OMB Meeting Book - Jan. 11, 2018

6. Batch-to-Batch Variation

Measurements of kit standards of several batches were conducted at 450 nm and OD values were tracked over a 1½ year period. OD values slightly differed from lot to lot, but the shape of the standard curve stayed the same.

Batch-to-Batch Variation of Standards

3,0

2,5

2,0

1,5

1,0 OD [450 nm]

0,5

0,0

0

20

40

60

80

100 120 140 160 180 200

Kit standards [mg/kg gluten]

Figure 1: OD values of standards from various batches measured at 450 nm

Table 2: OD values of standards from various batches measured at 450 nm

Standard OD [450 nm]

Test Date 05.01.2015 07.01.2015 27.01.2015 30.01.2015 25.02.2015 28.04.2015 30.04.2015 26.06.2015 19.08.2015 12.09.2015 03.01.2016 04.02.2015 19.02.2015 04.03.2016 31.03.2016 29.04.2016 04.05.2016 06.05.2016 09.05.2016

0

4

20

80

200

0,032 0,039 0,035 0,038 0,064 0,053 0,052 0,050 0,120 0,069 0,026 0,059 0,039 0,043 0,027 0,069 0,038 0,043 0,038 0,049

0,252 0,259 0,242 0,234 0,242 0,178 0,182 0,167 0,390 0,368 0,282 0,197 0,309 0,170 0,279 0,301 0,285 0,290 0,283 0,258

0,745 0,738 0,708 0,678 0,825 0,606 0,628 0,507 0,999 0,875 0,711 0,508 0,948 0,530 0,889 0,921 0,770 0,853 0,854 0,752

1,715 1,829 1,669 1,730 1,643 1,437 1,450 1,279 1,617 1,607 1,415 1,248 1,708 1,022 1,682 1,579 1,404 1,577 1,595 1,537

2,363 2,318 2,171 2,399 2,425 2,035 2,118 1,950 2,445 2,055 1,953 1,959 2,270 1,825 2,113 2,272 1,957 2,195 2,245 2,161

Overall mean, OD

Reproducibility SD, OD Reproducibility RSD, %

0,02

0,06

0,15

0,20

0,19

44

24

20

13

9

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