Biologics Research Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea
Copyright ©2017, Korea Centers for Disease Control and Prevention
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
CONFLICTS OF INTEREST
No potential conflict of interest relevant to this article was reported.
Lot | FACS assay | CFU assay | ||||||||
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Ia | IIa | IIIa | SD | CV(%) | Ia | IIa | IIIa | SD | CV (%) | |
A. BCG vaccines for percutaneous administration | ||||||||||
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A | 13.22 | 13.57 | 14.78 | 0.82 | 5.91 | 7.43 | 45.90 | 12.40 | 20.92 | 95.49 |
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B | 15.37 | 15.24 | 16.75 | 0.83 | 5.28 | 8.35 | 30.65 | 17.60 | 11.20 | 59.38 |
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C | 17.08 | 16.84 | 18.10 | 0.67 | 3.88 | 8.47 | 31.35 | 18.80 | 11.46 | 58.65 |
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D | 18.83 | 18.64 | 20.18 | 0.84 | 4.39 | 7.72 | 28.45 | 25.60 | 11.24 | 54.58 |
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E | 18.85 | 18.24 | 20.22 | 1.01 | 5.31 | 8.15 | 32.75 | 20.00 | 12.30 | 60.60 |
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F | 19.27 | 18.42 | 20.67 | 1.14 | 5.85 | 7.65 | 22.55 | 27.60 | 10.37 | 53.84 |
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G | 19.56 | 18.24 | 21.07 | 1.42 | 7.22 | 9.07 | 27.10 | 25.60 | 10.01 | 48.60 |
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H | 20.61 | 18.74 | 21.92 | 1.59 | 7.81 | 9.78 | 37.11 | 26.80 | 13.80 | 56.18 |
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I | 18.99 | 18.25 | 20.04 | 0.90 | 4.72 | 10.12 | 36.10 | 23.60 | 12.99 | 55.84 |
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J | 17.86 | 17.20 | 18.99 | 0.91 | 5.03 | 10.65 | 34.90 | 16.40 | 12.67 | 61.35 |
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K | 19.75 | 19.91 | 21.22 | 0.81 | 3.98 | 12.18 | 11.70 | 23.20 | 6.51 | 41.46 |
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L | 18.87 | 18.81 | 19.58 | 0.43 | 2.23 | 11.53 | 26.83 | 28.40 | 9.32 | 41.87 |
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N | 19.04 | 19.82 | 20.11 | 0.55 | 2.81 | 11.16 | 46.20 | 22.80 | 17.84 | 66.78 |
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M | 17.18 | 17.73 | 18.07 | 0.45 | 2.56 | 11.79 | 41.72 | 27.20 | 14.97 | 55.64 |
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O | 18.73 | 19.50 | 19.46 | 0.43 | 2.25 | 11.22 | 44.06 | 33.60 | 16.78 | 56.63 |
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P | 18.05 | 18.31 | 18.46 | 0.21 | 1.13 | 12.14 | 32.55 | 11.60 | 11.94 | 63.64 |
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Q | 19.51 | 19.92 | 19.94 | 0.24 | 1.20 | 12.23 | 24.80 | 20.00 | 6.34 | 33.36 |
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B. BCG vaccines for intradermal administration | ||||||||||
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f | 0.88 | 0.23 | ||||||||
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g | 1.24 | 0.38 | ||||||||
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a | 1.16 | 1.13 | 1.10 | 0.03 | 2.44 | 1.22 | 0.64 | 1.32 | 0.37 | 34.67 |
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b | 1.28 | 1.22 | 1.19 | 0.05 | 4.01 | 1.13 | 1.30 | 2.11 | 0.52 | 34.50 |
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c | 1.19 | 1.16 | 1.13 | 0.03 | 2.56 | 1.23 | 0.94 | 1.08 | 0.15 | 13.39 |
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d | 1.26 | 1.23 | 1.20 | 0.03 | 2.54 | 1.17 | 0.90 | 1.34 | 0.22 | 19.52 |
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e | 1.27 | 1.20 | 1.21 | 0.04 | 3.25 | 1.32 | 1.56 | 1.58 | 0.14 | 9.60 |
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h | 1.29 | 1.47 | ||||||||
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i | 1.29 | 1.53 |
BCG vaccine | Laboratory | Pearson correlation coefficient (r) |
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Percutaneous | I–II | 0.9313 |
I–III | 0.9810 | |
II–III | 0.8729 | |
Intradermal | I–II | 0.9470 |
I–III | 0.9565 | |
II–III | 0.9118 |
Lot | FACS assay | CFU assay | ||||||||
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I | II | III | SD | CV(%) | I | II | III | SD | CV (%) | |
