CN101035429A - 定量侧向流***和测定 - Google Patents
定量侧向流***和测定 Download PDFInfo
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Abstract
Description
上层 | 化学特性 | 疏水性/亲水性 | 孔径(微米) | 流速(毫升/分钟) | 毛细引力(毫米/分钟) | 下层 | 是否能过滤红细胞 |
#111 | 纤维素 | 亲水 | 1 | 130 | 51 | 共轭物垫 | 不能 |
#141 | 玻璃纤维 | 疏水 | 3 | 350 | 79 | 共轭物垫 | 不能 |
#142 | 玻璃纤维 | 疏水 | 6 | 300 | 55 | #142 | 不能 |
#142 | 玻璃纤维 | 疏水 | 6 | 300 | 55 | 共轭物垫 | 可以 |
#1660 | 合成纤维(CytoSep) | 亲水 | 3 | 100 | 52 | 共轭物垫 | 不能 |
#1661 | 合成纤维(CytoSep) | 亲水 | 5 | 260 | 41 | 共轭物垫 | 不能 |
#1662 | 合成纤维(CytoSep) | 亲水 | 3 | 35 | 46 | 共轭物垫 | 不能 |
#1663 | 合成纤维(CytoSep) | 亲水 | 2 | 35 | 46 | 共轭物垫 | 不能 |
#319 | 合成纤维(CytoSep) | 亲水 | 19 | 375 | 54 | 共轭物垫 | 不能 |
共轭物垫 | 玻璃纤维 | 疏水 | 42 | 250 | 46 | 共轭物垫 | 不能 |
膜 | 样本 | 加样量(微升) | 红细胞泄漏 | 迁移速度(毫米/分钟) | 背景 | 红细胞在NC上出现的时间(分钟) |
Grade 111纤维 | 全血 | 100 | 有 | ≤16 | 红 | 8 |
100 | 有 | ≤16 | 红 | 8 | ||
100 | 有 | ≤16 | 红 | 8 | ||
100 | 有 | ≤16 | 红 | 8 | ||
100 | 有 | ≤16 | 红 | 8 | ||
Grade 141玻璃纤维 | 全血 | 100 | 有 | ≤16 | 红 | 3 |
100 | 有 | ≤16 | 红 | 3 | ||
100 | 有 | ≤16 | 红 | 3 | ||
100 | 有 | ≤16 | 红 | 3 | ||
100 | 有 | ≤16 | 红 | 3 | ||
Grade 142玻璃纤维 | 全血 | 100 | 有 | ≤16 | 红 | 2 |
100 | 有 | ≤16 | 红 | 2 | ||
100 | 有 | ≤16 | 红 | 2 | ||
100 | 有 | ≤16 | 红 | 2 | ||
100 | 有 | ≤16 | 红 | 2 | ||
Grade 1660Cytosep | 全血 | 100 | 有 | ≤16 | 红 | 2 |
100 | 有 | ≤16 | 红 | 2 | ||
100 | 有 | ≤16 | 红 | 2 | ||
100 | 有 | ≤16 | 红 | 2 | ||
100 | 有 | ≤16 | 红 | 2 | ||
Grade 1661Cytosep | 全血 | 100 | 有 | ≤16 | 红 | 3 |
100 | 有 | ≤16 | 红 | 3 | ||
100 | 有 | ≤16 | 红 | 3 | ||
100 | 有 | ≤16 | 红 | 3 | ||
100 | 有 | ≤16 | 红 | 3 | ||
Grade 1662Cytosep | 全血 | 100 | 有 | ≤16 | 红 | 4 |
100 | 有 | ≤16 | 红 | 4 | ||
100 | 有 | ≤16 | 红 | 4 | ||
100 | 有 | ≤16 | 红 | 4 | ||
100 | 有 | ≤16 | 红 | 4 | ||
Grade 1663Cytosep | 全血 | 100 | 有 | <16 | 红 | 10(粘性) |
100 | 有 | <16 | 红 | 10(粘性) | ||
100 | 有 | <16 | 红 | 10(粘性) | ||
100 | 有 | <16 | 红 | 10(粘性) | ||
100 | 有 | <16 | 红 | 10(粘性) |
膜 | 抗人红细胞抗体(毫克/毫升) | 样本 | 加样量(微升) | 红细胞泄漏 | 迁移速度(毫米/分钟) | 背景 | 红细胞在NC上出现的时间 |
Grade111 | 0.25 | 全血 | 100 | 无 | ≤16 | 干净 | 1小时后 |
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
Grade141 | 0.25 | 全血 | 100 | 无 | ≤16 | 干净 | 1小时后 |
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
Grade142 | 0.25 | 全血 | 100 | 无 | ≤16 | 干净 | 1小时后 |
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
