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Evaluation of the Nova StatSensor® Xpress(TM) Creatinine point-of-care handheld analyzer.

Kosack CS, de Kieviet W, Bayrak K, Milovic A, Page AL - PLoS ONE (2015)

Bottom Line: The concordance correlation agreement was good except for high values (>600 µmol/L).The Nova StatSensor Xpress Creatinine analyzers showed acceptable to good results in terms of repeatability, inter-device reproducibility and between-run reproducibility over time using quality control reagents.The analyzer was found sufficiently accurate for detecting pathological values in patients (age >10 year) and can be used with a moderate risk of misclassification.

View Article: PubMed Central - PubMed

Affiliation: Diagnostic Network, Médecins sans Frontières, Amsterdam, Netherlands.

ABSTRACT
Creatinine is a parameter that is required to monitor renal function and is important to follow in patients under treatment with potentially toxic renal drugs, such as the anti-HIV drug Tenofovir. A point of care instrument to measure creatinine would be useful for patients monitoring in resource-limited settings, where more instruments that are sophisticated are not available. The StatSensor Xpress Creatinine (Nova Biomedical Cooperation, Waltham, MA, USA) point of care analyzer was evaluated for its diagnostic performance in indicating drug therapy change. Creatinine was measured in parallel using the Nova StatSensor Xpress Creatinine analyzer and the Vitros 5,1FS (Ortho Clinical Diagnostics, Inc, Rochester, USA), which served as reference standard. The precision (i.e., repeatability and reproducibility) and accuracy of the StatSensor Xpress Creatinine analyzer were calculated using a panel of specimens with normal, low pathological and high pathological values. Two different Nova StatSensor Xpress Creatinine analyzers were used for the assessment of accuracy using repeated measurements. The coefficient of variation of the StatSensor Xpress Creatinine analyzers ranged from 2.3 to 5.9% for repeatability and from 4.2 to 9.0% for between-run reproducibility. The concordance correlation agreement was good except for high values (>600 µmol/L). The Bland-Altman analysis in high pathological specimens suggests that the Nova StatSensor Xpress Creatinine test tends to underestimate high creatinine values (i.e., >600 µmol/L). The Nova StatSensor Xpress Creatinine analyzers showed acceptable to good results in terms of repeatability, inter-device reproducibility and between-run reproducibility over time using quality control reagents. The analyzer was found sufficiently accurate for detecting pathological values in patients (age >10 year) and can be used with a moderate risk of misclassification.

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Scatter plot of Nova StatSensor Xpress Creatinine analyzer vs. Vitros 5,1FS (Ortho Clinical Diagnostics, Rochester, USA) measurements.
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pone.0122433.g001: Scatter plot of Nova StatSensor Xpress Creatinine analyzer vs. Vitros 5,1FS (Ortho Clinical Diagnostics, Rochester, USA) measurements.

Mentions: Using patient specimens, the graphic representation of the comparison of the means of repeated measurements on the two analyzers and the reference method with the y = x line shows that the agreement is good except for high values (>600 μmol/L with the reference method), where the Nova StatSensor Xpress Creatinine analyzers seem to reach a plateau (Fig 1).


Evaluation of the Nova StatSensor® Xpress(TM) Creatinine point-of-care handheld analyzer.

Kosack CS, de Kieviet W, Bayrak K, Milovic A, Page AL - PLoS ONE (2015)

Scatter plot of Nova StatSensor Xpress Creatinine analyzer vs. Vitros 5,1FS (Ortho Clinical Diagnostics, Rochester, USA) measurements.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4401790&req=5

pone.0122433.g001: Scatter plot of Nova StatSensor Xpress Creatinine analyzer vs. Vitros 5,1FS (Ortho Clinical Diagnostics, Rochester, USA) measurements.
Mentions: Using patient specimens, the graphic representation of the comparison of the means of repeated measurements on the two analyzers and the reference method with the y = x line shows that the agreement is good except for high values (>600 μmol/L with the reference method), where the Nova StatSensor Xpress Creatinine analyzers seem to reach a plateau (Fig 1).

Bottom Line: The concordance correlation agreement was good except for high values (>600 µmol/L).The Nova StatSensor Xpress Creatinine analyzers showed acceptable to good results in terms of repeatability, inter-device reproducibility and between-run reproducibility over time using quality control reagents.The analyzer was found sufficiently accurate for detecting pathological values in patients (age >10 year) and can be used with a moderate risk of misclassification.

View Article: PubMed Central - PubMed

Affiliation: Diagnostic Network, Médecins sans Frontières, Amsterdam, Netherlands.

ABSTRACT
Creatinine is a parameter that is required to monitor renal function and is important to follow in patients under treatment with potentially toxic renal drugs, such as the anti-HIV drug Tenofovir. A point of care instrument to measure creatinine would be useful for patients monitoring in resource-limited settings, where more instruments that are sophisticated are not available. The StatSensor Xpress Creatinine (Nova Biomedical Cooperation, Waltham, MA, USA) point of care analyzer was evaluated for its diagnostic performance in indicating drug therapy change. Creatinine was measured in parallel using the Nova StatSensor Xpress Creatinine analyzer and the Vitros 5,1FS (Ortho Clinical Diagnostics, Inc, Rochester, USA), which served as reference standard. The precision (i.e., repeatability and reproducibility) and accuracy of the StatSensor Xpress Creatinine analyzer were calculated using a panel of specimens with normal, low pathological and high pathological values. Two different Nova StatSensor Xpress Creatinine analyzers were used for the assessment of accuracy using repeated measurements. The coefficient of variation of the StatSensor Xpress Creatinine analyzers ranged from 2.3 to 5.9% for repeatability and from 4.2 to 9.0% for between-run reproducibility. The concordance correlation agreement was good except for high values (>600 µmol/L). The Bland-Altman analysis in high pathological specimens suggests that the Nova StatSensor Xpress Creatinine test tends to underestimate high creatinine values (i.e., >600 µmol/L). The Nova StatSensor Xpress Creatinine analyzers showed acceptable to good results in terms of repeatability, inter-device reproducibility and between-run reproducibility over time using quality control reagents. The analyzer was found sufficiently accurate for detecting pathological values in patients (age >10 year) and can be used with a moderate risk of misclassification.

Show MeSH
Related in: MedlinePlus