Background: Inaccuracy in glucose POCT can lead to inappropriate therapeutic decisions. Here we evaluated the performance of three POCT glucometers by comparing results to those by an automated system traceable to higher-order references. Methods: 31 heparinized venous blood samples were collected and assayed in duplicate for whole blood glucose concentrations with Roche Accu-Check Compact Plus, Nova Biomedical NovaPro and OKBiotech OKmeterDirect glucometers. All systems were calibrated to report plasma-equivalent results. Samples were then centrifuged and plasma glucose was immediately determined by the hexokinase assay on Abbott Architect c16000 platform. The traceability of Abbott assay was checked by comparison with the hexokinase reference procedure performed on three samples. POCT performance was evaluated according to CLSI POCT12-A3 criteria [max 5% of results >±12 mg/dL (for reference results <100 mg/dL) or >±12.5% (for reference results ≥100 mg/dL)] and consensus error grid (CEG) analysis. Results: The Abbott assay was perfectly standardized (mean bias, 0.13%). Sample glucose concentrations were from 62 to 326 mg/dL, with haematocrit spanning from 0.27 to 0.58 L/L. Average CV on duplicates was 2.2% Roche, 3.3% Nova and 5.9% OKBiotech. All meters gave more than 5% of results (Roche 19.4%, Nova 16.1% and OKBiotech 22.6%) outside the CLSI criteria. However, all results, except two borderline values for OKBiotech, were within the low-risk zone according to CEG. Conclusions: By using CLSI acceptability criteria, the evaluated glucometers were not accurate enough for clinical use. CEG analysis suggests, however, that this inaccuracy would not have any significant impact on patient outcome. Sacks DB, Bruns DE, Horton J et al. Point-of-care blood glucose testing in acute and chronic care facilities; approved guideline – Third edition. The Clinical and Laboratory Standards Institute 2013, document POCT12-A
Verification of the accuracy of three glucose point-of-care testing (POCT) devices for their use in a hospital setting / E. Aloisio, E. Frusciante, A. Dolci, M. Panteghini. - In: BIOCHIMICA CLINICA. - ISSN 0393-0564. - 40 Special Supplement:4(2016), pp. P003.39-P003.39. ((Intervento presentato al 48. convegno Congresso Nazionale SIBioC tenutosi a Torino nel 2016.
Verification of the accuracy of three glucose point-of-care testing (POCT) devices for their use in a hospital setting
E. AloisioPrimo
;A. Dolci;M. PanteghiniUltimo
2016
Abstract
Background: Inaccuracy in glucose POCT can lead to inappropriate therapeutic decisions. Here we evaluated the performance of three POCT glucometers by comparing results to those by an automated system traceable to higher-order references. Methods: 31 heparinized venous blood samples were collected and assayed in duplicate for whole blood glucose concentrations with Roche Accu-Check Compact Plus, Nova Biomedical NovaPro and OKBiotech OKmeterDirect glucometers. All systems were calibrated to report plasma-equivalent results. Samples were then centrifuged and plasma glucose was immediately determined by the hexokinase assay on Abbott Architect c16000 platform. The traceability of Abbott assay was checked by comparison with the hexokinase reference procedure performed on three samples. POCT performance was evaluated according to CLSI POCT12-A3 criteria [max 5% of results >±12 mg/dL (for reference results <100 mg/dL) or >±12.5% (for reference results ≥100 mg/dL)] and consensus error grid (CEG) analysis. Results: The Abbott assay was perfectly standardized (mean bias, 0.13%). Sample glucose concentrations were from 62 to 326 mg/dL, with haematocrit spanning from 0.27 to 0.58 L/L. Average CV on duplicates was 2.2% Roche, 3.3% Nova and 5.9% OKBiotech. All meters gave more than 5% of results (Roche 19.4%, Nova 16.1% and OKBiotech 22.6%) outside the CLSI criteria. However, all results, except two borderline values for OKBiotech, were within the low-risk zone according to CEG. Conclusions: By using CLSI acceptability criteria, the evaluated glucometers were not accurate enough for clinical use. CEG analysis suggests, however, that this inaccuracy would not have any significant impact on patient outcome. Sacks DB, Bruns DE, Horton J et al. Point-of-care blood glucose testing in acute and chronic care facilities; approved guideline – Third edition. The Clinical and Laboratory Standards Institute 2013, document POCT12-A
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