Grade1660 | 0.25 | 全血 | 100 | 无 | ≤16 | 干净 | 1小时后 |
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
Grade1661 | 0.25 | 全血 | 100 | 无 | ≤16 | 干净 | 1小时后 |
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 |
Grade1662 | 0.25 | 全血 | 100 | 无 | ≤16 | 干净 | 1小时后 |
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
100 | 无 | ≤16 | 干净 | 1小时后 | |||
Grade1663 | 0.25 | 全血 | 100 | --- | --- | 无过滤 | --- |
100 | --- | --- | 无过滤 | --- | |||
100 | --- | --- | 无过滤 | --- | |||
100 | --- | --- | 无过滤 | --- | |||
100 | --- | --- | 无过滤 | --- |
膜 | 抗人红细胞抗体 | 样本 | 红细胞泄漏 | 检测时间(分钟) | HCDr | LCDr | TESTDr | RI=TestDr/LCDr | S/CO | 红细胞泄漏时间 |
#142 | 无 | HIV阳性全血50微升 | 有 | 30 | --- | --- | --- | --- | 2分钟 | |
无 | 有 | 30 | --- | --- | --- | --- | 2分钟 | |||
无 | 有 | 30 | --- | --- | --- | --- | 2分钟 | |||
无 | 有 | 30 | --- | --- | --- | --- | 2分钟 | |||
无 | 有 | 30 | --- | --- | --- | --- | 2分钟 | |||
缓冲液垫 | 有 | 一些 | 30 | --- | --- | --- | --- | 3分钟 | ||
有 | 一些 | 30 | --- | --- | --- | --- | 3分钟 | |||
有 | 一些 | 30 | --- | --- | --- | --- | 3分钟 | |||
有 | 一些 | 30 | --- | --- | --- | --- | 3分钟 | |||
有 | 一些 | 30 | --- | --- | --- | --- | 3分钟 | |||
#142 | 有 | 无 | 30 | 0.2713 | 0.2116 | 0.182 | 0.8601 | 8.603 | 1小时后 | |
有 | 无 | 30 | 0.1422 | 0.1715 | 0.1761 | 1.0268 | 10.2693 | 1小时后 | ||
有 | 无 | 30 | 0.1981 | 0.1921 | 0.2282 | 1.1879 | 11.8776 | 1小时后 | ||
有 | 无 | 30 | 0.2037 | 0.1843 | 0.1899 | 1.0304 | 10.3033 | 1小时后 | ||
有 | 无 | 30 | 0.2287 | 0.1899 | 0.1846 | 0.9721 | 9.723 | 1小时后 |
膜 | 抗人红血胞抗体(毫克/毫升) | 样本 | 加样量(微升) | 红细胞泄漏 | 检测时间(分钟) | HCDr | LCDr | TESTDr | RI=TESTDr/LC Dr | S/CO | 结果 |
#142 | 0.25 | HIV阴性血 | 50 | 无 | 30 | 0.1777 | 0.0862 | 0 | 0 | 0 | 阴性 |
0.25 | 50 | 无 | 30 | 0.2268 | 0.0967 | 0 | 0 | 0 | 阴性 | ||
0.25 | 50 | 无 | 30 | 0.073 | 0.1083 | 0 | 0 | 0 | 阴性 | ||
0.25 | 50 | 无 | 30 | 0.183 | 0.0728 | 0 | 0 | 0 | 阴性 | ||
0.25 | 50 | 无 | 30 | 0.3277 | 0.109 | 0 | 0 | 0 | 阴性 | ||
#142 | 0.25 | HIV阴性血浆 | 50 | 无 | 15 | 0.4033 | 0.1926 | 0 | 0 | 0 | 阴性 |
0.25 | 50 | 无 | 15 | 0.3587 | 0.1945 | 0 | 0 | 0 | 阴性 | ||
0.25 | 50 | 无 | 15 | 0.36 | 0.1919 | 0 | 0 | 0 | 阴性 | ||
0.25 | 50 | 无 | 15 | 0.3822 | 0.1955 | 0 | 0 | 0 | 阴性 | ||
0.25 | 50 | 无 | 15 | 0.3759 | 0.1964 | 0 | 0 | 0 | 阴性 | ||
#142 | 0.25 | HIV阳性血 | 50 | 无 | 30 | 0.1213 | 0.1781 | 0.2014 | 1.1308 | 11.311 | 阳性 |
