[1]谭玉华,马有成,王春波,等.全自动时间分辨荧光免疫分析检测新生儿滤纸血斑甲状腺素（T4）改良竞争法的建立与评价[J].现代检验医学杂志,2026,41(05):31-39.[doi:10.3969/j.issn.1671-7414.2026.05.006]
　TAN Yuhua,MA Youcheng,WANG Chunbo,et al.Establishment and Evaluation of a Modified Competitive Method for Detecting Thyroxine (T4) in Neonatal Dried Blood Spots by Fully Automatic Time- Resolved Fluoroimmunoassay[J].Journal of Modern Laboratory Medicine,2026,41(05):31-39.[doi:10.3969/j.issn.1671-7414.2026.05.006]
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全自动时间分辨荧光免疫分析检测新生儿滤纸血斑甲状腺素（T4）改良竞争法的建立与评价()

《现代检验医学杂志》[ISSN:/CN:]

卷:
第41卷
期数:
2026年05期
页码:
31-39
栏目:
论著
出版日期:
2026-09-15

文章信息/Info

Title:
Establishment and Evaluation of a Modified Competitive Method for Detecting Thyroxine (T4) in Neonatal Dried Blood Spots by Fully Automatic Time- Resolved Fluoroimmunoassay
文章编号:
1671-7414 （2026） 05-031-09
作者:
谭玉华1，马有成2，王春波1，徐思滢1，郑丹3，余海枷1，冯健明1
（1.广州市丰华生物股份有限公司体外诊断试剂研发中心，广州510730；2.成都市妇女儿童中心医院新生儿疾病筛查中心，成都610000；3.中山大学附属第一医院医学检验科，广州510080）
Author(s):
TAN Yuhua1, MA Youcheng2, WANG Chunbo1, XU Siying1, ZHENG Dan3, YU Haijia1, FENG Jianming1
(1.In vitro Diagnostic Reagent Research and Development Center, Guangzhou Fenghua Biotech Co.,Ltd., Guangzhou 510730, China; 2.Neonatal Disease Screening Center, Chengdu Women and Children’s Central Hospital, Chengdu 610000, China; 3.Department of Medical Laboratory, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China)
关键词:
时间分辨荧光免疫分析;  滤纸干血片;  甲状腺素;  竞争法
分类号:
R581.2； R446.61
DOI:
10.3969/j.issn.1671-7414.2026.05.006
文献标志码:
A
摘要:
目的 建立一种全自动时间分辨荧光免疫分析 （TRFIA） 检测新生儿滤纸干血片 （DBS） 甲状腺素 （T4） 改良竞争法， 并评价其性能。 方法 T4 竞争法配对单克隆抗体 （包被抗体） 包被微孔板作为反应板， 铕标记T4 单克隆抗体 （抗T4） 作为铕 标记物， 应用全自动TRFIA定量检测板针固定滤纸血斑中T4 浓度， 对其分析灵敏度、 准确度、 线性、 精密度、 特异度、 色谱 效应、 基质效应、 回收试验、 体积效应、 红细胞压积效应和稳定性等性能指标进行评价。 选择120份同源的血清样品和DBS 样品， 用于自建方法与T4 化学发光法的比对试验。 收集新生儿足跟血DBS剩余样品312份， 用于T4 和促甲状腺素 （TSH） 联 合检测。 结果 空白限为0.44μg/dl血清， 检出限为0.81μg/dl血清， 定量限为1.61μg/dl血清， 检测标准参考物质的相对 偏差在-5.33%~1.83%间； 在1.61~50.00?g/dl血清范围内， r可达0.999 6； 批内、 批间、 重复性、 实验室内和实验室间变异系 数 （CV） 均在6.00%内； 检测9种高浓度的交叉物的反应率在0.021%~1.980%内， 检测20?g/dl的D-T4 DBS样品的交叉反 应率为43.900%； 9种高浓度的干扰物质对T4 检测结果的干扰率均在±10%以内。 边缘打孔的血斑检测结果高于中央、 中 央至边缘1/2处打孔检测结果 （t=4.44、 5.26， 均P?0.05） ； 3个不同批次的903滤纸制作的DBS样品实测值与理论值的相对 偏差均在允许范围 （±15.00%） 内； 回收率在91.64%~104.07%间； 与50μl/滴制备的DBS样品检测结果比较， 其他点样体 积制备的DBS样品检测结果的差异具有统计学意义 （均P<0.05） ； 在35%~60%红细胞压积下制得DBS样品较50%红细胞 压积制得DBS样品的检测结果的相对偏差均在±15%内； -20℃下标记物可反复冻融4次， 试剂在2~8℃下可保存14个月， 试剂在37±1℃下可保存9天。 在2.07~36.11?g/dl血清内， 自建方法与对比方法检测结果高度相关 （r=0.995 5， tr=112.73， P<0.05） ； 检出率差异无统计学意义 （χ2 =0.50、 0.50， 均P>0.05） 。 新生儿DBS样品T4 的平均浓度为18.90?g/dl血清， T4 与TSH 的检出率差异具有统计学意义 （χ2 =11.56、 16.52， 均P<0.05） 。 结论 自建方法具有灵敏度高、 准确度好、 线性范围宽、 精密 度好和特异度高等优点， 与对比方法检测结果具有高度的相关性和一致性， 满足临床检测需求。
Abstract:
