胶乳比浊试剂，国内自产的很多，但是一个涉及到接近20多个项目的方法学，很大部分采用的所谓的二步法（活化、清洗、偶联、清洗）以及一步法（活化、偶联、超声、（离心）），反复的更换溶液以及采用暴力物理的方法去分散溶液，会导致每次偶联的差异很大。而且涉及到各种设备的使用，如何才能做到大批量的生产。像生研这样的日本企业，人工成本已经很高吧，而且每年的比浊试剂应该生产不少吧。像我们这种自产乳胶试剂工艺，那公司需要多少人，需要多少设备，需要多少场地来做呢。
我们国产的大部分乳胶比浊试剂，尤其像全量程CRP这种试剂，自产的企业都宣称自己的试剂可以从0.5-320mg/L,一般5mg/L的反应吸光度在0.01-0.02左右，很少能做到0.05的，那1mg/L的重复性就没有保证。生研的全量程CRP（1:1），0.8mg/L重复性可以做到7%左右。那自己所谓标识的0.5mg/L就成了一个所谓的理论值。
我们国产的大部分乳胶试剂，R2就像纯牛奶一样的，乳胶的含量很高。生研的肌红蛋白，CRP外观看起来其实很淡，很淡。而且线性宽、灵敏度高。像有些自产试剂的厂家，像CYSC、MYO检测限度差不多差1000倍，但是偶联的抗体却又差不多呢。抗体的亲和力也不至于差这么多吧。生研的大包装为什么开始的价格很高，到现在这么低还是能做。也许别人的本身的工艺就已经做到了很低的成本了吧。
比浊试剂，尤其是附加值比较高的项目，感觉一直在被国外的牵着鼻子走，最开始的时候，跟你说灵敏度，说某某进口的抗体是国产的多少倍，等你国产抗体出来了，然后说干扰；等国产的阻断剂上来了，然后又开始说批间差等等。
做了差不多10年的乳胶试剂，发点小感慨。感觉自己差不多入门了。
附：肌红蛋白比对数据
肌红比对数据
| 序号 |
A |
B |
C |
生研 |
A-生研偏差 |
B-生研偏差 |
C-生研偏差 |
| 1 |
36.29 |
76.34 |
40.38 |
37.89 |
-4.20% |
101.48% |
6.57% |
| 2 |
41.01 |
62.31 |
47.35 |
40.64 |
0.90% |
53.32% |
16.51% |
| 3 |
45.7 |
55.46 |
50.15 |
47.61 |
-4.00% |
16.49% |
5.34% |
| 4 |
41.79 |
62.79 |
46.39 |
41.14 |
1.60% |
52.63% |
12.76% |
| 5 |
40.23 |
289.14 |
42.05 |
43.14 |
-6.70% |
570.24% |
-2.53% |
| 6 |
52.64 |
62.75 |
56.38 |
53.33 |
-1.30% |
17.66% |
5.72% |
| 7 |
27.54 |
29.68 |
25.37 |
29.14 |
-5.50% |
1.85% |
-12.94% |
| 8 |
45.7 |
396.25 |
90.35 |
48.36 |
-5.50% |
719.38% |
86.83% |
| 9 |
45.7 |
703.67 |
50.11 |
46.62 |
-2.00% |
1409.37% |
7.49% |
| 10 |
33.13 |
54.27 |
24.39 |
33.14 |
0.00% |
63.76% |
-26.40% |
| 11 |
37.87 |
32.14 |
34.56 |
40.99 |
-7.60% |
-21.59% |
-15.69% |
| 12 |
46.48 |
469.37 |
47.21 |
48.36 |
-3.90% |
870.57% |
-2.38% |
| 13 |
38.66 |
992.42 |
30.57 |
41.38 |
-6.60% |
2298.31% |
-26.12% |
| 14 |
51.1 |
52.34 |
60.38 |
53.33 |
-4.20% |
-1.86% |
13.22% |
| 15 |
45.7 |
603.89 |
666.23 |
45.12 |
1.30% |
1238.41% |
1376.57% |
| 16 |
30.73 |
56.14 |
32.45 |
33.64 |
-8.60% |
66.88% |
-3.54% |
| 17 |
34.71 |
25.37 |
38.45 |