0.25 | 50 | 无 | 30 | 0.1419 | 0.1441 | 0.2181 | 1.5135 | 15.1325 | 阳性 | ||
0.25 | 50 | 无 | 30 | 0.1781 | 0.1408 | 0.2153 | 1.5291 | 15.2911 | 阳性 | ||
0.25 | 50 | 无 | 30 | 0.074 | 0.075 | 0.1032 | 1.3760 | 13.7626 | 阳性 | ||
0.25 | 50 | 无 | 30 | 0.1653 | 0.1605 | 0.2142 | 1.3346 | 13.3458 | 阳性 | ||
#142 | 0.25 | HIV阳性血浆 | 50 | 无 | 15 | 0.2755 | 0.1423 | 0.2011 | 1.4132 | 14.13 | 阳性 |
0.25 | 50 | 无 | 15 | 0.3628 | 0.18 | 0.2344 | 1.3022 | 13.0244 | 阳性 | ||
0.25 | 50 | 无 | 15 | 0.3084 | 0.1451 | 0.2005 | 1.3818 | 13.8166 | 阳性 | ||
0.25 | 50 | 无 | 15 | 0.3149 | 0.1468 | 0.1862 | 1.2684 | 12.6852 | 阳性 | ||
0.25 | 50 | 无 | 15 | 0.3425 | 0.1647 | 0.2164 | 1.3139 | 13.139 | 阳性 |
膜的型号 | 加样量(微升) | 血浆滤出时间(秒) | 红细胞泄漏时间(秒) | 血浆迁移速率(毫米/分钟) | 30分后残留在过滤器上的红细胞 |
1661 | 200 | 240 | 290 | 1.8 | 有 |
1660 | 200 | - | - | - | |
141 | 200 | 90 | 280 | 16.8 | 有 |
142 | 200 | 98 | 395 | 16.1 | |
111 | 200 | - | - | - | 有 |
膜的型号 | 加样量(微升) | 血浆滤出时间(秒) | 红细胞泄漏时间(秒) | 血浆迁移速率(毫米/分钟) |
142+142 | 200 | 457 | 582 | 5.87 |
141+141 | 200 | 135 | 1015 | 1.95 |
141+142 | 200 | 113 | 238 | 2.93 |
142+141 | 200 | 640 | 686 | 2.26 |
141+1661 | 200 | 111 | 236 | 5.74 |
142+1660 | 200 | 247 | 409 | 3.41 |
142+1661 | 200 | 112 | 253 | 2.83 |
141+1660 | 200 | 440 | 582 | 5.71 |
膜的型号 | 加样量(微升) | 血浆滤出时间(秒) | 红细胞漏出时间(秒) | 血浆迁移速率(毫米/分钟) | 30分钟后NC上显示红细胞 |
142*+CP | 200 | 140 | 1150 | >16 | 一些 |
142*+CP* | 200 | 126 | - | >16 | 没有 |
141*+CP | 200 | 130 | 680 | >16 | 一些 |
141*+CP* | 200 | 124 | 1350 | >16 | 少量 |
只有CP | 200 | 138 | 159 | >16 | 完全滤出 |
没有抗凝剂的#142 | 全血量 | ||||||||
50微升 | 75微升 | 150微升 | |||||||
红细胞漏出 | 血浆迁移(毫米/分) | 残留的红细胞 | 红细胞漏出 | 血浆迁移(毫米/分) | 残留的红细胞 | 红细胞漏出 | 血浆迁移(毫米/分) | 残留的红细胞 | |
没有抗凝剂的血样 | 否 | ≤16 | 微量 | 否 | >16 | 少量 | 否 | >16 | 较多 |
加EDTANa2的血样 | 否 | ≤16 | 微量 | 否 | >16 | 少量 | 否 | >16 | 较多 |
加柠檬酸三钠的血样 | 否 | ≤16 | 微量 | 否 | >16 | 少量 | 否 | >16 | 较多 |
加肝素钠的血样 | 否 | ≤16 | 微量 | 否 | >16 | 少量 | 否 | >16 | 较多 |
用抗凝剂预处理的#142 | 全血量 | ||||||||
50微升 | 75微升 | 150微升 | |||||||
红细胞漏出 | 血浆迁移(毫米/分) | 残留的红细胞 | 红细胞漏出 | 血浆迁移(毫米/分) | 残留的红细胞 | 红细胞漏出 | 血浆迁移(毫米/分) | 残留的红细胞 | |
没有抗凝剂的血样 | 否 | ≤16 | 微量 | 否 | >16 | 少量 | 否 | >16 | 较多 |
加EDTANa2的血样 | 否 | ≤16 | 微量 | 否 | >16 | 少量 | 否 | >16 | 较多 |
加柠檬酸三钠的血样 | 否 | ≤16 | 微量 | 否 | >16 | 少量 | 否 | >16 | 较多 |
