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Clinical utility of Abbott Precision Xceed Pro® ketone meter in diabetic patients.
Pediatr Diabetes 2011; 12(7):649-55PD

Abstract

BACKGROUND

Diagnosis and management of diabetic ketoacidosis (DKA) often rely on the measurement of urine ketones along with blood glucose, anion gap, and pH. These values, however, do not reliably reflect the severity of ketoacidosis. The Abbott Precision Xceed Pro® meter is an FDA-approved device that quantitatively measures β-hydroxybutyrate (BOH) in whole blood. This study was undertaken to determine whether the ketone meter meets the analytical criteria to aid DKA diagnosis and management in the hospital.

METHODS

54 heparinized venous whole blood BOH concentrations from 27 diabetic patients were measured by the Abbott meter, and compared with the plasma BOH concentrations measured with Stanbio reagent (reference method). Measurements were done in the hospital central laboratory.

RESULTS

Of the 54 pairs of specimens analyzed, 17 pairs displayed a difference of >15% between the two methods. Nearly all discrepant points occurred when BOH >5 mmol/L (reference method). Linearity evaluation revealed that the meter is not linear from 0.0 to 8.0 mmol/L, contrary to the claim by the manufacturer. Further, we identified acetoacetate, a metabolite commonly present in DKA patients, as a potential interfering substance for the meter BOH measurement.

CONCLUSIONS

BOH measurements by the Abbott meter up to 3 mmol/L correlate well with the reference method, but become discrepant above that point. While this characteristic may be useful in the diagnosis of DKA, it may not allow clinicians to serially follow the response to therapy in hospitalized DKA patients with BOH values greater than 5 mmol/L (reference method).

Authors+Show Affiliations

Department of Laboratory Medicine, Children's Hospital Boston, Boston, MA, USA. heyu@geisinger.eduNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

22034832

Citation

Yu, Hoi-Ying Elsie, et al. "Clinical Utility of Abbott Precision Xceed Pro® Ketone Meter in Diabetic Patients." Pediatric Diabetes, vol. 12, no. 7, 2011, pp. 649-55.
Yu HY, Agus M, Kellogg MD. Clinical utility of Abbott Precision Xceed Pro® ketone meter in diabetic patients. Pediatr Diabetes. 2011;12(7):649-55.
Yu, H. Y., Agus, M., & Kellogg, M. D. (2011). Clinical utility of Abbott Precision Xceed Pro® ketone meter in diabetic patients. Pediatric Diabetes, 12(7), pp. 649-55. doi:10.1111/j.1399-5448.2011.00768.x.
Yu HY, Agus M, Kellogg MD. Clinical Utility of Abbott Precision Xceed Pro® Ketone Meter in Diabetic Patients. Pediatr Diabetes. 2011;12(7):649-55. PubMed PMID: 22034832.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical utility of Abbott Precision Xceed Pro® ketone meter in diabetic patients. AU - Yu,Hoi-Ying Elsie, AU - Agus,Michael, AU - Kellogg,Mark D, Y1 - 2011/03/29/ PY - 2011/11/1/entrez PY - 2011/11/1/pubmed PY - 2012/3/16/medline SP - 649 EP - 55 JF - Pediatric diabetes JO - Pediatr Diabetes VL - 12 IS - 7 N2 - BACKGROUND: Diagnosis and management of diabetic ketoacidosis (DKA) often rely on the measurement of urine ketones along with blood glucose, anion gap, and pH. These values, however, do not reliably reflect the severity of ketoacidosis. The Abbott Precision Xceed Pro® meter is an FDA-approved device that quantitatively measures β-hydroxybutyrate (BOH) in whole blood. This study was undertaken to determine whether the ketone meter meets the analytical criteria to aid DKA diagnosis and management in the hospital. METHODS: 54 heparinized venous whole blood BOH concentrations from 27 diabetic patients were measured by the Abbott meter, and compared with the plasma BOH concentrations measured with Stanbio reagent (reference method). Measurements were done in the hospital central laboratory. RESULTS: Of the 54 pairs of specimens analyzed, 17 pairs displayed a difference of >15% between the two methods. Nearly all discrepant points occurred when BOH >5 mmol/L (reference method). Linearity evaluation revealed that the meter is not linear from 0.0 to 8.0 mmol/L, contrary to the claim by the manufacturer. Further, we identified acetoacetate, a metabolite commonly present in DKA patients, as a potential interfering substance for the meter BOH measurement. CONCLUSIONS: BOH measurements by the Abbott meter up to 3 mmol/L correlate well with the reference method, but become discrepant above that point. While this characteristic may be useful in the diagnosis of DKA, it may not allow clinicians to serially follow the response to therapy in hospitalized DKA patients with BOH values greater than 5 mmol/L (reference method). SN - 1399-5448 UR - https://www.unboundmedicine.com/medline/citation/22034832/Clinical_utility_of_Abbott_Precision_Xceed_Pro®_ketone_meter_in_diabetic_patients_ L2 - https://doi.org/10.1111/j.1399-5448.2011.00768.x DB - PRIME DP - Unbound Medicine ER -