Objective To establish and evaluate a fully automatic time-resolved fluoroimmunoassay (TRFIA) based on a modified competitive method for detecting thyroxine (T4) in neonatal dried blood spots (DBS). Methods Microplates coated with T4 competitive-method paired monoclonal antibody (capture antibody) were used as the solid phase. Europium (Eu)-labeled T4 monoclonal antibody (anti-T4) was used as the tracer. The fully automatic TRFIA system was applied to quantitatively detect the T4 concentration in the blood spots on the ?lter paper ?xed onto plate needles. The analytical performance indicators, including sensitivity, accuracy, linearity, precision, specificity, chromatographic effect, matrix effect, recovery test, volume effect, hematocrit effect, and stability, were evaluated. 120 paired serum and DBS samples were selected for the comparison test between the self-developed method and the T4 chemiluminescence method. Residual DBS samples from 312 newborns were used for combined T4 and thyroid- stimulating hormone (TSH) detection. Results The limit of blank was 0.44 μg/dl serum, the limit of detection was 0.81μg/dl serum, and the limit of quanti?cation was 1.61 μg/dl serum. The relative deviations for certi?ed reference materials ranged from -5.33% to 1.83%. Excellent linearity was observed within the range of 1.61~50.00 ?g/dl serum (r=0.999 6). The intra-assay, inter-assay, repeatability, laboratory and inter-laboratory coe?cients of variation (CV) were all within 6.00%. The cross-reactivity rates for nine high-concentration cross-reaction substances ranged from 0.021% to 1.980%, and the cross-reactivity rate for 20?g/ dl D-T4 DBS sample was 43.900%. The interference rates of nine high-concentration interfering substances on T4 measurements were all within ±10%. Blood spots punched from the edge yielded higher results than those punched from the center or from the midpoint between the central and edge (t=4.44, 5.26, both P<0.05). The relative deviations between measured and theoretical values for DBS samples prepared with three different batches of 903 ?lter paper were all within the acceptable range (±15.00%). Recovery rates ranged from 91.64% to 104.07%. Compared with DBS samples prepared at a volume of 50 μL/drop, those prepared at other volumes showed statistically significant differences (all P<0.05). The relative deviations for DBS samples prepared at hematocrit levels of 35% to 60% compared with those at 50% were all within ±15%. The Eu-marker could withstand up to four freeze-thaw cycles at -20 ℃ , and the reagent could be stored at 2 to 8 ℃ for 14 months and at 37 ± 1 ℃ for 9 days. Within the range of 2.07~36.11 ?g/dl serum, the results of the established method showed a strong correlation with those of the comparator method (r=0.995 5, tr=112.73, P<0.05), with no statistically signi?cant difference in detection rates between the two methods (χ2 =0.50 and 0.50, both P>0.05). The average concentration of T4 in neonatal DBS samples was 18.90 ?g/dl serum. The detection rates of T4 and TSH differed significantly (χ2 =11.56 and 16.52, all P<0.05). Conclusions The established method demonstrates high sensitivity, good accuracy, wide linear range, excellent precision and high specificity. It shows strong correlation and consistency with the comparative method, and meets the requirements for routine clinical testing.

