促甲状腺激素即时检测技术的临床诊断价值评估  

Evaluation of clinical diagnostic value of a novel point of care testing for thyroid stimulating hormone

作　　者：徐家蓉[1] 金晖[2] 潘明麟[1] 缪珩[1,3] Xu Jiarong;Jin Hui;Pan Minglin;Miao Heng(Department of Endocrinology,the Second Affiliated Hospital of Nanjing Medical University,Nanjing 210011,China;Department of Endocrinology,the Affiliated Zhongda Hospital of Southeast University,Nanjing 210009,China;Department of Endocrinology,Nanjing Pukou Hospital,Nanjing 210032,China)

机构地区：[1]南京医科大学第二附属医院内分泌科,210011 [2]东南大学附属中大医院内分泌科,南京210009 [3]南京市浦口医院内分泌科,210032

出　　处：《中华诊断学电子杂志》2018年第4期277-280,共4页Chinese Journal of Diagnostics(Electronic Edition)

摘　　要：目的探讨促甲状腺激素(TSH)即时检测(POCT)技术—"TSH闪测卡"的临床效果。方法选取2014年9月至2015年2月分别就诊于南京医科大学第二附属医院内分泌科(n=120例)和东南大学附属中大医院内分泌科(n=120例),并需要进行甲状腺功能检测的受试者共240例,收集受试者的指尖血和静脉血样本,分别进行TSH水平的即时定性检测(TSH闪测卡)和电化学发光法的定量检测,以高于TSH定量方法检测的正常值范围上限转换为阳性结果,以介于正常值范围或低于正常值范围下限转换为阴性结果。对测得的结果分别进行配对卡方检验和Kappa一致性检验,比较两种检测方法的差异性和一致性。结果 TSH闪测卡测得阳性结果共计122例,阴性结果共计118例;电化学发光法测得阳性结果共计120例,阴性结果共计120例;其中两种检测方法均为阳性者有119例,不一致者共有4例。两种方法阳性率比较差异无统计学意义(χ~2=1. 00,P>0. 05),阳性一致性为99. 17%(95%CI:97. 54%～100. 00%),阴性一致性为97. 50%(95%CI:94. 71%～100. 00%),总一致性为98. 33%(95%CI:96. 71%～99. 95%),Kappa值为0. 97 (95%CI:0. 93～1. 00),两种方法检测结果一致性极强(χ~2=224. 33,P <0. 01)。结论 TSH闪测卡定性检测与TSH电化学发光法定量检测技术具有极高的临床一致性,其可用于甲状腺功能减退或亚临床甲状腺功能减退患者的初筛检测,亦可用于甲状腺功能减退患者慢病治疗过程中的及时监测,为基层医疗机构提供新的诊断工具。Objective To evaluate the clinical efficacy of the latest thyroid stimulating hormone （TSH） point of care testing （POCT） technology-the “TSH flash card” by comparing with the TSH electrochemiluminescence quantitative detection technique. Methods Two hundred and forty cases who required for TSH detection from September 2014 to February 2015 in the Second Affiliated Hospital of Nanjing Medical University （ n =120） and the Affiliated Zhongda Hospital of Southeast University （ n =120） were enrolled. The tip of finger blood and venous blood samples of the subjects were collected for instant qualitative detection （TSH flash card） and quantitative detection of TSH level by electrochemiluminescence, in which the upper limit of normal value range detected by quantitative TSH method was converted to positive results, and the lower limit of normal value range or below normal value range was converted to negative results. Paired chi-square test and Kappa consistency test were respectively carried out to compare the difference and consistency of the two detection methods. Results A total of 122 positive results and 118 negative results of TSH flash cards were obtained. Simultaneously, there were 120 positive results and 120 negative results by electrochemiluminescence. There were 119 cases in which the two methods were positive and 4 cases were inconsistency. There was no statistical difference in the positive rate of the two methods （χ 2 = 1.00, P 〉0.05）. The positive consistency was 99.17% （95% CI ：97.54%-100.00%）, the negative consistency was 97.50%（95% CI ：94.71%-100.00%） and the total consistency was 98.33%（95%CI： 96.71% -99.95%）. The value of Kappa was 0.97 （95% CI ：0.93-1.00）, showing good consistency between the two methods （ χ 2 =224.33, P 〈0.01）. Conclusions The TSH flash card method shows good consistency compared with the TSH electrochemiluminescence method. This method can be used for primary screening of hypothyroidism or subclinical hypothyroidism, a

关 键 词：促甲状腺素 即时检测 胶体金法 电化学发光法 甲状腺功能减退症 

分 类 号：R446.6[医药卫生—诊断学] R581[医药卫生—临床医学]