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Suitability of POC lactate methods for fetal and perinatal lactate testing: considerations for accuracy, specificity and decision making criteria

  • Jean-Luc Orsonneau , François Fraissinet , Véronique Sébille-Rivain , Daniele Dudouet and Edith Bigot-Corbel EMAIL logo
Published/Copyright: August 3, 2012

Abstract

Background: Point of care (POC) testing for fetal scalp blood lactate is a more user friendly and more successful approach compared to scalp pH for intrapartum fetal monitoring. The aim of this study was to assess the analytical specificity and clinical reliability of three POC lactate methods.

Methods: The analytical performance of three POC lactate methods was compared to Cobas 6000 (Roche Diagnostics) laboratory reference method: Lactate Pro from Arkray, GEM 4000 from Instrumentation Laboratory and StatStrip Lactate from Nova Biomedical. The clinical performance and influences on accuracy and decision making criteria for the three POC methods was assessed with umbilical cord samples and compared to the laboratory reference method. The influence of varying ranges of hemoglobin, pH and partial oxygen pressure (pO2) on the accuracy of results was assessed.

Results: Although all three POC methods showed good correlation with the reference method for the umbilical cord sample population (r=0.989, 0.973 and 0.980, respectively), Lactate Pro and Gem 4000 showed a significant negative bias compared to the reference method. The degree of bias meant a significant readjustment of decision making criteria was required for fetal lactate use. The accuracy of the Lactate Pro results was affected by hemoglobin and to a lesser extent pH.

Conclusions: The three electrochemical POC devices can measure fetal lactate reliably. StatStrip Lactate showed a closer correlation and concordance to our laboratory reference method. The results of this study indicate the requirement for predetermining the reliability of POC lactate methods before use present in fetal and perinatal settings.


Corresponding author: Edith Bigot-Corbel, Laboratoire de Biochimie Générale, Pôle de Biologie, CHU de Nantes, 9 Quai Moncousu, 44035 Nantes Cedex, France, Phone: +33 240084004, Fax: +33 240165455

Authorship: All authors confirmed they have contributed to the intellectual content of this paper and have met the following three requirements: 1) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting or revising the article for intellectual content; and 3) final approval of the published article. JLO, FF and DD performed research, JLO, VS and EBC analyzed data and helped write the manuscript. JLO and EBC designed and supervised research, analyzed data and wrote the manuscript. The study was supported by furniture of StatStrip Lactate by Gael Gousset and Andreii Maliic from Nova Biomedical.

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

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Received: 2012-03-28
Accepted: 2012-06-27
Published Online: 2012-08-03
Published in Print: 2013-02-01

©2013 by Walter de Gruyter Berlin Boston

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