A new portable device, the Stat Sensor Point-of-care (POC) Whole Blood Creatinine Analyzer, provides accurate results in <30 s and requires minimal training. It is important to rapidly identify patients who have elevated creatinine to risk-stratify patients before administrating iodinated contrast media. Keywords: serum creatinine, point-of-care testing, Jaffé method, enzymatic methods, acute kidney injury, bilirubin, lactate, calcium, albumin, hemoglobin INTRODUCTION The provision of biochemical or hematological testing at or near the site of patient care is termed point-of-care testing (POCT).1 The recognition that rapid availabil- Point-of-care creatinine instruments are used to measure the blood creatinine level in patients who suffer from chronic kidney disease, kidney transplantation, and renal disorders. Disclaimer, National Library of Medicine N2 - BACKGROUND: Although measurement of whole-blood creatinine at the point of care offers rapid assessment of renal function, agreement of point-of-care (POC) results with central laboratory methods continues to be a concern. Place biosensor in meter The FDA has reviewed i-Stat Chem8+ and CLEA has waived it [15]. Emerging POCT Technologies. Our study also did not look at the accuracy of other values obtained on the i-Stat such as hemoglobin, hematocrit, and potassium or the repeatability of the measurements for the same patients. Also we can see how most outliers stand on the extremes of the difference. Joining us in this podcast is the lead author Dr. Joely Straseski. 88 - 92
The creatinine measurement obtained via i-Stat PoCT does not equal the values obtained via IDMS standard laboratory testing. However, the tests were only run on potassium. The Diagnostic Accuracy of a Urine Albumin-Creatinine Ratio Point-of-Care Test for Detection of Albuminuria in Primary Care Malcolm P. McTaggart, PhD,1 Christopher P. Price, PhD,2 Roger G. Pinnock, MBBS,3 Paul E. Stevens, FRCP,4 Ronald G. Newall, PhD,5 and Edmund J. Lamb, PhD1 Purpose To assess the utility and accuracy of creatinine measurement using point-of-care (POC) blood gas analysis compared to standard laboratory assay and to assess the effectiveness of frequent creatinine monitoring using POC blood gas analysis with respect to early detection of acute kidney injury (AKI). Cystatin C: new Point-of-Care assay for renal diagnostics and diabetes monitoring. We found a significant discrepancy between PoCT and IDMS creatinine values and found that this discrepancy could lead to improper risk stratification for CIN. iSTAT whole blood Creatinine testing is performed in authorized units by point of care operators. In addition, for data analysis purposes, we calculated the GFR for patients using the creatinine obtained from both samples using the Cockcroft-Gault formula [5], which is the formula our institution currently uses to accept patients for CT studies with IV contrast. Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc){whole blood} We investigated the measurement agreement between the PoCT i-Stat creatinine values and those from the central laboratory IDMS testing and how their discrepancy affected changes in the GFR risk categories. Our results seem to demonstrate a difference from the published data for accuracy from Abbott. Is point of care renal function testing reliable screening pre-IV contrast administration? Service. Previous studies have demonstrated that a glomerular filtration rate (GFR) <60 is a risk factor for CIN [3]. Cr: creatinine. Cystatin C is a parameter to monitor renal (kidney) function. Only 1uL of whole blood needed for HbA1c testing. Those are equal to 30.1% of total eligible sample population (22.9% to 37.3% with 95% CI). Because of the remote locations affected, traditional laboratory services are often unavailable. Mean IDMS creatinine values were 0.23 mg/dL higher when compared with i-Stat values. Physicians in our ED have the ability to obtain PoCT creatinine values. We know that i-Stat PoCT is a highly convenient device and we know that there is a high correlation of 0.98 between the two measurements. Qiu L, Guo X, Zhu Y, Shou W, Gong M, Zhang L, Han H, Quan G, Xu T, Li H, Li X. In addition, if GFRs were calculated using PoCT creatinine values, rather than IDMS creatinine values, 9 out of 156 patients (6%) may have been eligible for IV contrast based on GFR risk stratification and not received these studies due to underestimation of their GFR. To determine the accuracy of Point-Of-Care testing (PoCT) creatinine values when compared to standard central laboratory testing (IDMS) and to demonstrate if and how a discrepancy could lead to improper risk stratification for contrast induced nephropathy (CIN). uSf =¸jPLb²"_«m¡ £©Ñåg:CS,¶Éw¦nèN¶Em^Hü®Z×¼ÚÒ¼Wm~\Ïò¦5§¬Ý. Patients with preexisting renal impairment have an increased risk of developing CIN.
