme occurs in normal serum, while the Only' the cytoplasmic sc•enzyme occurs in normat serum, while the OCD Vitros 250 - 950 Proportional SE 520 96.1 XYZ Analyzor 97.5 Roc ho Cobas Logout i Abogout manufacturer's recommendation of the diluent to use with out-of- ufacturer•s recommendation cf the use with So the is delivering good performance for cholesterol. the you Visual Assessment Error Assessment 1.43 method. Reference Range expected, and tolerated sojue of these analytes are by so we'll need 1 238.1 238.1 Cobas c501 do usu Assessment Comparativo Comparative sø XYZ Analyzer o' the xyz XYZ XYZ Analyzer e C Oba• Cobas loo Comparative Method Method (X) (X) Roche c Q The teed *ere tested a selection of sarrOe tubes a selection of collection Tha types listed a of collection The sample gypes a collection The sample types listed a selection of collection The sample types listed tested with a selection of samp)le collection tubes The sample types listed tested a selection of samole collection tubes The sample types listed tested with a selection of sanple collection tubes The sample types listed tested with a selection ot sarrole collection tubes The sarrgle types listed tested with a selection of sample collection tubes The sample types listed tested with a selection of Sanwae collection tubes The sample types listed tested with a selection The sample types listed rare tested with a selection 01 satU)le collection lubes Creattmne 0 238M that 205 XYZ 5. Tietz NW. Clnical Gu•de to Tests, ed. Philadebhia. 5. Tietz NW, CEintcaI Gu•de to Laboratory Tests, ed. Philadebhia, 5. . Tietz NW. Gu•de Laboratory Tests. ed. Phila*hia, Bbs am a no: that performance of these assays meets most the random error. The precision is measured in terms of coefficient of variation random error. The precision is measured in terms of coeffcient of variation Aibs Evaluation nf a hemnatology Roche Roche C • Precision experiment —RE volunteers M' Comparative 50 r 710.0 Method (X) @ Roche Coba• ured sets of values determined to occur in a. Reference ranges are measured sets of values determined to occur in Now we have even more numbers. and some of them are good, white othevs ace not good at all, Now vwe have even more numbers. ane some of them are good, while others ate not good at all, Now we have even more numbers, and some of them are good, white others are not good at all, Now we have even more numbers, some of them are good, while others are not good at all, Comparison of Method Studies Method (X) identified fo ermined to occur in a. Reference ranges are measured sets Of values determined to occur in Precision Studies Lower of of measurement om Roche assessme Samples Completing our trilogy of Mindray hematology instruments, we go back to a 2013 study of the BC- Completing our trilogy of Mindray hematology instruments. We go back to a 2013 Study of the BC- Sigma-mettles assume that the can you p8rforming tm; role play at Method is the true value of a substance being measured. Verification of mitcchondhal, together the cytoplasmic isoenzyme, has been detected mitxhondhal, together wth the cytoplasmic isoenzyme, has been detected mitochondrial, together the has together with the cytoplasmic isoenzyme, has been mitxhondhal, together the cytoplasmic isoenzyme, has been mitcchondhal, together the cytoplasmic isoenzyme, has been mitxchondhal, together the cytoplasmic isoenzyme, has been detected together the cytcptasmic isoenzyme. has been detected mitcc:hondhial, together the cytoplasmic isoenzyme, has been detected mitcchondhal, together the cytoplasmic isoenzyme. has been detected wtn nas been Accuracy is the true value of a substance being measured. Verification of Accuracy is the true value of a substance being measured, Verification of a. Accuracy is the true value of a substance being measured. Verification of green where performance is acceptable. and highlight tn red where performance Works t the future, can you -ISD • Plan Plan Roc he Cobas Test Moth0d rest Method • Cancer Markers on the Y-int 'I-int What will you needo? What will you need? performance parameters will you need? need? rest Method study published in 2012. The focus ot the study was to find pvactical POC devices that could ence Method Plot the assigned values on the X-axis on graph paper Compa rat ive Preparation avaEhbIe at the time of i.e. an availabe Quality contro•l Quality control thet were time Of testing, •.e. all that were the of all available that were a! the Of testing, •e. all available that were commercially avaÄhbIe at the tire Of testing. i.e. all available that were commercially available at the tire Of testing. all available that were commercially available at the tire Of testing i.e. all available that were commercially available at the tire Of testirvg. i.e. all available that were commercially available at the tire Of testing. i.e. all available that were a-vaercially avaßlable at the tire Of testing. i.e. all availabl,e were at Of testing, no' range specimens. rcept/ rcept,• Incotnpatib'e? Chemistry Analyzer in PA: PA: WB • Remains the Sogma-metrics takes both ar,ct bias unto account a single eguat•cn, We're gomng to calculate Sigma-motoic analysis agree? rest Method •ccepf Sigma-metric. analysis agree? analysis agree? those relevant to the intended use of the concentration Plenary Sigma-motrtc agree? xyz it Comparative Roche Cobas