加肝素钠的血样 | 否 | ≤16 | 微量 | 否 | >16 | 少量 | 否 | >16 | 较多 |
加样量(微升) | 迁移速率(毫米/分) | HbsAg浓度(纳克/毫升) | 均值1(纳克/毫升) | 均值2(纳克/毫升) | SD | CV | |
正常=100% | 200 | >16 | 18.7 | 18.475 | 17.36 | 0.72 | 4.1% |
正常=100% | 200 | >16 | 19.4 | ||||
正常=100% | 200 | >16 | 18.6 | ||||
正常=100% | 200 | >16 | 17.2 | ||||
测试CV | 4.99% | ||||||
升高10% | 200 | >16 | 16.7 | 16.925 | |||
升高10% | 200 | >16 | 16.5 | ||||
升高10% | 200 | >16 | 19.3 | ||||
升高10% | 200 | >16 | 15.2 | ||||
测试CV | 10.1% | ||||||
升高20% | 200 | 16 | 18.2 | 16.9 | |||
升高20% | 200 | 16 | 16.7 | ||||
升高20% | 200 | 16 | 15.4 | ||||
升高20% | 200 | 16 | 17.3 |
测试CV | 7.0% | ||||||
升高30% | 200 | <16 | 15.8 | 17.3 | |||
升高30% | 200 | 15.6 | |||||
升高30% | 200 | 20.8 | |||||
升高30% | 200 | 17.1 | |||||
测试CV | 13.9% | ||||||
下降10% | 200 | >16 | 16.8 | 16.15 | |||
下降10% | 200 | >16 | 16 | ||||
下降10% | 200 | >16 | 16.2 | ||||
下降10% | 200 | >16 | 15.6 | ||||
测试CV | 3.1% | ||||||
下降20% | 200 | >16 | 17.3 | 16.98 | |||
下降20% | 200 | >16 | 18.6 | ||||
下降20% | 200 | >16 | 16.1 | ||||
下降20% | 200 | >16 | 15.9 | ||||
测试CV | 7.3% | ||||||
下降30% | 200 | >16 | 16.7 | 17.9 | |||
下降30% | 200 | >16 | 19 | ||||
下降30% | 200 | >16 | 18.2 | ||||
下降30% | 200 | >16 | 17.7 | ||||
测试CV | 5.4% | ||||||
下降40% | 200 | >16 | 18.5 | 17.48 | |||
下降40% | 200 | >16 | 17.6 | ||||
下降40% | 200 | >16 | 16.4 | ||||
下降40% | 200 | >16 | 17.4 | ||||
测试CV | 5.0% | ||||||
血浆 | 200 | >16 | 19.3 | 18.1 | |||
血浆 | 200 | >16 | 17.6 | ||||
血浆 | 200 | >16 | 18.7 | ||||
血浆 | 200 | >16 | 16.8 | ||||
结果CV | 6.2% | ||||||
注:SD指标准偏差 CV指变化系数 |
样本 | 窗口1加入量(微升) | 窗口2加入量(微升) | 测试时间(分钟) | HCDr | LCDr | 测试Dr | RI=TESTDr/LC Dr | 浓度(uIU/ml) | 均值-1(uIU/ml) | 均值2(uIU/ml) | SD | CV% |
正常 | 50 | 150 | 30 | 0.3679 | 0.4733 | 0.3456 | 0.7302 | 29.66 | 28.09 | 28.5758 | 2.1258 | 7.44 |
0.4209 | 0.4736 | 0.3368 | 0.7111 | 28.29 | ||||||||
0.4367 | 0.5451 | 0.4117 | 0.7553 | 31.56 | ||||||||
0.4582 | 0.5414 | 0.3797 | 0.7013 | 27.6 | ||||||||
0.3017 | 0.4605 | 0.2929 | 0.6360 | 23.34 | ||||||||
升高10% | 50 | 150 | 30 | 0.316 | 0.5106 | 0.3958 | 0.7752 | 33.13 | 28.858 | |||
0.3918 | 0.6377 | 0.4369 | 0.6851 | 26.49 | ||||||||
0.3019 | 0.4654 | 0.3739 | 0.8034 | 35.49 | ||||||||
0.3851 | 0.6016 | 0.3954 | 0.6572 | 24.66 | ||||||||
0.3654 | 0.5234 | 0.3428 | 0.6549 | 24.52 | ||||||||
