一种新型即时检测设备可准确测量全血、毛细血管血和血清中的促甲状腺激素。

A novel point-of-care device accurately measures thyrotropin in whole blood, capillary blood and serum.

机构信息

Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany.

Institute for Clinical Chemistry and Laboratory Medicine, Johannes Gutenberg University (JGU) Medical Center, Mainz, Germany.

出版信息

Clin Chem Lab Med. 2022 Aug 12;60(10):1607-1616. doi: 10.1515/cclm-2022-0525. Print 2022 Sep 27.

DOI:10.1515/cclm-2022-0525

PMID:35951769

Abstract

OBJECTIVES

Point-of-care (POC) measurement of thyrotropin (TSH) may facilitate prompt diagnosis of thyroid dysfunction. We evaluated the analytical performance of a new POC TSH assay (Wondfo).

METHODS

TSH measurements were made from 730 consecutive, unselected subjects in an outpatient setting, using Wondfo in whole blood, capillary blood and serum or automated reference equipment (serum only).

RESULTS

TSH measurements were user-independent. Total intra-and inter-assay variation (CV%) was 12.1 and 16.2%, respectively. Total CV% was 10.6-22.6% and 14.5-21.6% in serum and whole blood, respectively. Linearity was very good. Recovery rate was 97-127%. Prolongation of incubation time increased TSH results of 12% (13%) and 33% (35%) after 2 and 5 additional minutes in serum (blood), respectively. When measured simultaneously in two Wondfo devices, the slope of the regression line was 1.03 (serum) and 1.02 (blood), with Spearman's correlation of 0.99 for both. TSH measurements between Wondfo and reference correlated strongly (r=0.93-0.96), though TSH measurements were lower with Wondfo (slopes of plots of measurements made using the two devices were 0.94 [serum vs. serum]; 0.83 [whole blood vs. serum] and 0.64 [capillary blood vs. serum]). Depending on sample material, TSH in capillary blood was lower vs. whole blood (slope: 0.82) and for whole blood vs. serum (Wondfo and reference method; slope: 0.69 and 0.83). Total haemolysis, but not elevated bilirubin or lipemia, disrupted TSH measurement.

CONCLUSIONS

The Wondfo system was straightforward to use without need for specialist technicians and demonstrated analytic performance suitable for clinical use for the diagnosis of thyroid dysfunction.

摘要

目的

即时检测（POC）促甲状腺激素（TSH）的测定有助于快速诊断甲状腺功能障碍。我们评估了一种新的 POC TSH 检测试剂盒（万孚）的分析性能。

方法

在一个门诊环境中，对 730 例连续、未经选择的患者进行了 TSH 测量，使用万孚在全血、毛细血管血和血清或自动化参考设备（仅血清）中进行。

结果

TSH 测量结果与操作人员无关。总批内和批间变异系数（CV%）分别为 12.1%和 16.2%。在血清和全血中，总 CV%分别为 10.6-22.6%和 14.5-21.6%。线性很好。回收率为 97-127%。孵育时间延长 2 和 5 分钟后，血清（血液）中 TSH 结果分别增加 12%（13%）和 33%（35%）。当同时在两台万孚仪器上测量时，回归线的斜率分别为 1.03（血清）和 1.02（血液），Spearman 相关系数均为 0.99。万孚与参考方法的 TSH 测量结果相关性很强（r=0.93-0.96），但万孚的 TSH 测量结果较低（两条检测线的斜率分别为 0.94[血清与血清]；0.83[全血与血清]和 0.64[毛细血管血与血清]）。根据样本材料的不同，毛细血管血中的 TSH 比全血（斜率：0.82）和全血比血清（万孚和参考方法；斜率：0.69 和 0.83）低。总溶血，而不是胆红素或脂血升高，会破坏 TSH 测量。