摘要
目的评价电感耦合等离子体质谱法(ICP-MS)检测人全血中19种微量元素[钙(Ca)、镁(Mg)、铁(Fe)、铜(Cu)、锌(Zn)、铬(Cr)、硒(Se)、钼(Mo)、锰(Mn)、锂(Li)、锶(Sr)、铅(Pb)、镉(Cd)、汞(Hg)、铋(Bi)、钒(V)、砷(As)、钴(Co)、铊(Tl)]的分析性能,并探讨该方法在检测孕妇19种微量元素中的临床应用价值。方法对ICP-MS法检测人全血中19种微量元素的正确度、精密度、检出限、定量限、线性范围、稳定性进行验证,并与公认的质量指标或厂家声明的性能指标相比较。同时,对该院2019—2020年358例孕妇全血标本中微量元素的水平进行检测,采集肝素钠抗凝静脉血稀释40倍后利用ICP-MS测定,并比较非高龄组孕妇(<35岁)、高龄组孕妇(≥35岁)及妊娠早期组(<13周)、妊娠中晚期组(≥13周)孕妇的19种微量元素水平差异。结果19种微量元素的靶值在计算的验证区间内,正确度验证通过;批内和总变异系数(CV)均≤15%,表明该方法的精密度验证符合要求;定量限满足检测要求,相对偏倚及CV均≤15%;19种微量元素水平与相对响应比值具有良好的线性关系(r≥0.995);通过对标本稳定性的验证发现,检测微量元素的标本可在冷藏(2~8℃)存放5 d、室温(20~26℃)存放3 d的条件下满足检测需求,与全血标本一般保存要求一致。利用该方法对临床标本研究发现,高龄组孕妇与非高龄组孕妇血液中Mg、Tl元素水平差异有统计学意义(P<0.05),妊娠早期组和妊娠中晚期组孕妇血液中的Mg、Cu、Mn、Co元素水平差异有统计学意义(P<0.05)。结论ICP-MS在检测人全血中19种微量元素时具有良好的分析性能,该检测方法具有精密度高、准确度好、线性范围宽,以及临床标本测定结果准确、可靠等优势,可用于临床多种微量元素高通量快速测定。年龄和孕周是导致孕妇体内部分微量元素水平产生差异的重要影响因素,因此,定期监测微量元素有助于临床了解并研究孕期女性的营养状况,辅助识别相关疾病,并且指导孕妇对微量元素进行合理的补充。
Objective To evaluate and verify the methodological performance of Inductively Coupled Plasma Mass Spectrometry(ICP-MS)in the detection of 19 trace elements(Ca,Mg,Fe,Cu,Zn,Cr,Se,Mo,Mn,Li,Sr,Pb,Cd,Hg,Bi,V,As,Co,Tl)in whole blood.The clinical value of monitoring these 19 trace elements in pregnant women was also explored.Methods The detection accuracy,quantitative limit,precision,detection limit,linear range as well as stability of this method for these 19 trace elements were investigated,which were then compared with accepted quality indices and manufacturer-declared performance indices.Additionally,whole blood samples from 358 pregnant women from 2019 to 2020 were analyzed by this method to investigate its efficacy in practical work.These samples were collected in heparin sodium anticoagulant coated tube and diluted for 40 times to meet the requirement for ICP-MS detection.The levels of 19 trace elements in non elderly group(lower than 35 years old),elderly group(higher than 35 years old),early pregnancy group(lower than 13 weeks)and late pregnancy group(higher than 13 weeks)were compared.Results The verification interval of 19 trace elements all included the target values,and the accuracy was verified.The intra-batch and intra-lab total CV were both lower than 15%,which means the precision of this method matched request.The limits of detection(LOD)also fulfilled the requirement of clinical testing and the Bias and CV of them were all lower than 15%.The concentration and the ratio of relative intensity existed a linear relationship for all 19 trace elements(r≥0.995).Whole blood samples for elemental analysis through ICP-MS could be stored for 5 days at 2—8℃,and for 3 days at room temperature(20-26℃),which was consistent with the routine practice.With this method,the Mg,Cu,Mn and Co levels in samples had statistical differences(P<0.05)between the women in early and in late pregnancy group.Meanwhile,the levels of Mg and Tl were statistical different(P<0.05)between the non elderly group and elderly group.Conclusion The ICP-MS method evaluated in this study displays excellent performance by its high precision,good accuracy,wide linear range,accurate and reliable clinical sample results.Age and gestational age are important factors that lead to the difference of some trace elements in pregnant women.By investigating the clinical samples using this method,the results indicate that the periodical element testing for pregnant women could help monitoring the nutritional status and studying the elemental related diseases in practice,and also have values in the guidance of nutritional supplementation.
作者
李悦
豆小文
纪翔
熊丹
王萌萌
宗曾艳
陈大洋
张秀明
LI Yue;DOU Xiaowen;JI Xiang;XIONG Dan;WANG Mengmeng;ZONG Zengyan;CHEN Dayang;ZHANG Xiuming(Medical Laboratory of Luohu Hospital Group/Department of Clinical Laboratory of Third Affiliated Hospital of Shenzhen University,Shenzhen,Guangdong 518001,China)
出处
《国际检验医学杂志》
CAS
2020年第20期2438-2444,2449,共8页
International Journal of Laboratory Medicine
基金
国家自然科学基金面上项目(81772921)
深圳市基础研究自由探索项目(JCYJ20180306172209668)
深圳市卫生和计划生育委员会学科建设能力提升项目(SZXJ2017018)
深圳市医疗卫生三名工程(SZSM201601062)。
关键词
电感耦合等离子体质谱法
微量元素
性能评价
Inductively Coupled Plasma Mass Spectrometry
trace element
performance evaluation
作者简介
李悦,女,技师,主要从事临床生化检验与质谱分析方面的研究;通信作者:张秀明,E-mail:zxm0760@163.com。
