17- 羟基孕酮 25-OH- 维生素 D 促肾上腺皮质激素 甲胎蛋白 (AFP) PAGE 2 OF 18

R A ND 免疫质控品 货号 : IA3109 批号 : 1619EC X 包装 : 12 x 5 ml 效期 : 2019-04 产品描述本品适用于临床化学体外诊断的免疫质控, 用于监测免疫测定的正确度或重复度 朗道供应三种浓度水平 ( 水平 1:IA3109; 水平 2:IA3110; 水平 3:IA3111) 安全预防措施和警告本产品仅用于体外诊断 禁止用口吸 按照实验室常规预防措施对试剂进行处理 该质控品采用人基质血清, 对所有捐献者的血清均进行了 HIV(HIV1 HIV2) 抗体 肝炎 B 表面抗原 (HbsAg) 和肝炎 C 病毒 (HCV) 抗体的测试, 发现均呈阴性 所采用的方法均经 FDA 认证 然而, 既然没有一种方法能够完全保证其没有传染物质, 因此该质控品和所有的病人样品均应当按照能够传播疾病的样品小心处理 保存和稳定性开瓶后,2~8 保存 复溶后的血清如果保存在原始容器, 并且无污染, 可在 2~8 保存 7 天, 并可在 -20 保存 4 周, 只能冻融一次 C 肽在 2~8 可稳定 1 天 甲状旁腺素 (PTH) 和甲状腺球蛋白 (TG) 复溶后如果 2~8 保存, 要在 4 小时内检测 ; 若 -20 保存, 则须在 2 周内检测 促肾上腺皮质激素 (ACTH) 如果 2~ 8 保存, 要在 4 小时内检测 不提供促肾上腺皮质激素 (ACTH) 醛固酮和 C- 肽的冷冻稳定性说明 每次使用只吸取所需用量, 剩余的样品不可返回原瓶 未开瓶,2~8 可保存至效期末 复溶后的血清在受到细菌污染后, 会导致许多组分稳定性的下降, 应该将该瓶样品抛弃, 重新复溶一瓶新的血清 使用说明该免疫质控品为冻干粉 1. 小心打开瓶盖, 往瓶中准确加入 5 ml 蒸馏水, 在 15~25 的条件下复溶, 盖上瓶盖, 放置 30 分钟 轻轻翻转瓶子, 确保内容物完全溶解 ; 不要振荡, 避免气泡的产生 2. 参照各个分析仪的质控说明 3. 冷藏未使用的材料, 再次使用前, 确保样品充分混合均匀 需要自备的材料移液管蒸馏水 赋值每一批质控血清都要送到参考实验室, 这些实验室通过独特的统计分析方法得到一个结果进行赋值 质控范围值是平均值 ±2 S.D., 质控结果应该落在这个区间内 ; 然而, 朗道赋值系统与客户检测系统存在的差异不可避免, 所以靶值书仅供参考, 建议每个实验室建立自己的参考靶值和可接受范围 该质控品可用于醛固酮项目, 但只提供水平 2 和水平 3 的靶值 该材料还可用于 PTH 项目的质控, 但不作定值参考范围和稳定性的声明 雅培 Abbott Architect 的 CA19-9 检验原理为抗原抗体反应, 所使用的抗体材料是 1116-NA-19-9, 有报道指出 1116-NA-19-9 的浓度很高时,Abbott Architect 系统的检验结果比其它方法的结果可能更高 下载 注 : 详细赋值信息请以原版英文说明书为准, 原版说明书请在英国朗道公司官网 www.randox.com 进行 1/18

17- 羟基孕酮 25-OH- 维生素 D 促肾上腺皮质激素 甲胎蛋白 (AFP) PAGE 2 OF 18

丁胺卡那霉素 µmol/l 6.40 5.12 7.68 Gravimetric µg/ml 3.75 3.00 4.50 雄烯二酮 nmol/l 5.43 4.07 6.79 Siemens Immulite 2000 ng/ml 1.56 1.17 1.95 µg/ml = mg/l 1.33 1.06 1.60 BioMerieux Vidas µg/ml = mg/l 1.21 0.968 1.45 Roche Tinaquant β -2- 微球蛋白 µg/ml = mg/l 1.05 0.840 1.26 Siemens Immulite 2000/2500 µg/ml = mg/l 1.13 0.904 1.36 Abbott Architect µg/ml = mg/l 1.15 0.920 1.38 Roche Cobas 6000/8000 nmol/l 0.382 0.287 0.478 Siemens Immulite 2000/2500 ng/ml 1.15 0.866 1.43 nmol/l 0.534 0.401 0.668 Roche Cobas 6000/8000 C- 肽 ng/ml 1.61 1.21 2.01 nmol/l 0.589 0.442 0.736 Diasorin Liaison ng/ml 1.78 1.33 2.23 nmol/l 0.525 0.394 0.656 Roche Cobas E411 ng/ml 1.58 1.19 1.97 nmol/l 0.412 0.309 0.515 Abbott Architect ng/ml 1.24 0.933 1.55 CA 15-3 U/ml 19.7 15.8 23.6 Roche Elecsys U/ml 19.1 15.3 22.9 BioMerieux Vidas U/ml 21.1 13.9 28.3 Siemens Centaur XP/XPT/Classic U/ml 22.0 17.6 26.4 Abbott Architect U/ml 25.8 20.6 31.0 Siemens Immulite 2000/2500 U/ml 18.7 15.0 22.4 Vitros ECi U/ml 20.1 16.1 24.1 Roche Modular E170 U/ml 10.9 8.72 13.1 Beckman Access U/ml 11.5 9.20 13.8 Beckman DxI800 U/ml 19.9 15.9 23.9 Roche Cobas 6000/8000 U/ml 19.9 15.9 23.9 Roche Cobas E411 CA 19-9 U/ml 39.8 31.8 47.8 BioMerieux Vidas U/ml 19.3 15.4 23.2 Roche Elecsys U/ml 64.4 42.5 86.3 Siemens Centaur XP/XPT/Classic U/ml 23.4 18.7 28.1 Siemens Immulite 2000/2500 U/ml 198 158 238 Abbott Architect U/ml 45.2 36.2 54.2 Vitros ECi U/ml 19.5 15.6 23.4 Roche Modular E170 U/ml 27.7 22.2 33.2 Beckman Access U/ml 23.8 19.0 28.6 Beckman DxI800 U/ml 194 155 233 Abbott Architect XR/XR2 kit U/ml 18.9 15.1 22.7 Roche Cobas 6000/8000 U/ml 20.0 16.0 24.0 Roche Cobas E411 U/ml 76.0 50.2 102 Siemens Centaur CP CA125 U/ml 21.3 17.0 25.6 Siemens Immulite 1000 U/ml 19.1 15.3 22.9 BioMerieux Vidas Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 18

