Performance verification of Addcare Elisa800 automatic enzyme immunoassay workstation and its clinical application

doi:10.3969/j.issn.1673-8640.2016.09.014

Abstract

Abstract:

Objective To verify the performance of Addcare Elisa800 automatic enzyme immunoassay workstation,and to evaluate its clinical application. Methods Electronic balance was used to determine the sample capacity and residue capacity of washing machine,thermometer was used to determine temperature of each incubation model,standard filter was used to determine the performance of enzyme-mark analyzer,carry-over rate was calculated,and whether the performance met technical requirements or not was evaluated,which was compared with that of Tecan Freedom Evolyzer automatic enzyme immunoassay system. The significance of Addcare Elisa800 automatic enzyme immunoassay workstation was verified. Results Sample capacities,residue capacities of washing machines,the temperatures of incubation models,the performance of enzyme-mark analyzers and carry-over rates were all in line with technical requirements. Compared with Tecan Freedom Evolyzer automatic enzyme immunoassay system,the coincidence rate was 100%,without statistical significance（P>0.05）. Conclusions Addcare Elisa800 automatic enzyme immunoassay workstation can provide high quality of determination results,and it can provide scientific reference for clinical diagnosis and treatment.

Key words: Addcare Elisa800 automatic enzyme immunoassay workstation, Performance verification, Clinical application

CLC Number:

R446.61

FU Jie, SU Peng, JIANG Xingyu, PU Xiaoyun. Performance verification of Addcare Elisa800 automatic enzyme immunoassay workstation and its clinical application[J]. Laboratory Medicine, 2016, 31(9): 797-800.

Figures/Tables 4

References 13

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通道	100 μL		50 μL		10 μL
通道	测定值（μL）	CV（%）	测定值（μL）	CV（%）	测定值（μL）	CV（%）
1	100.53	0.44	50.07	0.95	10.32	2.99
2	100.39	0.40	49.95	0.81	10.29	3.12
3	99.74	0.40	49.94	0.54	9.94	2.72
4	99.78	0.68	49.92	0.84	9.93	4.91
5	99.96	0.31	50.12	0.61	10.00	2.74
6	99.83	0.67	49.81	0.63	10.22	2.56
7	100.18	0.34	50.39	0.84	10.18	3.30
8	99.84	0.57	50.41	0.66	10.02	3.87

通道	100 μL		50 μL		10 μL
通道	测定值（μL）	CV（%）	测定值（μL）	CV（%）	测定值（μL）	CV（%）
1	100.53	0.44	50.07	0.95	10.32	2.99
2	100.39	0.40	49.95	0.81	10.29	3.12
3	99.74	0.40	49.94	0.54	9.94	2.72
4	99.78	0.68	49.92	0.84	9.93	4.91
5	99.96	0.31	50.12	0.61	10.00	2.74
6	99.83	0.67	49.81	0.63	10.22	2.56
7	100.18	0.34	50.39	0.84	10.18	3.30
8	99.84	0.57	50.41	0.66	10.02	3.87

单元模块	目标温度（℃）	检测温度（℃）	误差（℃）
1	37.0	37.0	0.0
2	37.0	36.8	0.2
3	37.0	37.1	0.1
4	37.0	37.1	0.1
5	37.0	36.9	0.1
6	37.0	37.0	0.0
7	37.0	36.8	0.2
8	37.0	36.9	0.1
9	37.0	37.1	0.1
10	37.0	37.0	0.0
11	37.0	37.0	0.0
12	37.0	37.0	0.0
13	37.0	36.8	0.2
14	37.0	37.0	0.0
15	37.0	36.7	0.3
16	37.0	36.7	0.3

单元模块	目标温度（℃）	检测温度（℃）	误差（℃）
1	37.0	37.0	0.0
2	37.0	36.8	0.2
3	37.0	37.1	0.1
4	37.0	37.1	0.1
5	37.0	36.9	0.1
6	37.0	37.0	0.0
7	37.0	36.8	0.2
8	37.0	36.9	0.1
9	37.0	37.1	0.1
10	37.0	37.0	0.0
11	37.0	37.0	0.0
12	37.0	37.0	0.0
13	37.0	36.8	0.2
14	37.0	37.0	0.0
15	37.0	36.7	0.3
16	37.0	36.7	0.3

酶标仪波长（nm）	稳定度	吸光度准确度	吸光度重复性（%）
450	0.004	0.001 8	0.28
630	0.004	-0.001 5	0.29