Rege V, Mojiminiyi O, Wilcox H, Barron J
Department of Chemical Pathology, St. Helier Hospital, Carshalton, Surrey, UK.
Clin Biochem. 1996 Feb;29(1):1-4. doi: 10.1016/0009-9120(95)02009-8.
To evaluate the effect of test automation and a change in strategy for thyroid function tests (TFT) on personnel needs and turn-around time. The first-line TFT were changed from T4 and TSH to FT4 and TSH-30.
Samples received for TFT from 357 randomly selected patients were analyzed by RIA for T4, and by IRMA for TSH as first-line tests. FT3 and TBG were requested as back-up tests when indicated. Patients were classified on the basis of these results and the clinical information received. All the samples were reanalyzed for FT4 and TSH on the Amerlite Processing Center, which is a batch, semiautomated immunoassay system. The thyroid status of the patients was compared using the two protocols and available clinical data.
There was good correlation between TSH-IRMA and TSH-30 in the 160 patients classified as euthyroid (r = 0.956; p < 0.001) and no euthyroid patient was reclassified with the new strategy. In 21 patients with borderline raised TSH-IRMA, FT4 was found to be low in only 2. All 11 patients classified as hypothyroid had TSH results greater than 10 mU/L and all except 2 patients had FT4 less than 11 nmol/L. The status of 21 hyperthyroid as well as 40 patients on carbimazole could be determined biochemically on the basis of agreement between both the FT4 and TSH-30 results. FT3 was only required if the FT4 and TSH-30 results were not in agreement. In 42 patients on T4 therapy, adequacy of replacement was assessed better using FT4 and TSH-30. No patient required backup testing with TBG to determine thyroid status using the new testing protocol. The change in TFT protocol reduced the 95% turn-around time from 3 days to 1 day.
The introduction of FT4 and TSH-30 as first-line TFT improved the turn-around time for TFT, resulted in 25% reduction in personnel requirements, 60% reduction in FT3 assays, and discontinuation of TBG assay.
评估检测自动化以及甲状腺功能检测（TFT）策略的改变对人员需求和周转时间的影响。一线TFT从T4和促甲状腺激素（TSH）改为游离甲状腺素（FT4）和TSH-30。
对随机选取的357例患者送检的TFT样本，采用放射免疫分析法（RIA）检测T4，采用免疫放射分析法（IRMA）检测TSH作为一线检测项目。必要时要求检测游离三碘甲状腺原氨酸（FT3）和甲状腺素结合球蛋白（TBG）作为备用检测项目。根据这些结果以及所获得的临床信息对患者进行分类。所有样本均在Amerlite处理中心重新检测FT4和TSH，该中心是一个批量、半自动免疫分析系统。采用这两种方案以及现有的临床数据对患者的甲状腺状态进行比较。
在160例分类为甲状腺功能正常的患者中，TSH-IRMA与TSH-30之间具有良好的相关性（r = 0.956；p < 0.001），且没有甲状腺功能正常的患者因新策略而被重新分类。在21例TSH-IRMA临界升高的患者中，仅2例FT4较低。所有11例分类为甲状腺功能减退的患者TSH结果均大于10 mU/L，除2例患者外，所有患者的FT4均低于11 nmol/L。根据FT4与TSH-30结果的一致性，可通过生化方法确定21例甲状腺功能亢进患者以及40例服用卡比马唑患者的状态。仅在FT4与TSH-30结果不一致时才需要检测FT3。在42例接受T4治疗的患者中，使用FT4和TSH-30能更好地评估替代治疗的充分性。采用新的检测方案时，没有患者需要用TBG进行备用检测来确定甲状腺状态。TFT方案的改变将95%的周转时间从3天缩短至1天。
采用FT4和TSH-30作为一线TFT检测项目，缩短了TFT的周转时间，人员需求减少了25%，FT3检测减少了60%，并停止了TBG检测。
