Nova StatStrip Glucose Test Strips are intended for use only with the StatStrip Glucose Hospital Meter for quantitative tests. Mut Q-GDH = glucose dehydrogenase with pyrroloquinolinequinone modified to eliminate maltose interference . 3.6 in x 2.3 in x 0.9 in (91 mm x 58 mm x 23 mm) Data Storage. Glucose Meter Measurement Range 0.6 to 33.3 mmol/L Result Alerts Take note of the following meter result alerts when interpreting patient glucose test results: a. Nova now offers a full range of StatStrip Glucose/Ketone wireless connectivity capabilities, including wireless meters, wireless carrying cases, and wireless docking stations. Leslie . Measuring your A1C is an alternative to measuring fasting blood glucose. strict range of 80-110 mg/dL . **References include: (1) Screen guidelines for newborns at risk for low blood glucose. The Nova StatStrip™ Glucose and ß-Ketone Hospital Meter System (StatStrip) is intended for measuring glucose in fresh capillary, venous, or arterial blood including neonate blood, by health care professionals. Measuring Blood Glucose Using Capillary Blood with Blood Glucose Meters in all Hospital Settings Meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel. Tests: Tests Measured: Glucose and Hematocrit Test Reported: Glucose Test Time: 6 Seconds Test Strip Volume: 1.2 µL Test Methodology: Electrochemistry. Concerns of accuracy. The doctor tests your blood glucose degrees after not eating for 8 hrs as well as it's more than 126 mg/dL. Glucose values should be interpreted with caution when intensive glucose control protocols are being used during cardiac surgery. Discussion Diabetes mellitus is a disorder of carbohydrate metabolism caused by a lack of insulin or nonfunctional insulin and characterized by high blood glucose levels. Nova Biomedical StatStrip BGMS FDA clearance and CLIA waiver Now up your study game with Learn mode. The FDA approved the Nova StatStrip Glucose Hospital Meter System for use among all hospitalized patients on September 24, 2014. Contact Getallcourses.net Show details . Measuring blood glucose directly with a finger prick (glucometer) or a blood draw at your doctor's office lets you know your blood sugar at that moment, while the A1c value you get provides an estimate of your average blood sugar levels over the past 3 months. • different instruments used to measure blood glucose. Medical diagnosis. Glucose Monitor Normal Range (mmol/L)* Critical Results (mmol/L)* Neonate (<28 days) 2.6-7.0 * <2.0 * >20 * Non-Neonate StatStrip Glucose Test Str. 180 days same as 6months after opening or until manufacturer exp date, whichever comes first. Measures ketones* with same meter. March 30, 2018. Glucose Meter Measurement Range. The Meter either reports glucose results in mg/dL, 43404, or mmol/L, 44321, and can not be changed. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control. After not eating for 8 hrs, you get a special sweet drink . Measurement (Technical) Range 0.6 to 33.3 mmol/L Glucose . All wireless devices use the industry standard POCT1-A2 data format and are compatible with a choice of middleware partners. validate the performance of the StatStrip Glucose Hospital Meter (Nova Biomedical, Waltham, USA) in performing glycemic profile in hospitalized diabetic patients undergoing intensified insulin therapy. Completed Bccancer.bc.ca Show details . Nova Statstrip Training Quiz Answers GetAllCourses.Net. The nova statstrip™ glucose and ß- ketone hospital meter system ( statstrip) is intended for measuring glucose in fresh capillary, venous, or arterial blood including neonate blood, by health care professionals. Results within the normal range are displayed in blue. 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. The glucose results are calibrated to agree with a method measuring the concentration in plasma. A new generation of POC glucose meter (StatStrip glucose hospital meter, Nova Biomedical) is accurate and reliable for glucose monitoring in various clinical situations. The Nova StatStrip System is intended for in vitro diagnostic use by health care professionals for the quantitative measurement of glucose and ketone in fresh capillary, venous, arterial, whole blood samples. Flexible POC Control allows you to optimally configure the connection of the device to the lab network. • if a result cannot be obtained on the glucose meter or is questionable after repeating, a blood sample should be sent to the main laboratory. Test Methodology: Electrochemistry Sample Types & Operating Modes Whole Blood: Arterial, Venous, Capillary, Neonatal Glucose Measurement Range .5-33.43 mmol/L (I0-600 mg/dL) Interlerences . For samples exhibiting values at or above 600 mg/dL, the screen displays Hi. The StatStrip™ meter is a revolutionary glucose/ketone monitoring system from Nova BioMedical specifically designed for bed side use in clinical settings. Nova Biomedical's StatStrip® and StatStrip Xpress®2 are glucose/ketone level measurement devices. UP or DOWN RED arrow indicate high or low results b. In one of the largest studies ever carried out with glucose measuring devices (35 participating hospitals, 1,703 data points), StatStrip® achieved excellent correlations over the entire measuring range to the plasma hexokinase reference method of 10 to 600 mg / dl (0.5 to 33.3 mmol / l) . 