Estimated glomerular filtration rate using a point of care measure of creatinine in patients with iohexol determinate GFR

Stojkovic, Violeta; Delanaye, Pierre; Collard, Gregory; Ferrante, Nunzio; Goff, Caroline Le; Lutteri, Laurence; Cavalier, Étienne

doi:10.1016/j.cca.2019.08.032

Cited by 14 publications

(12 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Todos estos resultados están en consonancia con los obtenidos por diversos autores (13,14) que apoyan el buen rendimiento diagnóstico de NSS en la determinación de creatinina.…”

Section: Discussionunclassified

Validación del medidor de creatinina sanguínea Nova StatSensor Xpress® en una farmacia comunitaria

Guerrero¹,

McGouh²,

Ramos³

et al. 2020

View full text Add to dashboard Cite

Introducción: en la farmacia comunitaria se realizan determinaciones de parámetros analíticos cada vez con más frecuencia. Los valores obtenidos son muy útiles en el trabajo de atención farmacéutica. Uno de ellos, la creatinina en sangre, puede ser especialmente útil para la detección y seguimiento de la enfermedad renal crónica. Además, permitiría sugerir al clínico la desprescripción o ajuste de dosis de determinados medicamentos nefrotóxicos o de eliminación renal en función del filtrado glomerular calculado. Se plantea valorar la utilidad de un nuevo aparato, el StatSensor Xpress Creatinine® de Nova Biomedical como paso previo a la realización de un estudio sobre la posibilidad de implantar un servicio con estas características. Material y métodos: a partir de una muestra de sangre proporcionada por uno de los investigadores y una solución control de creatinina se preparan 35 muestras que son analizadas con el aparato problema. Otras 35 muestras alícuotas de las primeras son analizadas por un laboratorio de referencia. Se evalúan la exactitud, rendimiento diagnóstico y precisión mediante las pruebas Passing Bablock, coeficiente de correlación de Lin, Bland Altman, sensibilidad y especificidad diagnóstica y coeficiente de variación. Resultados: la prueba de Passing Bablock y el coeficiente de Lin son correctos. Bland Altman es estadísticamente significativa en valores superiores a 5 mg/dl. La sensibilidad y especificidad diagnósticas son del 100 % y el coeficiente de variación es menor del 5 %. Conclusión: el analizador de mano StatSensor Xpress Creatinine® es válido en el rango de valores habituales en farmacia comunitaria.

show abstract

“…Todos estos resultados están en consonancia con los obtenidos por diversos autores (13,14) que apoyan el buen rendimiento diagnóstico de NSS en la determinación de creatinina.…”

Section: Discussionunclassified

Validación del medidor de creatinina sanguínea Nova StatSensor Xpress® en una farmacia comunitaria

Guerrero¹,

McGouh²,

Ramos³

et al. 2020

View full text Add to dashboard Cite

show abstract

“…Twenty-six studies reported measurement bias or correlation results for a StatSensor POC device 14,28,30-32, 36,37,39-46,53,62,67,69-76 Eight studies were available only as a conference abstract. 40,43,45,53,[70][71][72]74 A large majority of studies were of the StatSensor or StatSensor-i model, with six studies being of the StatSensor Xpress (or Xpress-I) model. 28,39,42,44,53,76 Sample sizes ranged from 15 to 1467 patients.…”

Section: Studies Of Statsensor Devicesmentioning

confidence: 99%

“…Most studies reported measurement bias results based on levels of creatinine, with only three studies reporting results based on eGFR. 30,62,70 Among the studies that either explicitly reported mean measurement bias results or for which an indication of mean bias could be derived from Bland-Altman plots, there appeared to be no clear trend in terms of the direction of bias, with nearly as many studies reporting positive bias (in StatSensor creatinine measurements) as reporting negative bias. Only two studies reported results following offset correction to adjust for bias.…”