CA125 U/ml 19.2 15.4 23.0 Roche Elecsys 立痛定 ( 卡马西平 ) 癌胚抗原 (CEA) 皮质醇 U/ml 18.5 14.8 22.2 Siemens Immulite 2000/2500 U/ml 18.3 14.6 22.0 Vitros ECi U/ml 19.8 15.8 23.8 Roche Modular E170 U/ml 28.0 22.4 33.6 Abbott Architect U/ml 22.3 14.7 29.9 Siemens Centaur XP/XPT/Classic CA125 II kit U/ml 17.0 13.6 20.4 Beckman Access U/ml 17.5 14.0 21.0 Beckman DxI800 U/ml 19.8 15.8 23.8 Roche Cobas E411 U/ml 19.7 15.8 23.6 Roche Cobas 6000/8000 µmol/l 16.3 11.7 20.9 Siemens Centaur XP/XPT/Classic µg/ml 3.85 2.77 4.93 µmol/l 11.9 9.52 14.3 Siemens Immulite 1000 µg/ml 2.81 2.25 3.37 µmol/l 15.8 12.6 19.0 Roche Integra µg/ml 3.74 2.98 4.50 µmol/l 13.6 10.9 16.3 Siemens Immulite 2000/2500 µg/ml 3.22 2.58 3.86 µmol/l 15.2 12.2 18.2 Abbott Architect µg/ml 3.59 2.88 4.30 µmol/l 13.6 10.9 16.3 Beckman DxC µg/ml 3.22 2.58 3.86 µmol/l 14.3 11.4 17.2 Roche Cobas 6000/8000 µg/ml 3.38 2.69 4.07 µmol/l 15.4 12.3 18.4 Gravimetric µg/ml 3.63 2.91 4.35 ng/ml = µg/l 3.43 2.74 4.12 BioMerieux Vidas ng/ml = µg/l 4.80 3.84 5.76 Siemens Immulite 1000 ng/ml = µg/l 3.75 3.00 4.50 Roche Elecsys ng/ml = µg/l 5.61 4.49 6.73 Vitros ECi ng/ml = µg/l 3.75 3.00 4.50 Beckman Access ng/ml = µg/l 4.04 2.67 5.41 Siemens Centaur XP/XPT/Classic ng/ml = µg/l 4.77 3.82 5.72 Siemens Immulite 2000/2500 ng/ml = µg/l 4.16 3.33 4.99 Abbott Architect ng/ml = µg/l 3.63 2.90 4.36 Roche Modular E170 ng/ml = µg/l 3.56 2.85 4.27 Beckman DxI800 ng/ml = µg/l 3.63 2.90 4.36 Roche Cobas 6000/8000 ng/ml = µg/l 3.75 3.00 4.50 Roche Cobas E411 nmol/l 131 98.3 164 BioMerieux Vidas µg/dl 4.72 3.54 5.90 nmol/l 186 140 233 Siemens Immulite 1000 µg/dl 6.70 5.04 8.36 nmol/l 186 140 233 Roche Elecsys µg/dl 6.70 5.04 8.36 nmol/l 198 149 248 Beckman Access µg/dl 7.13 5.36 8.90 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 18

规格 :12 x 5 ml 范围低值 = 靶值 -2SD 高值 = 靶值 +2SD 分析物单位靶值低值高值方法学 皮质醇 去表雄酮硫酸盐 地高辛 nmol/l 195 129 261 Siemens Centaur XP/XPT/Classic µg/dl 7.02 4.63 9.41 nmol/l 199 149 249 Siemens Immulite 2000/2500 µg/dl 7.16 5.36 8.96 nmol/l 144 108 180 Vitros ECi µg/dl 5.18 3.89 6.47 nmol/l 204 153 255 Abbott Architect µg/dl 7.34 5.51 9.17 nmol/l 180 135 225 Roche Modular E170 µg/dl 6.48 4.86 8.10 nmol/l 183 137 229 Beckman DxI800 µg/dl 6.59 4.93 8.25 nmol/l 171 128 214 Roche Cobas 6000/8000 µg/dl 6.16 4.61 7.71 nmol/l 179 134 224 Roche Cobas E411 µg/dl 6.44 4.82 8.06 nmol/l 169 127 211 Roche Modular E170 Gen II µg/dl 6.08 4.57 7.59 nmol/l 176 132 220 Roche Cobas 4000/e411 Gen II µg/dl 6.34 4.75 7.93 nmol/l 169 127 211 Roche Cobas 6000/8000 Gen II µg/dl 6.08 4.57 7.59 nmol/l 173 130 216 Roche Elecsys Gen II µg/dl 6.23 4.68 7.78 µmol/l 2.05 1.64 2.46 Siemens Immulite 2000/2500 µmol/l 3.18 2.54 3.82 Roche Elecsys µmol/l 3.04 2.43 3.65 Roche Modular E170 µmol/l 2.64 2.11 3.17 Abbott Architect µmol/l 2.27 1.82 2.72 Beckman DxI800 µmol/l 2.13 1.38 2.88 Siemens Centaur XP/XPT/Classic µmol/l 3.17 2.54 3.80 Roche Cobas E411 µmol/l 3.01 2.41 3.61 Roche Cobas 6000/8000 nmol/l 0.855 0.684 1.03 Vitros ng/ml 0.668 0.534 0.802 nmol/l 0.995 0.746 1.24 Siemens Centaur XP/XPT/Classic ng/ml 0.777 0.583 0.971 nmol/l 0.597 0.478 0.716 Abbott Architect ng/ml 0.466 0.373 0.559 nmol/l 0.608 0.486 0.730 Siemens Dimension ng/ml 0.475 0.380 0.570 nmol/l 0.781 0.625 0.937 Beckman DxI800 ng/ml 0.610 0.488 0.732 nmol/l 0.852 0.682 1.02 Roche Cobas 6000/8000 ng/ml 0.665 0.533 0.797 nmol/l 0.929 0.743 1.11 Roche Cobas 4000/E411 ng/ml 0.726 0.580 0.872 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 18

