[1]顾益凤,张小霞,张　敏,等.不同稀释介质对化学发光免疫法检测血清游离前列腺特异性抗原结果的评估[J].现代检验医学杂志,2022,37(02):157-161.[doi:10.3969/j.issn.1671-7414.2022.02.032]
　GU Yi-feng,ZHANG Xiao-xia,ZHANG Min,et al.Result Evaluation of Serum Free Prostate Specific Antigen by Chemiluminescence Immunomethods in Different Dilution Media[J].Journal of Modern Laboratory Medicine,2022,37(02):157-161.[doi:10.3969/j.issn.1671-7414.2022.02.032]
点击复制

不同稀释介质对化学发光免疫法检测血清游离前列腺特异性抗原结果的评估()
分享到：

《现代检验医学杂志》[ISSN:/CN:]

卷:
第37卷
期数:
2022年02期
页码:
157-161
栏目:
研究简报·实验技术
出版日期:
2022-03-15

文章信息/Info

Title:
Result Evaluation of Serum Free Prostate Specific Antigen by Chemiluminescence Immunomethods in Different Dilution Media
文章编号:
1671-7414（2022）02-157-05
作者:
顾益凤;  张小霞;  张　敏;  刘红利
（南通市肿瘤医院检验科，江苏南通 226361）
Author(s):
GU Yi-feng;  ZHANG Xiao-xia;  ZHANG Min;  LIU Hong-li
（Department of Clinical Laboratory, Nantong Tumor Hospital, Jiangsu Nantong 226361, China）
关键词:
游离前列腺特异性抗原; 化学发光免疫分析法; 稀释试验; 稀释介质
分类号:
R392.11
DOI:
10.3969/j.issn.1671-7414.2022.02.032
文献标志码:
A
摘要:
目的　评估不同稀释介质、稀释倍数在罗氏和新产业两仪器上稀释测定游离前列腺特异性抗原（free prostate specific antigen，FPSA）的可行性。方法　选取2020 年7~12 月在南通市肿瘤医院检测血清FPSA 浓度在40~50ng/ml 的样本60 例为研究对象，运用化学发光免疫法稀释验证。根据罗氏仪器的检测上限，选取30 例FPSA 浓度为40~50ng/ml 的血清样本，在罗氏仪器上分别用罗氏稀释液、蒸馏水、生理盐水和低值混合血清进行2，4 和8 倍稀释验证。根据新产业仪器的检测上限选取30 例FPSA 浓度为40~50ng/ml 的血清样本，在新产业仪器上分别用蒸馏水、生理盐水和低值混合血清进行2，4 和8 倍稀释验证。对样本使用配对t 检验，比较不同稀释介质和稀释倍数稀释后FPSA 测定值与原倍值的差异，并计算两者的偏差。结果　FPSA 在罗氏仪器上使用罗氏稀释液、蒸馏水、生理盐水和低值混合血清按不同比例稀释后测定，测定值的偏倚分别为-33.92%~63.51%，-36.83%~133.0%，-44.82%~116.2% 和-33.0%~74.2%，其中罗氏稀释液和低值混合血清2 倍稀释后结果与原倍值比较差异无统计学意义（t=0.387，0.707，均P>0.05），其余稀释后测定值与原倍值差异均有统计学意义（罗氏稀释液4 和8 倍，t=2.33，3.364；蒸馏水2，4 和8 倍，t=2.072，3.898，6.619；生理盐水2，4 和8 倍，t=2.052，3.078，6.507；低值混合血清4 和8 倍，t=3.584，6.229，均P<0.05）。FPSA 在新产业仪器上使用蒸馏水、生理盐水和低值混合血清按不同比例稀释后测定，测定值偏倚分别为-32.14%~112.07%，-30.89% ～ 95.22% 和-31.85% ～ 112.7%，稀释后测定值与原倍值差异均有统计学意义（蒸馏水2，4 和8 倍，t=2.169，2.706，3.996； 生理盐水2，4 和8 倍，t=2.149，2.617，3.757； 低值混合血清2，4 和8 倍，t=2.058，2.932，4.639， 均P<0.05）。结论　对于超出检测上限的FPSA，罗氏仪器可用罗氏稀释液和低值混合血清进行2 倍稀释，而新产业仪器不宜进行稀释检测。
Abstract:
Objective　To evalue the feasibility of dilution determination free prostate specific antigen（FPSA) on Roche and New Industry Instruments with different dilution media. Methods　The FPSA concentration in 40~50ng/ml were collected from 60 patients in Nantong Tumor Hospital from July 2020 to December 2020 and diluted verification by chemiluminescene method. According to the upper limit of Roche instrument, 30 serum samples with FPSA concentration of 40~50ng/ml were selected and diluted with Roche diluent, distilled water, normal saline and low value mixed serum for 2, 4 and 8 times respectively. According to the upper limit of New Industrial Instrument, 30 serum samples with FPSA concentration of 40~50ng/ml were selected and diluted with distilled water, normal saline and low value mixed serum for 2, 4 and 8 times respectively. After diluted FPSA with different dilution medium and dilution times, the two values were used to compare the difference between the measured value and the original value with paired t test. Results　FPSA was diluted with Roche diluent, distilled water, normal saline and low value mixed serum in different proportion, subsequently FPSA was measured in Roche. The bias of measured value were -33.92%~63.51%, -36.83%~133.0%, -44.82%~116.2% and -33.0%~74.2% ,respectively. There was no significant difference between the original value and the measured value in Roche diluent or low value mixed serum after 2 times dilution (t= 0.701, 0.485, all P>0.05), and the other diluted values were statistically significant(t=2.33, 3.364 with 4, 8 times Roche diluent; t=2.072, 3.898, 6.619 with 2, 4 and 8 times distilled water; t=2.052, 3.078, 6.507 with 2, 4 and 8 times normal saline, and t=3.584, 6.229 with 4 and 8 times low value mixed serum, all P <0.05). FPSA was diluted with distilled water, normal saline and low value mixed serum in different proportion, subsequently FPSA was measured in New Industrial Instrument.The bias of the measured value were -32.14%~112.07%, -30.89%~95.22% and -331.85%~112.7% ,respectively, and the difference between the measured value and the original value after dilution was statistically significant(t=2.169, 2.706, 3.996 with 2, 4 and 8 times distilled water;t=2.149, 2.617, 3.757 with 2, 4 and 8 times normal saline and t=2.058, 2.932, 4.639 with 2, 4 and 8 times low value mixed serum, all P <0.05). Conclusion　FPSA which exceed the upper limit of detection can be measured with 2 times Roche dilution or low value mixed serum in Roche, while FPSA can not be diluted to measure in New Industrial Instrument.

