理想的质控品应具备的特性:
1.质控品基质分布均匀。
2.稳定并有足够的效期、易于保存。
3.添加剂和调制物的数量少。
4.无传染性。
5.瓶间变异小。
6开瓶或复溶后应有足够的稳定期。
要实现以上特性,离不开好的质控品基质。嘉中蓝海AccuSift采用“类器官技术”模式人体外环境生产的人工血清基质,
具有基质效应低,稳定性好,批间差小,无个体差异等优点,既可做液态质控又可做冻干质控。并在市场上得到了好评。
我们整理了部分数据,给有需要的老师一些参考。
以下为不同浓度的瓶间与瓶内质控数据对比,分别测试冻干质控品复溶后第1天、第15天、第30天、第45天荧光POCT平台测试的数据。
注:人源血清批次差异大,有些人源血清冻干复溶后变化很大,不适合做冻干质控,需筛选合适的血清批次,比较费时费力。
各基质瓶间差对比 | |||||||||||||
人工血清基质 | 人工血清基质 | 胎牛血清 | 正常人血清 | ||||||||||
高浓度 | 中浓度 | 低浓度 | 高浓度 | 中浓度 | 低浓度 | 高浓度 | 中浓度 | 低浓度 | 高浓度 | 中浓度 | 低浓度 | ||
第1天 | 瓶1 | 8.856 | 2.857 | 0.374 | 9.695 | 1.778 | 0.267 | 11.030 | 2.722 | 0.313 | 10.803 | 2.599 | 0.346 |
瓶2 | 9.778 | 3.029 | 0.363 | 7.950 | 1.881 | 0.293 | 14.586 | 2.832 | 0.278 | 12.710 | 2.666 | 0.382 | |
瓶3 | 9.962 | 2.676 | 0.375 | 10.502 | 2.338 | 0.290 | 15.169 | 2.333 | 0.276 | 10.167 | 2.911 | 0.311 | |
瓶4 | 10.770 | 2.609 | 0.407 | 7.055 | 1.731 | 0.264 | 13.702 | 2.215 | 0.265 | 14.672 | 3.335 | 0.221 | |
瓶5 | 11.538 | 2.269 | 0.314 | 10.348 | 2.140 | 0.259 | 11.766 | 2.710 | 0.346 | 12.933 | 2.746 | 0.317 | |
第15天 | 瓶1 | 11.242 | 2.723 | 0.350 | 10.866 | 1.954 | 0.218 | 13.374 | 2.992 | 0.256 | 14.604 | 2.386 | 0.287 |
瓶2 | 11.770 | 2.572 | 0.311 | 8.997 | 1.998 | 0.222 | 11.495 | 2.692 | 0.261 | 12.818 | 2.885 | 0.386 | |
瓶3 | 10.140 | 2.149 | 0.347 | 8.396 | 2.212 | 0.233 | 14.972 | 2.466 | 0.268 | 9.514 | 2.145 | 0.275 | |
瓶4 | 9.542 | 2.227 | 0.329 | 6.999 | 2.030 | 0.239 | 11.599 | 2.815 | 0.289 | 11.195 | 2.257 | 0.336 | |
瓶5 | 11.431 | 2.718 | 0.338 | 8.704 | 2.337 | 0.219 | 12.244 | 2.588 | 0.288 | 10.722 | 2.091 | 0.306 | |
第30天 | 瓶1 | 10.474 | 2.363 | 0.315 | 9.114 | 1.690 | 0.251 | 11.548 | 1.966 | 0.244 | 9.024 | 2.278 | 0.279 |
瓶2 | 11.828 | 2.828 | 0.315 | 7.003 | 1.939 | 0.232 | 10.730 | 2.485 | 0.234 | 11.599 | 2.420 | 0.247 | |
瓶3 | 9.853 | 2.129 | 0.365 | 8.979 | 2.042 | 0.236 | 10.267 | 2.151 | 0.244 | 8.568 | 2.239 | 0.328 | |
瓶4 | 9.978 | 2.239 | 0.344 | 7.814 | 1.797 | 0.274 | 6.452 | 1.864 | 0.212 | 13.081 | 1.738 | 0.182 | |
瓶5 | 12.878 | 2.152 | 0.346 | 8.487 | 2.004 | 0.222 | 8.181 | 2.033 | 0.225 | 9.307 | 2.344 | 0.182 | |