规格 :12 x 5 ml 范围低值 = 靶值 -2SD 高值 = 靶值 +2SD 分析物单位靶值低值高值方法学 地高辛 乙琥胺血清铁蛋白叶酸游离 T3 nmol/l 0.896 0.720 1.08 Gravimetric ng/ml 0.700 0.560 0.840 µmol/l 226 180 271 Gravimetric µg/ml 32.0 25.5 38.4 ng/ml = µg/l 14.6 11.7 17.5 Siemens Immulite 1000 ng/ml = µg/l 16.6 13.3 19.9 Roche Elecsys ng/ml = µg/l 10.9 8.72 13.1 Beckman Access ng/ml = µg/l 12.2 9.76 14.6 Vitros ECi ng/ml = µg/l 15.3 11.5 19.1 Siemens Centaur XP/XPT/Classic ng/ml = µg/l 15.4 12.3 18.5 Siemens Immulite 2000/2500 ng/ml = µg/l 16.0 12.8 19.2 Abbott Architect ng/ml = µg/l 14.6 11.7 17.5 Diasorin Liaison ng/ml = µg/l 16.4 13.1 19.7 Roche Modular E170 ng/ml = µg/l 16.9 13.5 20.3 Siemens Dimension ng/ml = µg/l 11.1 8.88 13.3 Beckman DxI800 ng/ml = µg/l 15.6 12.5 18.7 Roche Cobas E411 ng/ml = µg/l 13.8 10.4 17.2 Siemens Centaur CP nmol/l 4.26 3.24 5.28 Beckman Access ng/ml 1.88 1.43 2.33 nmol/l 3.16 2.40 3.92 Siemens Immulite 2000 ng/ml 1.39 1.06 1.72 nmol/l 4.25 3.23 5.27 Vitros ECi ng/ml 1.87 1.42 2.32 nmol/l 4.27 3.25 5.29 Abbott Architect ng/ml 1.88 1.43 2.33 nmol/l 7.51 5.71 9.31 Roche Modular E170 ng/ml 3.31 2.52 4.10 nmol/l 8.95 4.92 13.0 Siemens Centaur XP/XPT/Classic (enhanced kit) ng/ml 3.95 2.17 5.73 nmol/l 4.10 3.12 5.08 Beckman DxI800 ng/ml 1.81 1.38 2.24 nmol/l 7.25 5.51 8.99 Roche Cobas 6000/8000 ng/ml 3.20 2.43 3.97 pmol/l 4.62 3.47 5.78 BioMerieux Vidas ng/dl 0.300 0.226 0.374 pg/ml 3.01 2.26 3.76 pmol/l 6.02 4.52 7.53 Roche Elecsys ng/dl 0.391 0.294 0.488 pg/ml 3.92 2.94 4.90 pmol/l 5.16 3.87 6.45 Beckman Access ng/dl 0.335 0.252 0.418 pg/ml 3.36 2.52 4.20 pmol/l 4.67 3.50 5.84 Siemens Immulite 1000 ng/dl 0.304 0.228 0.380 pg/ml 3.04 2.28 3.80 pmol/l 10.9 8.18 13.6 Vitros ECi ng/dl 0.709 0.532 0.886 pg/ml 7.10 5.33 8.87 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 18

规格 :12 x 5 ml 范围低值 = 靶值 -2SD 高值 = 靶值 +2SD 分析物单位靶值低值高值方法学 游离 T3 游离 T4 pmol/l 5.27 3.16 7.38 Siemens Centaur XP/XPT/Classic ng/dl 0.343 0.206 0.480 pg/ml 3.43 2.06 4.80 pmol/l 4.48 3.36 5.60 Siemens Immulite 2000/2500 ng/dl 0.291 0.218 0.364 pg/ml 2.92 2.19 3.65 pmol/l 3.59 2.69 4.49 Abbott Architect ng/dl 0.233 0.175 0.291 pg/ml 2.34 1.75 2.93 pmol/l 5.77 4.33 7.21 Roche Modular E170 ng/dl 0.375 0.281 0.469 pg/ml 3.76 2.82 4.70 pmol/l 5.03 3.77 6.29 Beckman DxI800 ng/dl 0.327 0.245 0.409 pg/ml 3.27 2.45 4.09 pmol/l 6.03 4.52 7.54 Roche Cobas E411 ng/dl 0.392 0.294 0.490 pg/ml 3.93 2.94 4.92 pmol/l 5.85 4.39 7.31 Roche Cobas 6000/8000 ng/dl 0.380 0.285 0.475 pg/ml 3.81 2.86 4.76 pmol/l 5.53 3.32 7.74 Siemens Centaur CP ng/dl 0.359 0.215 0.503 pg/ml 3.60 2.16 5.04 pmol/l 12.8 9.60 16.0 Siemens Immulite 1000 ng/dl 0.998 0.749 1.25 pg/ml 9.98 7.49 12.5 pmol/l 13.8 10.4 17.3 Roche Elecsys ng/dl 1.08 0.811 1.35 pg/ml 10.8 8.11 13.5 pmol/l 10.8 8.10 13.5 Beckman Access ng/dl 0.842 0.632 1.05 pg/ml 8.42 6.32 10.5 pmol/l 10.9 8.18 13.6 Tosoh AIA360 ng/dl 0.850 0.638 1.06 pg/ml 8.50 6.38 10.6 pmol/l 20.9 15.7 26.1 Vitros ECi ng/dl 1.63 1.22 2.04 pg/ml 16.3 12.2 20.4 pmol/l 9.50 7.13 11.9 Siemens Centaur XP/XPT/Classic ng/dl 0.741 0.556 0.926 pg/ml 7.41 5.56 9.26 pmol/l 13.1 9.83 16.4 Siemens Immulite 2000/2500 ng/dl 1.02 0.767 1.27 pg/ml 10.2 7.67 12.7 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 18

