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PEPFAR Quality Control and Method Validation Activity 14: Part 3

In this activity, participants will perform method verification experiments and assess data to
determine if the method is acceptable or not.

Note: Any reference to page numbers in the video may not correlate with supporting documents as documents may have been updated.

Within-run Pre 1300 35 50 Precision (Replication) Experiment Experiment Summary Sheet Precision Experiment Precision Experiment Worksheet Handout 4: AST Validation Summa 1406 Experiment 1900 35 Precision Experiment Worksheet Precision Experiment Precision Experiment Worksheet Precision Experiment 50 between 35 Long Term (Between-run) Long Term (Between-run) Short Term (Within-run) Short Term (Within-run) 1300 Method Validation Validation Summary Report Method Method cobas c501(Serial #12345) cobas c501(Seria #12345) Method cobas c501(Serial #12345) c501(serial #12345) Method 0900 1 60 1 50 35 35 55 Roche 90 Roche Roche Manufacturer's Manufacturer's Manufacturer Manufacturer Analyst's AST Analystes Analyst's AST Summan Sheet Summary Sheet Summary sneet Summany Sheet Summan sneet Summany sneet Summan sneer Purpose: OValidation Verification Of Manufacturer's Purpose: C]Re-Validation Verification Of Manufacturer's Purpose: CIRe-Validation Verification Of Manufacturer's Method IJ/L IJ/L Units of Measure Units of Measure loc) Claims 2 loc) Sample Name/Description•. Sample Name/Description:. Sample Name/Description: loc) Sample Name/Description: Within-run Precision 205 Between-run Precision Withien-run Precision Observed Results Experiment Results loo (00 analyst First, always determine if the within-run precision Analyze,s 120 Description Of Equipment/Process: QC Multi 1; ; QC Multi 1; QC Multi 2; ; QC Multi 1; ; QC Multi 2; ; QC Multi 1; QC 1; Lott' QC123; exp 30-Aug Lott' QC123; exp 3D-Aug Lot#t QC123; exp 3D-Aug QC123; exp 3D-Aug QC123; exp 30-Aug Lot# QC123; exp 3D-Aug Lot#' QC123; exp 3D-Aug QC123; exp 3D-Aug 20XX zoo Lottt QC123; exp 30-Aug QC223; exp 30-Aug 120 Expected Results 20 QC Multi 1; ; QC Multi 2; ; QC Multi 2; ; exp Material 2 Material 1 LOU/ QC223, exp 30-Aug LOU* QC223, exp 30-Aug QC223; exp 30-Aug LOt# QC223, exp 30.Aug Lott' QC123; exp 30-Aug Lottt QC123; exp 30-Aug analyst, on the sami 205 Equipment/Process: Roche Cobas c501 Chemistry Analyzer regarding AST only zoo QC Multi 1; ; QC Multi 1; ; QC Multi 2; ; Lottt QC123; exp 30-Aug QC223; exp 30-Aug QC123; exp 3D-Aug LOU/ QC223, exp 30-Aug LOU*t QC223; exp 30-Aug QC123; exp 30-Aug Material 1 Material 3 Material 2 zoo Serial Number: 12345 The closeness of agreement Lisa Johnson The closeness of agreement The closene ss of agreement Analyste Analyze Analystes Analyst, Analyte is acceptable. is acceptable. X Acceptability Acceptable Acceptablet Material 3 Material 1 Material 2 conditions Material Material Analyte November 5, 2013 Date Location: Cape Clinic Laboratory, 111 Main Street, Arusha, Tanzania 5; 5' between results of test between results of test Experiment Results Observed Results Expected Results Expected Results Date: November I through 30, 2013 preliminary Estimate Of Precision, Short Term Experiment Results Observed Results Expected Results Preliminary Estimate Of Precision, Short Term Preliminary Estimate Of Precision, Long Term If the within-run precision (best case scenario) short Time Material 2 Material 3 Time Time Material 1 Material 3 Material 1 Run Run Date Date Run Run Date Date FDA Approval Status: Approved CIN0t approved performed on the same performed on the same Run Material Material Material Material Run Material Material Material Material short Initials Initials Initials Procedure: 120 90 50 2 100 lop method items, by the same method is not acceptable, then the random error must method items in a single User user UJser 11.Nov.13 6-Now13 7-Now13 0700 0700 Repeatability same Refer to the Cape Clinic Laboratory Validation Plan for Cobas c501 regarding AST 90 35.0 IJ/L 0.3 U/L 1.0 U/L 120 u/L 35.0 UJ/L 1.3 U/L 120.0 U/L 120 u/L 2.1 U/L 1.1 u/L 35.0 U/L 120.5 U/L 35.0 u/L 120.0 UJ/L 118 Mean 205 2 100 loo 120 2 loo 120 120 121 Analyste 0.8 L-J/L 0.8 IJ/L 0.3 U/L 0.8 LJ/L 0.0 IJ/L 1.5 U/L 1.0 u/L 120.0 U/L 130 u/L 0.3 U/L 2.1 U/L 1.3 U/L 1.5 u/L 0.8 IJ/L SD AST AST Analyze a sample 2 data reports and statistical analysis can be found in the Cobas Results: All raw data reports and statistical analysis can be found in the Cobas analyst, on the same laboratory but over an laboratory ut over an 1180 34 118 18 36 10 Value c501 Validation binder. 