Vitros 5öOC 5ö0C 528 529 XYZ Analyzer MethOd (X) Comparative lower Of the Lower delecf,bn Of the test Lower detection Of the test Lower Of Of the (0 instrument Roe he rest Met i Continue Reading Roche Cobas in the serum of patients with coronary ar•.d hepatciiliary disease, in the serum of patients with hepaWiary disease in 'ha serum of with hepaWiary in the serum ot patients with coronary and hepatobiliary disease. in the serum of patients with coronary ar,d hepatobiliary disease, in the serum ot patients with coronary an,d hepatobiliary disease, in the serum of patients with coronary ar•.d hepatobiliary disease, in the serum ot patients with coronary an,d hepatcbiliary disease, Pool I 12 0% Observed Results Method (X) method. ' must verify that The laboratory must verify that a healthy, non-diseased population. The laboratory must verify that 11 13 Paperwork Roche Cholesterol e MethodA/atidation Plan Method Validation Plan Continue Systematic Error (SE) • Systematic Error (SE) Practice performing the role play at • Practice performing the role play at Test Method rost Motho€ rocess Of determininq that the test system is producing accuracy is the process of determining that the test system is producing Quality Control Goid Control Grid Grid rest rest Mothoe 5.56 Analyzer were tested Sample collection systems For quality control, use control materials as Listed in the For quality control, use control materials as listed in the Quaii:y Quality Contr04 Grid tubes Sample systems from tubes of manufacvcrs tested, Sample systems tubes of all manufacturers were testefl Sample collection systems from tubes Of all manufactu.•ers were testeff Sample collection systems from tubes of al' were testeff Sample collection systems from tubes of al' manufaeu.•ers were testeff Sample collection systems trom tubes of all manufacturers were tes.teff Sample collection systems trom tubes of all manufaetuters were tes.teff Sample collection systems trom tubes of all manufacturers were testeff Sample collection systems from tubes of a"l' manutacluc•ers were tes.tefl Sample collection systems from Recall that In outstde healthcare. Sigma the performance 5.6 5.17 first step in QC of the • 2CCCi (Y) ADAMS Method (X) 18CCi 'Judge the acceptability of observed •Judge the acceptability of observed Roche Cobas L-actate rest Method glucose device 6 use of A ntkoaguÄnts in Diagnostic Lat•oratory Investigatbns, 6. Use of Anticoaguhnts in Diagnostic Investigations, use Anticoaguäants in Diagnostic Laboratory Investigatbons, Lactate by the AST Method glucose Sysmex 180CCi Methoeoq Test Moth0d amounts of the analyte XYZ 205 lalyzer C. Select a patient specimen near the detection limit and another Plot the mean of the measured values on the Y-axis, Plot the mean of the measured values on the Y-axis. 200Ci 5 u,'L 1476.4 analysrs of the analysis the assume quality xyz Anatyzer • Eva'uat•on of POC Method (Y) 3600. The study authors concluded this inst' untent•s is "satisfactoty." Does 3600. The study authors concluded this instrument's performance is "satisfact01V'" Does Sigma- 3600. The study authors concluded this insttument•s performance is "satisfactoty." Does a Stgma- Moth0d Method Method (X) each examination procedure shall relate to the intended each examination procedure shall relate to the -Intended no assurne that quality UniCet unacceptable DFFecence XYZ Analyzer Method (X) support faster decision making tot the countty•s large HIV population, The question is, do any 279% Test Method 'dy population. To ges is valid for their study population. To their choice of reference ranges is valid for their study population, To their choice of reference ranges is valid for their study population. To Ensuring your method is acceptable for your patients 12.85% quality b #ecence Abs Comparative study Of Roche Cobas XYZ •Order •Order Section. •Order section. Inspection Tips xyz Ghana d results. may contain dittehng materials which effect Aibs true, valid results. examination results. various manufacture's may contain materials "hich could affect various manufacturers may contain dittehing materials which could affect various manufacturers may contain dittefng materials which could affect various manufacturers may contain ditfehng materials which could affect various may contain dittehng materials which could affect various may contain ditfe,qng materials which could affect various manufacturers may contain differing materials which could affect rarious manufacturers may contain ditfehing materials which could affect . xyz xyz Analyzer root Method Rev,2, Inspection Test Test principle • Assures us Abcut of coj/eogues. of colleagues. WBC a SE 0500 a SE 9500 Between Day tivo Studies Observed Results Abgout (e.g. manufacturers) Changes in instrument or system components Observed Results LOX Bias Bias % .0297 -809 Mothod The detection Emit represents the lowest measurable anatyte The detection Emit represents the boweast measurable analyte The defection Emit the Tost Method Sigma-metrics of a cobas 8000)() (Y) Results subject variation as the "Ricos Goais"). Cholostech LOX Sigma-gnetrics of a cobas 8000 rest Method patient specimen near or slightly above the expected upper limit 2 loo laboratogy instrument, Can we assumeo that Manually draw a straight line through as many points as Manually draw a stra•ght line through as many points as draw a straight ae punts Calculator I Comparativo Method (X) • POC Glucose (Y) necases. When samples pnma.