pmol/l 9.75 7.31 12.2 Abbott Architect ng/dl 0.761 0.570 0.952 pg/ml 7.61 5.70 9.52 pmol/l 13.2 9.90 16.5 Diasorin Liaison ng/dl 1.03 0.772 1.29 pg/ml 10.3 7.72 12.9 游离 T4 pmol/l 13.5 10.1 16.9 Roche Modular E170 ng/dl 1.05 0.788 1.31 pg/ml 10.5 7.88 13.1 pmol/l 10.6 7.95 13.3 Beckman DxI800 ng/dl 0.827 0.620 1.03 pg/ml 8.27 6.20 10.3 pmol/l 13.6 10.2 17.0 Roche Cobas 6000/8000 ng/dl 1.06 0.796 1.32 pg/ml 10.6 7.96 13.2 pmol/l 13.8 10.4 17.3 Roche Cobas E411 ng/dl 1.08 0.811 1.35 pg/ml 10.8 8.11 13.5 pmol/l 11.1 8.33 13.9 Biomerieux Vidas FT4N Kit ng/dl 0.866 0.650 1.08 pg/ml 8.66 6.50 10.8 pmol/l 9.63 7.22 12.0 Siemens Centaur CP ng/dl 0.751 0.563 0.939 pg/ml 7.51 5.63 9.39 mu/ml 6.75 5.40 8.10 Siemens Immulite 1000 mu/ml 6.48 5.18 7.78 BioMerieux Vidas mu/ml 6.43 5.14 7.72 Beckman Access mu/ml 5.94 4.75 7.13 Roche/BM Elecsys mu/ml 5.15 4.12 6.18 Vitros ECi 卵泡刺激素 (FSH) mu/ml 8.59 6.01 11.2 Siemens Centaur XP/XPT/Classic mu/ml 6.87 5.50 8.24 Siemens Immulite 2000/2500 mu/ml 5.29 4.23 6.35 Abbott Architect mu/ml 7.19 5.75 8.63 Diasorin Liaison mu/ml 5.76 4.61 6.91 Roche Modular E170 mu/ml 6.30 5.04 7.56 Beckman DxI800 mu/ml 6.24 4.99 7.49 Roche Cobas E411 mu/ml 5.81 4.65 6.97 Roche Cobas 6000/8000 mu/ml 6.27 4.39 8.15 Siemens Centaur CP µmol/l 4.81 3.85 5.77 Roche Integra 庆大霉素 µg/ml 2.30 1.84 2.76 µmol/l 2.95 2.36 3.54 Roche Cobas 6000/8000 µg/ml 1.41 1.13 1.69 µmol/l 4.85 3.88 5.82 Gravimetric µg/ml 2.32 1.85 2.78 生长激素 (GH) µu/ml 9.43 7.54 11.3 Siemens Immulite 1000 ng/ml 3.14 2.51 3.77 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 8 OF 18

µu/ml 10.8 8.64 13.0 Siemens Immulite 2000/2500 ng/ml 3.60 2.88 4.32 µu/ml 7.37 5.90 8.84 Roche Modular E170 生长激素 (GH) ng/ml 2.45 1.96 2.94 µu/ml 7.92 6.34 9.50 Beckman DxI800 ng/ml 2.64 2.11 3.17 µu/ml 7.99 6.39 9.59 Diasorin Liaison ng/ml 2.66 2.13 3.19 µu/ml 7.60 6.08 9.12 Roche Cobas E411 ng/ml 2.53 2.02 3.04 µu/ml 7.83 6.26 9.40 Roche Cobas 6000/8000 ng/ml 2.61 2.08 3.14 µu/ml 8.37 6.70 10.0 IDS isys ng/ml 2.79 2.23 3.35 KIU/l = IU/ml 240 192 288 Siemens Immulite 1000 KIU/l = IU/ml 190 152 228 BioMerieux Vidas KIU/l = IU/ml 214 171 257 Roche Elecsys KIU/l = IU/ml 199 159 239 Tosoh AIA360 免疫球蛋白 E KIU/l = IU/ml 198 119 277 Siemens Centaur XP/XPT/Classic KIU/l = IU/ml 222 178 266 Siemens Immulite 2000/2500 KIU/l = IU/ml 207 166 248 Roche Modular E170 KIU/l = IU/ml 193 154 232 Beckman DxI800 KIU/l = IU/ml 209 167 251 Abbott Architect KIU/l = IU/ml 213 170 256 Roche Cobas E411 KIU/l = IU/ml 215 172 258 Roche Cobas 6000/8000 mu/l 1.31 0.983 1.64 Siemens Centaur XP/XPT/Classic pmol/l 9.10 6.83 11.4 mu/l 0.976 0.732 1.22 Roche Modular E170 pmol/l 6.78 5.08 8.48 胰岛素 mu/l 4.53 3.40 5.66 Siemens Immulite 2000 pmol/l 31.5 23.6 39.4 mu/l 0.633 0.475 0.791 Beckman Access pmol/l 4.40 3.30 5.50 mu/l 0.797 0.598 0.996 Abbott Architect pmol/l 5.54 4.15 6.93 mu/l 0.924 0.693 1.16 Roche Cobas E411 pmol/l 6.42 4.81 8.03 mu/l 0.875 0.656 1.09 Roche Cobas 6000/8000 pmol/l 6.08 4.56 7.60 mu/l 0.536 0.402 0.670 Beckman DxI 600/800 pmol/l 3.72 2.79 4.65 mu/l 1.02 0.765 1.28 Siemens Centaur CP pmol/l 7.08 5.31 8.85 促黄体生成素 (LH) mu/ml 2.13 1.70 2.56 Beckman Access mu/ml 2.75 2.20 3.30 BioMerieux Vidas Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 9 OF 18

