Point of Care Testing - Page Nova StatStrip™ and the StatStrip Xpress™ Glucose Meter 3101.1 5 of 19 Patient specimens cannot be tested until both levels of QC are within the acceptable limits. Glucose control solutions must be dated with the expiration date when first opened and must be discarded 3 months after opening. Table 2 shows the average of four different experiments. 3. 2000;124:257–266. Ketone as a word has its root from an old German word, aketon, which means Acetone. Continuous Glucose Monitoring . Glucose control tests should be run in the following circumstances: • Before using the meter for the patient testing the first time • At the glucose control intervals established by your facility, if established • When using a new test strip vial for the first time • When using a … Monday - Sunday. All readings fell within the acceptable range (total allowable error of < 10%), and the readings were linear across the glucose range of 10 – 580 mg/dL. The authors conclude that the Nova StatStrip glucose meter is an acceptable replacement for the Beckman or YSI glucose analyzers for real-time glucose determinations in glucose … • Eliminates glucose errors due to: hematocrit interference (hematocrit errors of 20 to 50% reported on every glucose meter system except for Nova’s StatStrip) electrochemica Glucose Meter Measurements. In ad- 2. 8. Now up your study game with Learn mode. Point of Care (POC) Glucose Testing Dated: December 2017 Reference: Policy LAB 23 -A; Point of Care Nova Stat Strip Glucose Meter §The Nova Stat Strip Blood Glucose meter is UHB’s approved Glucometer for patient testing §Operator certification status must be kept current §Use Universal Precautions when testing as per hospital policy StatStrip is the only glucose meter to earn this clearance and can now be used with arterial, venous, or capillary specimens from all … Appointments & … States how to recall POC glucose results from the Nova StatStrip Meter memory. Nonetheless, there have been concerns re-garding the measurement accuracy of glucose meters. Nova StatStrip Meter. 1. If needed, sodium, lithium, and ammonium heparin are the recommended anticoagulants for use with the StatStrip Glucose Meter. • Acceptable quality control ranges may differ at your institution from the ranges reported by Nova Biomedical. Testing for glucose in the urine will help prevent bacterial growth and avoid urinary tract infections. Determine the requirements a glucose meter needs to fulfill in order to be used for critically ill patients. Specimens were analyzed simultaneously and immediately upon collection by Beckman, YSI, and Nova. Specimen type a. Capillary finger stick, venous whole blood, arterial whole blood, neonate arterial ... Normal fasting glucose for an adult is 70-99 mg/dL with the neonatal range being slightly lower StatStrip is the only glucose meter to earn this clearance and can now be used with arterial, venous, or capillary specimens from all patients including critically ill. 1. ... replace with a spare meter kept in the lab. 2000;124:257–266. handheld glucose meter to be an accurate device in the measurement of blood glucose during the clamp study. Every 24 hours check performance statstrip meter/whenever problems such has storage, operator, and instrument. The Only Point of Care Glucose/ Ketones Meter Indicated for Critical Care Use in Australia StatStrip® is designed specifically to measure and correct for clinical interferences that can be present in critically ill patients. 5). It is a measure of the pressure exerted by that small portion (~5 %) of total CO 2 that remains in the gaseous state, dissolved in the blood plasma. Point-of-Care Glucose Testing: Effects of Critical Care Variables, Influence of Reference Instruments and a Modular Glucose Meter Design. Performing Laboratory. 180 days same as 6months after opening or until manufacturer exp date, whichever comes first. Linearity was acceptable for the Nova analyzer. Poirier et al. are therefore, beneficial for glucose-level monitoring in patients with diabetes [1]. The Glucose Meter is calibrated to provide plasma equivalent results to laboratory methods. commercially available glucose meters and the reference method (YSI 2300) at the same time. WALTHAM, Mass. Only nurses (RNs and RPNs) who are certified may use the Nova StatStripTM glucose meter (see Nursing Policies A-1250 and A-1257 for certification requirements and competency to perform). 2.1.1 The Nova StatStrip Glucose Hospital Meter System is intended for in vitro . Arch Pathol Lab Med. March 30, 2018. 