PEPFAR Quality Control and Method Validation Activity 8 Worksheet 6: Reagent Lot Number Change

Worksheet 6: Reagent Lot Number Change 812 Effective Date: 12/6/2016 HILS1746 By comparing the Total Error (TE) to the Total Allowable Error (TEA), we can assess whether or not a new lot number of reagent provides clinically acceptable results. In this exercise you will be evaluating two different lot numbers and answering questions pertaining to your data. Cape Clinic Laboratory Glucose (mmol/L) L-J Chart for Control XYZ (exp 30/11/XX) on Illustra Chemistry Analyzer (serial # 123) X assigned 5.80 mmol/L SD assigned 0.10 mmol/L Target 5.60 mmol/L TEA 6.9% 6.20 +4SD .................... 6.10 +3SD 6.00 + 2SD m 5.90 + 1SD 5.80 X 5.70 -1SD 5.60 - 2SD 5.50 -3SD 5.40 4SD Day 5 6 8 10 11 12 13 14 15 16 17 18 19 20 21 22 23 | 24 25 26 27 28 29 30 12. LO LO 00. LO ....... 5.68 5.70 5.97 LO LO LO LO LO LO Value 5.75 6.00 5.80 5.75 5.95 5.65 5.80 5.91 LO 5.64 5.78 Values (mmol/L) obtained with Control XYZ using the New Lot Number of Reagents Reagent Lot 5.7 5.74 5.75 5.73 5.7: 5.73 5.72 5.73 Number A Reagent Lot 5.83 5.84 5.84 5.83 5.84 5.84 5.85 5.85 Number B 83 Worksheet 6: Reagent Lot Number Change 812 Effective Date: 12/6/2016 HILS1746 Complete the table using the information from the previous page. Current Mean Current SD Target Value Bias Absolute Bias Current TE TEA Reagent Lot Number A Reagent Lot Number B New Reagent Lot Number Mean Current SD Target Value Bias Absolute Bias New Reagent Lot Number TE TEA TE < TEA (yes or no) By comparing the TE to the target value and TEA limit, we can conclude Reagent A is acceptable / unacceptable By comparing the TE to the target value and TEA limit, we can conclude Reagent B is acceptable / unacceptable Reagent B demonstrated a smaller shift from the current mean than Reagent A. Does this information support your conclusions regarding acceptability? Explain your answer. 84 Worksheet 6: Reagent Lot Number Change 812 HILS1746 Effective Date: 12/6/2016 Demonstrate your conclusions in the diagram below. Cut out and paste the Gaussian curves into the diagram with relationship to TEA limits. Illustrate the reagents' TE using arrows. TEL Linit Tarde Value 16. Umit Reagent A Reagent B 85