Section: Studies Of Statsensor Devicesmentioning

confidence: 99%

“…Results from studies that use enzymatic laboratory methods are therefore preferable to those using Jaffe methods. Of the 10 studies 28,30,31,36,37,53,62,70,73,76 that used an enzymatic laboratory reference, five reported a positive measurement bias in creatinine levels when using StatSensor 28,30,37,53,70 and five reported a negative bias. 31,36,62,73,76 However, some bias results were reported only as percentage changes.…”

Section: Studies Of Statsensor Devicesmentioning

confidence: 99%

See 1 more Smart Citation

Point-of-care creatinine tests to assess kidney function for outpatients requiring contrast-enhanced CT imaging: systematic reviews and economic evaluation

Corbett

Duarte

Llewellyn

et al. 2020

Health Technol Assess

View full text Add to dashboard Cite

Background Patients with low estimated glomerular filtration rates may be at higher risk of post-contrast acute kidney injury following contrast-enhanced computed tomography imaging. Point-of-care devices allow rapid measurement of estimated glomerular filtration rates for patients referred without a recent estimated glomerular filtration rate result. Objectives To assess the clinical effectiveness and cost-effectiveness of point-of-care creatinine tests for outpatients without a recent estimated glomerular filtration rate measurement who need contrast-enhanced computed tomography imaging. Methods Three systematic reviews of test accuracy, implementation and clinical outcomes, and economic analyses were carried out. Bibliographic databases were searched from inception to November 2018. Studies comparing the accuracy of point-of-care creatinine tests with laboratory reference tests to assess kidney function in adults in a non-emergency setting and studies reporting implementation and clinical outcomes were included. Risk of bias of diagnostic accuracy studies was assessed using a modified version of the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Probabilities of individuals having their estimated glomerular filtration rates correctly classified were estimated within a Bayesian framework and pooled using a fixed-effects model. A de novo probabilistic decision tree cohort model was developed to characterise the decision problem from an NHS and a Personal Social Services perspective. A range of alternative point-of-care testing approaches were considered. Scenario analyses were conducted. Results Fifty-four studies were included in the clinical reviews. Twelve studies reported diagnostic accuracy for estimated glomerular filtration rates; half were rated as being at low risk of bias, but there were applicability concerns for most. i-STAT (Abbott Point of Care, Inc., Princeton, NJ, USA) and ABL (Radiometer Ltd, Crawley, UK) devices had higher probabilities of correctly classifying individuals in the same estimated glomerular filtration rate categories as the reference laboratory test than StatSensor® devices (Nova Biomedical, Runcorn, UK). There was limited evidence for epoc® (Siemens Healthineers AG, Erlangen, Germany) and Piccolo Xpress® (Abaxis, Inc., Union City, CA, USA) devices and no studies of DRI-CHEM NX 500 (Fujifilm Corporation, Tokyo, Japan). The review of implementation and clinical outcomes included six studies showing practice variation in the management decisions when a point-of-care device indicated an abnormal estimated glomerular filtration rate. The review of cost-effectiveness evidence identified no relevant studies. The de novo decision model that was developed included a total of 14 strategies. Owing to limited data, the model included only i-STAT, ABL800 FLEX and StatSensor. In the base-case analysis, the cost-effective strategy appeared to be a three-step testing sequence involving initially screening all individuals for risk factors, point-of-care testing for those individuals with at least one risk factor, and including a final confirmatory laboratory test for individuals with a point-of-care-positive test result. Within this testing approach, the specific point-of-care device with the highest net benefit was i-STAT, although differences in net benefit with StatSensor were very small. Limitations There was insufficient evidence for patients with estimated glomerular filtration rates < 30 ml/minute/1.73 m2, and on the full potential health impact of delayed or rescheduled computed tomography scans or the use of alternative imaging modalities. Conclusions A three-step testing sequence combining a risk factor questionnaire with a point-of-care test and confirmatory laboratory testing appears to be a cost-effective use of NHS resources compared with current practice. The risk of contrast causing acute kidney injury to patients with an estimated glomerular filtration rate of < 30 ml/minute/1.73 m2 is uncertain. Cost-effectiveness of point-of-care testing appears largely driven by the potential of point-of-care tests to minimise delays within the current computed tomography pathway. Future work Studies evaluating the impact of risk-stratifying questionnaires on workflow outcomes in computed tomography patients without recent estimated glomerular filtration rate results are needed. Study registration This study is registered as PROSPERO CRD42018115818. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 39. See the NIHR Journals Library website for further project information.