参考文献/References:

[1] 先天性甲状腺功能减退症诊治指南工作组,中华医 学会内分泌学分会,中华医学会儿科学分会.先天性 甲状腺功能减退症诊治指南[J].中华内分泌代谢杂 志, 2025, 41(4): 267-288. Working Group on Guidelines for Diagnosis and Treat- ment of Congenital Hypothyroidism; Chinese Society of Endocrinology, Chinese Medical Association; Chi- nese Pediatric Society, Chinese Medical Association. Guidelines for diagnosis and treatment of congenital hypothyroidism[J]. Chinese Journal of Endocrinology and Metabolism, 2025, 41(4): 267-288.
[2] MARTYNA K, AGNIESZKA K, IWONA B S. Con- genital hypothyroidism in preterm newborns-the chal- lenges of diagnostics and treatment: a review[J]. Fron- tiers in Endocrinology, 2022, 13: 860862.
[3] BOELEN A, ZWAVELING-SOONAWALA N, HEI- JBOER A C, et al. Neonatal screening for primary and central congenital hypothyroidism: is it time to go Dutch?[J]. European Thyroid Journal, 2023, 12(4): e230041.
[4] BOELEN A, HEIJBOER A C. Newborn screening and the screening laboratory: past, present and future[J]. European Thyroid Journal, 2025, 14(1): e240325.
[5] MARK R G, CHRISTIAAN F M, ANITA B, et al. Newborn screening for central congenital hypothy- roidism: past, present and future[J]. European Thyroid Journal, 2025, 14(1): e240329.
[6] 刘畅,张立琴,杜玮,等.2023年美国儿科学会先天性 甲状腺功能减低症筛查与管理指南解读[J].中国儿 童保健杂志, 2024, 32(6): 637-642. LIU C, ZHANG L Q, DU W, et al. Interpretation of guideline on the screening and management of congen- ital hypothyroidism issued by American Academy of Pediatrics in 2023[J]. Chinese Journal of Child Health Care, 2024, 32(6): 637-642.
[7] 孙伟杰,高莹,侯新琳,等.胎儿及新生儿甲状腺功能 异常的产前诊断及管理[J].中华围产医学杂志, 2021, 24(5): 321-325. SUN W J, GAO Y, HOU X L, et al. Prenatal diagnosis and management of fetal/neonatal thyroid dysfunc- tion[J]. Chinese Journal of Perinatal Medicine, 2021, 24(5): 321-325.
[8] 刘启满,唐文佩.先天性甲状腺功能减退症的全球筛 查史[J].中华围产医学杂志, 2024, 27(7): 603-606. LIU Q M, TANG W P. Global history of screening for congenital hypothyroidism[J]. Chinese Journal of Peri- natal Medicine, 2024, 27(7): 603-606.
[9] 叶娟,罗小平.新生儿期甲状腺功能异常相关诊疗问 题[J].中华围产医学杂志, 2012, 15(2): 65-68. YE J, LUO X P. Diagnosis and treatment issues related to thyroid dysfunction in the neonatal period[J]. Chi- nese Journal of Perinatal Medicine, 2012, 15(2): 65-68.
[10] 中华预防医学会出生缺陷预防与控制专业委员会新 生儿遗传代谢病筛查学组,国家卫生健康委员会临 床检验中心新生儿遗传代谢病筛查室间质评专业委 员会.新生儿遗传代谢病筛查实验室检测技术规范 专家共识[J].中华新生儿科杂志, 2023, 38(8): 449- 454. Screening Group of Neonatal Genetic Metabolic Dis- ease, Special Committee of Birth Defects Prevention and Control, Chinese Preventive Medical Association; Newborn Genetic Metabolic Disease Screening Labo- ratory Quality Evaluation Professional Committee from Clinical Laboratory Center of National Health Commis- sion. Consensus on laboratory testing technical guide- lines of neonatal genetic metabolic disease screening [J]. Chinese Journal of Neonatology, 2023, 38(8): 449-454.