第45天 | 瓶1 | 12.050 | 2.838 | 0.250 | 7.334 | 1.876 | 0.272 | 12.482 | 1.784 | 0.223 | 9.979 | 3.109 | 0.341 |
瓶2 | 11.662 | 2.823 | 0.251 | 5.760 | 2.519 | 0.320 | 8.329 | 1.777 | 0.194 | 12.355 | 2.834 | 0.217 | |
瓶3 | 9.697 | 2.907 | 0.350 | 9.747 | 1.846 | 0.207 | 8.207 | 1.936 | 0.192 | 9.680 | 2.200 | 0.328 | |
瓶4 | 11.334 | 2.773 | 0.321 | 10.264 | 1.982 | 0.231 | 8.081 | 1.790 | 0.187 | 12.056 | 2.394 | 0.299 | |
瓶5 | 10.200 | 2.191 | 0.273 | 6.664 | 1.752 | 0.250 | 10.325 | 2.188 | 0.258 | 9.695 | 3.435 | 0.291 | |
均值M | 10.749 | 2.554 | 0.332 | 8.534 | 1.992 | 0.250 | 11.227 | 2.317 | 0.253 | 11.274 | 2.551 | 0.293 | |
标准差SD | 1.046 | 0.304 | 0.040 | 1.444 | 0.223 | 0.030 | 2.474 | 0.398 | 0.041 | 1.818 | 0.436 | 0.059 | |
3SD | 3.138 | 0.911 | 0.121 | 4.331 | 0.668 | 0.089 | 7.423 | 1.195 | 0.123 | 5.454 | 1.308 | 0.176 | |
M-3SD | 7.611 | 1.642 | 0.211 | 4.203 | 1.324 | 0.161 | 3.804 | 1.122 | 0.130 | 5.820 | 1.242 | 0.117 | |
M+3SD | 13.888 | 3.465 | 0.453 | 12.865 | 2.661 | 0.339 | 18.650 | 3.512 | 0.375 | 16.728 | 3.859 | 0.469 | |
CV | 9.73% | 11.90% | 12.13% | 16.92% | 11.18% | 11.85% | 22.04% | 17.19% | 16.20% | 16.13% | 17.10% | 20.01% | |
人工血清基质瓶内差异对比 | ||||||||||
高浓度A | 高浓度B | |||||||||
瓶1 | 瓶2 | 瓶3 | 瓶4 | 瓶5 | 瓶1 | 瓶2 | 瓶3 | 瓶4 | 瓶5 | |
第1天 | 8.856 | 9.778 | 9.962 | 10.770 | 11.538 | 9.695 | 7.950 | 10.502 | 7.055 | 10.248 |
第15天 | 11.242 | 11.770 | 10.140 | 9.542 | 11.431 | 11.066 | 8.857 | 8.396 | 6.999 | 8.704 |
第30天 | 10.474 | 11.828 | 9.853 | 9.978 | 12.878 | 9.114 | 7.003 | 8.979 | 7.814 | 8.487 |
第45天 | 12.050 | 11.662 | 9.697 | 11.334 | 10.200 | 7.334 | 5.760 | 9.747 | 10.164 | 6.664 |
均值M | 10.656 | 11.259 | 9.913 | 10.406 | 11.512 | 9.302 | 7.392 | 9.406 | 8.008 | 8.526 |
标准差SD | 1.361 | 0.990 | 0.186 | 0.801 | 1.094 | 1.547 | 1.325 | 0.917 | 1.484 | 1.468 |
3SD | 4.084 | 2.970 | 0.559 | 2.402 | 3.283 | 4.640 | 3.976 | 2.750 | 4.453 | 4.404 |
M-3SD | 6.572 | 8.289 | 9.354 | 8.004 | 8.229 | 4.663 | 3.416 | 6.656 | 3.555 | 4.122 |
M+3SD | 14.739 | 14.230 | 10.472 | 12.808 | 14.795 | 13.942 | 11.369 | 12.156 | 12.461 | 12.929 |