show abstract

“…Although most previous studies evaluating the performance of the StatSensor were performed in the prestandardization era, recently a study evaluated the StatSensor for the purposes of screening prior to intravenous contrast use. 22 The authors compared the creatinine measured by the StatSensor with those obtained from plasma laboratory method. In addition, CKD-EPI eGFR calculated from StatSensor and plasma creatinine were compared with GFR measure by iohexol plasma clearance.…”

Section: Amentioning

confidence: 99%

Performance of StatSensor Point-of-Care Device for Measuring Creatinine in Patients With Chronic Kidney Disease and Postkidney Transplantation

Nataatmadja

Fung

Jacobson³

et al. 2020

Can J Kidney Health Dis

View full text Add to dashboard Cite

Background: The StatSensor is a point-of-care device which measures creatinine in capillary whole blood. Previous studies reported an underestimation of the creatinine measurements at high creatinine concentrations and were performed in the prestandardization era for creatinine. Objective: This accuracy-based study evaluates the use of this device in kidney-transplanted patients and those with chronic kidney disease (CKD). Design: Cross-sectional diagnostic accuracy study. Setting: Nephrology outpatient clinic in an urban tertiary center. Participants: Adults with CKD or a functioning kidney transplant. Measurements: Duplicate StatSensor creatinine measurements were performed on capillary whole blood samples collected by direct fingerstick and SAFE-T-FILL collection device. Results were compared with simultaneous venous blood sampling for serum and plasma creatinine measured by an enzymatic method on the Roche Integra 400 mainframe analyzer with traceability to the ID-GC-MS (isotope dilution gas chromatography mass spectrometry) reference method. Methods: Deming regression, Pearson correlation coefficient, and Bland-Altman analysis were used to assess accuracy and comparability between capillary whole blood measured by StatSensor and plasma creatinine measured by routine analyzer with traceability to the reference method. Estimated glomerular filtration (eGFR) rates were calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation and concordance with Kidney Disease Improving Global Outcomes (KDIGO) CKD stage classification was evaluated. Results: There were 60 participants (mean age = 61.9 ± 15.0 years, 55% men, 33% transplant, mean plasma creatinine = 137 ± 59 µmol/L). Bland-Altman analysis indicated a positive mean bias of 12.7 µmol/L between StatSensor fingerstick creatinine measurement and plasma creatinine. Comparison of eGFR (CKD-EPI) calculated from the StatSensor fingerstick creatinine versus plasma creatinine showed misclassification across all KDIGO CKD stages. Postanalytical correction of the bias did not improve misclassifications. The use of mean of duplicate StatSensor creatinine results did not improve performance compared with the use of singlet results. Limitations: Single center, limited participant numbers. Conclusions: The results of our study suggest that the limiting characteristics of the StatSensor device are not only bias, but also imprecision. The level of imprecision observed may influence clinical decision-making and limit the usefulness of StatSensor as a CKD screening tool. If choosing to utilize it for either screening for or monitoring CKD, it is essential that clinicians understand the limitations of point-of-care devices and apply this knowledge to test interpretation.

show abstract

Estimated glomerular filtration rate using a point of care measure of creatinine in patients with iohexol determinate GFR

Cited by 14 publications

References 20 publications

Validación del medidor de creatinina sanguínea Nova StatSensor Xpress® en una farmacia comunitaria

Validación del medidor de creatinina sanguínea Nova StatSensor Xpress® en una farmacia comunitaria

Point-of-care creatinine tests to assess kidney function for outpatients requiring contrast-enhanced CT imaging: systematic reviews and economic evaluation

Performance of StatSensor Point-of-Care Device for Measuring Creatinine in Patients With Chronic Kidney Disease and Postkidney Transplantation

Contact Info

Product

Resources

About