[11] 周伶俐,魏力强.临床实验室应用不同检测系统检测 血清心肌肌钙蛋白I结果的一致性分析研究[J].现代 检验医学杂志, 2022, 37(2): 137-141, 161. ZHOU L L, WEI L Q. Consistency analysis of serum cardiac troponin I with different detection systems in clinical laboratory[J]. Journal of Modern Laboratory Medicine, 2022, 37(2): 137-141, 161.
[12] 广州市丰华生物股份有限公司.一种滤纸干血片甲状 腺素测定试剂盒及其检测方法: CN202510603128.5 [P]. 2025-08-05. Guangzhou Fenghua Biotech Co.,Ltd.. A ?lter paper dry blood tablet thyroid hormone determination kit and its detection method : CN202510603128.5 [P]. 2025-08-05.
[13] 中华人民共和国国家质量监督检验检疫总局,中国 国家标准化管理委员会.GB/T 21415-2008:体外诊断 医疗器械-生物样品中量的测量-校准品和控制物 质赋值的计量学溯源性[S]. 北京:中国标准出版社, 2008. General Administration of Quality Supervision, Inspec- tion and Quarantine of the People’s Republic of China; China National Standardization Administration. GB/T 21415-2008: In vitro diagnostic medical devices-mea- surement of quantities in biological samples-metrolog- ical traceability of values assigned to calibrators and control materials[S]. Beijing: Standards Press of China, 2008.
[14] 谭玉华,曹春玲,张润锋,等.时间分辨荧光免疫法检 测胎盘生长因子的方法建立及性能评价[J].现代检 验医学杂志, 2023, 38(1): 112-116, 146. TAN Y H, CAO C L, ZHANG R F, et al. Establishment and performance evaluation of a time-resolved fluo- rescence immunoassay for the detection of placental growth factor[J]. Journal of Modern Laboratory Medi- cine, 2023, 38(1): 112-116, 146.
[15] 国家药品监督管理局.YY/T 1789.3-2022:体外诊断检 验系统性能评价方法第3部分:检出限与定量限[S]. 北京:中国标准出版社, 2022. National Medical Products Administration. YY/T 1789.3-2022: In vitro diagnostic test systems—Perfor- mance evaluation method—Part 3: Limit of detection and limit of quantitation[S]. Beijing: Standards Press of China, 2022.
[16] 国家食品药品监督管理总局.YY/T 1223-2014:总甲 状腺素定量标记免疫分析试剂盒[S].北京:中国标准 出版社, 2014. State Food and Drug Administration. YY/T 1223-2014: Totle T4 quantitative labelling immunoassay kit[S]. Beijing: Standards Press of China, 2014.
[17] 国家药品监督管理局.YY/T1789.1-2021:体外诊断检 验系统性能评价方法第1部分:精密度[S].北京:中 国标准出版社出版, 2021. National Medical Products Administration. YY/T 1789.1-2021: In vitro diagnostic test systems—Perfor- mance evaluation method—Part 1: Precision[S]. Bei- jing: Standards Press of China, 2021.
[18] 方可欣,吴鼎文,胡真真,等.滤纸干血片打孔部位对 新生儿筛查实验检测结果的影响[J].现代诊断与治 疗, 2017, 28(6): 1068-1069. FANG K X, WU D W, HU Z Z, et al. The in?uence of perforated sites of ?lter paper dry blood tablets on the test results of neonatal screening experiments[J]. Mod- ern Diagnosis & Treatment, 2017, 28(6): 1068-1069.
[19] 周启凤,曹闻琦,吴虹林,等.干滤纸血片制备因素对 遗传代谢病串联质谱分析结果的影响[J].标记免疫 分析与临床, 2025, 32(1): 123-128. ZHOU Q F, CAO W Q, WU H L, et al. Investigation of the factors affecting the preparation of dry blood spot on tandem mass spectrometry analysis results for inher- ited metabolic disorders[J]. Labeled Immunoassays and Clinical Medicine, 2025, 32(1): 123-128.
[20] 宫竹君,陈荷芬,袁拥华,等.干血斑法概述及其在器 官移植免疫抑制药治疗药物监测中的研究进展[J]. 药物分析杂志, 2023, 43(8): 1277-1283. GONG Z J, CHEN H F, YUAN Y H, et al. Overview of dried blood spot method and its application in therapeu- tic drug monitoring of immunosuppressants in organ transplantation[J]. Chinese Journal of Pharmaceutical Analysis, 2023, 43(8): 1277-1283.
