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{"sheet":"Instructions","index":0,"n_rows":34,"n_cols":1,"rows_kept":34,"cut":false,"hidden":false,"merged":[]}
["NOTICE: This document is an example only. It must be revised to reflect your lab’s specific processes and/or specific protocol requirements."]
["Approved and current. Effective starting 12-Jun-2023. Last reviewed on 09-Jun-2023.\r\nVAL 2002 (version 1.1). Quantitative Accuracy Pack. Page 1 of 3"]
["Instructions:"]
[]
["Method Comparison:    "]
["1.   Plot the reference method on the X axis and the method being validated on the Y axis."]
["2.   Enter the Allowable Total Error (TEa) concentration and percent.  Refer to pSMILE Chemistry (EQA 1380a), Coagulation (EQA 1380b) or Hematology (EQA 1380c) TE Limits table. "]
["3.   Enter the results for the reference (X) and the new (Y) methods."]
["4.   Evaluate the statistics."]
["5.  If R value is <0.975, Data does not extend over acceptable range. More data must be evaluated over larger range."]
["6.   The correlation coefficient (R) must be >0.975. "]
["a.  95% of the data points from the comparative method must be within Total Allowable Error limits of the reference method. This can be evaluated by calculating the \"Error Index\" "]
["Alternate Method Comparison:"]
["Use if the standard method comparison has less than ideal results.  This method takes into account the Medical Decision Points and evaluates using the calculations and criteria below."]
["Error Index:  to measure the difference between the two methods as a ratio of the Total Allowable Error. "]
["1.  Using the Method Comparison spreadsheet tab the Error Index can be calculated by subtracting the reference method data point (X) from the method being validated data point (Y) and dividing by the Total Allowable Error (TEa). The equation is: (Y-X)/TEa. "]
["2.  Use the percent TEa or the minimum detectable difference (absolute TEa), whichever is greater."]
["3.  The absolute TEa value is calculated by converting the TEa percentage to a decimal and multiplying by the reference method data point. "]
["4. The Error Index is measured for each X-Y pair, and must fall within -1 and 1. If more than 5% of the specimens have an Error Index of less than -1 or greater than 1, the accuracy experiment fails"]
["5.  If 95% of Error Indices are acceptable, Accuracy is acceptable. Proceed with Linearity experiments"]
["6.  If < 95% Error Indices are acceptable, plot the data from the Method Comparison Tab. Deming Regression is preferred, however if not available regular regression is acceptable provided that the Correlation Coefficient (R) is >0.975."]
["a.  Plot the reference method on the X axis and the method being validated on the Y axis."]
["b.  Enter the Allowable Total Error (TEa) concentration and percent.  Refer to SMILE Chemistry, Coagulation or Hematology TE Limits table (EQA 1380a, EQA 1380b or EQA 1380c)."]
["c.  Enter Medical Decision Points (MDP)"]
["                   i.  A Medical Decision Point is the concentration of the analyte at which a medical decision is triggered. You may enter up to five values. These values are plotted on the graph, and the program computes a predicted Y value and confidence interval at each X decision point. "]
["                  ii.  For many analytes, the medical decision points correspond to the lower and upper limits of the normal range. It is advisable to also include medical decision points at the DAIDS Toxicity limits and/or laboratory established critical values."]
["95% Confidence limits and Error Indices: "]
["1. Subtract the X Method MDP from the low and the high 95% confidence limits for each Medical Decision Point."]
["2. Calculate Error Indices for each end of the 95% confidence limits for each Medical Decision Point as follows:  Divide the difference (from step i. above) by the SMILE TE Limit absolute value."]
["     a. Use the percent TEa or the minimum detectable difference, whichever is greater. "]
["     b. To calculate the absolute TEa value, convert the TEa percentage to a decimal and multiply by the reference method data point. "]
["                  i.       All error indices must fall within -1 and 1. Use the Error Index Calculation tab spreadsheet to calculate Error Indices."]
["3. All error indices fall between -1 and 1, accuracy is acceptable "]
["4. Any error indices fall outside -1 and 1, consider possible causes of inaccuracy. Troubleshoot before repeating accuracy studies. "]

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["NOTICE: This document is an example only. It must be revised to reflect your lab’s specific processes and/or specific protocol requirements."]
["Approved and current. Effective starting 12-Jun-2023. Last reviewed on 09-Jun-2023.\r\nVAL 2002 (version 1.1). Quantitative Accuracy Pack. Page 2 of 3"]
[null," Quantitative Method Comparison"]
[]
[null,"Method being evaluated (Y):",{"$nulls":7},"Date:"]
[null,"Reference Method (X): ",{"$nulls":7},"Total Allowable Error (TEa):"]
[null,null,null,"Analyte:",{"$nulls":5},"Conc.","Pct."]