mu/ml 5.65 4.52 6.78 Siemens Immulite 1000 mu/ml 3.36 2.69 4.03 Roche Elecsys mu/ml 6.43 5.14 7.72 Vitros ECi 促黄体生成素 (LH) mu/ml 2.78 2.09 3.47 Siemens Centaur XP/XPT/Classic mu/ml 5.11 4.09 6.13 Siemens Immulite 2000 mu/ml 2.25 1.80 2.70 Abbott Architect mu/ml 3.73 2.98 4.48 Diasorin Liaison mu/ml 3.30 2.64 3.96 Roche Modular E170 mu/ml 1.95 1.56 2.34 Beckman DxI800 mu/ml 3.35 2.68 4.02 Roche Cobas E411 mu/ml 3.31 2.65 3.97 Roche Cobas 6000/8000 mu/ml 2.41 1.81 3.01 Siemens Centaur CP pmol/l 191 153 229 BioMerieux Vidas pg/ml 52.0 41.6 62.4 雌二醇 (E2) pmol/l 171 137 205 Roche Elecsys (Estradiol II) pg/ml 46.5 37.3 55.7 pmol/l 106 84.8 127 Vitros ECi pg/ml 28.8 23.1 34.5 pmol/l 140 112 168 Siemens Immulite 2000/2500 pg/ml 38.1 30.5 45.7 pmol/l 188 150 226 Abbott Architect pg/ml 51.1 40.8 61.4 pmol/l 151 121 181 Roche Cobas 6000/8000 (Estradiol II) pg/ml 41.1 32.9 49.3 pmol/l 162 130 194 Roche Cobas 4000/E411 (Estradiol II) pg/ml 44.1 35.4 52.8 pmol/l 178 107 249 Siemens Centaur XP/XPT/Classic Enhanced (ee2) pg/ml 48.4 29.0 67.8 pmol/l 165 132 198 Roche Cobas 6000/8000 (Estradiol III) pg/ml 44.9 35.9 53.9 pmol/l 167 134 200 Roche Elecsys (Estradiol III) pg/ml 45.4 36.4 54.4 pmol/l 156 125 187 Roche Cobas 4000/E411 (Estradiol III) pg/ml 42.4 34.0 50.8 pmol/l 157 126 188 Roche Modular E170 (Estradiol III) pg/ml 42.7 34.3 51.1 mmol/l 0.167 0.134 0.200 Abbott Architect mg/l 25.3 20.3 30.3 扑热息痛 mmol/l 0.103 0.082 0.124 Roche Cobas 6000/8000 mg/l 15.6 12.4 18.8 mmol/l 0.166 0.130 0.200 Gravimetric mg/l 25.1 19.7 30.3 µmol/l 35.3 28.2 42.4 Abbott Architect 苯巴比妥 µg/ml 8.19 6.54 9.84 µmol/l 34.4 27.5 41.3 Siemens Immulite 2000/2500 µg/ml 7.98 6.38 9.58 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 10 OF 18

µmol/l 31.8 25.4 38.2 Beckman AU400/600/640/2700/5400 µg/ml 7.38 5.89 8.87 苯巴比妥 µmol/l 33.6 26.9 40.3 Siemens Immulite 1000 µg/ml 7.80 6.24 9.36 µmol/l 32.4 25.9 38.9 Beckman DxC µg/ml 7.52 6.01 9.03 µmol/l 34.5 27.6 41.4 Gravimetric µg/ml 8.00 6.40 9.60 µmol/l 19.1 14.3 23.9 Siemens Centaur XP/XPT/Classic µg/ml 4.82 3.62 6.02 苯妥英钠 µmol/l 16.6 13.3 19.9 Vitros µg/ml 4.19 3.36 5.02 µmol/l 19.1 15.3 22.9 Roche Integra µg/ml 4.82 3.86 5.78 µmol/l 20.0 16.0 24.0 Abbott Architect µg/ml 5.05 4.04 6.06 µmol/l 19.3 15.4 23.2 Beckman DxC µg/ml 4.87 3.89 5.85 µmol/l 19.3 15.4 23.2 Roche Cobas E411 µg/ml 4.87 3.89 5.85 µmol/l 18.5 14.8 22.2 Roche Cobas 6000/8000 µg/ml 4.67 3.74 5.60 µmol/l 20.2 16.2 24.2 Gravimetric µg/ml 5.10 4.09 6.11 µmol/l 12.3 9.86 14.8 Gravimetric 扑米酮 µg/ml 2.69 2.15 3.23 nmol/l 3.29 2.63 3.95 Siemens Immulite 1000 ng/ml 1.03 0.823 1.24 nmol/l 3.79 3.03 4.55 BioMerieux Vidas ng/ml 1.19 0.948 1.43 nmol/l 2.72 2.18 3.26 Roche Elecsys ng/ml 0.851 0.682 1.02 nmol/l 3.43 2.74 4.12 Vitros ECi ng/ml 1.07 0.858 1.28 孕酮 nmol/l 2.32 1.28 3.36 Siemens Centaur XP/XPT/Classic ng/ml 0.726 0.399 1.05 nmol/l 3.13 2.50 3.76 Siemens Immulite 2000/2500 ng/ml 0.980 0.783 1.18 nmol/l 3.15 2.52 3.78 Abbott Architect ng/ml 0.986 0.789 1.18 nmol/l 2.49 1.99 2.99 Roche Modular E170 ng/ml 0.779 0.623 0.935 nmol/l 3.17 2.54 3.80 Beckman DxI Prog Cal 33555 ng/ml 0.992 0.795 1.19 nmol/l 2.69 2.15 3.23 Roche Cobas E411 ng/ml 0.842 0.673 1.01 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 11 OF 18

