Review Team (February 2016)

Bio-02 (February 2016) FOR ERP USE ONLY DO NOT DISTRIBUTE

Table 4: Repeatability

Biotin (μg/100g)

SPIFAN SLV Samples

RSD

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Average

CLC10-b 197.42 201.01 196.08 196.28 197.93 201.54 198.54 198.39 199.34 198.81 197.00 197.30 198.30 0.86 11750017V3 12.77 12.73 12.67 12.77 12.69 12.69 12.53 12.73 12.61 12.62 12.65 12.70 12.68 0.55 1172572116 34.68 34.50 34.20 35.24 35.17 35.13 36.05 35.09 36.19 36.97 35.19 35.02 35.29 2.19 117257651Z 39.76 39.99 39.98 39.16 40.12 40.50 39.37 40.77 40.87 40.96 39.50 40.70 40.14 1.54 00394RF00 248.67 249.85 254.88 237.61 258.75 261.19 256.65 259.83 255.74 259.20 254.28 256.30 254.41 2.55 00412RF00 91.08 90.66 88.99 89.01 89.70 91.71 89.92 90.81 89.56 90.20 90.69 90.72 90.25 0.93 00403RF00 69.17 69.30 70.41 69.88 71.88 72.28 71.35 71.45 72.14 71.83 70.52 71.03 70.94 1.52 D04HTCVV 35.48 35.24 34.23 33.92 33.36 34.28 33.01 33.17 32.94 32.96 31.71 32.94 33.60 3.19 E29JVLV 43.30 43.25 45.40 44.72 45.02 44.38 45.29 44.85 45.15 44.78 44.76 45.08 44.67 1.58 Control Milk F 5.45 5.47 5.36 5.34 5.40 5.44 5.38 5.43 5.20 5.31 5.15 5.37 5.36 1.83 00414RF00 54.02 55.42 55.50 55.16 52.36 52.07 53.67 53.78 53.23 53.91 55.48 54.21 54.07 2.16 00406RF00 68.88 65.17 63.77 64.85 66.78 67.48 65.51 66.54 65.64 65.36 63.92 62.13 65.50 2.74 SRM 1849a 198.46 0.63 199.97 199.65 196.50 197.87 198.37 198.42 5.7 Comparison with alternative immunoaffinity column The laboratory has analysed the SPIFAN SLV samples using immunoaffinity column manufactured by Biotez Berlin Buch GmbH (Product, BioTeZ IAC Biotin) and compared with the average biotin results obtained from Biopharm Rhone, EASI-EXTRACT biotin column. The 3 RTF samples from the SPIFAN kit were not included in the comparison study due to

the microbial growth observed in the milk samples (Table 5). Table 5: Comparison with alternative immunoaffinity column SPIFAN SLV Samples

Biotin (μg/100g)

R- Biopharm

Biotez 199.87 12.85 36.04 41.29 86.62 69.24 30.57 43.13 243.68 199.99

Difference

CLC10-b

198.30 12.68 35.29 40.14 90.25 70.94 33.60 44.67 254.41 198.46

1.57 0.17 0.75 1.15 3.63 1.70 3.03 1.54 1.53 10.73

11750017V3 1172572116 117257651Z 00394RF00 00412RF00 00403RF00 D04HTCVV

E29JVLV

SRM 1849a

5841 v2

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