•y tubes In additOn, other suitable control can be used. In addition, other suitable control can be used. verlfy or transfer a published range, the lab must analyze specimens verify or transfer a published range, the lab must analyze specimens OCD Vitros 5, 1 FS the lest results cases When pnmary tubes [he test results in some cases. When proccessing samples primary tubes the test results in some cases. When processing samples primary tubes the results some cases When samples primary tubes the lest results in some cases, When p.•ccessing samples primary tubes the test results in some cases. When p.•ccessing samples primary tubes the test results in some cases When samples primary tubes the test results scoe cases When ptccessing in primary the test results nome cases. When samples ing primary lubes the test results in some cases. When pt•ccessing samples primary tubes Below •she table of average imprecision anci bias tor each instrument) cote labs results? XYZ Analyzer XYZ Analyzer in • Report Method • Evaluation of 3 POC • Evaluation ot a of a range specimens. range. the lab must analyze specimens 7. Schumann G. R. F. al. IFCC Primary Reference Schwn,ann G. R. Ceroti et FCC Primary Reference Schwnann G. Boncta R. herior,i et IFCC Primary Reference Expected Results BC-360C 90 t Z Analyzer This assay follows the recommendations Of the [FCC, but was This assay follows the recommendations Of the IFCC, but was This assay follows the recc•nmendations Of the FCC, but was This assay follows the recom•nmendations Of the IFCC, but was This assay follows the recommendations Of the IFCC,but was ThlS assay follows the recomnmendations Ot the IFCC, but was recommendations the FCC. was 1. Random Error will be evaluated by running between day and within day andom 1st one t,Ke i Slope determined by a minimum of 40 samples, tested in Accuracy will be determined by a minimum Of 40 samples, tested in Accuracy will be determined by a minimum of 40 samples, tested in by a minimpm samples, tested in For all of the instruments. the perfoutnance is not all good or anl bad There are some better assays and For all of the instruments. the performance is not all good or ail bad There are some better assays and For the instruments. the is not att good or all bad There are some better assays and For all of the instruments. the performance is not all good or all badl There are some better assays and For all of the instruments. the performance is not ailt good or all bad, There are some better assays and xyz Analyzer no longer XYZ Analyzer level that can be from C. It is calculated as the that can be distinguished from C, It is calculated as the value that can. be distinguished from C. It is calculated as the value 3.41% 6.60 Method oecwe . • Cancer Markers on the meth Compare error estimates to specifications for • Compare error estimates to specifications for no longer mnatters? •m parative metric analysis agree? loo tne More Articles ... Asistcncial analyzed new Validation Studies Intetwevv Westgate Bbs (Y) 7.72 Within Run POC devices provide adequate quality tor that type ot clinical care? Creat:mtne Creat:ntune Creatimjne Creatimtne Creattrune Creattntne 1.91% : 0 Intetvlew'i Westgard loo Within Run Creatintne Intervv€•w Westgatd Method (X) Westgardt Other Articles Sigma•metntcs of a ed' The Intervals and be adapted each The control intervals and limits should be adapted to each The intervals and limits should be adapted to each The the Instructions Of the tube manufacturer. systems). the instructons Of the tube manufacturer. Critical of Test (sample the o! the tube rnanutaauret. (sample collection systemns). follow the 01tructjons Of the tube manufacturer. (sample collection systems). follow the hstructions Of the tube manufacturer (sample collection systerns). follow the hstructions Of the tube manufacturer (sample collection systerns). follow the hnstructions Of the tube manufacturer, (sample collection systemns). follow the rnstructions Of the tube manufacturer. systems). the rstructnns Of the tube manufacturer. validation Procedures for the Measurement of CataMic Activity Ccncentratbns Procedures for the Measurement of CataMytic Activity Concentratbns ONLINE STORE Manufacturer's loc) 50 90 Normal Control Abn Control Normal Abn Control Normnal Control Abn Control optimized *formance ard optimized for performance and optimized performarce and stability.»t optimized *rformance stability.3'I optimized performance ard stability.3'I optimized performance and stabilityg•l optimized *rformance ard stability.»tI optimized performance stabilitygal optimized *rformarce and stability.»t optimized *erformance ard stability.3'I optimized performance ar•d Optimized *or performance art stability••l optimized for performarce ard stabilityg•l of the working range. Ensure that both specimens meet storage of the working range. Ensure that both speclmens meet storage Of the working range. Ensure that both specimens meet storage Continue Reading Reading using both "Ricos goals" and CLIA goals. -g When the POC ane the possible, making sure that the line adheres to the lower possible, maklng sure that the line adheres to the lower making search _ adheres to Method Method (X) ad individuals for each subgroup. If 2 or subgroup. If 2 or from 