nmol/l 2.55 2.04 3.06 Roche Cobas 6000/8000 孕酮 ng/ml 0.798 0.639 0.957 nmol/l 1.90 1.52 2.28 Beckman DxI Prog DE Cal A80773 ng/ml 0.595 0.476 0.714 µu/ml 134 107 161 Beckman Access µu/ml 124 99.0 149 BioMerieux Vidas µu/ml 149 119 179 Siemens Immulite 1000 µu/ml 131 105 157 Roche Elecsys 催乳素 µu/ml 175 140 210 Vitros ECi µu/ml 138 96.6 179 Siemens Centaur XP/XPT/Classic µu/ml 128 102 154 Siemens Immulite 2000/2500 µu/ml 148 118 178 Abbott Architect µu/ml 127 102 152 Diasorin Liaison µu/ml 126 101 151 Roche Modular E170 µu/ml 123 98.4 148 Beckman DxI800 µu/ml 123 98.4 148 Roche Elecsys/E170/Cobas 6000/8000 PRLII µu/ml 129 103 155 Roche Cobas E411 µu/ml 122 97.6 146 Roche Cobas 6000/8000 µu/ml 147 118 176 Abbott Architect restandardised ng/ml = µg/l 1.20 0.900 1.50 Siemens Immulite 2000/2500 ng/ml = µg/l 1.26 0.945 1.58 Roche Elecsys FPSA( 游离 ) ng/ml = µg/l 1.13 0.848 1.41 Abbott Architect ng/ml = µg/l 1.74 1.31 2.18 Beckman Access standardised to Hybritech ng/ml = µg/l 1.31 0.983 1.64 Siemens Centaur XP/XPT/Classic ng/ml = µg/l 1.20 0.900 1.50 Roche Modular E170 ng/ml = µg/l 1.71 1.28 2.14 Beckman DXI standardised to Hybritech ng/ml = µg/l 1.27 0.953 1.59 Roche Cobas E411 ng/ml = µg/l 1.24 0.930 1.55 Roche Cobas 6000/8000 ng/ml = µg/l 1.73 1.30 2.16 Beckman Access standardised to WHO IRP96/670 ng/ml = µg/l 1.08 0.810 1.35 Ortho Vitros 3600/5600/ECi PSA II ng/ml = µg/l 1.33 0.998 1.66 Siemens Immulite 1000 1st generation ng/ml = µg/l 1.80 1.35 2.25 Roche Elecsys ng/ml = µg/l 1.15 0.863 1.44 Tosoh AIA360 ng/ml = µg/l 1.61 1.21 2.01 Beckman Access standardised to Hybritech ng/ml = µg/l 1.42 1.07 1.77 Siemens Centaur XP/XPT/Classic ng/ml = µg/l 1.71 1.28 2.14 biomerieux VIDAS TPSA ng/ml = µg/l 1.27 0.953 1.59 Siemens Immulite 2000/2500 1st generation ng/ml = µg/l 1.50 1.13 1.88 Abbott Architect ng/ml = µg/l 1.54 1.16 1.93 Vitros ECi TPSA( 总 ) ng/ml = µg/l 0.562 0.422 0.703 Diasorin Liaison ng/ml = µg/l 1.83 1.37 2.29 Roche Modular E170 ng/ml = µg/l 1.61 1.21 2.01 Beckman Access standardised to WHO IRP96/670 ng/ml = µg/l 1.50 1.13 1.88 Beckman DxI standardisd to Hybritech ng/ml = µg/l 1.31 0.983 1.64 Beckman DxI800 standardised to WHO IRP96/670 ng/ml = µg/l 1.78 1.34 2.23 Roche Cobas E411 ng/ml = µg/l 1.81 1.36 2.26 Roche Cobas 6000/8000 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 12 OF 18

TPSA( 总 ) ng/ml = µg/l 1.67 1.25 2.09 Ortho Vitros 3600/5600/ECi PSA II ng/ml = µg/l 1.41 1.06 1.76 Siemens Centaur CP mmol/l 0.258 0.206 0.310 Abbott Architect mg/dl 3.56 2.85 4.27 水杨酸 mmol/l 0.286 0.230 0.340 Gravimetric mg/dl 3.95 3.18 4.70 nmol/l 12.4 9.92 14.9 Siemens Centaur XP/XPT/Classic 性激素结合球蛋白 nmol/l 12.4 9.92 14.9 Siemens Immulite 1000 nmol/l 12.7 10.2 15.2 Siemens Immulite 2000/2500 nmol/l 10.5 8.40 12.6 Roche Elecsys nmol/l 11.0 8.80 13.2 Roche Modular E170 nmol/l 10.7 8.56 12.8 Abbott Architect nmol/l 11.2 8.96 13.4 Roche Cobas E411 nmol/l 11.0 8.80 13.2 Roche Cobas 6000/8000 nmol/l 12.2 9.76 14.6 Beckman DxI800 甲状腺素结合力 %U 38.2 31.3 45.1 Siemens Immulite 2000 睾酮 nmol/l 0.989 0.791 1.19 Vitros ECi ng/ml 0.285 0.228 0.342 ng/dl 28.5 22.8 34.2 nmol/l 1.51 0.982 2.04 Siemens Centaur XP/XPT/Classic ng/ml 0.435 0.283 0.587 ng/dl 43.5 28.3 58.7 nmol/l 1.15 0.920 1.38 Siemens Immulite 2000/2500 ng/ml 0.331 0.265 0.397 ng/dl 33.1 26.5 39.7 nmol/l 1.57 1.26 1.88 Abbott Architect ng/ml 0.452 0.363 0.541 ng/dl 45.2 36.3 54.1 nmol/l 1.53 1.22 1.84 Beckman Access ng/ml 0.441 0.351 0.531 ng/dl 44.1 35.1 53.1 nmol/l 1.55 1.24 1.86 Beckman DxI800 ng/ml 0.446 0.357 0.535 ng/dl 44.6 35.7 53.5 nmol/l 1.74 1.39 2.09 Roche Elecsys Test II ng/ml 0.501 0.400 0.602 ng/dl 50.1 40.0 60.2 nmol/l 1.72 1.38 2.06 Roche Modular E170 Test II ng/ml 0.495 0.397 0.593 ng/dl 49.5 39.7 59.3 nmol/l 1.74 1.39 2.09 Roche Cobas 4000/e411 Test II ng/ml 0.501 0.400 0.602 ng/dl 50.1 40.0 60.2 nmol/l 1.67 1.34 2.00 Roche Cobas 6000 Test 2 ng/ml 0.481 0.386 0.576 ng/dl 48.1 38.6 57.6 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 13 OF 18

