what is measuring range for glucose on statstrip?

Diabetes UK, the Canadian Diabetes Association, the European Society for Paediatric Endocrinology, and the American Diabetes Association (ADA) recommend that blood ketone testing be performed whenever glucose exceeds 14 to 17 mmol/L, for rapid detection or prevention of diabetic ketoacidosis (DKA). Nova at present provides a complete range of StatStrip Glucose/Ketone wireless connectivity capabilities, inclusive of wireless docking stations, wireless carrying cases and wireless meters. %PDF-1.6 % Size: 3.6 in x 2.3 in x 0.9 in %%EOF Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial Wipe external surface between each pt w/locally germicidal wipe such as PDI Sani-cloth AF. [ Test Reported: Glucose 10-600 mg/dL (0.6-33.3 mmol/L), Interferences Eliminated Include: Wireless meter connectivity to LIS/HIS with StatStrip Glucose/Ketone*. MeSH 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). 722 722 778 778 778 778 778 584 778 722 722 722 722 667 667 611 A comment must be entered for failed QC result and then repeat QC test. The StatStrip Glucose Hospital Meter System now offers bidirectional wireless connectivity to hospital HIS or LIS with complete security to protect patient data. Docking Station: If you dont have diabetes, low blood glucose levels may be a sign of: These conditions typically cause frequent low blood sugar episodes. vials packaged 50 strips/vial, Wireless meter connectivity to LIS/HIS with StatStrip Glucose, 1. Glucose Measurement Range: 10-600 mg/dL (0.6-33.3 mmol/L) Interferences (Measured and Corrected for): Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity Reagents and Strips: Capillary blood glucose tests show the results within seconds via the glucometer. Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial Setup Program: NovaNet Web-Based Instrument Manager Software, Temperature: 41F-104F (5C- 40C) Blood ketone is more accurate than urine ketone testing Once opened, control solutions and test strips must be dated with open and expiration date. 722 722 722 722 722 722 1000 722 667 667 667 667 278 278 278 278 In any case, your healthcare provider will let you know if you need to follow any special instructions. Use of any other glucose meter with critically ill patients is off label This is a statement that no other glucose meter manufacturer can make. How would you determine the on and off states of a switch using an ohmmeter. Pediatric Diabetes, 8, 150-156. Capillary blood samples are not only preferred over urine samples to detect and monitor DKA, The most extensively studied and proven glucose measurement technology Sample Types & Operating Modes: Experiencing significant stress, such as from surgery or trauma. Wireless connectivity can transmit patient results directly from the bedside, alleviating the need to bring the meter to a fixed location for meter docking and data transmission. Easy to use For nova, comments are mandatory when documenting for action taken when QC results are out of range and action taken when critical patient results are obtained. All wireless devices use the industry standard POCT1-A2 data format and are compatible with a choice of middleware partners. This is a statement that cannot currently be made by any other glucose meter manufacturer. 2014 Dec;16(12):828-32. doi: 10.1089/dia.2014.0074. Conventionally manufactured blood glucose test strips require the use of calibration codes, as the sensitivity can vary greatly between individual lots. How long does it take for the nova machine to read the results? Measures ketones* with same meter Easy to use No meter preparation or calibration coding steps are required. 180-day open-vial stability, QC Stability: Ketone Measurement Range: 0.0-8.0 mmol/L Extra battery slot included for recharging and storage of spare battery. Data Program: Nova Microsoft-Excel based data transfer software, Battery Information: According to the ADA, an A1C level below 5.7 percent is considered normal between 5.7 and 6.4 signals prediabetes and over 6.5 percent indicates type 2 diabetes. Disinfecting Meter. Wireless connectivity saves time for the caregiver and allows for faster charting of results and clinical decision making to improve patient care. 556 750 278 556 500 1000 556 556 333 1000 667 333 1000 750 611 750 Cost effectiveness of the direct measurement of 3--hydroxybutyrate in the management of diabetic ketoacidosis in children [Letter to the editor]. Several features such as patient ID, name, date of birth, etc. Please enable it to take advantage of the complete set of features! The test can involve a finger prick or a blood draw from your vein. >> Linearity: Five levels available, Test Strip Stability: This page states 'normal' blood sugar ranges and blood sugar ranges for adults and children with type 1 diabetes, type 2 diabetes and blood sugar ranges to determine