System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods
Adherence to established standards (e.g., International Organization for Standardization [ISO] 15197) is important to ensure comparable and sufficient accuracy of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for different SMBG systems available in Europe wit...
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| Veröffentlicht in: | Diabetes technology & therapeutics 2015-09, Vol.17 (9), p.635-648 |
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| creator | Freckmann, Guido Link, Manuela Schmid, Christina Pleus, Stefan Baumstark, Annette Haug, Cornelia |
| description | Adherence to established standards (e.g., International Organization for Standardization [ISO] 15197) is important to ensure comparable and sufficient accuracy of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for different SMBG systems available in Europe with three reagent lots each.
Test procedures followed the recently published revision ISO 15197:2013. Comparison measurements were performed with a glucose oxidase (YSI 2300 STAT Plus™ glucose analyzer; YSI Inc., Yellow Springs, OH) and a hexokinase (cobas Integra(®) 400 Plus analyzer; Roche Instrument Center, Rotkreuz, Switzerland) method. Compliance with ISO 15197:2013 accuracy criteria was determined by calculating the percentage of results within ±15% or within ±0.83 mmol/L of the comparison measurement results for glucose concentrations at and above or below 5.55 mmol/L, respectively, and by calculating the percentage of results within consensus error grid Zones A and B.
Seven systems showed with all three tested lots that 95-100% of the results were within the accuracy limits of ISO 15197:2013 and that 100% of results were within consensus error grid Zones A and B, irrespective of the comparison method used. Regarding results of individual lots, slight differences between the glucose oxidase method and the hexokinase method were found. Accuracy criteria of ISO 15197:2003 (±20% for concentrations ≥4.2 mmol/L and±0.83 mmol/L for concentrations |
| doi_str_mv | 10.1089/dia.2015.0085 |
| format | Article |
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Test procedures followed the recently published revision ISO 15197:2013. Comparison measurements were performed with a glucose oxidase (YSI 2300 STAT Plus™ glucose analyzer; YSI Inc., Yellow Springs, OH) and a hexokinase (cobas Integra(®) 400 Plus analyzer; Roche Instrument Center, Rotkreuz, Switzerland) method. Compliance with ISO 15197:2013 accuracy criteria was determined by calculating the percentage of results within ±15% or within ±0.83 mmol/L of the comparison measurement results for glucose concentrations at and above or below 5.55 mmol/L, respectively, and by calculating the percentage of results within consensus error grid Zones A and B.
Seven systems showed with all three tested lots that 95-100% of the results were within the accuracy limits of ISO 15197:2013 and that 100% of results were within consensus error grid Zones A and B, irrespective of the comparison method used. Regarding results of individual lots, slight differences between the glucose oxidase method and the hexokinase method were found. Accuracy criteria of ISO 15197:2003 (±20% for concentrations ≥4.2 mmol/L and±0.83 mmol/L for concentrations <4.2 mmol/L) were fulfilled by eight systems with all three lots and by one system with two lots.
In this study, seven systems complied with the accuracy criteria of ISO 15197:2013. The results also indicate that the comparison measurement method/system is important, as it may have a considerable impact on accuracy data obtained for a system.</description><identifier>ISSN: 1520-9156</identifier><identifier>EISSN: 1557-8593</identifier><identifier>DOI: 10.1089/dia.2015.0085</identifier><identifier>PMID: 26110670</identifier><identifier>CODEN: DTTHFH</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Accuracy ; Blood Glucose - analysis ; Blood Glucose Self-Monitoring - instrumentation ; Blood Glucose Self-Monitoring - standards ; Diabetes Mellitus - blood ; Glucose ; Glucose Oxidase - analysis ; Hexokinase - analysis ; Humans ; Reagent Strips ; Reference Standards ; Reproducibility of Results</subject><ispartof>Diabetes technology & therapeutics, 2015-09, Vol.17 (9), p.635-648</ispartof><rights>(©) Copyright 2015, Mary Ann Liebert, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c321t-195a830ce9f4e2cee0849f7ab4c226a9f439f53b90b66fba569e9bdf03d7af0b3</citedby><cites>FETCH-LOGICAL-c321t-195a830ce9f4e2cee0849f7ab4c226a9f439f53b90b66fba569e9bdf03d7af0b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26110670$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Freckmann, Guido</creatorcontrib><creatorcontrib>Link, Manuela</creatorcontrib><creatorcontrib>Schmid, Christina</creatorcontrib><creatorcontrib>Pleus, Stefan</creatorcontrib><creatorcontrib>Baumstark, Annette</creatorcontrib><creatorcontrib>Haug, Cornelia</creatorcontrib><title>System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods</title><title>Diabetes technology & therapeutics</title><addtitle>Diabetes Technol Ther</addtitle><description>Adherence to established standards (e.g., International Organization for Standardization [ISO] 15197) is important to ensure comparable and sufficient accuracy of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for different SMBG systems available in Europe with three reagent lots each.