参考文献/References:

[1] RAOOFI M, GOLSAZ-SHIRAZI F, HOSSEINI M, et al. Characterization of monoclonal and polyclonal antibodies recognizing prostate specific antigen:implication for design of a sandwich ELISA[J]. Avicenna Journal of Medical Biotechnology, 2019, 3(1): 134-136.
[2] JUNG K, ELGETI U, LEIN M, et al. Ratio of free or complexed prostate-specific antigen(PSA)to total PSA:which ratio improves differentiation between benign prostatic hyperplasia and prostate cancer[J]. Clinical Chemistry, 2000, 46(1): 55-62.
[3] CAROBENE A, GUERRA E, LOCATELLI M, et al. Biological variation estimates for prostate specific antigen from the European Biological Variation Study; Consequences for diagnosis and monitoring of prostate cancer[J]. Clinica Chimica Acta, 2018, 486: 185-191.
[4] 周建平, 宋晓龙, 常琳, 等．国产化学发光免疫试剂 检测TRAb 的性能评估及临床应用价值[J]．现代检 验医学杂志, 2021, 36(2):92-97. ZHOU Jianping, SONG Xiaolong, CHANG Lin, et al. Performance evaluation and clinical application value of domestic chemiluminescence immunoassay reagent in detecting thyrotropin receptor antibody [J]. Journal of Modern Laboratory Medicine, 2021, 36(2):92-97.
[5] SIMANEK V, TOPOLCAN O, KARLIKOVA M, et al. Stability of total prostate-specific antigen and free prostate-specific antigen after 10 years’ storage[J]. The International Journal of Biological Markers, 2018, 33(4): 463-466.
[6] BAI Xiaojing, JIANG Yumei, ZHANG Xinwei, et al. The value of prostate-specific antigen-related indexes and imaging screening in the diagnosis of prostate cancer[J]. Cancer Management and Research, 2020, 12: 6821-6826.
[7] 戴玉柱, 王国政, 吴遥遥, 等．临床免疫学试验标本 稀释液的实验评价及选择原则[J]．现代检验医学杂 志, 2011, 26(5):52-54, 57. DAI Yuzhu, WANG Guozheng, WU Yaoyao, et al. Experimental evaluation and selection principles of sample diluents in clinical immunological test [J]. Journal of Modern Laboratory Medicine, 2011, 26(5): 52-54, 57.
[8] 李娜, 黎锋, 薛声能, 等. 不同标本稀释液对直接化 学发光法检测人血清FT4 结果的影响[J]. 检验医学 与临床, 2019, 16(16):2273-2275. LI Na, LI Feng, XUE Shengneng, et al. Impact of different sample diluents on results of human serum free thyroxine hormone detected by direct chemiluminescence [J]. Laboratory Medicine and Clinic, 2019, 16(16): 2273-2275.
[9] ELLINGTON A A, KULLO I J, BAILEY K R, et al. Antibody-based protein multiplex platforms: technical and operational challenges[J]. Clinical Chemistry, 2010, 56(2): 186-193.
[10] SU Benchao, WANG Yidan, PEI Hua, et al. Phagemediated double-nanobody sandwich immunoassay for detecting alpha fetal protein in human serum[J]. Analytical Methods, 2020, 12(39): 4742-4748.
[11] MASUDA S, IWASAKI S, TOMARU U, et al. Mechanism of Fcγ receptor-mediated trogocytosisbased false-positive results in flow cytometry[J]. PLoS One, 2012, 7(12): e52918.
[12] 吕世静．临床免疫学检验[M]. 北京: 中国医药科技 出版社, 2004． L? Shijing. Clinical Immunology Test[M].Beijing： China Medical Science and Technology Press, 2004.
[13] 无琼, 禹松林, 国秀芝, 等. 不同稀释介质对抗甲状 腺球蛋白抗体稀释测定的影响[J]. 中华检验医学杂 志, 2018, 44(11): 875-878. WU Qiong, YU Shonglin, GUO Xiuzhi, et al. Effect of different dilution media on the determination of thyroglobulin antibody dilution [J]. Chinese Journal of Laboratory Medicine, 2018, 44(11): 875-878.
[14] ESTEVE-TURRILLAS F A, AGULL? C , MERCADER J V,et al. Rationally designed haptens for highly sensitive monoclonal antibody-based immunoanalysis of fenhexamid [J]. Analyst, 2018, 143(17): 4057-4066.
[15] 倪娟, 高洪柳, 王国洪, 等．化学发光法检测促甲状 腺激素结果假性增高1 例[J]．临床检验杂志, 2016, 34（9）：720． NI Juan, GAO Hongliu, WANG Guohong, et al. A case of false increase of thyrotropin by chemiluminescence assay[J]. Chinese Journal of Clinical Laboratory Science, 2016, 34(9):720.
[16] 张磊, 李德涛, 朱艳, 等．6 种化学发光系统检测肿 瘤标志物的应用评估分析[J]．现代检验医学杂志, 2020, 35（2）：88-91． ZHANG Lei, LI Detao, ZHU Yan, et al. Methodological evaluation of six chemiluminescence detection systems for tumor markers[J]. Journal of Modern Laboratory Medicine, 2020, 35(2): 88-91.