11.Nov.13 11.Nov.13 13.Nov.13 123-Nov-13 be reduced or the method should be ao 2 100 instrument, under the same extended period of time 1. Precision refer to tab A 14 Manufacturers Claims Claims 14 Reflects 120.0 U/L 36.6 U/L 26.6 U/L 35.0 uJ/L 35.0 IJ/L 36.7 u/L 35.0 UJ/L 26.1 U/L 128 U/L 1.5 U/L 120.0 U/L 120.5 U/L 3.1 u/L Repleats Mean 10b Experiment Results 1300 35.0 abandoned. conditions in the same 3.1 u/L 0.3 U/L 0.0 I/L U/L 120.0 U/L 1600 0700 15 14 Between Day Between Day Intermediate Precision, Total Experiment Results Analyter precision 0.4% 0.8% 0.4% 0.8% precision I acceotable Manufacturer's Claims Manufacturers Claims Normal Control Abn Control 35 Expected Results 16 124 34 37 Introduction to Method Evaluation 35 50 location and repeated over a 119 119 1100 1180 117 1190 17 -- 'Orecision, Within-laboratory Precision, Within-laboratory Ex.•ALT EX:ALT 3.8% 25% ofCLiA AllowaK18Qrror is is acceptable. able 25% of CLIA Allowable error is 5% Within Run Method If the within-run precision is acceptable, then 119 18 119 AST 21.Nov.13 Short term precision is 42 120 short period of time 16-Nov-13 7s-Now-13 122 120 121 1100 122 1200 1200 acceotable / is acceptable. X acceotable / unacceotable Acceptability / unacceotable acceotable is acceptable. Acceptability Analyze a sample once each 2167-Now-13 0700 7s-Now-13 gs-.Nov-13 11.Nov.13 76-Now-13 2167-Now-13 8s-NOV-13 g7-.Nov-13 I65-Now-13 26-Nov-13 23-Nov-13 216-Now-13 I6-Nov-13 0700 01200 0730 1.3 216.Nov-13 1100 1.3 43 0730 216s-.Nov-13 0730 0730 33 determine the between-run precision 1200 122 1.3 120 Analyte Manufacturer's Observed Results Experiment Results Acceptability • Repeatability 16 1; 120 13 14 Expected Results Experiment Results day for 20 days Within Within Run Preliminary Estimate Of Precision, Long Term Preliminary Estimate Of Precision, Long Term Term Analystes Analyte Analyste Acceptabilety 34 119 117 118 CLIA Precision Normal Control Abn Control Manufacturer's 25% of User User user 15 cv% cv% Precision precision The goal is to have a imprecision less than 1/3 or 120 u/L 35.0 u/L 1.1 u/L 128 U/L 120 U/L 0.0 I/L 35.0 Analyze a sample 20 times in Analyze a sample 20 times 19 16 14 17 13 0.8% 2.6% 6.6% 3.3% Reflects the effects of long 1.1 u/L 35.0 u/L SD u/L 2.1 U/L 0.3 U/L SD 1.1 u/L 1.1 u/L SD u/L 1.3 U/L 1.5 u/L 12.0 u/L 0.8 IJ/L 2.1 U/L 128 U/L 0.3 U/L 36.6 U/L 1.5 U/L 1.1 u/L 1.3 U/L 128 u/L 32.1 U/L 1.0 U/L 0.1 U/L 35.0 uJ/L 1.8 U/L 2.1 u/L 26.6 U/L 120.0 U/L AST 5% 55 119 118 43 18 35 14 120 O/ocv O/'ocv Y/ocv Y,'ocv Yocv 13 35 34 36 55 120 122 123 one analytical run 5% 3.3% EXALT Acceptabilety is acceptable. Manufacturer's Claims Manufacturer's Manufacturer's Claims Manufacturers Claims Manufacturer's Manufacturer's Claims xyz Analyzer term variation due to day-to- 35 1/4 the total allowable error. 25% of CLIA Allowable error is 5% 25% of CLIA Allowable error is 122 120.0 20 50 36_7 u/L 1.0. U/L 130 u/L 36.7 u/L 36_7 u/L 35.0 u/L 36.6 U/L 35.0 uJ/L 3.8 IJ/L 120 u/L 36.7 u/L 1.0 U/L 130 u/L 128 U/L 120. u/L 1.1 u/L 120.0 U/L 15.0 36.7 Mean Mean Mean Comparative 120.0 U/L 1.5 U/L 1.0 U/L 0.8 U/L u/L SD SD SD 35 Method (X) AST 3.1% 1.3 • Reflects best-case scenario for 1.3 day changes in operating 1.3 1.3% O/ocv 1.3 Method XYZ Analyzer Roche Coba Roche Coba Roche COba 25% of CLIA Allowqble error is _5% 33% of CLIA Allowable error is 5% 33% of CLIA Allowable error is 1/4 the total allowable error. 25% of CLIA Allowable error is 5% 6.6%. Long term precision is Short term precision is 6.6%. Long term precision is Short term precision is 6.6%. Long term prec Roche Test comparative rest Method acceptable / unacceotable acceotable / unacceotable accentable / unacceotable conditions precision Method (X) Test Metho Activity '4: Introduction to Method Evaluation Activity 14: Introduction to Method Evaluation (Y) Method 42 43 34 13 (Y)