20 healthy, non-diseased individuals for each subgroup. If 2 or Materials lying 3 that the standard Iving 3 the standard Iving 3 that the standard Ying 3 standard that of the lowest standard 3 that of tne standard least one time Method searclv will primarily be patient samples. but may include Analyte Analyter Acceptability duplicate. These wi I primarily be patient samples, but may include duplicate. These will primarily be patient buvrnay duplicate. These will primarily be patient samples, but may include Reference • Handout: Guidelines -specific to changes Acceptability Acceptabilety Part 1 Q, search- :uecificr'co Moth0d (X) Method (X) Comparative rest M Roche Cobas Material 0 matter. how , Comparative C.omparative Tost Method Test Method Cove Lab agree 2 loo c 701 chemistry analyzer 33% of 33% of CLIA Comparative rest Method 2 100 100 50 c701 chemistry analyzer rest Moth0d indA'iduaI requirements. Values Obtained smould within the defined individual requirements. Values obtained should Within the defined individual Values Obtained within the def,ned requirements. Values Obtained should the defined about and Chinese Automated Chanese Wid-Volume Chemastry Method Tools Comparative AST n the sample catm'yzes an gup AST the sample catalyzes the an arum group between AST in the sample catalyzes the transfer ot an amino group between AST in the sample catatyzes the transfer ot an amino group between AST the sample catatyzes the transfer ot an amino group between AST in the sample catatyzes the transfer of an amino group between AST in the sample the transfer ot an amino group ot Enzymes at 37 • for ot Enzymes at 37 • Pant 5. for Enzymes at 37 Pan for Enzymes at 37 • Pant 5. Reference for the Centrifuge samp•es before performing the assay. precision using normal and abnormal control samples. Between-day will be Analyzer Cevices for Neonatal peapitates before performng the assay. Centrifuge samp•es precaining *recipitates before performing the assay. Centrifuge sarnp'es containing before performing the assay. Centrifuge sarn*s containing *ipitates before performing the assay. Centrifuge samp'es containing *ipitates before performing the assay. Centrifuge sarn*es containing *re:ipitates before performing the assay. Centrifuge samnp'es containing *recipitates before performing the assay. Centrifuge sarnp'es containing *ipitates before performing the assay. Centnifuge sarn*es containing precipitates before performing the assay. oge sarnees comainlng before performing 'he asey. Cholesterchl 238. set by the Ricoe, 1 loo loo Method same Normal Control Abn Control Norrnal Control Abn Control Roche Cobas :ontrol Abn Control Normal Control Abn Control Manufacturer's (standard + 3 SO, repeatability'. n 21). (standard I 3 SO, repeatability. n 21). precision Precision cvo,'o ot S poc xyz Analyzer Vista :onsidered verified. published range. it is considered verified. fewer results fall outside the published range, it is considered verified. Reference Interval(s): even though results are accurate and Comparative of Method experiment —SE • Comparative of Method experiment —SE 1200K If quality does and stability requirements as stated by the manufacturer. b#ecence (Y) tial proficiency testing or control samples in order to provide commercial proficiency testing or control samples in order to provide worse assays worse assays, assays = bias + 3SD < CLIA TEA 1120% ed in The points. commercial proficlency testing or control samples in order to provide testing provide Experimej xyz etQD th There are a few problems here not that many 1he herformance of these assays mreets most of the There are a few problems here but no: that many, The performance of these assays meets most of the set by Ricos goals in The Pathologist limits. Each laboratory Should establish measures limits. Each laboratory establish cc.•rective measures limits. laboratory Should establish corrective measures be limits. Each laboratory Should establish measures be 25% of 704 706 00 Method (X) Remember the equation for Sigma metnc is (TEa - bias%) CV system Roche (Y) Measurement of Aspartate Amhotransferase. Measurement cd Concentration Aspartate Amh-otransferase. Measurement cd Aspartate Amnotransferase. cd Catalylic Aspartate Ami-otransferase. Ricos Ricos Roche Cobas L•aspartate and form oxaVoacetate and L•aspartate and form and L•aspartate and and L•aspartate and form oxaloacetate and L•aspartate and form oxaioacetate and L•aspartate and form oxatoacetate and and and and form oxaVoacetate and Contro; Calculator anid Lim". Calculator | 1.59% Core Lab don't agree Control Limit Calculator S Resources aperformance characteristics performance parameters performance characteristics performance specifications 965% how are you Method (X) • Raw Data • Raw Overall, there are a lot of good mletrics here. Overall, there are a lot of good metrics here. Overall. there are a lot of good metrics here. Overall. there are a tot of good mletrics here. Overall, there are a lot of good muetrics here. cv% 24 hours at 15-25 at 15-25 15-25 cv% Cholestech I-ox 96.79 3.29 7.72 1.76 1.72 9.79 auc Going assure X YZ Analyzer precision Precision . Precision use of that examination. use of that examination 1 1.59% 1 1.590/0 1.596%, 1.596% 5.3590K, 0.89% 5.356% 1089% 1.590K, Roche Co XYZ Analyzer )lished range, a ults fail outside the published range, a If, however, more than 2 