[null,null,null,"Units:"]
[]
[{"$f":"IF(AND($C$37>0.975,$H$32>=19),\"Experiment: PASSED\",\"Experiment: FAILED (See Note Below**)\")","v":{"$error":"#DIV/0!"}}]
["Spec#","X","Y","Δ","Error Index","High lmt","Low lmt","Grade"]
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[{"$f":"A12+1","v":2},null,null,{"$f":"C13-B13","v":0},{"$f":"IF($J$8>B13*($K$8/100),D13/$J$8,D13/(B13*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B13+$J$8>B13*((100+$K$8)/100),B13+$J$8,B13*((100+$K$8)/100))","v":0},{"$f":"IF(B13-$J$8<B13*((100-$K$8)/100),B13-$J$8,B13*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E13>=-1,E13<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A13+1","v":3},null,null,{"$f":"C14-B14","v":0},{"$f":"IF($J$8>B14*($K$8/100),D14/$J$8,D14/(B14*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B14+$J$8>B14*((100+$K$8)/100),B14+$J$8,B14*((100+$K$8)/100))","v":0},{"$f":"IF(B14-$J$8<B14*((100-$K$8)/100),B14-$J$8,B14*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E14>=-1,E14<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A14+1","v":4},null,null,{"$f":"C15-B15","v":0},{"$f":"IF($J$8>B15*($K$8/100),D15/$J$8,D15/(B15*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B15+$J$8>B15*((100+$K$8)/100),B15+$J$8,B15*((100+$K$8)/100))","v":0},{"$f":"IF(B15-$J$8<B15*((100-$K$8)/100),B15-$J$8,B15*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E15>=-1,E15<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A15+1","v":5},null,null,{"$f":"C16-B16","v":0},{"$f":"IF($J$8>B16*($K$8/100),D16/$J$8,D16/(B16*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B16+$J$8>B16*((100+$K$8)/100),B16+$J$8,B16*((100+$K$8)/100))","v":0},{"$f":"IF(B16-$J$8<B16*((100-$K$8)/100),B16-$J$8,B16*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E16>=-1,E16<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A16+1","v":6},null,null,{"$f":"C17-B17","v":0},{"$f":"IF($J$8>B17*($K$8/100),D17/$J$8,D17/(B17*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B17+$J$8>B17*((100+$K$8)/100),B17+$J$8,B17*((100+$K$8)/100))","v":0},{"$f":"IF(B17-$J$8<B17*((100-$K$8)/100),B17-$J$8,B17*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E17>=-1,E17<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A17+1","v":7},null,null,{"$f":"C18-B18","v":0},{"$f":"IF($J$8>B18*($K$8/100),D18/$J$8,D18/(B18*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B18+$J$8>B18*((100+$K$8)/100),B18+$J$8,B18*((100+$K$8)/100))","v":0},{"$f":"IF(B18-$J$8<B18*((100-$K$8)/100),B18-$J$8,B18*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E18>=-1,E18<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A18+1","v":8},null,null,{"$f":"C19-B19","v":0},{"$f":"IF($J$8>B19*($K$8/100),D19/$J$8,D19/(B19*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B19+$J$8>B19*((100+$K$8)/100),B19+$J$8,B19*((100+$K$8)/100))","v":0},{"$f":"IF(B19-$J$8<B19*((100-$K$8)/100),B19-$J$8,B19*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E19>=-1,E19<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A19+1","v":9},null,null,{"$f":"C20-B20","v":0},{"$f":"IF($J$8>B20*($K$8/100),D20/$J$8,D20/(B20*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B20+$J$8>B20*((100+$K$8)/100),B20+$J$8,B20*((100+$K$8)/100))","v":0},{"$f":"IF(B20-$J$8<B20*((100-$K$8)/100),B20-$J$8,B20*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E20>=-1,E20<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A20+1","v":10},null,null,{"$f":"C21-B21","v":0},{"$f":"IF($J$8>B21*($K$8/100),D21/$J$8,D21/(B21*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B21+$J$8>B21*((100+$K$8)/100),B21+$J$8,B21*((100+$K$8)/100))","v":0},{"$f":"IF(B21-$J$8<B21*((100-$K$8)/100),B21-$J$8,B21*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E21>=-1,E21<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A21+1","v":11},null,null,{"$f":"C22-B22","v":0},{"$f":"IF($J$8>B22*($K$8/100),D22/$J$8,D22/(B22*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B22+$J$8>B22*((100+$K$8)/100),B22+$J$8,B22*((100+$K$8)/100))","v":0},{"$f":"IF(B22-$J$8<B22*((100-$K$8)/100),B22-$J$8,B22*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E22>=-1,E22<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A22+1","v":12},null,null,{"$f":"C23-B23","v":0},{"$f":"IF($J$8>B23*($K$8/100),D23/$J$8,D23/(B23*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B23+$J$8>B23*((100+$K$8)/100),B23+$J$8,B23*((100+$K$8)/100))","v":0},{"$f":"IF(B23-$J$8<B23*((100-$K$8)/100),B23-$J$8,B23*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