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). StatStrip TM Glucose Strips. The Nova StatStrip also had good concordance with the central laboratory (Bland-Altman plots r(2)=0.01), while Roche Inform had poorer correlation (Bland-Altman plots r(2)=0.46). Nova Biomedical- Hospital Based Blood Gas and Critical Care Analyzers Hospital Glucose Measuring System Only glucose meters accurate enough to be FDA-cleared for use with ALL patients, including critically ill ONLY glucose meters cleared by the FDA for use with all patients, in all professional healthcare settings, including critical care • Eliminates interference which cause incorrect . 1,2 Based on the underlying measurement technology of strips and devices, many factors, such as . The Nova StatStrip also had good concordance with . 5.1.2. blood glucose measurement using chosen glucometer-Glucocard X-Meter (Arkray). Nova StatStrip ® test strips a. Analyzer StatStrip Lactate- lactate portable analyzer capable of measuring the test directly from the patient's bed.Currently lactate measured on blood gas analyzers and electrolytes, which require 100-200 ml of blood sample analysis and takes time to 2.5 minutes. StatStrip ® and StatStrip Xpress ® 2 Glucose Meters The only glucose meters cleared by US FDA and Health Canada for use with all patients, including critically ill Because of the unacceptably high rate of adverse patient events, including deaths, linked to the point-of-care (POC) use of glucose meters within hospitals, there is a recognized need for more accuracy and better performance . 5.1.1. Blood glucose levels for people without diabetes are as follows: Adult Fasting 70-100 mg/dL Expected values for neonates (1 to 7 days old): 47 - 110 mg/dL 2. A blood glucose test is a blood test that screens for diabetes by measuring the level of glucose (sugar) in a person's blood. The unit of measure of the StatStrip Xpress Glucose Hospital Meter is factory set to the standards in the country of use. • Can cause undetected hypoglycemia • Can cause insulin overdose StatStrip™ uses a tiny drop of whole blood with results available in just 6 seconds for glucose and 10 seconds for ketones. Like the StatStrip™ Glucose Hospital Meter, StatStrip Xpress elevates bedside glucose testing to a new level of analytical performance that approaches the quality of central laboratory testing.It incorporates a new strip technology that uses four measuring wells.Nova's Multi-Well system measures and corrects hematocrit interference, as well . The operating range or Linearity of the StatStrip Glucose Meter is 10 - 600 mg/dL. All parts of the StatStrip Glucose Hospital Meter System are considered potentially infectious and can potentially transmit blood-borne pathogens between patients and healthcare professionals. 7 hours ago Nova StatStrip Glucose Meter Training Checklist. Throughout . 2 levels. Higher ranges could indicate pre-diabetes or diabetes. If the result is still >600 mg/dl, order a STAT Measuring blood glucose directly with a finger prick (glucometer) or a blood draw at your doctor's office lets you know your blood sugar at that moment, while the A1c value you get provides an estimate of your average blood sugar levels over the past 3 months. 3. Keep the Nova StatStripTM Glucose Test Strip vial tightly closed when not in use. Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. POC Critical Glucose Values a. measure glucose (sugar) in whole blood. Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. Normal fasting glucose for an adult is 70-99 mg/dL with the neonatal range being slightly lower 14. The aim of this study was to evaluate a glucose meter (StatStrip, Nova Biomedical) to assess its agreement with the standard laboratory method for testing glucose. Normal results are displayed in BLUE. The StatStrip glucose strip technology is a modified glucose oxidase-based amperometric test system, and the ketone E Baxter report Interim 1, 33541 Determination of potential interference of icodextrin and its metabolites on human blood glucose measurement using chosen glucometers. It is the only bedside meter to measure and correct for electrochemical interferences. Measurement Range and Units. Any critical result will be displayed in red, as opposed to blue. The meter has an internal thermometer probe. Measurement of Elevated Glucose Although the operating range of the StatStrip Glucose Meter is 10 - 600 mg/dL, the analytical measurement range is 30-500 mg/dL. Tests Measured: Blood Glucose, Hematocrit Corrected Test Reported: Glucose Test Time: 6 seconds Test Strip Volume: 1.2 µl. Measuring glucose meter accuracy in the