升高20% | 50 | 150 | 30 | 0.2492 | 0.4968 | 0.3521 | 0.7087 | 28.12 | 33.096 | |||
0.1325 | 0.4081 | 0.3378 | 0.8277 | 37.64 | ||||||||
0.4036 | 0.4981 | 0.3921 | 0.7872 | 34.12 | ||||||||
0.2374 | 0.4832 | 0.3663 | 0.7581 | 31.77 | ||||||||
0.3286 | 0.4739 | 0.3714 | 0.7837 | 33.83 | ||||||||
升高30% | 50 | 150 | 30 | 0.285 | 0.5246 | 0.3487 | 0.6647 | 25.14 | 25.976 | |||
0.3095 | 0.5654 | 0.3776 | 0.6678 | 25.35 | ||||||||
0.387 | 0.5638 | 0.3756 | 0.6662 | 25.24 | ||||||||
0.3331 | 0.5218 | 0.3613 | 0.6924 | 26.99 | ||||||||
0.4314 | 0.4937 | 0.3431 | 0.6950 | 27.16 | ||||||||
降低10% | 50 | 150 | 30 | 0.4032 | 0.58 | 0.4178 | 0.7203 | 28.95 | 30.118 | |||
0.4378 | 0.4639 | 0.3431 | 0.7396 | 30.37 | ||||||||
0.4119 | 0.534 | 0.406 | 0.7603 | 31.95 | ||||||||
0.3408 | 0.5217 | 0.3823 | 0.7328 | 29.86 | ||||||||
0.403 | 0.5726 | 0.4165 | 0.7274 | 29.46 | ||||||||
降低 | 50 | 150 | 30 | 0.2859 | 0.4134 | 0.5012 | 1.2124 | 28.8 | 27.944 |
20% | 0.3542 | 0.3538 | 0.5372 | 1.5184 | 28.03 | |||||||
0.1217 | 0.4228 | 0.5584 | 1.3207 | 26.65 | ||||||||
0.3955 | 0.3661 | 0.5727 | 1.5643 | 26.31 | ||||||||
0.1942 | 0.3896 | 0.4754 | 1.2202 | 29.93 | ||||||||
降低30% | 50 | 150 | 30 | 0.4156 | 0.531 | 0.3725 | 0.7015 | 27.62 | 28.176 | |||
0.4138 | 0.5416 | 0.3874 | 0.7153 | 28.58 | ||||||||
0.4028 | 0.5107 | 0.3742 | 0.7327 | 29.85 | ||||||||
0.3895 | 0.5227 | 0.3686 | 0.7052 | 27.87 | ||||||||
0.3955 | 0.5437 | 0.3763 | 0.6921 | 26.96 | ||||||||
降低40% | 50 | 150 | 30 | 0.3898 | 0.5024 | 0.3631 | 0.7227 | 29.12 | 28.732 | |||
0.4023 | 0.5343 | 0.412 | 0.7711 | 32.81 | ||||||||
0.369 | 0.5512 | 0.3706 | 0.6724 | 25.64 | ||||||||
0.3775 | 0.4997 | 0.3581 | 0.7166 | 28.68 | ||||||||
0.4182 | 0.5448 | 0.3806 | 0.6986 | 27.41 | ||||||||
血浆 | 50 | 150 | 30 | 0.4 | 0.4439 | 0.3034 | 0.6835 | 26.39 | 26.192 | |||
0.361 | 0.4208 | 0.2795 | 0.6642 | 25.12 | ||||||||
0.3539 | 0.4248 | 0.2846 | 0.6700 | 25.49 | ||||||||
0.4089 | 0.4244 | 0.3018 | 0.7111 | 28.29 | ||||||||
0.3799 | 0.448 | 0.3014 | 0.6728 | 25.67 | ||||||||
注:HC高浓度对照带光密度值 LC低浓度对照带光密度值 TD测试带光密度值“uIU/ml”指“微国际单位/毫升” SD指标准偏差 CV%指变化系数 |
红细胞容积 | 检测时间(分钟) | HCDr | LCDr | 测试Dr | RI=TESTDr/LCDr | S/CO | 均值1 | 均值2 | SD | CV |
正常=100% | 30 | 0.2341 | 0.1272 | 0.2059 | 1.6187 | 16.18 | 19.69 | 20.0019 | 1.8855 | 0.0943 |