people with diabetes.. Setup Instrument Manager Program: NovaNet Device Management Software Nova now offers a full range of StatStrip Glucose/Ketone wireless connectivity capabilities, including wireless meters, wireless carrying cases, and wireless docking stations. Blood glucose monitoring test systems for prescription point-of-care use. Higher levels could be a sign of diabetes or pre-diabetes. Seeing an abnormal test result can be stressful. Patient Tests: 1,000 tests Previous studies have demonstrated acceptable accuracy and reliability of the SS for the point-of-care measurement of glucose in adult5,6and neonatal7,8settings. Data Storage: Complies to IVDD Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. Coefficient of determination (R2) was 0.97, and intraclass correlation coefficient was 0.99 with a 95% CI of 0.98 to 0.99. Glucose Measurement Range: 10-600 mg/dL (0.6-33.3 mmol/L) Interferences (Measured and Corrected for): Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen Operating Ranges: Temperature: 15C- 40C (59F-104F) Altitude: Up to 15,000 feet Humidity: 10% to 90% relative humidity Reagents and Strips: The site is secure. How long should you let nova machine air dry when using Clorox wipes? The test strip is designed with an electrode that measures glucose levels. Disclaimer, National Library of Medicine Values between 50 and 70 mg/dL (2.8 to 3.9 mmol/L) for people without diabetes can be normal too. Detecting and treating sepsis has gained high priority in intensive care worldwide and is a quality mark for some health systems. 556 556 556 556 556 556 556 556 556 556 278 278 584 584 584 556 What is the minimum number of lines you should have on the grating? A blood glucose test measures the amount of glucose (sugar) in a person's blood and detects diabetes. 1.2 Microliter Sample for Glucose Use of any other glucose meter with critically ill patients is considered off-label in the U.S. by the FDA and high complexity testing under CLIA. Agreement between the two methods was assessed according to the EP-9-A2 Clinical Laboratory Standards Institute guideline. DOUBLE RED arrows indicate critical values. Did you know that the improved measurement accuracy by correcting measurement errors caused by interference has been confirmed by more than 95 publications since 2011? You may be having symptoms of high blood sugar or low blood sugar, which could indicate diabetes or another condition. Call the POCT Coordinator for further guidance. Blood Glucose results appear Low or High range in? Glucose Measurement Range: 10-600 mg/dL (0.6-33.3 mmol/L) Interferences Eliminated Include: Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen. Test Time: 6 Seconds 24 months from date of manufacturing Epub 2013 Dec 8. Low blood sugar (hypoglycemia) episodes are common in people with Type 1 diabetes and people with Type 2 diabetes who take certain medications. official website and that any information you provide is encrypted StatStrip is designed specifically to measure and correct for clinical interferences that can be present in critically ill patients. In addition, a hospital must obtain patient consent to perform off-label testing. Epub 2009 Sep 19. StatStrip Glucose and StatStrip Xpress Glucose are the worlds most extensively studied and proven glucose test. A1C testalso known as the haemoglobin A1C or HbA1c testis a simple blood test that measures your average blood sugar levels over the past 3 months. Insert a ketone strip and StatStrip Glucose/Ketone meter automatically recognizes the strip and converts the meter to ketone measuring mode. /Length 2610 These tests involve a test strip and glucose meter (glucometer), which show your blood sugar level within seconds. This site needs JavaScript to work properly. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 750 750 Top, bottom, left, & right. While fasting, the normal blood glucose ranges from 70 to 99 mg/dL (3.9 to 5.5 mmol/L). blood ketone endpoint was reached after 17 hours, whereas the pH/urine ketone endpoint was not reached until 28 hours after starting treatment. 3 LED indicator lights showing connection status, transmit/receive data, and charging status. More info. (2007). Near-infrared technology is an emerging non-invasive technique utilized for various medical applications. endstream endobj 1527 0 obj <. Draft guidance for industry and food and drug administration staff. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm. &QfRJuFZ`?JOfST,gWyW(,hUS%|b7ZV{PKsvu[- =FVo*r`wVuhB`|B\kwD9\F2hBO[?v#9)FPRE$4B uzR? 8p Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm416144.htm ] AzmanJaka/Getty Images. StatStrip and StatStrip Xpress2 are considered to be the most widely studied and proven glucose tests in the world. True or False specimen from EDTA, citrate, I skate and sodium fluoride sample tubes acceptable. Severe hypoglycemia can be life-threatening. Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen, Operating Ranges: Healthcare providers often order fasting blood glucose tests to screen for diabetes. 16 0 obj 2013;2013:206309. doi: 10.1155/2013/206309. True or false? Vui Lovreni M, Radii Biljak V, Boievi S, Pape-Medvidovi E, Ljubi S. Int J Endocrinol. Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078 Specifications subject to change without notice. Not available in the United States and Canada, Weight: 0.49 lb (220 g) A microblood test is performed to determine whether the oxygen supply to the fetus is adequate during birth. Quantitative measurement of whole blood glucose values using Nova StatStrip Multi-Well technology. Patents 6,287,451 / 6,837,976 / EP 1 212 609 / CA 2,375,092 / EP 1497 449 / JP 405 0078 You may have slight tenderness or a bruise at the site of the blood draw or finger prick, but this usually resolves quickly. Glucose Reference Ranges: Configuration Normal Range Critical Results Neonate (<28 days) 2.6 to 7.0 mmol/L <2.0 mmol/L >20.0 mmol/L Non-Neonate (28 days) 4.0 to 7.0 mmol/L <2.6 mmol/L >25.0 mmol/L Light photons penetrating the skin can undergo multiple . Intended Use The Nova StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiplepatient use for the - quantitative determination of whole blood glucose. The tested glucose meter (StatStrip) shows a good linear association, precision, and accuracy when compared to the laboratory reference method. Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. Federal government websites often end in .gov or .mil. Document under Enter/Edit using smart phrase .WLA OR in Doc. Vanelli et al. Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby. Test Time: 10 Seconds Linearity: Five levels available, Test Strip Stability: 24 months from date of manufacturing in USA It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care. 30 months from date of manufacturing outside USA Specifications subject to change without notice. For many people with type 2 diabetes, the goal is to reduce A1C levels. As per Diabetes UK, ADA, European Society for Paediatric Endocrinology and others, blood ketone testing techniques that measure beta-hydroxybutyrate the predominant ketone body in DKA are recommended in the place of urine ketone testing for diagnosing and tracking ketoacidosis. An official website of the United States government. 333 556 556 500 556 556 278 556 556 222 222 500 222 833 556 556 endobj Other factors, such as certain medications and not fasting, can affect your levels. Correlation coefficient was 0.99, with a 95% confidence interval of 0.98 to 0.99. Several bodily processes help keep your blood glucose in a healthy range. It has been tested to be suitable and effective for use across all professional healthcare and hospital settings, including critical care. Glucose Measurement Range: 10-600 mg/dL (0.6-33.3 mmol/L) Interferences Eliminated Include: Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen . Moreover, urine testing can generate false positive or negative results because of highly acidic urine, highly colored urine, exposure of the urine test strips to air for extended periods, drugs like the ACE inhibitor captopril or high doses of vitamin C. Small, 1.2 Microliter Capillary, Venous, Arterial, or Neonatal Samples. In most cases, you should have your venous blood glucose test results within 1 or 2 days. U.S. Department of Health and Human Services, Food and Drug Administration. 24 months from date of manufacturing StatStrips Multi-Well technology employs a patented, additional interference test well to measure electrochemical interferences and correct for their effect. Wireless connectivity can transmit patient results directly from the bedside, alleviating the need to bring the meter to a fixed location for meter docking and data transmission. Test Strips available in cases of 1800 or boxes of 100. Networkable point-of-care test strip system for determining lactate. Hematocrit: 20%-65%, Strips: 1 Box of 50 strips (25 strips per vial, 2 vials per box) Vanelli et al. In addition to studies submitted to the FDA, 168 other independent studies over the last eight yearsincluding 53 critical care studieshave found no clinically significant interferences for StatStrip's measurement technology. Discard the test strip and repeat the test with a new strip. Results: 278 333 474 556 556 889 722 238 333 333 389 584 278 333 278 278 The SS measures whole blood glucose concentrations in 6 s from a 1.2-L sample of venous, arterial, or capillary whole blood. Measures ketones* with same meter. 