Test procedures followed the recently published revision ISO 15197:2013. Comparison measurements were performed with a glucose oxidase (YSI 2300 STAT Plus™ glucose analyzer; YSI Inc., Yellow Springs, OH) and a hexokinase (cobas Integra(®) 400 Plus analyzer; Roche Instrument Center, Rotkreuz, Switzerland) method. Compliance with ISO 15197:2013 accuracy criteria was determined by calculating the percentage of results within ±15% or within ±0.83 mmol/L of the comparison measurement results for glucose concentrations at and above or below 5.55 mmol/L, respectively, and by calculating the percentage of results within consensus error grid Zones A and B.
Seven systems showed with all three tested lots that 95-100% of the results were within the accuracy limits of ISO 15197:2013 and that 100% of results were within consensus error grid Zones A and B, irrespective of the comparison method used. Regarding results of individual lots, slight differences between the glucose oxidase method and the hexokinase method were found. Accuracy criteria of ISO 15197:2003 (±20% for concentrations ≥4.2 mmol/L and±0.83 mmol/L for concentrations <4.2 mmol/L) were fulfilled by eight systems with all three lots and by one system with two lots.
In this study, seven systems complied with the accuracy criteria of ISO 15197:2013. The results also indicate that the comparison measurement method/system is important, as it may have a considerable impact on accuracy data obtained for a system.</description><subject>Accuracy</subject><subject>Blood Glucose - analysis</subject><subject>Blood Glucose Self-Monitoring - instrumentation</subject><subject>Blood Glucose Self-Monitoring - standards</subject><subject>Diabetes Mellitus - blood</subject><subject>Glucose</subject><subject>Glucose Oxidase - analysis</subject><subject>Hexokinase - analysis</subject><subject>Humans</subject><subject>Reagent Strips</subject><subject>Reference Standards</subject><subject>Reproducibility of Results</subject><issn>1520-9156</issn><issn>1557-8593</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkU9LwzAchoMo_j96lYAXL52_NEubeNO5TWFjh-m5pGmilbaZSevYZ_BLm7IpIjkkvDy8eeFB6ILAgAAXN0UpBzEQNgDgbA8dE8bSiDNB9_t3DJEgLDlCJ96_A0BKY3KIjuKEEEhSOEZfy41vdY3vlOqcVBs8_pRVJ9vSNtga_FAao51uWnxfWVvgadUp6zWe26ZsrSubV7wt8Hhiq8qu--RpucCEEZHehmEU5xv84vv8eW3_FI5svZKu9OGjuW7fbOHP0IGRldfnu_sUvUzGz6PHaLaYPo3uZpEK69uICCY5BaWFGepYaQ18KEwq86GK40SGlArDaC4gTxKTS5YILfLCAC1SaSCnp-h627ty9qPTvs3q0itdVbLRtvMZSYFzQYVIAnr1D323nWvCukBxDjQcFqhoSylnvXfaZCtX1tJtMgJZbykLlrLeUtZbCvzlrrXLa1380j9a6Dc8541I</recordid><startdate>201509</startdate><enddate>201509</enddate><creator>Freckmann, Guido</creator><creator>Link, Manuela</creator><creator>Schmid, Christina</creator><creator>Pleus, Stefan</creator><creator>Baumstark, Annette</creator><creator>Haug, Cornelia</creator><general>Mary Ann Liebert, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201509</creationdate><title>System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods</title><author>Freckmann, Guido ; Link, Manuela ; Schmid, Christina ; Pleus, Stefan ; Baumstark, Annette ; Haug, Cornelia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c321t-195a830ce9f4e2cee0849f7ab4c226a9f439f53b90b66fba569e9bdf03d7af0b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Accuracy</topic><topic>Blood Glucose - analysis</topic><topic>Blood Glucose Self-Monitoring - instrumentation</topic><topic>Blood Glucose Self-Monitoring - standards</topic><topic>Diabetes Mellitus - blood</topic><topic>Glucose</topic><topic>Glucose