ICU • Precision (prospective study) • Roche AccuChek Inform (20 ICU patients with 5x measurement at the bedside) o CV of 2.0% at an average glucose value of 142 mg/dL (7.89 mM) • Nova StatStrip (20 ICU patients with 5x measurement at the bedside) o CV of 2.7% at an average glucose value of 140 mg/dL . c. A single up arrow displays for abnormal high result. • see nova statstrip procedure on the poct web site for troubleshooting suggestions. Title: Glucose Testing: StatStrip Glucose Meter Page 5 of 6 G. Reference Ranges: 1. The Nova StatStrip Xpress-i Glucose and ß-Ketone Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical electrochemical test strips to measure glucose and ketone in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. ues were within the target range. The FreeStyle meter had better precision and less bias than StatStrip. 3. The reportable range for the Nova Statstrip is 10 mg/dL-600 mg/dL b. Normal blood glucose level (while fasting) range within 70 to 99 mg/dL (3.9 to 5.5 mmol/L). A subsequent oral glucose tolerance test (OGTT) was performed to evaluate the per-formance of the StatStrip meter for blood glucose levels exceeding the standard Stat-Strip limit of 600mg/dL (N=12). If HI is displayed, the blood glucose result is higher than 600 mg/dL. • the measurement range is 10 - 600 mg/dl. Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. Blood ketone testing should be performed whenever glucose exceeds 14 mmol/L (250 mg/dL) Blood glucose levels for people without diabetes are as follows: Adult Fasting 70-100 mg/dL Expected values for neonates (1 to 7 days old): 47 - 110 mg/dL 2. POC Critical Glucose Values a. Always wear a new pair of protective gloves before testing each new patient. Easy to use. 8 hours ago Nova StatStrip Glucose Meter Training Checklist Test Strip Port Range of Meter - 0.6 - 33.3 mmol/L Test Strip Release (Eject Button) If not completed you will be locked out and have to repeat the online course and in-person . DOUBLE RED arrows indicate critical values. More Point-of-Care meters. Nova StatStrip Control Solutions is intended for use with the Nova StatStrip Glucose Insert a ketone strip and StatStrip Glucose/Ketone meter automatically recognizes the strip and converts the meter to ketone measuring mode. 400 glucose measurements or QC tests. 0.2 lbs (75 g) Dimensions. Measuring range 0,3 - 20,0 mmol/L Features Color display, barcode scanner, docking station (optional) Communication protocols Networking via Novanet ™ (ASTM, HL7 or POCT01-A2) Do you have any questions about our test strip systems? References: A. Baxter report Interim 1, 33541 Determination of potential interference of icodextrin and its metabolites on human blood glucose measurement using chosen glucometers. Every 24 hours check performance statstrip meter/whenever problems such has storage, operator, and instrument. Ped Child Health (2004). The Meter either reports glucose results in mg/dL, 43404, or mmol/L, 44321, and can not be changed. Leuven: Bedside Blood Gas . StatStrip Hb/Hct's single-use biosensors do not require calibration or coding, and testing is as easy as glucose self-testing. Measuring your A1C is an alternative to measuring fasting blood glucose. - If HI is displayed, the blood glucose result is higher than 400 mg/dL. The NOVA StatStrip glucometer demonstrated an excellent coefficient of variation (<5%) for glucose across the entire analytical measurement range. b. d. (2) Thorton PS. The Nova StatStrip also had good concordance with the central laboratory (Bland-Altman plots r 2 = 0.01), while Roche Inform had poorer correlation (Bland-Altman plots r 2 = 0.46). The meter will only function when the internal thermometer temperature is within 59-104°F (15-40°C). The use of the latest technologies in the construction of the test strip and allowed the electronics measure the glucose in the sample in addition to more and hematocrit. Which can be used for critically ill patients, but not for fingerstick capillary blood. Blood Glucose Test. The operating range or Linearity of the StatStrip Glucose Meter is 10 - 600 mg/dL. The control solution test confirms that the meter and test strips are working correctly. measurement of glucose in capillary, venous, arterial, and neonate whole blood. The measurement technique does not require calibration of the instrument. clinical status of the patient, independent verification of unexpected Nova StatStrip glucose results is still recommended, in this case, by measurement of laboratory plasma glucose. StatStrip® Glu/Ket To date, only one meter system, the StatStrip Glucose/Ketones Meter System, is indicated for critical care use in Australia. The accuracy of StatStrip glucose measurements at baseline (99%, 100%) and before CPB (95%, 98%), but not during (early: 84%, 97%; late: 83%, 96%) and after (92%, 100%) CPB, satisfied the CLSI POCT12-A3 criteria. Reference Range and Reportable Range a. 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