E23>=-1,E23<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A23+1","v":13},null,null,{"$f":"C24-B24","v":0},{"$f":"IF($J$8>B24*($K$8/100),D24/$J$8,D24/(B24*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B24+$J$8>B24*((100+$K$8)/100),B24+$J$8,B24*((100+$K$8)/100))","v":0},{"$f":"IF(B24-$J$8<B24*((100-$K$8)/100),B24-$J$8,B24*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E24>=-1,E24<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A24+1","v":14},null,null,{"$f":"C25-B25","v":0},{"$f":"IF($J$8>B25*($K$8/100),D25/$J$8,D25/(B25*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B25+$J$8>B25*((100+$K$8)/100),B25+$J$8,B25*((100+$K$8)/100))","v":0},{"$f":"IF(B25-$J$8<B25*((100-$K$8)/100),B25-$J$8,B25*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E25>=-1,E25<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A25+1","v":15},null,null,{"$f":"C26-B26","v":0},{"$f":"IF($J$8>B26*($K$8/100),D26/$J$8,D26/(B26*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B26+$J$8>B26*((100+$K$8)/100),B26+$J$8,B26*((100+$K$8)/100))","v":0},{"$f":"IF(B26-$J$8<B26*((100-$K$8)/100),B26-$J$8,B26*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E26>=-1,E26<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A26+1","v":16},null,null,{"$f":"C27-B27","v":0},{"$f":"IF($J$8>B27*($K$8/100),D27/$J$8,D27/(B27*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B27+$J$8>B27*((100+$K$8)/100),B27+$J$8,B27*((100+$K$8)/100))","v":0},{"$f":"IF(B27-$J$8<B27*((100-$K$8)/100),B27-$J$8,B27*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E27>=-1,E27<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A27+1","v":17},null,null,{"$f":"C28-B28","v":0},{"$f":"IF($J$8>B28*($K$8/100),D28/$J$8,D28/(B28*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B28+$J$8>B28*((100+$K$8)/100),B28+$J$8,B28*((100+$K$8)/100))","v":0},{"$f":"IF(B28-$J$8<B28*((100-$K$8)/100),B28-$J$8,B28*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E28>=-1,E28<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A28+1","v":18},null,null,{"$f":"C29-B29","v":0},{"$f":"IF($J$8>B29*($K$8/100),D29/$J$8,D29/(B29*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B29+$J$8>B29*((100+$K$8)/100),B29+$J$8,B29*((100+$K$8)/100))","v":0},{"$f":"IF(B29-$J$8<B29*((100-$K$8)/100),B29-$J$8,B29*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E29>=-1,E29<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A29+1","v":19},null,null,{"$f":"C30-B30","v":0},{"$f":"IF($J$8>B30*($K$8/100),D30/$J$8,D30/(B30*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B30+$J$8>B30*((100+$K$8)/100),B30+$J$8,B30*((100+$K$8)/100))","v":0},{"$f":"IF(B30-$J$8<B30*((100-$K$8)/100),B30-$J$8,B30*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E30>=-1,E30<=1),1,0)","v":{"$error":"#DIV/0!"}}]
[{"$f":"A30+1","v":20},null,null,{"$f":"C31-B31","v":0},{"$f":"IF($J$8>B31*($K$8/100),D31/$J$8,D31/(B31*($K$8/100)))","v":{"$error":"#DIV/0!"}},{"$f":"IF(B31+$J$8>B31*((100+$K$8)/100),B31+$J$8,B31*((100+$K$8)/100))","v":0},{"$f":"IF(B31-$J$8<B31*((100-$K$8)/100),B31-$J$8,B31*((100-$K$8)/100))","v":0},{"$f":"IF(AND(E31>=-1,E31<=1),1,0)","v":{"$error":"#DIV/0!"}}]
["Mean",{"$f":"AVERAGE(B12:B31)","v":{"$error":"#DIV/0!"}},{"$f":"AVERAGE(C12:C31)","v":{"$error":"#DIV/0!"}},{"$f":"AVERAGE(D12:D31)","v":0},{"$f":"AVERAGE(E12:E31)","v":{"$error":"#DIV/0!"}},null,null,{"$f":"SUM(H12:H31)","v":{"$error":"#DIV/0!"}}]
["Min",{"$f":"MIN(B12:B31)","v":0},{"$f":"MIN(C12:C31)","v":0},{"$f":"MIN(D12:D31)","v":0},{"$f":"MIN(E12:E31)","v":{"$error":"#DIV/0!"}},{"$f":"IF($H$32<19,\"**Greater than 5% of the error indices are unacceptable. IF the correlation coeficient is greater than 0.975 (see below-left), see Alt Method Comparison tab for evaluation.\",\"\")","v":{"$error":"#DIV/0!"}}]
["Max",{"$f":"MAX(B12:B31)","v":0},{"$f":"MAX(C12:C31)","v":0},{"$f":"MAX(D12:D31)","v":0},{"$f":"MAX(E12:E31)","v":{"$error":"#DIV/0!"}}]
["Slope",null,{"$f":"SLOPE(C12:C31,B12:B31)","v":{"$error":"#DIV/0!"}}]
["Intercept",null,{"$f":"INTERCEPT(C12:C31,B12:B31)","v":{"$error":"#DIV/0!"}}]
["Correl. Coef. (R)",null,{"$f":"CORREL(B12:B31,C12:C31)","v":{"$error":"#DIV/0!"}},{"$f":"IF(C37<0.975,\"**Correlation Coefficient is too low. Troubleshoot Assay and re-analyse specimens\",\"\")","v":{"$error":"#DIV/0!"}}]

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["NOTICE: This document is an example only. It must be revised to reflect your lab’s specific processes and/or specific protocol requirements."]