[21] LAIN S J, RIFAS-SHIMAN S L, PEARCE E N, et al. Neonatal thyroxine, maternal thyroid function, and cog- nition in mid-childhood in a US cohort[J]. Maternal and Child Health Journal, 2020, 24(4): 503-513.
[22] 周伟燕,张江涛,李铭,等.同位素稀释液相色谱串 联质谱法测定血清甲状腺素[J].中华检验医学杂志, 2015, 38(2): 91-97. ZHOU W Y, ZHANG J T, LI M, et al. Serum total thy- roxine measured by isotope dilution liquid chromatog- raphy tandem mass spectrometry[J]. Chinese Journal of Laboratory Medicine, 2015, 38(2): 91-97.
[23] 徐杭,宋浩,樊高成,等.单克隆抗体制备技术的研究 现状[J].中国农业科技导报, 2024, 26(11): 210-224. XU H, SONG H, FAN G C, et al. Research advances of monoclonal antibody production technologies[J]. Journal of Agricultural Science and Technology, 2024, 26(11): 210-224.
[24] WANG Y Y, ZHANG Y, FANG Z G, et al. Develop- ment and evaluation of a novel non-competitive MA- GLUMI estradiol chemiluminescence immunoassay[J]. Clinica Chimica Acta, 2025, 575: 120356.
[25] DAI P, ZHANG Y, HONG Y P, et al. Production of high a?nity monoclonal antibody and development of indirect competitive chemiluminescence enzyme im- munoassay for gentamicin residue in animal tissues[J]. Food Chem, 2023, 400: 134067.
[26] 国家卫生健康委临床检验中心新生儿遗传代谢病筛 查室间质评委员会.新生儿先天性肾上腺皮质增生 症筛查与诊断实验室检测技术专家共识[J].中华检 验医学杂志, 2019, 42(12): 1014-1019. Committee on Quality Assessment of Newborn Screen- ing, National Center for Clinical Laboratory. Laborato- ry testing consensus on neonatal congenital adrenal hy- perplasia: screening and diagnosis[J]. Chinese Journal of Laboratory Medicine, 2019, 42(12): 1014-1019.
[27] 国家卫健委临床检验中心新生儿疾病筛查室间质 量评价委员会.新生儿疾病筛查滤纸血片采集和 递送及保存专家共识[J].中华检验医学杂志, 2019, 42(10): 836-840. External Quality Assessment Committee for Neonatal Disease Screening of Clinical Laboratory Center of National Health and Health Commission. Expert con- sensus on collection, delivery and preservation of ?lter paper blood tablets for neonatal disease screening[J]. Chinese Journal of Laboratory Medicine, 2019, 42(10): 836-840.
[28] 邹海飞,李敏,邓顺艳,等.凝胶过滤层析结合液相色 谱-串联质谱法测定血清中游离甲状腺激素[J].分析 测试学报, 2023, 42(12): 1639-1644, 1651. ZOU H F, LI M, DENG S Y, et al. Determination of free thyroid hormones in serum by gel ?ltration chro- matography combined with liquid chromatography-tan- dem mass spectrometry[J]. Journal of Instrumental Analysis, 2023, 42(12): 1639-1644, 1651.
[29] 广州科方生物技术股份有限公司.一种通用于血清中 TT3和TT4的解离剂及其制备方法: 202110036268.0 [P]. 2021-02-12. Guangzhou Kofa Biotechnology Co.,Ltd. A general dissociating agent for TT3 and TT4 in serum and its preparation method: 202110036268.0[P]. 2021-02-12.
[30] 南京岚轩生物科技有限公司.用于检测TT3和TT4含 量的解离剂及其制备方法:202111467228.8[P]. 2021- 12-31. Nanjing Lanxuan Biotechnology Co., Ltd. Dissociating agents for detecting the content of TT3 and TT4 and their preparation methods: 202111467228.8[P]. 2021- 12-31.