results fall outside the published range, a If, however, more than 2 results fall outside the published range. a 2<90 Roche Cobas (Y) A direct enzymatic A enzyntattc A Wrect enzytnattc A d:rect enzymatic XYZ Analyzer ACTIVITY: labs results? xyz As we a nutybers and ave' age keep In Comparative material that covers the reportable range. The samples will be tested on material that covers the reportable ransge. The samples will be tested on 43% Test Method Chemistty Analyzer analyzer 2009 ICU 2009 Method (X) taken if values fall outside the defined •mts. taken it values fall outside the defined limits. XYZ Analyzer Prepare 5 pools for testing as follows: there are a tot of good metrics here, Bias% . An alternative to creating g g use L Inaar data An alternative to creating a graph is to use the Linear-data (X) analyzer Clin Chem Lab Med Clin Chemn Lab Med that WHERE 10358 A enzymatic The then reacts With NADH. in the preserce Of malate The oxa,ioacetafe reacts with NADH. in 'he presence Of The oxaloacetale then reacts With NADH. in 'he presence Of malate The oxaloacetat.e then reacts With NADH. in the presence Of malate The oxaloaceta•.e then reacts With NADH. in the presence Of malate The oxaloacetate then reacts With NADH, in the presence Of malate The oxaloacetat.e then reacts With NADH, in the presence Of malate Expected tested by running each sample once per day for 20 days or 4 samples per tested by running •ach sample once per day for 20 days or 4 samples per • A direct enzymatic Roche Cobas Expected values" Expected values t' Comparative Bias % Bias % Sigma-metric 3 2<90 • Cancer on the Abs • A direct enzyntattc Roche your assigned experiment Roche Reflotron Roche Reflotron I ao • Cancer cn CRP Cancer cn Reportable examination results. Evaluate the data and determine Roche matter. how are you • Requires extensive studies Constant SE Constant Experiments to be performed Cancer on the OCD Vitros 5600 • Judge the acceptability of observed performance characteristics Judge the acceptability of observed performance characteristics 'Bias % Bias Oh 130 A study the pcjfonnance ot Roche erence int Comparative Cobas Cobas I our blood the k 00 r ac of Test ie conducted. 6.6% Ex-AL T 2.6% more extensive study must be conducted. 26% 260/0 2.60/0 6.6% 1.3% 2.6% 6.56% 2.3 3.6% 30/0 desuab;e specifications set by the 20 IA Ricos goals. desvrab'e specifications set by the 20M Ricos goals. specificatons set by the 20 IA Ricos goals. the appcable regulations and the applicable government regulations and gÆines the applicable regulations and Sigmna-metrics for HBV When the POC and the Core L-ab) When the POC and the Core Lab E Ryder KW, Jackson SA GraphCaI Cornpansons Of E. Glick MN, Ryder KW, Jackson SR Interferences Glick MR. Ryder KW, Jackson SA Companiscns Of Interferences Glick MN, Ryder KW, Jackson SR Graphtal Comparisons Of Interferences Remember the equaton Sigma metnc (TEA - CV Des. CV Dos. Bias rost Method Comparat dehyon:genase (MO"), to form dehydtcqenase IMOH), torm NAD', dehydtcgenase (MOB). to form NAD'. dehydrgenase to form NAD'. dehydn:genase to form NAD'. dehydrogenase (YDH), to form NAD'. dehydn:genase (MOR), to form NAD'. dehydrogenase (NOH), to form NAD'. dehydn:genase (YDH), to form NAD'. dehydrogenase to form NAD'. dehydrogenase (MO"). to form NAD'. dehydn:genase (VDH), form NAD'. a XYZ Chemistry Analyzer located at Cape Clinic Laboratory chemistry a XYZ Chemistry Analyzer located at Cape Clinic Laboratory chemistryi Sigma-metrics for HBV Acc, optimized standard W)thod (comparable to the IFCC Acc, standard method to the IFCC Acc, the optimized standard method (comparable to the IFCC Act the 'FCC the to the OT60 Test MothOd Sigma-metrics of Mindray BC-3600 automated hematology analyzer Sigma-metrics of a Mindray BC-360()0 automated hematology analyzer Set up the method in the physical location At this point in the process, ensure that all Label the low specimen Pool 1 and the high specimen Pool Label the low specimen Pool' 1 and the high specimen Pool Sigma-metrics of two blood-gas Plotter located on the mvw.westgard.com website. Plotter located on the www.westgard.com website. Plotter located on the mvrww.westgard.com website. AST 3 2Öo 9.19 3.1% 31 (Y) 3 2<30 Test Method Comparative cheniistry analyzer rest Method Perform the role play for the class • Perform the role play for the class assay 'YoHbA 'c assay 'YoHbAtc Method (X) • Increases by a over a range of xyz Analyzer Evaluation of four POC analyzers and one HbA1c analyzer Cobas c501 C 0 m pa Sigma-metrtcs of a chemistry analyzer in Ghana Sigma-metrics of a chetnistry analyzer in Ghana that better 0/ worse at the upper lower of these? ao XYZ Analyzer of a chemistry analyzer jn Ghana '7.0% 'ethod (X) • poc • Three POC Three poc for quality ccntrc•l, quality 1089% 7.0% Evaluation of Mir,dray assay for tc on in Clinical Instrumentation. Chem in Clinical Chemis:ry Instrumentation Clin Chem '2.81% to assure it? Method (X) assay for 'YoHbA 23 24 25 26 24/5 (What does "negattve" Sigma mean? It means that the bias actually exceeds the allowable total error The [What does "negative" Sigma mean? It means that tshe bias actually exceeds the allowable total error. The [WVhat does "negattve" Sigma mean? It means that the bias actually exceeds the anlowable total error. The [What does "negative" Sigma mean? It means that the bias actually exceeds the allowable total error The IVVhat does "negative" Sigma mean? It means that the bias actually exceeds the allowable total error. The 2. 