["Approved and current. Effective starting 12-Jun-2023. Last reviewed on 09-Jun-2023.\r\nVAL 2002 (version 1.1). Quantitative Accuracy Pack. Page 3 of 3"]
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[{"$f":"A17+1","v":7},{"$f":"'Method Comparison'!B18","v":0},{"$f":"'Method Comparison'!C18","v":0},{"$f":"C18-B18","v":0},{"$f":"POWER(D18-$D$35,2)","v":0},{"$f":"E18/19","v":0},{"$nulls":11},{"$f":"(D27/B27)*100","v":{"$error":"#DIV/0!"}}]
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[{"$f":"A19+1","v":9},{"$f":"'Method Comparison'!B20","v":0},{"$f":"'Method Comparison'!C20","v":0},{"$f":"C20-B20","v":0},{"$f":"POWER(D20-$D$35,2)","v":0},{"$f":"E20/19","v":0},{"$nulls":11},{"$f":"(D29/B29)*100","v":{"$error":"#DIV/0!"}}]
[{"$f":"A20+1","v":10},{"$f":"'Method Comparison'!B21","v":0},{"$f":"'Method Comparison'!C21","v":0},{"$f":"C21-B21","v":0},{"$f":"POWER(D21-$D$35,2)","v":0},{"$f":"E21/19","v":0},{"$nulls":11},{"$f":"(D30/B30)*100","v":{"$error":"#DIV/0!"}}]
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[{"$f":"A22+1","v":12},{"$f":"'Method Comparison'!B23","v":0},{"$f":"'Method Comparison'!C23","v":0},{"$f":"C23-B23","v":0},{"$f":"POWER(D23-$D$35,2)","v":0},{"$f":"E23/19","v":0}]
[{"$f":"A23+1","v":13},{"$f":"'Method Comparison'!B24","v":0},{"$f":"'Method Comparison'!C24","v":0},{"$f":"C24-B24","v":0},{"$f":"POWER(D24-$D$35,2)","v":0},{"$f":"E24/19","v":0}]
[{"$f":"A24+1","v":14},{"$f":"'Method Comparison'!B25","v":0},{"$f":"'Method Comparison'!C25","v":0},{"$f":"C25-B25","v":0},{"$f":"POWER(D25-$D$35,2)","v":0},{"$f":"E25/19","v":0}]
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["SD",{"$f":"STDEV(B11:B31)","v":0},{"$f":"STDEV(C12:C31)","v":0},{"$f":"STDEV(D12:D31)","v":0},null,null,{"$f":"IF(($P$9/100)*H33>$O$9,($P$9/100)*H33,$O$9)","v":0}]
["Bias",null,null,{"$f":"C32-B32","v":0},{"$f":"E32/19","v":0}]
[null,null,null,{"$f":"ABS(D34)","v":0}]
[{"$nulls":8},"Regression Statistics"]
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[null,0,0,{"$nulls":5},"Std Err Est",{"$f":"STEYX(C12:C31,B12:B31)","v":{"$error":"#DIV/0!"}},null,null,null,1,0]
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[null,{"$f":"IF(B18*($P$9/100)>$O$9,B18+(B18*($P$9/100)),B18+$O$9)","v":0},{"$f":"IF($B18*($P$9/100)>$O$9,$B18-($B18*($P$9/100)),$B18-$O$9)","v":0}]
[null,{"$f":"IF(B19*($P$9/100)>$O$9,B19+(B19*($P$9/100)),B19+$O$9)","v":0},{"$f":"IF($B19*($P$9/100)>$O$9,$B19-($B19*($P$9/100)),$B19-$O$9)","v":0}]
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