[31] SHIGENOBU N, 王朝辉,刘吉生.用滤纸干燥血清样 品同时测定甲状腺素和促甲状腺激素检查新生儿甲 低[J].地方病通讯, 1981, 9(4): 53-55. SHIGENOBU N, WANG C H, LIU J S. Serum samples were dried with ?lter paper to simultaneously determine thyroid hormone and thyroid stimulating hormone for neonatal hypothyroidism[J]. Endemic Disease Commu- nication, 1981, 9(4): 53-55.
[32] 李文杰,李明训,林闽华,等.检测干血片样品中促甲 状腺素和苯丙氨酸实验影响因素的研究[J].上海医 学检验杂志, 2003, 18(1): 49-51. LI W J, LI M X, LIN M H, et al. Study on the in?uenc- ing factors of TSH and phenylalanine detection in dried blood spot samples[J]. Shanghai Journal of Medical Laboratory Sciences, 2003, 18(1): 49-51.
[33] 陈丕绩,蒋明,谢意文,等.影响新生儿干血片 G6PD 筛查试验结果的相关因素分析[J].检验医学与临床, 2015, 12(4): 505-506, 509. CHEN P J, JIANG M, XIE Y W, et al. Analysis of factors infecting result of neonatal dried blood G6PD screening test[J]. Laboratory Medicine and Clinic, 2015, 12(4): 505-506, 509.
[34] 中华人民共和国卫生部.卫生部关于印发 《新生儿 疾病筛查技术规范(2010年版)》的通知[EB/OL]. (2010-11-10)[2025-11-01]. https://www.nhc.gov.cn/ wjw/c100175/201012/f9005a3ba04140898b4c333aeba- d0a46.shtml. Ministry of Health of the People’s Republic of Chi- na. Notice of the Ministry of Health on Issuing the Technical Specifications for Screening of Neonatal Diseases (2010 Edition)[EB/OL]. (2010-11-10)[2025- 11-01]. https://www.nhc.gov.cn/wjw/c100175/201012/ f9005a3ba04140898b4c333aebad0a46.shtml.
[35] 梁肖云,区小冰,关小珊.新生儿红细胞压积两种检 测方法的比较[J].现代临床医学生物工程杂志, 2004, 10(5): 419-421. LIANG X Y, OU X B, GUAN X S. Comparison of two methods for measuring hematocrit in newborns[J]. Journal of Modern Clinical Medical Bioengineering, 2004, 10(5): 419-421.
[36] 蒋翔,黄永兰,李蓓,等.根据采血时间调整新生儿先 天性甲状腺功能减退症筛查切值的初步研究[J].中 华新生儿科杂志, 2019, 34(5): 347-352. JIANG X, HUANG Y L, LI B, et al. Pilot study on the adjustment of the cut-off value for congenital hypothy- roidism screening according to the age at sampling[J]. Chin J Neonatol, 2019, 34(5): 347-352.
[37] 杨丽涓,欧明才,张钰,等.四川省新生儿促甲状腺素 的季节变化与切值探讨[J].中国实验诊断学, 2019, 23(1): 16-19. YANG L J, OU M C, ZHANG Y, et al. Seasonal vari- ation and cut-off value of thyrotropin in neonates in Sichuan[J]. Chinese Journal of Laboratory Diagnosis, 2019, 23(1): 16-19.
[38] 李仲梅,陈朴,余永雄,等.梧州地区新生儿促甲状腺 素季节变化与切值探讨[J].医药卫生, 2024, 16(3): 73-77. LI Z M, CHEN P, YU Y X, et al. Seasonal variation and cut-off value of neonatal thyrotropin in Wuzhou area[J]. Medicine and Hygiene, 2024, 16(3): 73-77.
[39] 刘利军.新生儿暂时性低甲状腺素血症的影响因素 及甲状腺素替代治疗的效果评估[J].江西医药, 2022, 57(12): 2186-2187, 2190. LIU L J. In?uencing factors of transient hypothyroxin- emia in neonates and evaluation of the effect of thyrox- ine replacement therapy[J]. Jiangxi Medical Journal, 2022, 57(12): 2186-2187, 2190.

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备注/Memo

备注/Memo:
作者简介： 谭玉华（1980-），男，医学硕士，医疗器械高级工程师、临床医学检验技师、二级企业培训师、三级健康管理师，主要从事医疗器械
更新日期/Last Update: 2026-09-15