AOAC Guidance on FA Immunoassay Validation (August 2023)

1.5.8. Data Output

1541

Result ~ (Lot+Analyst)/TP

Analyst not nested within Lot, TP nested within (Lot+Analyst)

Name

DF

SS

MS

VC

%Total

SD

CV[%]

1 total

3.182687 92.85136

100 9.635941 10.04162

2 Lot

2 1109.537 554.7684 66.82999 71.97524 8.174961 8.519134 1 207.8743 207.8743 15.64549 16.85003 3.955437 4.121965 8 161.0281 20.12851 9.752615 10.50347 3.122918 3.254395 12 7.479314 0.623276 0.623276 0.671262 0.789478 0.822716

3 Analyst

4 Lot:Analyst:TP

5 error

Mean:

95.96 (N=24)

1542

Result ~ Lot/Analyst/TP

Analyst nested within Lot and TP Nested within Analyst

Name

DF

SS

MS

VC

%Total

SD

CV[%]

1 total

2.958485 85.02862

100 9.221097 9.609313

2 Lot

2 1109.537 554.7684 59.10844 69.51594 7.688202 8.011882

3 Lot:Analyst

3 245.7025 81.90085 15.34189

18.0432 3.916872 4.081776

4 Lot:Analyst:TP

6 123.1998 20.53331 9.955015 11.70784 3.155157 3.287992 12 7.479314 0.623276 0.623276 0.733019 0.789478 0.822716

5 error

Mean:

95.96 (N=24)

1543 1544 1545 1546 1547 1548 1549 1550 1551 1552 1553

1.5.9. Use the same code for Design 2a. 1.5.10. Reporting Precision Estimates

1.5.10.1.

Calculation procedures for repeatability standard deviation and intermediate precision from Designs 2a and 2b depend on whether or not the standard method protocol requires measurement of multiple ELISA wells for each test portion. For instances where the standard method protocol requires the measurement of multiple replicate ELISA wells (n) for each test portion, with the results averaged to give a single result, the repeatability standard deviation (s r ) is the square root of the sum of the test portion variance component and the ELISA variance divided by

1.5.10.2.

= + = �

the number of replicate wells:

1554

1555