26 day for 5 days. Within day will be tested by running each sample 20 times in dayfor 5 days. Within day will be tested by running each sample 20 times in 30 31 Roche CObas Q) Method Neonatai During this step, these characteristics should metrod WMhout pyridoxal phosphate activation method Without phosphate activation 12): method Without pyridcxal phosphate activation method phosphate activation phcsph?te Run 1 8 9 10 11 12 assay 'c assay for '%HbA assay for lc AST 5% 5. 25% medically allowable error for an objective medically allowable error for a'n objective Different skill level of the operators method WVtnout phosphate phosphate The samples be tested in duplicate on both the test and section. The samples will be tested in duplicate on both the test and section. ,The samples will be tested in duplicate on both the test and Roche Cobas going to assure It? Vista. Second± Look Vista. Look Method (X) Reference Range o.g9% 7.0% 0.89% 7.0% 7.0% 3.3% 280% Vista. Second 1.00k AST 1 0.89% Vista. Second Look assay Method ( X) Method (X) Rec two with coau (X) Materials provided Materia s provided Materiel S provided Visually inspect the plot for a linear relationship. Roche Samplies Materials prov ided cceef the of about precise, reported results will be clinically misleading if the Example calculatiom WBC. with a quality 2.99% Imprectson and What's New L-Åspana!e + 9 Report on Symposium •Drug Effects in Clinical Chemistry 9, J, Repont the Symposium •Drug Effects in Clinical Chemistry 9, J, Report on the Symposium in Clinical Chemistry L-Asparrate + L-Aspantate + L•Aspartate + b Aspartate + oxaloaceäte I-glutamate oxaJoacetate + L-glutamate oxaJoacetate + I-glutamate oxaJoacetate + I—glutamate oxaloacetate + I-glutamate + L-glutamate Albumin 2.8% 1.84 analyzer and the ot Acceptab e oxaJoacetate + 5.7% don't agree Cholesterol Calibratiors Method (X) Calculation Calibrations comparative instruments and duplicates will be averaged. Ideally, testing devices and a core lab analyzer A 2015 study in Revista de Catdida Interference (Y) A POC A poc STORE Linearity Precision •king solutions' section 'Or reagents. See •RoagenE working solutions' reagents. See •Reagen* • working secutions' reagents. See •Reagents working solutions' fectior reagents. See •Reagents working solutions' section reagents. See •Reagents Morking sctutions• sectary for reagents. See •Reagents • working sc•Lubons• section for reagents. roles: See •Reagents working solutions' secttn reagents. See •Reagents working solutions' reagents. • BOrking reagents- Evaluation of a Chinese Automated Chemistry Analyzer 9.55%, Uevices and a cove lab analyzer Recovery •omparative Vales: up to 40 Roche Reflotron Evaluat»on of a Chinese Automated Chemistry Analyzer A 2015 study in Revista de Caldida (up 2800/0 605 BC 680C Hematology • Materials to create the necessary s to create the necesse:y Evaluaton o' a Chinese Automated BC Hematology BC 6800 Hematology POC (Y) A POC Chemlstry • POC Chemtstry Methods' J Clin Chern Clin 199634385-386. Methods•. J Clin Chem Clin eochern Methods•. J Clin Chem Clin Methods'. J Clin Chem Clin 80them 1996;34385-386. adlowab'e total error? Would that delver the sam•.e verdict: or a one? POC deu:ce method ts significantly differrent than the central laboratory method, it's like they're aiming at POC deu:ce method ts significantly differrent than the central laboratory method, It's like they're aimhing at POC dev:ce method ts significantly differrent than the central laboratory method, It's like they're aimning at POC dev:ce method is significantly differrent than the central :aboratory method. It's like they're aiming at tests Allowable Total Error (TEa) % A POC Chemistry Prepare Pool 2 (750/250) with 3 parts Pool 1 + 1 parts Pool 5. Prepare Pool 2 (75/25) with 3.i:erts , aart Pool 5 one day. The mean, standard deviation (SD) and CVwill be calculated of one day. The mean, standard deviation (SD) and CV will be calculated of and tv Note on the graph the observed linearity range. Note on the graph the Observed inearity range. Note on the graph the observed inearity range. Note on the graph the Observed linearity range. Note on the graph thle observed linearity range. A POC Chentnistty CObas Requires studies to • Requires studies to WORKSTATION glucose device direct methoe Calculator Quantifyjng Quantifying AST Method • direct HbA1'c method Roche,'Hitachj cobas c systems automatically calculate the anatyte Calculator Calculator Quantifying Test Method Chinese direct HbA 'c method Oxalc•acetate NADH H' Oxalcacetate NADH H' Oxalo•acetate NADH H' cobas c systems automatically calculate the anatyte cobas c systems automatically calculate the analyte NADH H' L-malate NAD• L-malate NAD' NAD• NAD' Comparative - necess Bias % laboratocy Can we that A direct direct search to reveal and assess the That's the ot two separate components. What about using Sigma.metnics and ailowab!e total error? Would the or a one? That's the Simple comparison of two separate components, What about using Sigma-metrics and That's the simp;e compartson of two separate comnponents. WVhat about using Sigma-metrics and will occur on both instruments within 2 hours. Summary of Performnance by Sigtna-metrics Method Decision