36.64 |
-5.30% |
-30.76% |
4.94% |
| 18 |
42.59 |
45.69 |
50.67 |
42.88 |
-0.70% |
6.55% |
18.17% |
| 19 |
36.29 |
21.43 |
42.34 |
36.89 |
-1.60% |
-41.91% |
14.77% |
| 20 |
39.44 |
38.45 |
42.38 |
43.13 |
-8.60% |
-10.85% |
-1.74% |
| 21 |
54.93 |
42.34 |
45.17 |
55.56 |
-1.10% |
-23.79% |
-18.70% |
| 22 |
66.93 |
55.27 |
58.34 |
65.44 |
2.30% |
-15.54% |
-10.85% |
| 23 |
35.5 |
36.59 |
706.21 |
39.89 |
-11.00% |
-8.27% |
1670.39% |
| 24 |
54.16 |
52.17 |
51.34 |
56.3 |
-3.80% |
-7.34% |
-8.81% |
| 25 |
34.71 |
20.68 |
23.68 |
37.14 |
-6.50% |
-44.32% |
-36.24% |
| 26 |
93.13 |
106.24 |
75.39 |
90.36 |
3.10% |
17.57% |
-16.57% |
| 27 |
21.91 |
29.34 |
10.64 |
22.62 |
-3.10% |
29.71% |
-52.96% |
| 28 |
77.82 |
68.11 |
69.31 |
76.25 |
2.10% |
-10.68% |
-9.10% |
| 29 |
28.34 |
18.46 |
31.67 |
28.13 |
0.80% |
-34.38% |
12.58% |
| 30 |
43.37 |
55.29 |
50.48 |
46.37 |
-6.50% |
19.24% |
8.86% |
| 31 |
63.96 |
55.24 |
58.19 |
64.46 |
-0.80% |
-14.30% |
-9.73% |
| 32 |
14.64 |
13.41 |
29.34 |
24.37 |
-39.90% |
-44.97% |
20.39% |
| 33 |
38.66 |
45.64 |
26.34 |
39.64 |
-2.50% |
15.14% |
-33.55% |
| 34 |
30.73 |
36.88 |
36.58 |
32.89 |
-6.60% |
12.13% |
11.22% |
| 35 |
28.34 |
42.35 |
28.39 |
31.89 |
-11.10% |
32.80% |
-10.98% |
| 36 |
41.01 |
50.27 |
35.47 |
42.13 |
-2.70% |
19.32% |
-15.81% |
| 37 |
77.82 |
48.68 |
83.74 |
76.25 |
2.10% |
-36.16% |
9.82% |
| 38 |
58.39 |
45.24 |
45.26 |
52.76 |
3.40% |
-14.25% |
-14.22% |
| 39 |
29.83 |
39.58 |
22.48 |
25.74 |
8.30% |
53.77% |
-12.67% |
| 40 |
56.53 |
35.61 |
61.27 |
59.99 |
-11.90% |
-40.64% |
2.13% |
| 41 |
112.35 |
108.49 |
103.54 |
109.08 |
-3.70% |
-0.54% |
-5.08% |
| 42 |
205.59 |
211.36 |
223.67 |
212.64 |
-9.60% |
-0.60% |
5.19% |
| 43 |
412.7 |
434.27 |
413.58 |
407.77 |
-5.40% |
6.50% |
1.42% |
| 44 |
827.57 |
903.25 |
806.34 |
754.49 |
2.50% |
19.72% |
6.87% |
注：红色字体样本为RF>100iu/ml,41-44为梯度血清