Assessment of the Nova StatSensor whole blood point-of-care creatinine analyzer for the measurement of kidney function in screening for chronic kidney disease

Shephard, Mark Douglas; Peake, M J; Corso, Olivia; Shephard, Anne; Mazzachi, Beryl; Spaeth, Brooke; Barbara, Jeffrey A J; Mathew, Timothy H.

doi:10.1515/cclm.2010.238

Cited by 39 publications

(70 citation statements)

References 17 publications

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“…It has previously been reported that the STA analyzer was highly sensitive in determining whether renal function was normal or impaired and that without adjustment, it may underestimate sCr levels (9,14). The present study demonstrates that it overestimates sCr with and without adjustment.…”

Section: Discussionsupporting

confidence: 54%

“…1), measures the sCr levels in blood samples in 30 sec. It is used to screen for chronic kidney disease (CKD) (9), adjusting doses of potentially toxic renal drugs whose administration requires renal function monitoring (10) and to monitor kidney transplant recipients (11). The instrument is also used for evaluating renal function in radiology suites (12)(13)(14).…”

Section: Introductionmentioning

confidence: 99%

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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: Discussionsupporting

confidence: 54%

Section: Introductionmentioning

confidence: 99%

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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“…Participants identified as at risk of CKD moved to step 2, where clinical measurements, including point-of-care creatinine testing (Stat Sensor) and urinalysis, were obtained. The StatSensor tool has demonstrated good sensitivity (96%) and moderate specificity (79%) for detecting CKD, and has been suggested for use in screening of CKD (13)(14)(15)(16). However, the single random urine dipstick measurement does not capture albuminuria, and thus CKD was defined using a single creatinine measurement.…”

Section: Overview Of the Seekd Screening Programmentioning

confidence: 99%

The See Kidney Disease Targeted Screening Program for CKD

Galbraith¹,

Ronksley²,

Barnieh

et al. 2016

CJASN

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Background and objectives The effectiveness of targeted screening for identification of CKD is largely unknown. The See Kidney Disease (SeeKD) targeted screening project aimed to determine the prevalence of unrecognized CKD in Canada.Design, setting, participants, & measurements The SeeKD project was conducted across Canada using a convenience sample approach and events to identify adults with risk factors for CKD (i.e., diabetes, hypertension, vascular disease, family history of kidney problems, etc.). Participants with at least one risk factor received a point-of-care creatinine measurement to identify unrecognized CKD (CKD-Epidemiology Collaboration eGFR ,60 ml/min per 1.73 m 2 ). Baseline information included clinical characteristics, sociodemographics, and health knowledge. Semistructured telephone interviews were conducted with each Kidney Foundation of Canada branch (regionalized locations) after the screening events to characterize local screening strategies, which were subsequently categorized as individual-targeted (specifically targeting individuals at risk of CKD) and community-targeted (event in a community location in proximity to a high-risk population). We calculated the prevalence of unrecognized CKD overall, and by screening strategy.Results Between January 2011 and February 2014, 6329 Canadians participated in SeeKD screening events. Participants were predominantly female (65.3%), middle-aged (mean, 58.5 years), and the majority (88.9%) selfreported at least one risk factor for CKD. Of participants with at least one risk factor, 92.3% (n=5194) were screened, of whom 18.8% (95% confidence interval [95% CI], 17.8 to 19.9) had unrecognized CKD; the majority (13.8%) had stage 3a CKD (eGFR=45-60 ml/min per 1.73 m 2 ). The prevalence of unrecognized CKD was higher for branches with individual versus community-targeted events (21.9% [95% CI, 20.5 to 23.4] versus 14.7% [95% CI, 13.2 to 16.2]).Conclusions Targeted screening identified a high proportion of individuals with risk factors for CKD and a high prevalence of unrecognized CKD. Future research will evaluate the ability of targeted screening to promote selfmanagement behaviors addressing priorities for people with CKD.

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“…6 Regarding acceptability, 99% found it convenient, and 96% felt immediate results and feedback helped them understand their condition.…”

Section: Impact Compared With Existing Technologymentioning

confidence: 99%

“…PrevIous reseArCh Accuracy compared with existing technology Most studies found creatinine POC devices to be reliable alternatives to laboratory testing; however, some noted a tendency of devices to underestimate renal impairment, [4][5][6] as well as poor inter-device concordance. 7 A study comparing creatinine levels from two Nova StatSensor™ devices against laboratory values in 401 consecutive patients undergoing contrast CT scans showed that correlation between the two POC devices differed between the two study centres (mean r = 0.93, P<0.0001; versus mean r = 0.84, P<0.0001).…”

mentioning

confidence: 99%

Creatinine point-of-care testing for detection and monitoring of chronic kidney disease: primary care diagnostic technology update

Gbinigie¹,

Price²,

Heneghan³

et al. 2015

Br J Gen Pract

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Assessment of the Nova StatSensor whole blood point-of-care creatinine analyzer for the measurement of kidney function in screening for chronic kidney disease

Cited by 39 publications

References 17 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

The See Kidney Disease Targeted Screening Program for CKD

Creatinine point-of-care testing for detection and monitoring of chronic kidney disease: primary care diagnostic technology update

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