Background: In conclusion, the use of point-of care creatinine tests is a promising tool for the early diagnosis and management of conditions threatening kidney function. 9 lbs. 2007; 45(11): 1536-1541. MG/DL - milligrams per deciliter . Evidence-based recommendations on point-of-care creatinine devices to assess kidney function before CT imaging with intravenous contrast. a 50 % or greater rise in serum creatinine within past 7 days. 1. Conclusions: PoCT: point-of-care testing; GFR: glomerular filtration rate; IDMS: isotope dilution mass spectrometry. Whether testing is performed in the central laboratory or in emergency, surgical, critical, or respiratory care areas, Nova analyzers can help to improve patient outcomes while reducing the cost of care. We hope that a future study will look into the accuracy of those values as well. POCC - Point of Care Coordinator . Thirty-eight out of those 47 patients (80.9%, 99% CI 66.1 to 95.6%) were actually at a higher risk category for CIN. Eurolyser introduces a new test paramter for smart and CUBE point-of-care instruments: Cystatin C. Background. Background Renal dysfunction is the most important factor to consider when predicting a patient's risk of developing contrast-induced nephropathy (CIN). Figure 2 demonstrates the agreement between PoCT i-Stat creatinine values and the IDMS values in our study. StatSensor® Point-of-Care Creatinine and eGFR Analyzers Features StatSensor Creatinine is a handheld analyzer and miniaturized, disposable biosensor for whole blood creatinine testing. 8600 Rockville Pike While the responsibility for providing the service is in the hands .
However, in this study, it was identified that the analyser concordance with the laboratory reference varies. Results: Eur Radiol. (8 days ago) Point of Care- Creatinine, i-Stat. It can be measured either in specialized laboratories or using ACR point-of-care testing (POCT). Creatinine with eGFR Enhances Renal Function Assessment. These values were then categorized according to the levels of risk following the Guidelines for Contrast Administration from the American College of Radiology [8–13]. In risk classification, the ABL800 FLEX and i-STAT identified all patients with an eGFR≤30, whereas the StatSensor resulted in a small number of missed high-risk cases (n=4/13) and also operated outside of the established performance goals.
Point-of-care creatinine tests to assess kidney function for outpatients requiring contrast-enhanced CT imaging: systematic reviews and economic evaluation. It is intended for use only at Point-of-Care (POC) sites by professionals. Evaluation of rapid point-of-care creatinine testing in the radiology service of a large academic medical center: impact on clinical operations and patient disposition Clin. The four categories consist of high, intermediate, low, and negligible risk. Lab-quality results to improve accuracy and decision making in diabetes patient care. In our hands, the i-STAT creatinine test required a minimum volume of 65 L. PRESS RELEASE // Radiometer today announced the commercial launch of its CE-marked point-of-care tests for creatinine and urea, the latest additions to the ABL90 FLEX PLUS blood gas analyzer's test menu. Methods: A device study compared three PoC analysers (Nova StatSensor, Abbott i-STAT and Radiometer ABL800 FLEX) with a reference laboratory standard (Roche Cobas 8000 series, enzymatic creatinine). 2019 Aug 27;57(9):e214-e217. The Bland-Altman test found that the mean value of the difference between the two measurements is 0.23 mg/dL and since it is different than a perfect agreement of 0, it is considered a fixed bias between two methods. Background: Measurements of creatinine and glucose on the i-STAT point-of-care testing (POCT) device are known to be elevated in the presence of hydroxyurea. This range accounts for fixed bias as well as error measurement. 95% of the time, the IDMS creatinine value was variable and ranged from −0.45 mg/dL to +0.91 mg/dL when compared to the i-Stat creatinine. In this study, we are interested in the accuracy of PoCT creatinine testing compared to IDMS creatinine. Careers. Microalbumin testing allows for early detection of kidney disease - results . The Afinion™ 2 analyzer is a compact, rapid, multi-assay analyzer that provides valuable near patient testing at the point-of-care. Point-of-care (POC) creatinine devices are capable of providing a quantitative estimation of a patient's serum creatinine concentration. Patients with a GFR <60 are not recommended to receive IV contrast studies. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. Point-of-care testing, also known as near-patient testing, typically means carrying out a test using a device or test kit in the presence of the patient and without the need to send a sample to a laboratory. Features. Calculations reveal an average of 22% difference between IDMS and the i-Stat creatinine values, which is significantly higher than the desirable analytical goal of 8.87% total error for creatinine serum as indicated by Westgard [14]. As an example, we feel that if we could use point-of-care testing (PoCT) rather than sending the samples to the central laboratory, this could expedite decision making in traumas and critical patients. Sample discrepancy between the two methods of measurement. Point-of-care testing for lactate was considered most beneficial for use in the HDU, for regular monitoring of sick patients, to guide clinicians on a patient's progress or to . StatSensor ® Creatinine with eGFR provides a simple 30-second assessment of renal function by fingerstick capillary blood sampling at the point of care. The Epic and Abbott Precision Web system made it possible to include all eligible patients and analyze all data points including age, sex, weight, collection times, and sample type (arterial or venous). However, it was possible that the laboratory’s calibration methods lacked the required degree of accuracy. All statistical analysis was performed by use of a commercially available statistical program (Excel Microsoft 2008 and Excel Analyze-it 2007 Method Validation Edition). With the Afinion™ System, there's no need to send test results to the lab or spend time tracking them down. Corbett M, Duarte A, Llewellyn A, Altunkaya J, Harden M, Harris M, Walker S, Palmer S, Dias S, Soares M. Health Technol Assess. reduction in urine output to less than 0.5 mL/kg/hr for 6 hours. Previous studies reported an underestimation of the creatinine measurements at high creatinine concentrations and were performed in the prestandardization era for creatinine. The authors investigated the performance of the point of care analyzer in comparison to traditional creatinine methods used in most laboratories. In our emergency department, on average, IDMS creatinine is 0.23 mg/dL higher than the one from the i-Stat testing. Acute kidney injury (AKI) can occur rarely in patients exposed to iodinated contrast and result in contrast-induced AKI (CI-AKI). It is proposed that further research exploring PoC implementation in imaging department pathways is needed.