7. FDA has recently cleared the StatStrip glucose hospital meter by Nova Biomedical, Waltham, Mass, for fingerstick capillary testing with critically ill patients. StatStrip is the only glucose meter to earn this clearance and can now be used with arterial, venous, or capillary specimens from all … I. : DH-350-3820-3.0 Page 5 of 14 iii. Some substances, such as vitamin C and maltose, are considered re-sponsible for errors in glucose measurements using point-of-care testing glucose meters [1-3]. - Keeps meter on flat surface when running QC 1,2,3,4,5 . Direct Observation/ Exam . Day(s) Test Set Up. Nova Statstrip Glucometer 1. Higher ranges could indicate pre-diabetes or diabetes. The Nova StatStripTM glucose meter is the only glucose meter approved for use at Kingston General Hospital. Lancets (10)* 5. Whole blood fingerstick. Test Code LAB700 Glucose Meter Important Note Additional Codes. Use of a blood glucose meter involves placing a drop of blood on a blood glucose test strip before or after inserting the strip into the meter, depending on the type of blood glucose meter. The need for an accurate and fast method for the determination of PG levels during a clamp study has led us to test the Nova StatStrip Glucose Monitor (Nova Biomedical, Waltham, MA). • Describe meter operations and cleaning procedures • State process and rationale for timely communication of blood glucose results to RN. Store the strips at a temperature between 4 and 30°C (39 and 86°F). Arch Pathol Lab Med. The need for an accurate and fast method for the determination of PG levels during a clamp study has led us to test the Nova StatStrip Glucose Monitor (Nova Biomedical, Waltham, MA). have been affected by rough handling such as dropping the meter. StatStrip is the only glucose meter to earn this clearance and can now be used with arterial, venous, or capillary specimens from all patients including critically ill. 3. Observations of interferences in critically ill patient populations effecting glucose meters . 9. Waltham, MA – Nova Biomedical is pleased to announce that the StatStrip Glucose Hospital Meter System has been cleared by the U.S. Food and Drug Administration (FDA) for fingerstick capillary testing with critically ill patients (K181043). Inaccuracy (bias) of the meters and analytical interference were evaluated by comparing results from whole blood specimens with results from plasma samples obtained from these whole blood specimens run on a hexokinase reference method. 4. Acceptable capillary samples are fingerstick (side of the finger) or neonate heelstick specimens. Do not place meter on patient’s bed. Nova Biomedical is pleased to announce that the StatStrip Glucose Hospital Meter System has been cleared by the U.S. Food and Drug Administration (FDA) for fingerstick capillary testing with critically ill patients (K181043*). Specimens were analyzed simultaneously and immediately upon collection by Beckman, YSI, and Nova. _____5. Observations of interferences in critically ill patient populations effecting glucose meters . Carbon dioxide (CO 2) is an acidic gas; the amount of CO 2 in blood is largely controlled by the rate and depth of breathing or ventilation. Results: Of 1004 data pairs for the Nova device versus Beckman, the Nova data points ranged from 32 to 444, while Beckman ranged from 42 to 412. Denfield . have been affected by rough handling such as dropping the meter. Immerse the reagent area of the strip in the urine specimen and take it … The Nova Max Blood Glucose Monitor can test your blood glu- cose on the fingers, forearm, or palm. The sample size is just 0.3 µL of blood. Reasons to Check for Low Blood Glucose. • You have symptoms such as weakness, sweating, nervous- ness, headache, or confusion. Iden’fy meter maintenance & infec’on control preven’on. Nova StatStrip Glucose Test Strips are intended for use only with the StatStrip Glucose Hospital Meter for quantitative tests. • Do not place the meter in water. • StatStrip Glucose Meter rapidly becoming standard in accurate. ii. Specimen Collection : States acceptable specimen type (finger stick, heel stick or lithium heparinized syringe) and Measurement (Technical) Range 0.6 to 33.3 mmol/L Glucose . Objective To validate a three-step protocol that assesses the clinical risk associated with using blood glucose monitoring systems (BGMS) in neonates for the management of dysglycaemia. When using the system to measure glucose on critically ill patients, StatStrip and StatStrip Xpress are cleared for use with arterial, venous, neonatal heel stick and neonatal arterial specimens. Blood glucose monitoring Revised: May 12, 2017 Introduction Blood glucose meters measure blood glucose concentrations. The coefficient for the slope of Beckman versus Nova was 1.009 (r = 0.978). Evaluate the clinical practice of using blood glucose meters for critically ill patients. Clean meter and return to docking station. Measuring Blood Glucose Using Capillary Blood with Blood Glucose Meters in all Hospital Settings Meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel. All healthcare facilities need to define and educate on the use of glucose meters with “critically ill” patients to ensure Forty heparinized specimens with hematocrit between 30 and 47%, and creatinine between 0.3 and 12.3 mg/dL were used for comparative study between Nova StatSensor (test method) and Jaffe rate method (Beckman Coulter DxC 800, Synchron® System) of