Commutability of a Whole-Blood External Quality Assessment Material for Point-of-Care C-Reactive Protein, Glucose, and Hemoglobin Testing

Abstract

BACKGROUND The optimal situation in external quality assessment (EQA) is to use commutable materials. No previous study has examined the commutability of a whole-blood material for point-of-care (POC) testing. The aim of this study was to determine the commutability of the Norwegian Quality Improvement of Laboratory Examinations (Noklus) organization's “in-house” whole-blood EQA material for C-reactive protein (CRP), glucose, and hemoglobin for frequently used POC instruments in Norway and to determine the possibility of using a common target value for each analyte. METHODS The study was performed according to the Clinical and Laboratory Standards Institute guidelines. The EQA material was pooled stabilized EDTA venous whole-blood containing different concentrations of the analytes. The EQA material and native routine patient samples were analyzed using 17 POC and 3 hospital instruments. The commutability was assessed using Deming regression analysis with 95% prediction intervals for each instrument comparison. RESULTS The EQA material was commutable for all CRP and hemoglobin POC instruments, whereas for glucose the material was commutable for all POC instruments at the lowest concentration analyzed [126.0 mg/dL (7.0 mmol/L)] and for 3 POC instruments at all of the concentrations analyzed. CONCLUSIONS Noklus EQA participants using CRP and hemoglobin POC instruments now receive results that are compared with a reference target value, whereas the results for participants using glucose POC instruments are still compared with method-specific target values. Systematic deviations from a reference target value for the commutable glucose POC instruments can be calculated, and this additional information can now be offered to these participants and to the manufacturers.

Messqualität bei der Glukosemessung im Rahmen der Diabetesdiagnose und -therapie in Deutschland

“…Daher kommen glukosestabilisierende Zusätze bei Ringversuchsproben zum Einsatz. Solche Zusätze können aber zu Störungen bei der Glukosemessung führen, im Sinne von analytischen Interferenzen [12][13][14]…”

“…Daher kommen glukosestabilisierende Zusätze bei Ringversuchsproben zum Einsatz. Solche Zusätze können aber zu Störungen bei der Glukosemessung führen, im Sinne von analytischen Interferenzen 12 13 14 . Das Ausmaß des Einflusses auf die Messergebnisse hängt von der eingesetzten Messmethode ab 14 .…”

“…. Das Ausmaß des Einflusses auf die Messergebnisse hängt von der eingesetzten Messmethode ab[14].Die Kommutabilität eines Kontrollmaterials beschreibt eine Probeneigenschaft, die gewährleisten soll, dass der Vergleich von Messergebnissen zweier Methoden bei einem Methodenvergleich unter Verwendung dieser Kontrollproben zu dem gleichen Ergebnis führt wie die Verwendung von Patientenproben. Kommutables Ringversuchsmaterial für die externe Qualitätssicherung bereitzustellen liegt in der Verantwortung der Ringversuchsorganisationen.…”

A strategy for low-cost portable monitoring of plasma drug concentrations using a sustainable boron-doped-diamond chip

“…A scatter plot indicated that the slope of Deming regression was 0.88 ( Fig. 5 b), which likely rivals the performance of commercially available sensors for C-reactive protein, glucose, or haemoglobin [ 37 ]. In the Bland−Altman plot ( Fig.…”

Improving the Bias of Comparator Methods in Analytical Performance Assessments Through Recalibration

“…Especially with POC or OTC BGMS, aqueous, serum, or plasma samples may not work, and whole-blood samples may have added preservatives for stabilization of glucose concentrations that might interfere with the measurement. 8 An advantage is that reference materials, like NIST SRM, may be easier to access than higher-order methods, like a mass spectrometry.…”