Oxidase - analysis</topic><topic>Hexokinase - analysis</topic><topic>Humans</topic><topic>Reagent Strips</topic><topic>Reference Standards</topic><topic>Reproducibility of Results</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Freckmann, Guido</creatorcontrib><creatorcontrib>Link, Manuela</creatorcontrib><creatorcontrib>Schmid, Christina</creatorcontrib><creatorcontrib>Pleus, Stefan</creatorcontrib><creatorcontrib>Baumstark, Annette</creatorcontrib><creatorcontrib>Haug, Cornelia</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes technology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Freckmann, Guido</au><au>Link, Manuela</au><au>Schmid, Christina</au><au>Pleus, Stefan</au><au>Baumstark, Annette</au><au>Haug, Cornelia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods</atitle><jtitle>Diabetes technology & therapeutics</jtitle><addtitle>Diabetes Technol Ther</addtitle><date>2015-09</date><risdate>2015</risdate><volume>17</volume><issue>9</issue><spage>635</spage><epage>648</epage><pages>635-648</pages><issn>1520-9156</issn><eissn>1557-8593</eissn><coden>DTTHFH</coden><abstract>Adherence to established standards (e.g., International Organization for Standardization [ISO] 15197) is important to ensure comparable and sufficient accuracy of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for different SMBG systems available in Europe with three reagent lots each.
Test procedures followed the recently published revision ISO 15197:2013. Comparison measurements were performed with a glucose oxidase (YSI 2300 STAT Plus™ glucose analyzer; YSI Inc., Yellow Springs, OH) and a hexokinase (cobas Integra(®) 400 Plus analyzer; Roche Instrument Center, Rotkreuz, Switzerland) method. Compliance with ISO 15197:2013 accuracy criteria was determined by calculating the percentage of results within ±15% or within ±0.83 mmol/L of the comparison measurement results for glucose concentrations at and above or below 5.55 mmol/L, respectively, and by calculating the percentage of results within consensus error grid Zones A and B.
Seven systems showed with all three tested lots that 95-100% of the results were within the accuracy limits of ISO 15197:2013 and that 100% of results were within consensus error grid Zones A and B, irrespective of the comparison method used. Regarding results of individual lots, slight differences between the glucose oxidase method and the hexokinase method were found. Accuracy criteria of ISO 15197:2003 (±20% for concentrations ≥4.2 mmol/L and±0.83 mmol/L for concentrations <4.2 mmol/L) were fulfilled by eight systems with all three lots and by one system with two lots.
In this study, seven systems complied with the accuracy criteria of ISO 15197:2013. The results also indicate that the comparison measurement method/system is important, as it may have a considerable impact on accuracy data obtained for a system.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>26110670</pmid><doi>10.1089/dia.2015.0085</doi><tpages>14</tpages></addata></record> |
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| subjects | Accuracy Blood Glucose - analysis Blood Glucose Self-Monitoring - instrumentation Blood Glucose Self-Monitoring - standards Diabetes Mellitus - blood Glucose Glucose Oxidase - analysis Hexokinase - analysis Humans Reagent Strips Reference Standards Reproducibility of Results |
| title | System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods |
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