R A ND 睾酮 茶碱 甲状腺球蛋白 促甲状腺素 (TSH) 妥布霉素 总 β-hcg X 规格 :12 x 5 ml 范围低值 = 靶值 -2SD 高值 = 靶值 +2SD 分析物单位靶值低值高值方法学 nmol/l 1.55 1.24 1.86 Abbott Architect 2nd Generation ng/ml 0.446 0.357 0.535 ng/dl 44.6 35.7 53.5 nmol/l 1.07 0.856 1.28 BioMerieux Vidas Testosterone II ng/ml 0.308 0.247 0.369 ng/dl 30.8 24.7 36.9 µmol/l 26.4 21.1 31.7 Abbott Architect µg/ml 4.76 3.80 5.72 µmol/l 23.2 18.6 27.8 Beckman DxC µg/ml 4.18 3.35 5.01 µmol/l 28.3 22.6 34.0 Gravimetric µg/ml 5.10 4.07 6.13 ng/ml 2.46 1.85 3.08 Beckman DxI800 ng/ml 2.93 2.20 3.66 Roche Cobas E411 ng/ml 2.96 2.22 3.70 Roche Cobas 6000/8000 ng/ml 2.94 2.21 3.68 Roche Cobas 6000 TGII ng/ml 2.86 2.15 3.58 Roche Elecsys TGII ng/ml 3.13 2.35 3.91 Roche Cobas 4000/E411 TGII µu/ml = mlu/l 0.101 0.081 0.121 biomerieux VIDAS TSH µu/ml = mlu/l 0.165 0.132 0.198 Siemens Immulite 1000 µu/ml = mlu/l 0.167 0.134 0.200 Roche Elecsys µu/ml = mlu/l 0.133 0.106 0.160 Beckman Access hypertsh 3rd Generation µu/ml = mlu/l 0.188 0.150 0.226 Vitros ECi µu/ml = mlu/l 0.141 0.096 0.186 Siemens Centaur XP/XPT/Classic µu/ml = mlu/l 0.135 0.108 0.162 Siemens Immulite 2000/2500 µu/ml = mlu/l 0.139 0.111 0.167 Abbott Architect µu/ml = mlu/l 0.165 0.132 0.198 Roche Modular E170 µu/ml = mlu/l 0.102 0.082 0.122 biomerieux VIDAS TSH3 Ultrasensitive µu/ml = mlu/l 0.146 0.117 0.175 Beckman Access Fast TSH µu/ml = mlu/l 0.144 0.115 0.173 Beckman DxI800 Fast TSH µu/ml = mlu/l 0.170 0.136 0.204 Roche Cobas E411 µu/ml = mlu/l 0.169 0.135 0.203 Roche Cobas 6000/8000 µu/ml = mlu/l 0.139 0.111 0.167 Beckman DxI800 Hyper TSH µu/ml = mlu/l 0.147 0.100 0.194 Siemens Centaur XP/XPT/Classic TSH3-Ultra µu/ml = mlu/l 0.138 0.094 0.182 Siemens Centaur CP µu/ml = mlu/l 0.141 0.096 0.186 Siemens Centaur CP TSH3-Ultra µmol/l 4.17 3.33 5.00 Gravimetric µg/ml 1.95 1.56 2.34 mu/ml=iu/l 16.0 12.8 19.2 BioMerieux Vidas IU/ml 0.016 0.013 0.019 mu/ml=iu/l 21.4 17.1 25.7 Siemens Immulite 1000 IU/ml 0.021 0.017 0.025 mu/ml=iu/l 14.4 11.5 17.3 Roche Cobas Core EIA IU/ml 0.014 0.012 0.016 mu/ml=iu/l 19.4 15.5 23.3 Beckman Access IU/ml 0.019 0.016 0.022 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 14 OF 18

R A ND X 规格 :12 x 5 ml 范围低值 = 靶值 -2SD 高值 = 靶值 +2SD 分析物单位靶值低值高值方法学 mu/ml=iu/l 16.5 13.2 19.8 Vitros ECi IU/ml 0.017 0.013 0.021 mu/ml=iu/l 21.1 12.7 29.5 Siemens Centaur XP/XPT/Classic IU/ml 0.021 0.013 0.029 mu/ml=iu/l 23.3 18.6 28.0 Siemens Immulite 2000 IU/ml 0.023 0.019 0.027 总 β-hcg mu/ml=iu/l 17.7 14.2 21.2 Abbott Architect IU/ml 0.018 0.014 0.022 mu/ml=iu/l 17.8 14.2 21.4 Diasorin Liaison IU/ml 0.018 0.014 0.022 mu/ml=iu/l 15.2 12.2 18.2 IU/ml 0.015 0.012 0.018 Siemens Dimension mu/ml=iu/l 18.9 15.1 22.7 Beckman DxI800 IU/ml 0.019 0.015 0.023 mu/ml=iu/l 14.4 11.5 17.3 Roche STAT (Intact) IU/ml 0.014 0.012 0.016 mu/ml=iu/l 14.6 11.7 17.5 Roche hcg+beta IU/ml 0.015 0.012 0.018 mu/ml=iu/l 16.5 13.2 19.8 Radiometer AQT90 Flex IU/ml 0.017 0.013 0.021 mu/ml=iu/l 18.6 14.9 22.3 Beckman Access Total BhCG (5th IS) IU/ml 0.019 0.015 0.023 mu/ml=iu/l 18.8 15.0 22.6 Beckman DxI Total BhCG (5th IS) IU/ml 0.019 0.015 0.023 总 T3 nmol/l 1.12 0.840 1.40 BioMerieux Vidas ng/ml 0.729 0.547 0.911 ng/dl 72.9 54.7 91.1 nmol/l 0.959 0.719 1.20 Siemens Immulite 1000 ng/ml 0.624 0.468 0.780 ng/dl 62.4 46.8 78.0 nmol/l 1.96 1.47 2.45 Roche Elecsys ng/ml 1.28 0.957 1.60 ng/dl 128 95.7 160 nmol/l 1.48 1.11 1.85 Beckman Access ng/ml 0.963 0.723 1.20 ng/dl 96.3 72.3 120 nmol/l 1.03 0.773 1.29 Siemens Centaur XP/XPT/Classic ng/ml 0.671 0.503 0.839 ng/dl 67.1 50.3 83.9 nmol/l 0.796 0.597 0.995 Siemens Immulite 2000/2500 ng/ml 0.518 0.389 0.647 ng/dl 51.8 38.9 64.7 nmol/l 1.05 0.788 1.31 Abbott Architect ng/ml 0.684 0.513 0.855 ng/dl 68.4 51.3 85.5 nmol/l 1.49 1.12 1.86 Vitros ECi ng/ml 0.970 0.729 1.21 ng/dl 97.0 72.9 121 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 15 OF 18