正常=100% | 30 | 0.2066 | 0.0941 | 0.2123 | 2.2561 | 22.57 | ||||
正常=100% | 30 | 0.2824 | 0.0942 | 0.1914 | 2.0318 | 20.32 | ||||
升高10% | 30 | 0.3702 | 0.1324 | 0.2564 | 1.9366 | 19.36 | 19.61 | |||
升高10% | 30 | 0.225 | 0.1193 | 0.2241 | 1.8785 | 18.78 | ||||
升高10% | 30 | 0.0961 | 0.1044 | 0.216 | 2.0690 | 20.69 | ||||
升高20% | 30 | 0.0503 | 0.1144 | 0.1752 | 1.5315 | 15.32 | 17.9233 | |||
升高20% | 30 | 0.0753 | 0.136 | 0.2474 | 1.8191 | 18.19 | ||||
升高20% | 30 | 0.0747 | 0.1107 | 0.2243 | 2.0262 | 20.26 | ||||
升高30% | 30 | 0.1036 | 0.1056 | 0.2463 | 2.3324 | 23.32 | 17.3633 | |||
升高30% | 30 | 0.2257 | 0.1545 | 0.2548 | 1.6492 | 16.49 | ||||
升高30% | 30 | 0.2486 | 0.1975 | 0.2425 | 1.2278 | 12.28 | ||||
降低10% | 30 | 0.2859 | 0.0954 | 0.2555 | 2.6782 | 26.78 | 22.8267 | |||
降低10% | 30 | 0.1217 | 0.12 | 0.3136 | 2.6133 | 26.13 | ||||
降低10% | 30 | 0.3955 | 0.1297 | 0.202 | 1.5574 | 15.57 | ||||
降低20% | 30 | 0.3806 | 0.1136 | 0.254 | 2.2359 | 22.36 | 18.7033 | |||
降低20% | 30 | 0.2666 | 0.1149 | 0.1925 | 1.6754 | 16.75 | ||||
降低20% | 30 | 0.3167 | 0.1075 | 0.1828 | 1.7005 | 17 | ||||
降低30% | 30 | 0.3931 | 0.1031 | 0.2531 | 2.4549 | 24.55 | 20.2467 | |||
降低30% | 30 | 0.4278 | 0.1615 | 0.2365 | 1.4644 | 14.64 | ||||
降低30% | 30 | 0.1701 | 0.1014 | 0.2185 | 2.1548 | 21.55 | ||||
降低40% | 30 | 0.2957 | 0.0805 | 0.2067 | 2.5677 | 25.67 | 21.3167 | |||
降低40% | 30 | 0.3816 | 0.1069 | 0.188 | 1.7587 | 17.59 | ||||
降低40% | 30 | 0.3317 | 0.0905 | 0.1873 | 2.0696 | 20.69 | ||||
血浆 | 15 | 0.3661 | 0.0844 | 0.1688 | 2.0000 | 20 | 22.3367 | |||
血浆 | 15 | 0.2843 | 0.0741 | 0.1689 | 2.2794 | 22.79 | ||||
血浆 | 15 | 0.3869 | 0.0898 | 0.2175 | 2.4220 | 24.22 | ||||
注:HC指高浓度对照带光密度值 LC指低浓度对照带光密度值 TD指测试带光密度值S/CO指信噪比 (S指信号,CO指截止值) AVE指平均值SD指标准偏差 CV%指变化系数 |
涂敷方法 | 样本 | 体积(微升) | 背景 | HC Dr | LC Dr | TestDr | RI=TESTDR/LCDR | S/CO | AVS/CO |
清洗 | HIV阳性血 | 50 | 干净 | 0.1564 | 0.1785 | 0.1736 | 0.9725 | 9.7255 | 平均值9.614标准偏差0.457CV 4.76% |
清洗 | 50 | 干净 | 0.1458 | 0.1793 | 0.1806 | 1.0073 | 10.0725 | ||
清洗 | 50 | 干净 | 0.1135 | 0.2106 | 0.2094 | 0.9943 | 9.943 | ||
清洗 | 50 | 干净 | 0.1356 | 0.1883 | 0.1683 | 0.8938 | 8.9379 | ||
清洗 | 50 | 干净 | 0.1079 | 0.1872 | 0.1758 | 0.9391 | 9.391 | ||
喷射 | 50 | 干净 | 0.1456 | 0.2281 | 0.2107 | 0.9237 | 9.2372 | 平均值9.456标准偏差0.731CV 7.7% | |
