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使用存储数据验证凝血试验的参考区间。

Verifying reference intervals for coagulation tests by using stored data.

机构信息

Clinical Biochemistry Laboratory, Ministry of Health Istanbul Research and Training Hospital, Istanbul, Turkey.

出版信息

Scand J Clin Lab Invest. 2011 Dec;71(8):647-52. doi: 10.3109/00365513.2011.618546. Epub 2011 Oct 21.

DOI:10.3109/00365513.2011.618546
PMID:22017165
Abstract

OBJECTIVE

The purpose of the study was to verify the reference intervals for prothrombin time (PT) and activated partial thromboplastin time (APTT), using stored data of ambulatory pre-op subjects with exclusion of certain clinics, according to age and sex.

MATERIALS AND METHODS

Results of test requests (13,600 PT and 14,083 APTT) of subjects aged 15?80 made from outpatient clinics of surgical departments before surgical interventions in 2008 were retrieved from the electronic medical record. Thromborel S and Actin (Dade Behring, Germany) were used on the Sysmex® CA-1500 coagulation analyzer. Extreme values were determined by using Horn's algorithm after Box-Cox transformation, and the upper and lower reference limits were determined as the 2.5th and 97.5th percentiles of the cleaned data.

RESULTS

The values outside the interval of PT data 10.5-17.0 seconds and the interval of APTT data 20.6-35.8 seconds were excluded from the analysis. There were significant differences among age subsets of PT measurements ( p < 0.0001) and of APTT measurements ( p < 0.0001). Accordingly, the data were tested for gender differences and a significant difference was found in PT ( p = 0.002). APPT results did not differ statistically between men and women.

CONCLUSION

Although we found values different from the limits stated in the kit insert, it would be better to confirm our findings with the direct method, especially in APTT for patients under the age of 40 and over the age of 59, and also for sex differences in PT.

摘要

目的

本研究旨在根据年龄和性别,排除某些科室后,使用门诊术前患者的存储数据验证凝血酶原时间(PT)和活化部分凝血活酶时间(APTT)的参考区间。

材料与方法

从 2008 年外科门诊手术前患者的电子病历中检索出在 Sysmex®CA-1500 凝血分析仪上使用 Thromborel S 和 Actin(Dade Behring,德国)进行的 13600 次 PT 和 14083 次 APTT 检测的请求结果。使用 Horn 算法在 Box-Cox 变换后确定极值,并将清洗后数据的第 2.5 百分位数和第 97.5 百分位数确定为上下参考限。

结果

PT 数据 10.5-17.0 秒和 APTT 数据 20.6-35.8 秒的间隔外的数据值被排除在分析之外。PT 测量的年龄亚组(p<0.0001)和 APTT 测量的年龄亚组(p<0.0001)之间存在显著差异。因此,对性别差异进行了测试,发现 PT 有显著差异(p=0.002)。男性和女性之间的 APPT 结果没有统计学差异。

结论

尽管我们发现了与试剂盒说明书中规定的限值不同的值,但最好使用直接方法确认我们的发现,特别是对于年龄在 40 岁以下和 59 岁以上的患者以及 PT 的性别差异的 APTT。

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