title: A validation study: assessing the reliability of the hand held StatStripXPress lactate meter to test lactate in amniotic fluid.
abstract: 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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Sydney, Camperdown, Sydney, New South Wales 2006, Australia. Beverley.Hall@sesiahs.health.nsw.gov.au.
authors.forename: Beverley
authors.initials: B
authors.lastname: Hall
authors.forename: Diana D
authors.initials: DD
authors.lastname: Wong
authors.forename: William D
authors.initials: WD
authors.lastname: Rawlinson
authors.forename: Mark B
authors.initials: MB
authors.lastname: Tracy
authors.forename: Sally K
authors.initials: SK
authors.lastname: Tracy
mesh_terms: D000328:Adult; D000653:Amniotic Fluid / Q000737:chemistry*; D034201:Computers, Handheld / Q000592:standards*; D004420:Dystocia / Q000175:diagnosis* / Q000378:metabolism / Q000503:physiopathology; D005260:Female; D006801:Humans; D007743:Labor, Obstetric / Q000378:metabolism*; D019344:Lactic Acid / Q000032:analysis* / Q000378:metabolism; D016014:Linear Models; D019095:Point-of-Care Systems / Q000592:standards*; D011247:Pregnancy; D012680:Sensitivity and Specificity
chemical_list: D019344:Lactic Acid