A validation study: assessing the reliability of the hand held StatStripXPress lactate meter to test lactate in amniotic fluid

BMC Research Notes

Sally K Tracy³  Mark B Tracy⁴  William D Rawlinson¹  Diana D Wong¹  Beverley Hall² 

[1] School of Medical Sciences, Faculty of Medicine, University of New South Wales, Kensington, NSW 2031, Australia;Department of Clinical Chemistry, South Eastern Area Laboratory Services, Randwick 2031, Australia;Midwifery and Women’s Health Research Unit, Royal Hospital for Women, 1st Floor, Randwick, NSW 2031, Australia;Westmead NICU, Westmead Hospital, Westmead, NSW 2145, Australia

关键词: Point of care;    Labour;    Amniotic fluid;    Lactate;    Dystocia;   

Others  :  1091362
DOI  :  10.1186/1756-0500-7-935

 received in 2014-08-12, accepted in 2014-12-12,  发布年份 2014

【 摘 要 】

Background

The level of lactate in amniotic fluid may provide useful clinical information when assessing whether a woman in labour is experiencing labour dystocia. If so, a rapid, reliable method to assess the concentration of amniotic fluid lactate at the bedside will be required in order to be clinically relevant. To assess efficacy, we compared the hand held StatStripXPreass lactate meter (Nova Biomedical) to the reference laboratory analyser ABX Pentra 400 (Horiba) in a controlled environment. Baseline biological lactate concentration was measured in triplicate and samples of a known quantity of thawed amniotic fluid spiked with lactate substrate (62 mmol/L) from the LDH12 kit (Roche, SUI) to yield a predetermined lactate concentration above baseline then measured in triplicate. Deming Regression was used to determine the linear agreement and a Bland Altman plot used to determine the paired agreement across the range of values.

Findings

The mean difference with Bland-Altman plot between hand held meter and lab instrument was -1.0 mmol/L (SD 3.0 mmol/L) with 95% CI limits of agreement between -6.9 mmol/L to 4.9 mmol/L. The Deming regression co-efficient or slope of agreement was 0.91 (SD of 0.21).

Conclusion

The measurement of amniotic fluid lactate using the StatStripXPress hand held meter was reliable compared to reference laboratory methods for measuring lactate levels in amniotic fluid.

【 授权许可】

   
2014 Hall et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

Figure 2.

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