A. BCG vaccines for percutaneous administration | ||||||||||
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A | 13.22 | 13.57 | 14.78 | 0.82 | 5.91 | 7.43 | 45.90 | 12.40 | 20.92 | 95.49 |
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B | 15.37 | 15.24 | 16.75 | 0.83 | 5.28 | 8.35 | 30.65 | 17.60 | 11.20 | 59.38 |
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C | 17.08 | 16.84 | 18.10 | 0.67 | 3.88 | 8.47 | 31.35 | 18.80 | 11.46 | 58.65 |
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D | 18.83 | 18.64 | 20.18 | 0.84 | 4.39 | 7.72 | 28.45 | 25.60 | 11.24 | 54.58 |
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E | 18.85 | 18.24 | 20.22 | 1.01 | 5.31 | 8.15 | 32.75 | 20.00 | 12.30 | 60.60 |
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F | 19.27 | 18.42 | 20.67 | 1.14 | 5.85 | 7.65 | 22.55 | 27.60 | 10.37 | 53.84 |
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G | 19.56 | 18.24 | 21.07 | 1.42 | 7.22 | 9.07 | 27.10 | 25.60 | 10.01 | 48.60 |
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H | 20.61 | 18.74 | 21.92 | 1.59 | 7.81 | 9.78 | 37.11 | 26.80 | 13.80 | 56.18 |
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I | 18.99 | 18.25 | 20.04 | 0.90 | 4.72 | 10.12 | 36.10 | 23.60 | 12.99 | 55.84 |
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J | 17.86 | 17.20 | 18.99 | 0.91 | 5.03 | 10.65 | 34.90 | 16.40 | 12.67 | 61.35 |
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K | 19.75 | 19.91 | 21.22 | 0.81 | 3.98 | 12.18 | 11.70 | 23.20 | 6.51 | 41.46 |
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L | 18.87 | 18.81 | 19.58 | 0.43 | 2.23 | 11.53 | 26.83 | 28.40 | 9.32 | 41.87 |
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N | 19.04 | 19.82 | 20.11 | 0.55 | 2.81 | 11.16 | 46.20 | 22.80 | 17.84 | 66.78 |
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M | 17.18 | 17.73 | 18.07 | 0.45 | 2.56 | 11.79 | 41.72 | 27.20 | 14.97 | 55.64 |
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O | 18.73 | 19.50 | 19.46 | 0.43 | 2.25 | 11.22 | 44.06 | 33.60 | 16.78 | 56.63 |
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P | 18.05 | 18.31 | 18.46 | 0.21 | 1.13 | 12.14 | 32.55 | 11.60 | 11.94 | 63.64 |
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Q | 19.51 | 19.92 | 19.94 | 0.24 | 1.20 | 12.23 | 24.80 | 20.00 | 6.34 | 33.36 |
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B. BCG vaccines for intradermal administration | ||||||||||
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f | 0.88 | 0.23 | ||||||||
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g | 1.24 | 0.38 | ||||||||
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a | 1.16 | 1.13 | 1.10 | 0.03 | 2.44 | 1.22 | 0.64 | 1.32 | 0.37 | 34.67 |
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b | 1.28 | 1.22 | 1.19 | 0.05 | 4.01 | 1.13 | 1.30 | 2.11 | 0.52 | 34.50 |
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c | 1.19 | 1.16 | 1.13 | 0.03 | 2.56 | 1.23 | 0.94 | 1.08 | 0.15 | 13.39 |
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d | 1.26 | 1.23 | 1.20 | 0.03 | 2.54 | 1.17 | 0.90 | 1.34 | 0.22 | 19.52 |
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e | 1.27 | 1.20 | 1.21 | 0.04 | 3.25 | 1.32 | 1.56 | 1.58 | 0.14 | 9.60 |
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h | 1.29 | 1.47 | ||||||||
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i | 1.29 | 1.53 |
BCG vaccine | Laboratory | Pearson correlation coefficient (r) |
---|---|---|
Percutaneous | I–II | 0.9313 |
I–III | 0.9810 | |
II–III | 0.8729 | |
Intradermal | I–II | 0.9470 |
I–III | 0.9565 | |
II–III | 0.9118 |
BCG vaccine | Log10 FACS | Log10 CFU | Pearson correlation coefficient (r) |
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A. Percutaneous | 7.273 ± 0.044 | 7.201 ± 0.090 | 0.6962 |
B. Intradermal | 6.072 ± 0.051 | 5.981 ± 0.299 | 0.7428 |
BCG, Bacille Calmette–Guérin; FACS, flow cytometry; CFU, colony-forming unit; SD, standard deviation; CV, coefficient of variation. ×106.
FACS, flow cytometry; BCG, Bacille Calmette–Guérin.
Values are presented as mean ± standard deviation. FACS, flow cytometry; CFU, colony-forming unit; BCG, Bacille Calmette–Guérin. Pearson correlation coefficient (r) is 0.6962 for A and 0.7428 for B.