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 02-Aug-2023. Last reviewed on 09-Jun-2023.
VAL 2003 (version 1.1). Quantitative Linearity Pack. Page 1 of 3
Please refer to VAL 2001 Quantitative Validation Guidelines for additional guidance and instructions.

Linearity- Plot the data in regression analysis program. The pSMILE Linearity spreadsheet performs all necessary

1. Plot the known values of the standards on the X-axis (Assigned Column)
2. Plot the mean of the measured values on the Y-axis. (Under Measured-Rep 1, 2, or 3 reps)
4. Calculate slope and intercept using linear regression. This can be done using the Excel SLOPE and INTERCEPT
5. Using slope and intercept, calculate a predicted Y value for each X value.
6. Plot the predicted Y values versus the corresponding known X values on the same graph mentioned in 1 and 2 ab
connect all the predicted Y points on the graph.
7. Subtract each measured Y value from the associated predicted Y value. This difference is the systematic error du
8. Compare that systematic error to 50% of the total error. The systematic error must be less than 50% of the total e
9. The method is linear if the difference between the predicted Y value and the measured Y value is less than the all
specimen point.
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 02-Aug-2023. Last reviewed on 09-Jun-2023.
VAL 2003 (version 1.1). Quantitative Linearity Pack. Page 2 of 3
Method Being Evaluated: Date:
Analyte: Total Allowable Error (TEa):
Units: Conc.: Percent:
Enter values in ascending order Manufacturer's stated analytical measurement range:
(lowest value data in top cells, highest value data in bottom cells) Low: High:
Measured
Rep 1 Rep 2 Rep 3 Avg Assigned Target ± Diff % Diff ± Limit % Limit Grade
#DIV/0! Err:502 #DIV/0! #DIV/0! Err:502 0% #DIV/0!
#DIV/0! Err:502 #DIV/0! #DIV/0! Err:502 0% #DIV/0!
#DIV/0! Err:502 #DIV/0! #DIV/0! Err:502 0% #DIV/0!
#DIV/0! Err:502 #DIV/0! #DIV/0! Err:502 0% #DIV/0!
#DIV/0! Err:502 #DIV/0! #DIV/0! Err:502 0% #DIV/0!
#DIV/0! Err:502 #DIV/0! #DIV/0! Err:502 0% #DIV/0!

Err:502 Err:502
Coefficients Std Err Err:502 Err:502 ABCDEF #DIV/0! #DIV/0!
Intercept Err:502 Err:502 Err:502 Err:502 ABCDE #DIV/0! #DIV/0!
Slope Err:502 Err:502 Err:502 Err:502 ABCD #DIV/0! #DIV/0!
Correl. (r) #VALUE! Err:502 Err:502 ABC #DIV/0! #DIV/0!
ACDEF #DIV/0! #DIV/0!
Your Linearity Evaluation: NON-LINEAR #DIV/0! ABDEF #DIV/0! #DIV/0!
Verified AMR: 0 to 0 ABCEF #DIV/0! #DIV/0!
#N/A #DIV/0! #DIV/0! #N/A ABCDF #DIV/0! #DIV/0!
12 #DIV/0! #DIV/0! #DIV/0! #DIV/0! BCDEF #DIV/0! #DIV/0!
0 0 BCDE #DIV/0! #DIV/0!
10 Err:502 0 BCD #DIV/0! #DIV/0!
#DIV/0! 0 ABCE #DIV/0! #DIV/0!
8 CDEF #DIV/0! #DIV/0!
Measured Values

Err:502 Err:502 CDE #DIV/0! #DIV/0!

6 Err:502 Err:502 ABCDF #DIV/0! #DIV/0!
Err:502 Err:502 DEF #DIV/0! #DIV/0!
4 Err:502 Err:502 ADEF #DIV/0! #DIV/0!
50% TEa Limit
Err:502 1:1 Line
Err:502 BDEF #DIV/0! #DIV/0!
2 Err:502 Err:502 ABCF #DIV/0! #DIV/0!
BCDF #DIV/0! #DIV/0!
0 ACDE #DIV/0! #DIV/0!
0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1
Assigned Values
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 02-Aug-2023. Last reviewed on 09-Jun-2023.
VAL 2003 (version 1.1). Quantitative Linearity Pack. Page 3 of 3
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 09-Jun-2023. Last reviewed on 09-Jun-2023.
VAL 2003 (version 1.0). Quantitative Linearity Pack. Page 2 of 2
12

10

8
Measured Values

0
0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Assigned Values

sheet1
rotocol requirements.

rotocol requirements.

0.9 1