相似文献/References:

[1]董璐艳,王菊英,苏 明,等.采用化学发光免疫分析法筛查丙肝的结果分析[J].现代检验医学杂志,2018,33(02):78.[doi:10.3969/j.issn.1671-7414.2018.02.001]
　DONG Lu-yan,WANG Ju-ying,SU Ming,et al.Investigation and Analysis of Hepatitis C Screened by Chemiluminescent Immu-noassay[J].Journal of Modern Laboratory Medicine,2018,33(02):78.[doi:10.3969/j.issn.1671-7414.2018.02.001]
[2]胡纪文,王恩运,阚丽娟,等.三种化学发光法检测新型冠状病毒（SARS-CoV-2）抗体试剂盒的临床应用评价[J].现代检验医学杂志,2020,35(04):100.[doi:10.3969/j.issn.1671-7414.2020.04.025]
　HU Ji-wen,WANG En-yun,KAN Li-juan,et al.Evaluation of Clinical Application of Three Chemiluminescence Detection Kits for Detection of Novel Coronavirus (SARS-CoV-2) Antibody[J].Journal of Modern Laboratory Medicine,2020,35(02):100.[doi:10.3969/j.issn.1671-7414.2020.04.025]
[3]安　哲,李思鹏,屈　梦,等.CMIA与 ELISA法检测慢性 HBV感染者 HBeAg/抗 HBe双阳性现象的血清学特征和方法学差异[J].现代检验医学杂志,2021,36(01):22.[doi:10.3969/j.issn.1671-7414.2021.01.006]
　AN Zhe,LI Si-peng,QU Meng,et al.Serological Characteristics and Methodological Differences of HBeAg / Anti-HBe Double Positive in Patients with Chronic HBV Infection[J].Journal of Modern Laboratory Medicine,2021,36(02):22.[doi:10.3969/j.issn.1671-7414.2021.01.006]
[4]陈翠翠,梁焕坤,钟树海,等.化学发光免疫分析法快速检测血清登革热病毒NS1 抗原方法的建立及初步应用评价[J].现代检验医学杂志,2023,38(03):176.[doi:10.3969/j.issn.1671-7414.2023.03.032]
　CHEN Cui-cui,LIANG Huan-kun,ZHONG Shu-hai,et al.Establishment and Preliminary Evaluation of Chemiluminescence Immunoassay Method for Rapid Detection of Dengue Virus NS1 Antigen in Serum[J].Journal of Modern Laboratory Medicine,2023,38(02):176.[doi:10.3969/j.issn.1671-7414.2023.03.032]

备注/Memo

备注/Memo:
作者简介：顾益凤（1974-），女，硕士，副主任技师，从事肿瘤分子诊断方面的研究，E-mail:gyfkry@163.com。
更新日期/Last Update: 1900-01-01