Evaluation of the Nova StatSensor® XpressTM Creatinine Point-Of-Care Handheld Analyzer

Hdl Handle:
http://hdl.handle.net/10144/550548
Title:
Evaluation of the Nova StatSensor® XpressTM Creatinine Point-Of-Care Handheld Analyzer
Authors:
Kosack, Cara Simone; de Kieviet, Wim; Bayrak, Kubra; Milovic, Anastacija; Page, Anne Laure
Journal:
PloS One
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.
Publisher:
Public Library of Science
Issue Date:
17-Apr-2015
URI:
http://hdl.handle.net/10144/550548
DOI:
10.1371/journal.pone.0122433
PubMed ID:
25886375
Language:
en
ISSN:
1932-6203
Appears in Collections:
Laboratory

Full metadata record

DC FieldValue Language
dc.contributor.authorKosack, Cara Simoneen_GB
dc.contributor.authorde Kieviet, Wimen_GB
dc.contributor.authorBayrak, Kubraen_GB
dc.contributor.authorMilovic, Anastacijaen_GB
dc.contributor.authorPage, Anne Laureen_GB
dc.date.accessioned2015-04-23T20:24:33Z-
dc.date.available2015-04-23T20:24:33Z-
dc.date.issued2015-04-17-
dc.identifier.citationEvaluation of the Nova StatSensor® XpressTM Creatinine Point-Of-Care Handheld Analyzer. 2015, 10 (4):e0122433 PLoS ONEen_GB
dc.identifier.issn1932-6203-
dc.identifier.pmid25886375-
dc.identifier.doi10.1371/journal.pone.0122433-
dc.identifier.urihttp://hdl.handle.net/10144/550548-
dc.description.abstractCreatinine 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.en_GB
dc.language.isoenen
dc.publisherPublic Library of Scienceen_GB
dc.rightsPublished by Public Library of Science, [url]http://www.plosone.org/[/url] Archived on this site by Open Access permissionen_GB
dc.titleEvaluation of the Nova StatSensor® XpressTM Creatinine Point-Of-Care Handheld Analyzeren
dc.identifier.journalPloS Oneen_GB

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