Chart and OPSpecs Summary of Performnance by Sigma-metrics Method Decision Chart and OPSpecs Summary of Performntance by Sigmna-metrics Method Decision Chart and OPSpecs Summary of Perfortnance by Sigmna-metrics Method Decision Chart and OPSpecs method than central laboratory method like they're at 1083% 250% 1083% 2500K, 250% negative Females: up to 32 (up to 0.53 1073% Value '6361 CALCULATORS 6200 610.0 6350 620 0 (up to 655.0 6600 Value Value 615.0 660_0 635.0 610.0 Sonntag O, Scholer A. Drug hterfererce in Clinical chemistry: Sonntag O, ScWoJer A. Drug hnterfererce in clinical Chemistry. If MV experiments are acceptable, then the Poly-Chem 620.0 660.0 Example WÜC, With a quality requirement. WORK S "ON Data WE ARE is 356.060 1.54 0.92 88 - 98 88 - 99 2.359 273% 2.39 when called upon by the facilitator WORK sun ON i CALCULATORS Summary of Performance by Sigma-metrics Method Decision Chart and OPSpecs of two blood-gas but not provided) moncen:ration 01 each sample. concentration each sample. CALCULAiORS Materials required (but not Materials required (but not provided) Cevvce Oevvce Test Method Asistencial analyzed a new core laboratory Asistcnctal analyzedl a new core laboratory Date and sign your initials. Intercept • The Precision and Compartson data The Precision and Comparison data Validation Studios Olympus AU27CO Three POC Lipid AU2tCO IA Method (X) • '"troduction into Routine Service Introduction into Routine Service Evaluatjon of BC 6800 Hematology analyzer Linearity range is Linearity Studies Linearity Experiment Linearity Experimnent analyzer rt0N Prepare Poai 3 (50/50) 2 parts poo: 2 pans Pool . POC Oev•ce Roche Cobas Linear regression analysis will be used to determine The rate o! the NADH oxidation 'rectry ptcmrtic.-.al to the catalytic AST The rate at the NADH oxidation 's (Erectly prcportic.".al to the cataly.ic AST The rate at the NADH c«idation is (freely prcporticnal to the catalytic AST The rate ot the NADH c«idalion is (frectly prcportinoal to the catalytic AST The rate at the NADH c«idation is (freetly prcporticnal to the catalytic AST The rate at the NADH c«idalion is (Erectly prcporticnal to the catalytic AST The rate ot the NADH c«idalion is (Erectly prcporticoal to the catalytic AST The rate ot the NADH c«idation is &Erectly proporticoal to the catalytic AST NADH is prcørticoaj to catalytic AST is Acceptability criteria: Linear regression analysis will be used to determine 3cceptability criteria: Linear regression analysis will be used to determine Prepare Pool 2 (750/250) with 3 parts Pool 1 + 1 parts Pool 5. Plenary Cobas clll • The and Companson data • The Precision and Comparison data = + < CLIA Comparison of Method 90 ON recommendation dugs and their cccentrations to be used in drug recommendation and their used drug recommendation and their cc.-centrations to be used in drug dugs and their concentrations to be used in drug Lineality Linearity Tngiycendes Tnigiycenides ides Precision Deuice Oevtce for "BV C. a. 2. completely targets .) comple:eiy different targets.) completely different targets .1 completely targets I1 completeiy d:fferent targets.) completely targets.) completely d:fferent targets.) the replicates. Cevtce POC Errors oe completely different 3.36% Evaluation for concentrations Taiglycendes of a • Evaluation of 3 Chemistry Analyzer Evalua•.ton ot 3 See secton. across percentage See "Order Information" secton. See •Order sectOon See 'Order •nforrnaton" See "Order information" secton. See "Order information" section. Roche Cobas 2 loo loo ccepf secton, blood gas vesnlts LS Initials AM Initials AM AM AM AM AM AM AM AM AM AM AM TK WORK s Westgate Award Linda Giucose *thOd Convers±on+ Conversion factor: Conversion factor factor u,'Lx props for the role play Introduction to Method Evaluation Introduction to Meth iod Evaluation Calculated values: A factor Of 2.13 is used 'or the converse' Calculated values: A factor Of 2.13 is used for the conversion Calculated values: A Of 2.13 is used the allowable total error? Would that delrver the satne verdict. or a different one? allowable total error? Would that deliver the same verdict, or a different one? hematology int be considered and expected quality ops the role play Proportional SE Proportlohal SE hematology analyzer identified for routine operations. activity. It is determined measuring the decrease in absorbar•ce. actvity. It is determined measuring the decrease in absorbarce. actvity. It is determined measuring the decrease in absorbance. acfvity. It is determined measuring the decrease in absorbance. activity. It is determined measuring the decrease in absorbance. activity. It is determined measuting the decrease in absorban•ce. Can we calculate Sigma.metrics for Validation Studies File the graph in the linearity portion of your method File the graph In the linearity portion of your method File the graph in the portion rt.etncd interference Ann Clin 200138376-395. interference sludies, Ann Clin Bicchem 200138376-335. interference sludies, Ann Clin Bicchem It is determhed the de-ease in absorbarce_ [s determned measunng the decrease in absorbance Ann Clin Comparative Method Result (X) (Y) C. 2.2 2. a. Analyzer required ancillary equipment ( e.g. centrifuge, White, G.H. & Fraser, C G. (1984). The evaluation kit for clinical chemistry: A White, G.H. & Fraser, C.G. (1984). The evaluation kit for clinical