doi:10.3969/j.issn.1673-8640.2026.09.016

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References 7

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[5]	Liu J, Cui D, Jiang Y, et al. Selection and characterization of a novel affibody peptide and its application in a two-site ELISA for the detection of cancer biomarker alpha-fetoprotein[J]. Int J Biol Macromol, 2021, 166:884-892. DOI PMID
[6]	Zhu X, Yuyingguo, Huang Z, et al. Rheumatoid factor interference of α-fetoprotein evaluations in human serum by ELISA[J]. Clin Lab, 2014, 60(11):1795-1800. PMID
[7]	Gramer M J, Maas J, Lieberman M M. Use of hollow fiber systems for rapid and direct scale up of antibody production from hybridoma cell lines cultured in CL-1000 flasks using BD cell MAb medium[J]. Cytotechnology, 2003, 42(3):155-162. DOI PMID

抗原批号	稀释比例	浓度回算值/ （ng·mL^-1）	浓度均值/ （ng·mL^-1）
批次1	1∶500 0	3 566 330	3 179 550
	1∶1 000 0	2 945 520
	1∶2 000 0	3 026 800
批次2	1∶5000	1 995 405	2 004 618
	1∶1000 0	1 808 110
	1∶2 000 0	2 210 340
批次3	1∶5000	1 780 900	2 014 740
	1∶1 000 0	2 010 220
	1∶2 000 0	2 240 100

抗原批号	稀释比例	浓度回算值/ （ng·mL^-1）	浓度均值/ （ng·mL^-1）
批次1	1∶500 0	3 566 330	3 179 550
	1∶1 000 0	2 945 520
	1∶2 000 0	3 026 800
批次2	1∶5000	1 995 405	2 004 618
	1∶1000 0	1 808 110
	1∶2 000 0	2 210 340
批次3	1∶5000	1 780 900	2 014 740
	1∶1 000 0	2 010 220
	1∶2 000 0	2 240 100

批次	在产对照/（ng·mL^-1）	2~8 ℃复溶稳定性		37 ℃热稳定性
批次	在产对照/（ng·mL^-1）	检测值/（ng·mL^-1）	变化幅度/%	检测值/（ng·mL^-1）	变化幅度/%
批次1
低	10.48	10.60	1.15	10.44	-0.34
中	80.77	74.53	-7.73	77.02	-4.64
高	168.47	178.42	5.90	167.70	-0.46
批次2
低	10.64	10.09	-5.15	9.88	-7.11
中	73.50	74.27	1.05	73.11	-0.53
高	155.51	152.66	-1.83	154.85	-0.43
批次3
低	10.49	10.32	-1.62	10.05	-4.17
中	73.00	75.10	2.87	75.06	2.82
高	164.71	163.94	-0.46	168.70	2.43

批次	在产对照/（ng·mL^-1）	2~8 ℃复溶稳定性		37 ℃热稳定性
批次	在产对照/（ng·mL^-1）	检测值/（ng·mL^-1）	变化幅度/%	检测值/（ng·mL^-1）	变化幅度/%
批次1
低	10.48	10.60	1.15	10.44	-0.34
中	80.77	74.53	-7.73	77.02	-4.64
高	168.47	178.42	5.90	167.70	-0.46
批次2
低	10.64	10.09	-5.15	9.88	-7.11
中	73.50	74.27	1.05	73.11	-0.53
高	155.51	152.66	-1.83	154.85	-0.43
批次3
低	10.49	10.32	-1.62	10.05	-4.17
中	73.00	75.10	2.87	75.06	2.82
高	164.71	163.94	-0.46	168.70	2.43

项目	AFP/（ng·mL^-1）	罗氏系统	雅培系统	贝克曼系统	西门子系统	CV/%
腹水质检品
低水平	10	6.56±0.05	7.76±0.01	8.02±0.05	7.20±0.09	9
中水平	100	78.57±0.92	98.60±1.24	88.25±0.49	95.00±1.19	18
高水平	200	176.80±1.66	203.28±0.75	196.42±1.56	193.30±1.42	8
批次1
低水平	10	9.79±0.15	10.26±0.04	11.49±0.13	9.70±0.10	1
中水平	100	87.62±0.60	99.86±0.63	91.84±1.14	93.90±2.07	10
高水平	200	198.20±2.65	214.99±2.87	204.89±0.14	205.10±3.36	5
批次2
低水平	10	8.56±0.10	9.79±0.10	10.65±0.03	9.00±0.05	1
中水平	100	83.28±0.88	90.53±1.13	88.12±0.89	89.40±1.32	7
高水平	200	174.10±1.66	197.97±1.29	193.50±2.00	199.20±1.11	8
批次3
低水平	10	9.15±0.11	9.73±0.13	10.77±0.14	10.2±0.23	1
中水平	100	83.30±0.41	94.4±1.81	94.14±1.28	95.00±1.41	11
高水平	200	197.7 0± 0.14	205.38±2.73	199.64±2.3	212.7±2.96	5

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