Evaluation of the point-of-care devices KetoSureTM and StatStrip Express® blood ketone tests using ß-hydroxybutyrate spiked samples.

Measurement of ß-hydroxybutyrate (BHB) in blood is used clinically as a measure of ketosis when diabetic ketoacidosis is expected. With the introduction of point-of-care testing (POCT) for blood-BHB, nonproductive time is reduced to a minimum in a potential critical situation; however, studies have observed inferior quality of POCT-BHB. Recently, the POCT device KetoSure (Roche) has been introduced to the clinic. In this study, we evaluated the imprecision and linearity of KetoSure and compared this to the established StatStrip Express (Nova Biomedical) based on spiked full blood samples. We found comparable imprecision for KetoSure and StatStrip Express. However, linearity was only observed in the lower part of the measuring range for both devices. In a method comparison, higher values of BHB were measured by KetoSure than by an enzymatic endpoint spectrophotometric reference method (mean bias: 21% (95% confidence interval (CI): 4%-37%)). Conversely, StatStrip Express returned lower values of BHB (mean bias: -16% (95% CI: -38%-7%), while the widely applied POCT device FreeStyle Precision Neo (Abbott) returned values equivalent with the reference method (mean bias: 5% (95% CI: -14%-24%). In samples with concentrations of BHB above the measuring range, the POCT devices could be provoked to return falsely low results. In conclusion, the quality of KetoSure is in line with other established POCT devices; however, the KetoSure measures higher concentrations than other POCT devices. As, linearity only was observed in the lower part of the measuring range and as falsely low measures could be provoked, we advise users to interpret results with precaution.

Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting.

OBJECTIVES: The glycated haemoglobin fraction A1c (HbA1c) is widely used in the management of diabetes mellitus, and the Siemens DCA Vantage™ point-of-care testing (POCT) instrument offers rapid HbA1c results even far from a clinical laboratory. However, the analytical performance has been questioned, and not much is known about effects of changing reagent lot, instrument and operator. We therefore compared the analytical performance of the DCA Vantage™ with established routine methods (Tosoh G8/G11 ion exchange HPLC) in a true clinical setting at two Danish hospitals. METHODS: We extracted all routine clinical HbA1c results incidentally drawn from the same patient within 48 h (n=960 pairs) and evaluated the effect of reagent lot, operator and instrument. We also performed a prospective method comparison in our diabetes out-patient clinic (n=97). RESULTS: The critical difference (CD) between two POCT results varied between 5.14 and 6.61 mmol/mol (0.47-0.55%), and the analytical imprecision of the DCA Vantage™ (CVA) was >3%. Significant effect of reagent lot and inter-instrument differences were found, whereas no effect of operator was seen. CONCLUSIONS: The DCA Vantage™ HbA1c analysis does not fulfil the prevailing analytical performance specifications, but rigorous validation of new reagent lots and continuous recalibration of instruments may potentially improve the precision substantially. Our findings, therefore, clearly emphasise the necessity of a close collaboration between clinicians and laboratory professionals in the POCT field. Finally, POCT HbA1c results should always be interpreted together with other measures of glycaemic control to avoid inappropriate change of patient treatments due to measurement uncertainty.

An evaluation of total 25-hydroxyvitamin D assay standardization: Where are we today?

BACKGROUND: Serum total 25-hydroxyvitamin D is a measure of the total circulating 25-hydroxyvitamin D concentration and is the primary measurement for estimating vitamin D status. A number of automated immunoassays are commercially available, and in an attempt to standardize the assays the Vitamin D Standardization Program (VDSP) was established in 2010. Therefore, the aim of the current project is to evaluate the status of the standardization of routinely used 25-hydroxyvitamin D assays. METHODS: 200 patient serum samples were measured in Spring 2017 on seven different assays for 25-hydroxyvitamin D. Samples were measured in duplicate for the evaluation of precision. A certified standard reference material (SRM972a) from The National Institute of Standardization and Technology (NIST) was measured to evaluate the accuracy of the assays. Finally, the agreement of the assays of clinically categorizing patients into vitamin D deficiency, inadequacy or adequacy was evaluated. RESULTS: All seven assays achieved precision below the VDSP requirement of CV < 10%. However, only two of the assays achieved an accuracy bias <5% when measuring the SRM972a. When comparing methods using Deming regression, substantial proportional and/or systematic bias was found between many of the assays. Finally, when evaluating the ability of the assays to categorize patients into "vitamin D deficiency" (25-hydroxyvitamin D concentration < 30 nmol/L (<12 ng/mL)), "vitamin D inadequacy" (30-50 nmol/L (12-20 ng/mL)), "vitamin D adequacy" (50-250 nmol/L (20-100 ng/mL)) and "risk of toxicity" (>250 nmol/L (>100 ng/mL)), clinically relevant differences between assays were detected. Especially in the deficiency group, major discrepancies were found as the percentage of patients ranged from 1.5%-14.3% between the assays.. CONCLUSIONS: In conclusion, some of the commercially available assays have been standardized with performance as required by the VDSP. However, several of the assays do still not comply with the VDSP requirements even eight years after the program was started. This may have clinical consequences for patients, and manufacturers are therefore encouraged to continue their work on standardizing serum 25-hydroxyvitamin D assays.