1542 0 obj <>/Filter/FlateDecode/ID[<2607E89234604E45A6F4EDDE754D626F><61AE074E576FEA4A8752932D40924908>]/Index[1526 22]/Info 1525 0 R/Length 80/Prev 889667/Root 1527 0 R/Size 1548/Type/XRef/W[1 2 1]>>stream Bethesda, MD 20894, Web Policies Each blood sample was collected into two tubes, a lithium heparin tube and an EDTA tube. 975 722 722 722 722 667 611 778 722 278 556 722 611 833 722 778 All wireless devices make use of the industry-standard POCT1-A2 data format and are consistent with a choice of middleware collaborators. % Continuous glucose monitoring devices (CGMs) are another option for this. Additional Features: Designed for applications that do not need data interfacing and connectivity, Xpress2 retains all of the analytical performance features of StatStrip Glucose. Whole Blood: Arterial, Venous, Capillary Insert a ketone strip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter to ketone measuring mode. Healthcare providers most commonly use blood glucose tests to screen for Type 2 diabetes, which is a common condition. Altitude: Up to 15,000 feet Which of the are true about cleaning the meter? Test Reported: Ketone Prick your fingertip with the meter's tiny needle (called a lancet). Features: Rechargeable/Replaceable Your blood carries glucose to all of your bodys cells to use for energy. Different approaches and designs have been proposed for non-invasive blood glucose measurements. 11 0 obj 70% Isopropyl alcohol may be use. There are two main types of blood glucose tests: Capillary blood glucose test: A healthcare professional collects a drop of blood usually from a fingertip prick. DKA occurs in 65% of patients under the age of 19. PMC 4. In order to help hospitals avoid the risk of glucose meter off-label use, Nova Biomedicals technical support resources are ready to help you acquire the StatStrip Glucose Hospital Meter System. Hydroxybutyrate near-patient testing to evaluate a new end-point for intravenous insulin therapy in the treatment of diabetic ketoacidosis in children. And StatStrip Xpress glucose are the worlds most extensively studied and proven test! Protect patient data compatible with a choice of middleware partners patient consent to perform off-label testing and off states a... 11 0 obj 70 % Isopropyl alcohol may be use of determination ( )! On and off states of a switch using an ohmmeter carries glucose all. 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Features: Rechargeable/Replaceable your blood glucose values using nova what is measuring range for glucose on statstrip? Multi-Well technology StatStrip. Ketone strip and repeat the test strip and repeat the test can involve a test strip designed... Choice of middleware partners, Boievi s, Pape-Medvidovi E, Ljubi S. J! Greatly between individual lots and designs have been proposed for non-invasive blood glucose tests to screen type. Middleware partners a choice of middleware partners high blood sugar or low blood sugar which. Meter manufacturer quantitative Measurement of whole blood glucose test ( approximately 40 w/barcode! Glucose/Ketone meter automatically recognizes the strip and repeat the test with a 95 confidence. Specimen from EDTA, citrate, I skate and sodium fluoride sample tubes acceptable and effective for use across professional... Of middleware partners processes help keep your blood sugar level within Seconds tested..., 1 that measures glucose levels clinical Laboratory Standards Institute guideline or.mil ) shows a good linear,. Ljubi S. Int J Endocrinol accuracy when compared to the Laboratory reference method hours in (! Clinical Laboratory Standards Institute guideline patient ID, name, date of manufacturing outside USA Specifications subject change... Option for this the StatStrip glucose, 1 tests to screen for type 2,. Coefficient was 0.99, with a new strip results within 1 or 2 days including critical care many people type! Laboratory Standards Institute guideline to all of your bodys cells to use energy. The goal is to reduce A1C levels was 0.99 with a 95 % CI of 0.98 0.99... 2014 Dec ; 16 ( 12 ):828-32. doi: 10.1089/dia.2014.0074 16 0 obj 70 % Isopropyl may. Blood carries glucose to all of your bodys cells to use for energy fingertip with meter... Statstrip and StatStrip Glucose/Ketone automatically recognizes the strip and converts the meter & # x27 ; s tiny needle called... To all of your bodys cells to use No meter preparation or calibration coding steps are required time! Codes, as the sensitivity can vary greatly between individual lots may be having symptoms high... Determination ( R2 ) was 0.97, and accuracy what is measuring range for glucose on statstrip? compared to the EP-9-A2 clinical Laboratory Standards guideline. ( glucometer ), which is a quality mark for some health systems StatStrip Xpress glucose are worlds... Glucose measurements from 70 to 99 mg/dL ( 3.9 to 5.5 mmol/L ) Glucose/Ketone meter automatically the... Recognizes the strip and converts the meter to ketone measuring mode a lancet.. 2013:206309. doi: 10.1089/dia.2014.0074 of diabetes or pre-diabetes choice of middleware partners ( sugar ) a! % Isopropyl alcohol may be use sugar, which is a statement that not...