喷射 | 50 | 干净 | 0.1175 | 0.1758 | 0.1658 | 0.9431 | 9.4312 | ||
喷射 | 50 | 干净 | 0.1334 | 0.1606 | 0.1708 | 1.0635 | 10.6351 | ||
喷射 | 50 | 干净 | 0.1238 | 0.2301 | 0.2152 | 0.9352 | 9.3525 | ||
喷射 | 50 | 干净 | 0.1034 | 0.1898 | 0.1637 | 0.8625 | 0.8625 |
Jet | 高对照带DR | 低对照带DR | HbsAg DR | RI=HbsAgDR/高对照带DR | ng/ml | Resin | 高对照带DR | 低对照带DR | HbsAg DR | RI=HbsAgDR/高对照带DR | ng/ml |
1 | 0.2153 | 0.1433 | 0.0153 | 0.0711 | 3.9 | 1 | 0.23 | 0.25 | 0.011 | 0.0478 | 2.6 |
2 | 0.1879 | 0.1163 | 0.0144 | 0.0766 | 4.3 | 2 | 0.31 | 0.33 | 0.019 | 0.0613 | 3.4 |
3 | 0.1759 | 0.1245 | 0.0167 | 0.0949 | 5.5 | 3 | 0.34 | 0.34 | 0.017 | 0.0500 | 2.5 |
4 | 0.1419 | 0.0845 | 0.0135 | 0.0951 | 5.5 | 4 | 0.26 | 0.29 | 0.013 | 0.0500 | 2.6 |
5 | 0.1985 | 0.1242 | 0.0176 | 0.0887 | 5.1 | 5 | 0.36 | 0.35 | 0.02 | 0.0556 | 3 |
6 | 0.202 | 0.1267 | 0.014 | 0.0693 | 3.8 | 6 | 0.35 | 0.34 | 0.017 | 0.0486 | 2.6 |
7 | 0.1898 | 0.1291 | 0.0152 | 0.0801 | 4.5 | 7 | 0.34 | 0.33 | 0.019 | 0.0559 | 3 |
8 | 0.1764 | 0.1456 | 0.0143 | 0.0811 | 4.6 | 8 | 0.43 | 0.36 | 0.021 | 0.0488 | 2.5 |
9 | 0.2306 | 0.1917 | 0.0206 | 0.0893 | 5.1 | 9 | 0.36 | 0.36 | 0.18 | 0.0500 | 2.6 |
10 | 0.192 | 0.1168 | 0.0139 | 0.0724 | 4 | 10 | 0.35 | 0.34 | 0.019 | 0.0543 | 2.9 |
11 | 0.1895 | 0.1219 | 0.017 | 0.0897 | 5.2 | 11 | 0.27 | 0.28 | 0.016 | 00593 | 3.1 |
12 | 0.2355 | 0.1692 | 0.021 | 0.0892 | 5.1 | 12 | 0.39 | 0.36 | 0.02 | 0.0513 | 2.7 |
13 | 0.2369 | 0.1589 | 0.0156 | 0.0659 | 3.6 | 13 | 0.38 | 0.35 | 0.019 | 0.0500 | 2.7 |
14 | 0.2041 | 0.1543 | 0.015 | 0.0735 | 4.1 | 14 | 0.32 | 0.29 | 0.013 | 0.0406 | 2.1 |
15 | 0.2294 | 0.1633 | 0.0175 | 0.0763 | 4.3 | 15 | 0.37 | 0.33 | 0.019 | 0.0514 | 2.7 |
16 | 0.1611 | 0.0947 | 0.0146 | 0.0906 | 5.2 | 16 | 0.32 | 0.28 | 0.014 | 0.0438 | 2.3 |
17 | 0.2204 | 0.1518 | 0.0218 | 0.0989 | 5.8 | 17 | 0.2 | 0.22 | 0.013 | 0.0650 | 3.6 |
18 | 0.1785 | 0.1272 | 0.0151 | 0.0846 | 4.8 | 18 | 0.33 | 0.27 | 0.017 | 0.0515 | 2.7 |
19 | 0.2607 | 0.1911 | 0.0231 | 0.0886 | 5.1 | 19 | 0.32 | 0.26 | 0.019 | 0.0594 | 3.1 |
20 | 0.1884 | 0.1161 | 0.0162 | 0.0860 | 4.9 | 20 | 0.28 | 0.3 | 0.015 | 0.0536 | 2.9 |
AV | 0.2007 | 0.1376 | 0.0166 | 0.0831 | 4.72 | AV | 0.3255 | 0.3115 | 0.0170 | 0.0524 | 2.780 |