chemistry: A Can we calculate ics for Can we calculate Stgma.metcics for if the methods are accurate within the specified T Ea when the Correlation if the methods are accurate within the specified TEa when the Correlation reference interval does not match your population Expected Results coo-as Cholesterol 1.65%}/ we have A, Gereral laboratory equipment General Laboratory equipment General laboratory equipment Genera' laboratory equivnent we haven't WORKS Augment and uonnuatunooa WORKS r/ ON we ARCHITECT chemistry analyzer and the imnportance ot chemistry analyzer and the importance ot Acceptabilety A study • Determine quality requirements at the decision level at the 'aw you to the method Evaluation of 4 POC Method from 25 cc to 37 from 25 •C to 37 Prepare Pool 4 (25/75) with 1 Poo' S.gma.me•.ncs of SIX methods chemistry analyzer and the importance of • of a POC of Prepare Pool 2 (750/250) with 3 parts Pool 1 + 1 parts Pool 5. Prepare Pool 3 (250/750) with 2 parts Pool 1 + 2 parts Pool 5. S.gma•metncs of Six lbA1c methods Pool 5 WORKSTATION methods Award • ARCHITECT • Determ•ne the quality requirement for CRP Determtne the quality requirement for CRP rest Method Il. Thefeld W. H. Busch et al fir Thefeld W, H, Busch EW, et a'. Thefeld W. H, Busch EW, et al Thefeld W. H, Busch et al Referenzwe.•te fir W H, assessment of the errors assessment oft 25 5 231/5 23/5 30/5 Within Run 15 Abbott ARCHITECT Acceptability criteria: The % CV for each assay is expected to be equal to or Date Date 1/6 2/6 28/6 • Abbott ARCHITECT rA WORK s Glucose monitoring Glucose >0975. If the Correlation Coefficient is < 0.975. then Coefficient (r) is >0.975. If the Correlation Coefficient is < 0.975, then Coefficient (r) is If the Correlation Coefficient is < 0.975, then Coefficient (r) is if the Correlation Coefficient is < 0.975, then 1. Bias, %Bias valuation binder. validation binder. 15 core labs Comparisol ef Method Com of Met lod WORKS st solutions cc Analyte Analyter ON 0.56 What's New WORKS rA a. WORKS Sigma-metrjcs of Six SA (15 - 1.4) 1 2.99 = 13.6 2.99 = 4.5 Sigma S "ON 2010 chart Molecular Diagnostic methods? We camne When a point-of-care device is compared to negative die Bestirnmungen de," Transaminasen GOT und CPT sowie der die Bestimnmungen de:" Transaminasen GOT und GPT sowie der de• GO• GPI Some Nothinc but Manual QC A SSay confirm manufacturer's • Roche Nothing but the Manual ac 0.99 t 5.7% methods? wo When a point-of-cate device is compared to CRP tests Westgarc± Award: lacp CC Each laboratory should investigate the transferabiity Of the expected values to Each laboratory st-auld investigate the transferabiity Of the expected values to Each labora:ory ineestj*te 'he Of the vaues to 2016 Westgard Award error present Error Assessment • If method is acceptable, then perform reference range experiment If method is acceptable, then perform reference range experiment bias at each of those levels , 25 15 1.07% Roche Cobas c 501 A 2016 study the performance of A 2015 study comnpared the performance of rmust be collected. IT the Correlation Coefficient more patient data must be collected. If the Correlation Coefficient more patlent data must be collected. If the Correlation Coefficient Reportable Range Normal Control Abn Control WORKSTATION Test Method SD, 0/0Cv • Calculate Sigma metncs 118 A Study compared tho Of implementing an analytical quality control A 2016 study compared the performance of WORKSTATION HbA POC TWO 1.44 5.56 1.43 lot Sample method HbA c8000 poc WORKSTATION a new Abs WORÄS r ION r 'ON cgooc alkalischen Phosphatase im Serum mit optimie'ten Standardmethoden. alkalischen Phosphatase Serum mit optimierten Standardmethoden. SD, O/ocv For optimum performance of the assay. follow the directions givon in For optimum of the assay, follow the directions given For optimum performarce of the assay, follow the directions given For optimum pertormarce of the assay, follow the directions given For optimum performance ot the assay. tot'ow the cfrect'•ons given For optimum ot the assay, follow the directions given Sigma mettlCS AMR (analytical measurement range) is lance ot the assay, the directions given RI 284 (37 RI mmoUL,pH RI mmoUL,pH 792 mmobL; RI 264 pH RI 264 mmoUL, pH RI RI pH RI 264 mmoUL,pH 264 7.8 (37 For optimum pedorrname ot the assay, follow the guen For optimum portormar& Of the assay, follow the &recttons given For optimum of the assay, follow the &rections given • Sign•.a metncs AMR (analytical measurement _ has hauo hav ha•• the hias cBOOC its own patient population and if necessary deternr,e its own reference ranges. its patient populatOon and if necessary detennr,e its own reference ranges _ • Calculate Stgma metrics less than the manufacturer's performance specifications for precision. In the r has has tho tho the . its and it necessary determine its Own ranges. WORKS 3 2<90 (Y) • Workstation set-up table WHERE WE XYZ Analyzer practical guide for the eval lation of methods, instruments, and reagent kits. practical guide for the evaluation of methods, instruments, and reagent kits. 25% of XYZ Analyzer • Increases by an 2 loo n a then paired data calculations or another regression remains < 0.975, then paired data calculations Or another regression remains < 0 975, then paired data calculations or another regression remains < 0 975, then paired data calculations Or another regression