Hematocrit correction does not improve glucose monitor accuracy in the assessment of neonatal hypoglycemia

Li Wang; John L. Sievenpiper; Russell J. de Souza; Michele Thomaz; Susan Blatz; Vijaylaxmi Grey; Christoph Fusch; Cynthia Balion

doi:10.1515/cclm-2012-0436

Article

Hematocrit correction does not improve glucose monitor accuracy in the assessment of neonatal hypoglycemia

Li Wang , John L. Sievenpiper , Russell J. de Souza , Michele Thomaz , Susan Blatz , Vijaylaxmi Grey , Christoph Fusch and Cynthia Balion

Published/Copyright: February 18, 2013

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 51 Issue 8

Abstract

Background: The lack of accuracy of point of care (POC) glucose monitors has limited their use in the diagnosis of neonatal hypoglycemia. Hematocrit plays an important role in explaining discordant results. The objective of this study was to to assess the effect of hematocrit on the diagnostic performance of Abbott Precision Xceed Pro (PXP) and Nova StatStrip (StatStrip) monitors in neonates.

Methods: All blood samples ordered for laboratory glucose measurement were analyzed using the PXP and StatStrip and compared with the laboratory analyzer (ABL 800 Blood Gas analyzer [ABL]). Acceptable error targets were ±15% for glucose monitoring and ±5% for diagnosis.

Results: A total of 307 samples from 176 neonates were analyzed. Overall, 90% of StatStrip and 75% of PXP values met the 15% error limit and 45% of StatStrip and 32% of PXP values met the 5% error limit. At glucose concentrations ≤4 mmol/L, 83% of StatStrip and 79% of PXP values met the 15% error limit, while 37% of StatStrip and 38% of PXP values met the 5% error limit. Hematocrit explained 7.4% of the difference between the PXP and ABL whereas it accounted for only 0.09% of the difference between the StatStrip and ABL. The ROC analysis showed the screening cut point with the best performance for identifying neonatal hypoglycemia was 3.2 mmol/L for StatStrip and 3.3 mmol/L for PXP.

Conclusions: Despite a negligible hematocrit effect for the StatStrip, it did not achieve recommended error limits. The StatStrip and PXP glucose monitors remain suitable only for neonatal hypoglycemia screening with confirmation required from a laboratory analyzer.

Keywords: acceptable performance criteria; glucose monitor; hematocrit; neonatal hypoglycemia; point of care (POC)

Corresponding author: Dr. Li Wang, MD, MSc, Faculty of Health Sciences, Department of Pathology and Molecular Medicine, McMaster University HSC-2N22B, 1200 Main St. W Hamilton, ON, L8N 3Z5, Canada, Phone: +1 905 5212100, ext. 76594, Fax: +1 905 5212344

We sincerely thank Dr. Lauren Griffith for her assistance in the interpretation of the statistical analyses. We kindly acknowledge the support of the vendors for providing glucose devices and reagents, and for the training of the technologists. We are also grateful to all the nurses and technologists who helped in this study.

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 played no role in thestudy design; in the collection, analysis, and interpretationof data; in the writing of the report; or in the decision tosubmit the report for publication.

Research funding: Funding was provided to LW by a Resident Research Grant from the Department of Pathology and Molecular Medicine, Faculty of Health Sciences, McMaster University. Nova Biomedical Co. kindly provided two Nova StatStrip glucose monitors and test strips for this study; Abbott Co. provided Abbott PXP test strips for this study.

Employment or leadership: None declared.

Honorarium: Dr. L. Sievenpiper has received travel expenses and honoraria from Abbott Laboratories Ltd. in relation to nutrition consulting work which is unrelated to this paper. Dr. Fusch has received an honorarium for a workshop on infant nutrition from Abbott Laboratories Ltd. which is unrelated to this paper. None of the other authors report any conflicts of interest related to this paper.

Contributor’s statement: Dr. Li Wang and Dr. John L. Sievenpiper cowrote the manuscript; Drs. Li Wang, Cynthia Balion, Vijaylaxmi Grey, Christoph Fusch and Susan Blatz conceived and designed the research; Drs. Li Wang, John L. Sievenpiper and Vijaylaxmi Grey conducted the research; Drs. Christoph Fusch, Michele Thomaz and Susan Blatz coordinated participant recruitment. Dr. Russell J. de Souza assisted in statistical analysis and contributed to writing of the manuscript. All authors critically revised the manuscript for important intellectual content and approved the final version of the manuscript for publication.

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Received: 2012-07-04

Accepted: 2013-01-22

Published Online: 2013-02-18

Published in Print: 2013-08-01

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Articles in the same Issue

https://doi.org/10.1515/cclm-2012-0436

Keywords for this article

acceptable performance criteria; glucose monitor; hematocrit; neonatal hypoglycemia; point of care (POC)