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[通过血气分析和实验室金标准测量胎儿血红蛋白的准确性比较:一项前瞻性诊断研究]

[Comparison of the Accuracy of the Measurement of Fetal Hemoglobin by Blood Gas Analysis and by Laboratory Gold Standard: a Prospective Diagnostic Study].

作者信息

Wittenmeier Eva, Lesmeister Linda, Schmidtmann Irene, Lotz Johannes, Dette Frank, Mildenberger Eva

机构信息

Abteilung für Klinische Anästhesie, Klinik für Anästhesiologie, Universitätsmedizin Mainz, Mainz.

Klinik und Poliklinik für Kinder- und Jugendmedizin, Uniklinik Köln, Köln.

出版信息

Z Geburtshilfe Neonatol. 2021 Jun;225(3):257-261. doi: 10.1055/a-1250-9072. Epub 2020 Sep 29.

DOI:10.1055/a-1250-9072
PMID:32992404
Abstract

BACKGROUND

In neonatologic clinical practice and research the percentage of fetal hemoglobin (HbF) of total hemoglobin can be of interest. Blood gas analyzers offer the measurement of HbF. However, it is not known if results are accurate enough to apply in clinical decision-making or scientific questions. In this prospective diagnostic study, we examined the accuracy of HbF measurement by a blood gas analyzer.

METHODS

On a neonatal intensive care and neonatal ward, the percentage of HbF was measured using both the laboratory gold standard (HbFlab, reference method) and the blood gas analyzer (HbFgas) (ABL 800 Flex, Radiometer). Agreement of HbFlab and HbFgas was assessed by the Bland-Altman method including bias and limits of agreement and by calculation of the root mean square error (RMSE).

RESULTS

Thirty-five measurements in 23 term and preterm infants with a median body weight of 2190 g (min-max 967-3800 g) and a median postmenstrual age of 36+1 weeks (min-max 29+6-43+2) were performed. The Bland-Altman diagram for the measurement of HbF(gas) versus HbF(lab) shows an overestimation of HbF by the blood gas analyzer (bias 9.3%, limits of agreement 1 to 17.6%). RMSE was 10.2%; 45.7% of HbFgas measurements were >10% out of range from HbFlab. There was no influence of age, body temperature or oxygen saturation on the bias (p=0,132; p=0,194; p=0,970), but bias increased with increasing HbFlab (Pearson correlation r=0,426; p=0,011).

CONCLUSION

The measurement of HbF in term and preterm infants by a blood gas analyzer lacked sufficient agreement with that of the reference method to recommend this application for clinical decision-making or scientific purposes.

摘要

背景

在新生儿临床实践和研究中,胎儿血红蛋白(HbF)占总血红蛋白的百分比可能具有重要意义。血气分析仪可用于测量HbF。然而,目前尚不清楚其测量结果是否准确到足以应用于临床决策或科学问题。在这项前瞻性诊断研究中,我们检测了血气分析仪测量HbF的准确性。

方法

在新生儿重症监护病房和新生儿病房,使用实验室金标准方法(HbFlab,参考方法)和血气分析仪(HbFgas)(ABL 800 Flex,雷度米特公司)测量HbF的百分比。采用Bland-Altman方法评估HbFlab和HbFgas的一致性,包括偏差和一致性界限,并计算均方根误差(RMSE)。

结果

对23名足月儿和早产儿进行了35次测量,中位体重为2190g(最小值-最大值967-3800g),中位孕龄为36+1周(最小值-最大值29+6-43+2)。HbF(气体)与HbF(实验室)测量的Bland-Altman图显示,血气分析仪对HbF的测量值存在高估(偏差9.3%,一致性界限为1%至17.6%)。RMSE为10.2%;45.7%的HbFgas测量值与HbFlab的偏差超过10%。年龄、体温或氧饱和度对偏差无影响(p=0.132;p=0.194;p=0.970),但偏差随HbFlab的增加而增加(Pearson相关系数r=0.426;p=0.011)。

结论

血气分析仪测量足月儿和早产儿HbF的结果与参考方法的一致性不足,不建议将其用于临床决策或科学研究。

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