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。
柏雷丁生物采用“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。
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各基质瓶间差对比 |
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人工血清 |
人工血清 |
胎牛血清 |
正常人血清 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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% |
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人工血清基质瓶内差异对比 |
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高浓度A |
高浓度B |
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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% |
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中浓度A |
中浓度B |
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|
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% |
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低浓度A |
低浓度B |
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|
瓶1 |
瓶2 |
瓶3 |
瓶4 |
瓶5 |
瓶1 |
瓶2 |
瓶3 |
瓶4 |
瓶5 |
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|
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 |
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M-3SD |
0.160 |
0.172 |
0.319 |
0.233 |
0.219 |
0.179 |
0.125 |
0.136 |
0.192 |
0.178 |
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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
深圳市柏雷丁生物有限公司
Shenzhen Braveds Biotech co.,Ltd.
微信：13424241976
邮箱：sale@braveds.com
网址：www.braveds.com