StatSensor Creatinine incorporates a patented Multi-Well™ technology adapted from Nova's hospital glucose monitoring system. iSTAT whole blood Creatinine testing is performed in authorized units by point of care operators. Creatinine value is an essential component when determining GFR. The creatinine POC (StatSensor Point‐of‐Care Whole Blood Creatinine and eGFR Testing, Nova, Biomedical, Waltham, Massachusetts; measurement range: 0.3‐12 mg/dL) was calibrated according to manufacturer's recommendations at least once in the 24 hours prior to sample testing . 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 <45ml 2/min/1.73 m . According to their study, they noted specifically that acetaminophen, acetylcysteine, ascorbate, bromide, creatine, glycolic acid, and hydroxyurea could affect their Chem8+ values. Diabetes: Featured Topics Learn about how in-office HbA1c testing can improve diabetes decision-making and patient outcomes, all while helping lead to a healthier life. Creatinine is a well-established marker for renal function and it is widely used to estimate the GFR [14]. Ideally, this test can take at least thirty minutes for the laboratory to analyze. July 3, 2017. November 2013. The prevalence of AKI was 45.5% using the reference creatinine, and 27.1 and 32.3% using the unadjusted and adjusted point-of-care creatinine values, respectively. Together, they create the i-STAT System — a point-of-care-testing platform that provides healthcare professionals with diagnostic information when and where it's needed.
The high risk category includes GFR values less than 30 mL/min/1.73 m2; the intermediate risk category includes GFR values between 30 and 44 mL/min/1.73 m2; the low risk category includes GFR values between 45 and 60 mL/min/1.73 m2; the negligible risk category includes GFR values higher than 60 mL/min/1.73 m2. Therefore, basing GFR calculations on i-Stat creatinine in our ED could mean wrongly risk-stratifying the patients. A. Kellum, A. Tang, L. Cataldo, A. Kancharla, and N. I. Shapiro, “Risk factors for radiocontrast nephropathy after emergency department contrast-enhanced computerized tomography,”, C. Papadea, J. If PoCT is as accurate as the IDMS from the central laboratory, using PoCT in these situations could allow the ED physician to quickly send a patient to CT scan for the appropriate study without delay. The Point of Care Creatinine Instruments report provides information about the market area, which is further subdivided into sub-regions and countries/regions. The ABL800 FLEX had the strongest concordance with laboratory measured serum creatinine (mean bias=-0.86, 95% limits of agreement=-9.6 to 7.9) followed by the i-STAT (average bias=3.88, 95% limits of agreement=-8.8 to 16.6) and StatSensor (average bias=3.56, 95% limits of agreement=-27.7 to 34.8). Point of Care Testing for Creatinine Measurement: Proceed With Educated Caution Angela N. Bartley, MD Creatinine, a waste product of muscle catabolism, is used to assess renal function, monitor the course of renal disease, and adjust renal function dependent drug dosages. Accuracy of point-of-care serum creatinine devices for detecting patients at risk of contrast-induced nephropathy: a critical overview. The limits of agreement were calculated as the bias ±1.96 standard deviations of 0.35, which calculates the difference value between the creatinine obtained by both measurements to range from −0.45 mg/dL to 0.91 mg/dL. Many new point-of-care devices utilise technological advancement to improve the quality of care. Whole blood creatinine concentration was first measured by the .