CV | 12.77% | 8.79% | 1.88% | 7.69% | 9.51% | 16.63% | 17.93% | 9.74% | 18.53% | 17.22% |
中浓度A | 中浓度B | |||||||||
瓶1 | 瓶2 | 瓶3 | 瓶4 | 瓶5 | 瓶1 | 瓶2 | 瓶3 | 瓶4 | 瓶5 | |
第1天 | 2.857 | 3.029 | 2.676 | 2.609 | 2.269 | 1.778 | 1.881 | 2.338 | 1.731 | 2.140 |
第15天 | 2.723 | 2.572 | 2.149 | 2.227 | 2.718 | 1.954 | 1.998 | 2.212 | 2.030 | 2.337 |
第30天 | 2.363 | 2.828 | 2.129 | 2.239 | 2.152 | 1.690 | 1.939 | 2.042 | 1.797 | 2.004 |
第45天 | 2.838 | 2.823 | 2.907 | 2.773 | 2.191 | 1.876 | 2.419 | 1.846 | 1.982 | 1.752 |
均值M | 2.695 | 2.813 | 2.465 | 2.462 | 2.333 | 1.825 | 2.059 | 2.110 | 1.885 | 2.058 |
标准差SD | 0.229 | 0.187 | 0.388 | 0.273 | 0.261 | 0.115 | 0.245 | 0.213 | 0.144 | 0.246 |
3SD | 0.688 | 0.561 | 1.165 | 0.818 | 0.784 | 0.345 | 0.734 | 0.640 | 0.431 | 0.737 |
M-3SD | 2.008 | 2.252 | 1.301 | 1.644 | 1.549 | 1.479 | 1.325 | 1.469 | 1.454 | 1.322 |
M+3SD | 3.383 | 3.374 | 3.630 | 3.280 | 3.117 | 2.170 | 2.793 | 2.750 | 2.316 | 2.795 |
CV | 8.51% | 6.64% | 15.75% | 11.08% | 11.20% | 6.31% | 11.88% | 10.12% | 7.62% | 11.93% |
低浓度A | 低浓度B | |||||||||
瓶1 | 瓶2 | 瓶3 | 瓶4 | 瓶5 | 瓶1 | 瓶2 | 瓶3 | 瓶4 | 瓶5 | |
第1天 | 0.374 | 0.363 | 0.375 | 0.407 | 0.314 | 0.267 | 0.293 | 0.290 | 0.264 | 0.259 |
第15天 | 0.350 | 0.311 | 0.347 | 0.329 | 0.338 | 0.218 | 0.222 | 0.233 | 0.239 | 0.219 |
第30天 | 0.315 | 0.315 | 0.365 | 0.344 | 0.346 | 0.251 | 0.232 | 0.236 | 0.274 | 0.222 |
第45天 | 0.250 | 0.251 | 0.350 | 0.321 | 0.273 | 0.272 | 0.320 | 0.207 | 0.231 | 0.250 |
均值M | 0.322 | 0.310 | 0.359 | 0.350 | 0.317 | 0.252 | 0.267 | 0.241 | 0.252 | 0.237 |
标准差SD | 0.054 | 0.046 | 0.013 | 0.039 | 0.033 | 0.024 | 0.047 | 0.035 | 0.020 | 0.020 |
3SD | 0.162 | 0.139 | 0.040 | 0.117 | 0.099 | 0.073 | 0.142 | 0.105 | 0.060 | 0.060 |
M-3SD | 0.160 | 0.172 | 0.319 | 0.233 | 0.219 | 0.179 | 0.125 | 0.136 | 0.192 | 0.178 |
M+3SD | 0.484 | 0.449 | 0.399 | 0.467 | 0.416 | 0.325 | 0.408 | 0.346 | 0.312 | 0.297 |
CV | 16.75% | 14.89% | 3.71% | 11.14% | 10.38% | 9.66% | 17.71% | 14.53% | 7.99% | 8.39% |
产品链接:
人工血清基质Artificial serum