SD | 0.0289 | 0.0285 | 0.0028 | 0.0095 | 0.63 | SD | 0.0556 | 0.0417 | 0.0029 | 0.0058 | 0.3548 |
CV | 11.5% | 13.0% | CV | 11.2% | 12.8% |
样本 | 加样量(微升) | 迁移速度(毫米/分钟) | 残留的红细胞 | NC上的背景 | 高浓度对照带(Dr) | 低浓度对照带(Dr) | 测试带(Dr) | RI=测试Dr/低浓度Dr | S/CO | 均值 | CV | 检测时间(分钟) |
HIV(+)血样 | 30 | .16 | 无 | 干净 | 0.4752 | 0.226 | 0 | 0 | 0 | 0 | --- | 20 |
30 | .16 | 无 | 干净 | 0.4154 | 0.2432 | 0 | 0 | 0 | ||||
30 | .16 | 无 | 干净 | 0.4163 | 0.2317 | 0 | 0 | 0 | ||||
40 | .16 | 无 | 干净 | 0.2936 | 0.1979 | 0.2043 | 1.0323 | 10.3223 | 9.0592 | 12.9% | 20 | |
40 | .16 | 无 | 干净 | 0.2697 | 0.1958 | 0.1731 | 0.8841 | 8.8396 | ||||
40 | .16 | 无 | 干净 | 0.2994 | 0.1986 | 0.1592 | 0.8016 | 8.0156 | ||||
40 | .16 | 无 | 干净 | 0.371 | 0.225 | 0.2507 | 1.1142 | 9.1408 | 9.5644 | 8.86% | 30 | |
40 | .16 | 无 | 干净 | 0.1701 | 0.1983 | 0.209 | 1.054 | 10.5396 | ||||
40 | .16 | 无 | 干净 | 0.3206 | 0.1955 | 0.1762 | 0.9013 | 9.0128 | ||||
50 | ≤16 | (+/-) | 干净 | 0.2037 | 0.1697 | 0.2164 | 1.2752 | 12.7513 | 12.0134 | 65% | 30 | |
50 | ≤16 | (+/-) | 干净 | 0.2572 | 0.1876 | 0.2271 | 1.2106 | 12.1034 | ||||
50 | ≤16 | (+/-) | 干净 | 0.0603 | 0.1729 | 0.1934 | 1.1186 | 11.1856 | ||||
60 | .16 | (+) | 干净 | 0.3271 | 0.2474 | 0.2005 | 0.8104 | 8.105 | 9.8273 | 20.42% | 50 | |
60 | .16 | (+) | 干净 | 0.3456 | 0.1984 | 0.2387 | 1.2031 | 12.0302 | ||||
60 | .16 | (+) | 干净 | 0.1926 | 0.246 | 0.2299 | 0.9346 | 9.3467 | ||||
70 | .16 | (+) | 干净 | 0.1296 | 0.1983 | 0.1913 | 0.647 | 9.649 | 9.6556 | 8.4% | 30 | |
70 | .16 | (+) | 干净 | 0.1387 | 0.245 | 0.2168 | 0.8849 | 8.8477 | ||||
70 | .16 | (+) | 干净 | 0.1119 | 0.2401 | 0.2514 | 1.0471 | 10.4702 |
全血(微升) | 红细胞漏出 | 血浆迁移速率(毫米/分钟) | 检测结果 | |||||||||
20分钟 | 30分钟 | 40分钟 | ||||||||||
残留的红细胞 | HBsAg(纳克/毫升) | CV% | 残留的红细胞 | HBsAg(纳克/毫升) | CV% | 残留的红细胞 | HBsAg(纳克/毫升) | CV% | ||||
150 | 无 | >16 | (+/-) | 3.2 | 42% | (-) | 3.94 | 42% | (-) | 4.1 | 46% | |
200 | 无 | >16 | (+) | 3.267 | 9% | (+/-) | 3.467 | 3% | (-) | 3.267 | 19% | |
250 | 无 | >16 | (++) | 2.633 | 6% | (+) | 2.7 | 6% | (+/-) | 2.7 | 4% | |
300 | 无 | >16 | (+++) | 2.767 | 6% | (++) | 2.833 | 9% | (++) | 3.133 | 10% | |
350 | -------- | -------- | --------- | -------- | -------- | |||||||
血浆150(微升) | 30分钟 | CV% | ||||||||||
3.36 | 5% | |||||||||||
注:CV指变化系数 |
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