Investigating Interferences of a Whole-Blood Point-of-Care Creatinine Analyzer: Comparison to Plasma Enzymatic and Definitive Creatinine Methods in an Acute-Care Setting

Straseski, Joely A.; Lyon, Martha E.; Clarke, William; DuBois, Jeffrey A.; Phelan, Lois A.; Lyon, Andrew W.

doi:10.1373/clinchem.2011.165480

Cited by 29 publications

(41 citation statements)

References 25 publications

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“…This may have resulted in an improved correlation coefficient for samples with sCr value <3.0 mg/dl. The present study did not evaluate other laboratory values, although glucose interference (≥200 mg/dl) results in higher sCr levels (20) and red blood cell, plasma water fractions and hematocrit explain 91.8% of differences in sCr values obtained with the STA analyzer (21). Finally, the present study could not ascertain whether the eGFR was <30 ml/min/1.73 m 2 both prior to and following adjustment, as few samples were available from patients with an eGFR <30 ml/min/1.73 m 2 .…”

Section: Discussionmentioning

confidence: 81%

StatSensor-i point-of-care creatinine analyzer may identify patients at high-risk of contrast-induced nephropathy

Inoue

Nitta

Ohta

et al. 2017

Experimental and Therapeutic Medicine

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Abstract. The current study assessed the accuracy of the StatSensor-i (STA) point-of-care creatinine analyzer prior to and following adjustment (offset correction) by linear regression scatter plots produced by the reference samples from patients and volunteers for detecting high risk of contrast-induced nephropathy in patients with an estimated glomerular filtration rate <45 ml/min/1.73 m 2 . Blood samples were obtained from 233 consecutive outpatients scheduled for contrast-enhanced CT studies. Of the 233 patients, 123 patient samples were evaluated prior to adjustment and the other 110 following adjustment. Serum creatinine levels and estimated glomerular filtration rate were measured using the analyzer and compared with the values returned by laboratory tests. Analysis was with the paired t-test, the Pearson correlation coefficient and Bland-Altman plotting. The sensitivity, specificity, positive and negative predictive values (PPV, NPV), and accuracy for detecting patients with an estimated glomerular filtration rate <45 ml/min/1.73 m 2 were subsequently calculated. Mean serum creatinine levels measured with the analyzer were significantly higher than those returned by laboratory tests before (P<0.0001) and after adjustment (P<0.01). Following adjustment, the difference in serum creatinine values obtained with the STA analyzer and by laboratory methods did not exceed 0.3 mg/dl. Prior to adjustment, 9.7% of the samples were overdiagnosed as having an estimated glomerular filtration rate of <45 ml/min/1.73 m 2 ; following adjustment, the overdiagnosis rate was 2.7%. The sensitivity, specificity, PPV, NPV and accuracy were 100, 89, 50, 100 and 90.2% before and 100, 96.3, 33.3, 100 and 96.4% after adjustment, respectively. With the adjusted point-of-care creatinine analyzer, estimated glomerular filtration rate may be reliably evaluated in the radiology suite.

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Section: Discussionmentioning

confidence: 81%

StatSensor-i point-of-care creatinine analyzer may identify patients at high-risk of contrast-induced nephropathy

Inoue

Nitta

Ohta

et al. 2017

Experimental and Therapeutic Medicine

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“…failed to explain the discrepancy. 15 Nichols et al compared the I-STAT and IRMA TRUpoint analyzers with Jaffe and enzymatic creatinine methods using 49 samples and found significant positive bias with I-STAT (0.16 mg/dL for Jaffe and 0.22 mg/dL for enzymatic) but no significant bias found with IRMA TRUpoint. 16 We initially thought that a chemotherapeutic agent might have been the cause of the observed intermethod bias by either affecting the biosensor or affecting the molality to molarity conversion, but this was not confirmed by our results.…”

Section: Discussionmentioning

confidence: 99%

Investigation of Falsely Decreased Creatinine Results Observed From the Abbott I-STAT Point-of-Care Device in Use for Testing Specimens From Ambulatory Oncology Patients

Bahar

DeChristopher

Holmes

et al. 2016

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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The goals of this study were to assess the use of the I-STAT for blood creatinine measurement in oncology patients and to determine whether chemotherapy or other factors contributed to the discrepant point-of-care creatinine test results observed in specimens from patients in ambulatory oncology settings. Our studies led us to consider other possible causes of observed discrepancies beyond the effects of chemotherapeutic drugs, including lot-to-lot variation in I-STAT reagent cartridges.S erum and plasma creatinine concentrations are common indices of renal function in clinical practice. 1 Renal impairment in oncology patients often results in the need to measure blood creatinine measurements to assess renal function before the start of chemotherapy. 2 In 2011, we observed multiple instances of discrepancies between creatinine results measured using the I-STAT (Abbott Diagnostics, Abbott Park, IL) at 3 ambulatory oncology sites within our health system compared to results obtained in our core laboratory (CL). At that time, results from the I-STAT were 30% to 70% lower than the patients' creatinine results measured in the CL. Approximately during this same time period, other sites, some ambulatory oncology sites, also reported similar creatinine intermethod discrepancies on the American Association for Clinical Chemistry's point-of-care testing (POCT) listserv. 3 The goals of this study were to assess the use of the I-STAT for blood creatinine measurement in oncology patients and to determine whether chemotherapy or other factors contributed to the discrepant point-of-care (POC) creatinine test results observed in specimens from patients in ambulatory oncology settings. Our studies led us to consider other possible causes of observed discrepancies beyond the effects of chemotherapeutic drugs, including lot-to-lot variation in I-STAT reagent cartridges.

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“…In other tests, standardization, traceability, and improvement of the reagents used should be the focus that can diminish the bias between different tests of different vendors [5,17]. The discussion is still open as to whether different analytical performance standards might be acceptable between central laboratory tests and point of care tests such as in the determination of cardiac peptides or creatinine [18,19].…”

Section: Challenges Of Hta For Diagnostic Proceduresmentioning

confidence: 99%

Are regulation-driven performance criteria still acceptable? – The German point of view

Orth¹

2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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Performance criteria should be a challenge for the laboratories to improve their quality. In countries with mandatory proficiency testing, the definition of performance criteria is a particular issue. If the definition of performance criteria is mandated from the regulatory bodies to medicoscientific institutions, scientific approaches (i.e., based on biological variation), the state-of-the-art approach (i.e., based on technical feasibility) as well as medical needs can be used to set up performance criteria such as the Richtlinie der Bundesärztekammer (RiliBÄK; Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Examinations) in Germany. The experiences with RiliBÄK show that these performance criteria have to be revised on an ongoing basis.

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Investigating Interferences of a Whole-Blood Point-of-Care Creatinine Analyzer: Comparison to Plasma Enzymatic and Definitive Creatinine Methods in an Acute-Care Setting

Cited by 29 publications

References 25 publications

StatSensor-i point-of-care creatinine analyzer may identify patients at high-risk of contrast-induced nephropathy

StatSensor-i point-of-care creatinine analyzer may identify patients at high-risk of contrast-induced nephropathy

Investigation of Falsely Decreased Creatinine Results Observed From the Abbott I-STAT Point-of-Care Device in Use for Testing Specimens From Ambulatory Oncology Patients

Are regulation-driven performance criteria still acceptable? – The German point of view

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