the central laboratory (comparative method). Objectives • Describe handling and labeling procedures for both test strips and QC solutions. Testing your blood glucose regularly can make a big difference in how you manage your diabetes every day. Only nurses (RNs and RPNs) who are certified may use the Nova StatStripTM glucose meter (see Nursing Policies A-1250 and A-1257 for certification requirements and competency to perform). The Variability of Results Between Point-of-Care Testing Glucose Meters and the Central Laboratory Analyzer. Correlation and bias This was performed by analysing 120 heparinised whole blood specimens on the four glucose meters, compared to plasma obtained from those specimens and analysed on the CI8200 as reference method. 4. To ensure accuracy of Glucose Ketone meter (henceforth referred to as “meter”) function by ensuring staff compliance with both internal and external Quality Control Programs and complying with the manufacturer’s instructions. Results: Of 1004 data pairs for the Nova device versus Beckman, the Nova data points ranged from 32 to 444, while Beckman ranged from 42 to 412. pCO 2 is the partial pressure of CO 2 in blood. This occurred when self-monitoring blood glucose meters (SMBG) designed for diabetic patient self-use migrated into the hospital. Battery (CR2450, 3V) 7. specimens.¹,² The Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System is not cleared by the FDA for use in “critically ill” patient populations.3 A definition of “critically ill” is important. This list includes updates from Change Request FFS 10958 * Newly added waived test system. Aims/Hypothesis: The Andres clamp technique, which requires accurate and timely determination of glucose, utilizes the Beckman or Yellow Springs Instruments (YSI) glucose analyzers. - Demonstrates performance of QC and obtains acceptable results. To date, only one meter system, the StatStrip Glucose/Ketones Meter System, is indicated for critical care use in Australia. You just studied 39 terms! 5. A CGM is a glucometer that stays attached to your body, reducing (though not fully eliminating) the need for multiple fingerpricks. • Clean surface of meter with damp cloth and mild soap. Concerns of accuracy. 33–35 One study, a Monte Carlo simulation model, evaluated the clinical significance of glucose meter precision. _____4. • Time it takes from specimen collection to processing in the lab (ex vivo glycolysis) • Capillary versus Venous specimens • Interferences (Sugar Confusion) Log out. 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. Iden’fy correct ’mes, intervals and frequency to perform glucose tes’ng using the StatStrip Meter. Normal results are displayed in BLUE. Nova Biomedical Nova Max Plus Glucose and B-Ketone Monitoring System Nova Biomedical Corp. TESTS GRANTED WAIVED STATUS UNDER CLIA . Use a paper towel barrier on the surface that the meter … True Metrix glucose meter main and special thing is that it is available in every another medical shop and online stored too. This glucose meter almost met the FDA goal with one result being outside the ± 20% (20.7%) at blood glucose concentrations between 1.7 and 22.2 mmol/L. was acceptable. Nova Max Blood Glucose Control Solution, Normal (1 bottle)* 6. For this reason we have compared the Nova StatStrip connectible glucose meter and the Abbott NeoH glucose meter with the two other methods used in our laboratory – the Abbott Architect c16000 and the Gem Premier 4000 blood gas machine. 4. Protocols vary by institution, but there is general consensus among providers that this process is an essential component of patient care. Log Book 10. - July 16, 2018 - PRLog-- Nova Biomedical is pleased to announce that the StatStrip Glucose Hospital Meter System has been cleared by the U.S. Food and Drug Administration (FDA) for fingerstick capillary testing with critically ill patients (K181043). The Accu-Chek Inform II system is designed to deliver data with speed and efficiency, helping you provide optimal care. EPIC Test Code. 1 Nova StatStrip’s system was first approved for … … It is NOT acceptable to obtain a capillary sample for glucose testing when the following impaired peripheral circulation condition (s) apply: all of the avoce 6. The Ultimate Guide to Ketone Testing. Point-of-Care Glucose Testing: Effects of Critical Care Variables, Influence of Reference Instruments and a Modular Glucose Meter Design. Moreover, the Nova glucose meter is significantly easier to operate and is well suited to the glucose clamp study. • Identify the signs and symptoms of hyperglycemia and hypoglycemia • Describe troubleshooting and procedures when questionable results are obtained. The blood specimen was collected in blood gas syringes from 40 cardiac perfusion patients for the comparison study on epoc® (all 3meters), Instrumentation Laboratory GEM4000, Abbott iSTAT, Nova CCX, and Roche Accu-Chek Inform II and Performa glucose meters. 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