总 T3 nmol/l 1.75 1.31 2.19 Roche Modular E170 ng/ml 1.14 0.853 1.43 ng/dl 114 85.3 143 nmol/l 1.27 0.953 1.59 Beckman DxI800 ng/ml 0.827 0.620 1.03 ng/dl 82.7 62.0 103 nmol/l 1.92 1.44 2.40 Roche Cobas E411 ng/ml 1.25 0.937 1.56 ng/dl 125 93.7 156 nmol/l 1.80 1.35 2.25 Roche Cobas 6000/8000 ng/ml 1.17 0.879 1.46 ng/dl 117 87.9 146 nmol/l 1.33 0.998 1.66 Monobind Inc. ELISA / CLIA ng/ml 0.866 0.650 1.08 ng/dl 86.6 65.0 108 总 T4 nmol/l 27.5 20.6 34.4 Vitros ECi µg/dl 2.15 1.61 2.69 ng/ml 21.5 16.1 26.9 nmol/l 36.0 27.0 45.0 BioMerieux Vidas µg/dl 2.81 2.11 3.51 ng/ml 28.1 21.1 35.1 nmol/l 39.1 29.3 48.9 Roche Elecsys µg/dl 3.05 2.29 3.81 ng/ml 30.5 22.9 38.1 nmol/l 23.9 16.7 31.1 Siemens Centaur XP/XPT/Classic µg/dl 1.86 1.30 2.42 ng/ml 18.6 13.0 24.2 nmol/l 26.7 20.0 33.4 Siemens Immulite 2000/2500 µg/dl 2.08 1.56 2.60 ng/ml 20.8 15.6 26.0 nmol/l 40.4 30.3 50.5 Abbott Architect µg/dl 3.15 2.36 3.94 ng/ml 31.5 23.6 39.4 nmol/l 36.7 27.5 45.9 Roche Modular E170 µg/dl 2.86 2.15 3.57 ng/ml 28.6 21.5 35.7 nmol/l 25.3 19.0 31.6 Beckman DxI800 µg/dl 1.97 1.48 2.46 ng/ml 19.7 14.8 24.6 nmol/l 39.0 29.3 48.8 Roche Cobas E411 µg/dl 3.04 2.29 3.79 ng/ml 30.4 22.9 37.9 nmol/l 36.1 27.1 45.1 Roche Cobas 6000/8000 µg/dl 2.82 2.11 3.53 ng/ml 28.2 21.1 35.3 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 16 OF 18

总 T4 nmol/l 37.6 28.2 47.0 Monobind Inc. ELISA / CLIA µg/dl 2.93 2.20 3.66 ng/ml 29.3 22.0 36.6 nmol/l 26.8 18.8 24.8 Siemens Centaur CP µg/dl 2.09 1.46 2.72 ng/ml 20.9 14.6 27.2 丙戊酸 µmol/l 200 160 240 Siemens Immulite 1000 µg/ml 28.9 23.1 34.7 µmol/l 198 158 238 Roche Integra µg/ml 28.6 22.8 34.4 µmol/l 197 158 236 Siemens Immulite 2000/2500 µg/ml 28.4 22.8 34.0 µmol/l 206 144 268 Siemens Centaur XP/XPT/Classic µg/ml 29.7 20.8 38.6 µmol/l 188 150 226 Vitros µg/ml 27.1 21.6 32.6 µmol/l 190 152 228 Siemens Dimension µg/ml 27.4 21.9 32.9 µmol/l 210 168 252 Abbott Architect µg/ml 30.3 24.2 36.4 µmol/l 175 140 210 Beckman DxC µg/ml 25.3 20.2 30.4 µmol/l 206 165 247 Roche Cobas 6000/8000 µg/ml 29.7 23.8 35.6 µmol/l 201 161 241 Beckman AU400/600/640/2700/5400 µg/ml 29.0 23.2 34.8 µmol/l 243 194 291 Gravimetric µg/ml 35.0 28.0 42.0 万古霉素 µmol/l 3.47 2.78 4.16 Ortho Vitros Microslide Systems µg/ml 5.16 4.13 6.19 µmol/l 3.72 2.98 4.46 Abbott Architect µg/ml 5.53 4.43 6.63 µmol/l 3.01 2.41 3.61 Siemens Dimension µg/ml 4.47 3.58 5.36 µmol/l 3.39 2.71 4.07 Roche Cobas 6000/8000 µg/ml 5.04 4.03 6.05 µmol/l 3.43 2.74 4.12 Gravimetric µg/ml 5.10 4.07 6.12 维生素 B12 pmol/l 84.5 67.6 101 Beckman Access pg/ml 114 91.6 136 pmol/l 116 81.2 151 Siemens Centaur XP/XPT/Classic pg/ml 157 110 204 pmol/l 111 88.8 133 Siemens Immulite 2000 pg/ml 150 120 180 pmol/l 133 106 160 Abbott Architect pg/ml 180 144 216 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 17 OF 18

维生素 B12 pmol/l 129 103 155 Vitros ECi pg/ml 175 140 210 pmol/l 107 85.6 128 Roche Modular E170 pg/ml 145 116 174 pmol/l 77.3 61.8 92.8 Beckman DxI800 pg/ml 105 83.7 126 pmol/l 130 104 156 Roche Cobas E411 pg/ml 176 141 211 pmol/l 100 80.0 120 Roche Cobas 6000/8000 pg/ml 136 108 164 Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 18 OF 18