Evaluation of clinical diagnostic value of a novel point of care testing for thyroid stimulating hormone
Xu Jiarong1， Jin Hui2， Pan Minglin1， Miao Heng1,3
1Department of Endocrinology, the Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, China; 2Department of Endocrinology, the Affiliated Zhongda Hospital of Southeast University, Nanjing 210009, China; 3Department of Endocrinology, Nanjing Pukou Hospital, Nanjing 210032, China
Abstract：ObjectiveTo 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. ResultsA 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 (χ2=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 (χ2=224.33，P＜0.01). ConclusionsThe 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, and it can also provide timely monitoring of patients with hypothyroidism during the treatment of chronic disease, providing a new diagnostic tool for grassroots medical systems.
【Key words】Thyrotropin;Point of Care Testing (POCT);Colloidal
徐家蓉 金晖 潘明麟 缪珩. 促甲状腺激素即时检测技术的临床诊断价值评估[J]. 中华诊断学电子杂志, 2018, 6(4): 277-280.
Xu Jiarong，Jin Hui，Pan Minglin，Miao Heng. Evaluation of clinical diagnostic value of a novel point of care testing for thyroid stimulating hormone. zhzdx, 2018, 6(4): 277-280.
