Comparison of SensoCard Glucometer versus Routine Clinical Chemistry Analyzer Humastar80
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Date
2016-06
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Addis Abeba University
Abstract
Background: Diabetes mellitus (DM) is a chronic disease which requires continuing medicalcare and ongoing patient self-management. SensoCard is one of pocket Glucose meter devicesused to measure blood glucose for screening and monitoring diabetes mellitus.
Objective: The aim of this study was to assess the accuracy of the cheapest and more availablePOCGD SensoCard glucose meter by comparing with conventional clinical chemistry analyzerHumaStar80 at Mettu Karl hospital.
Methods: Data’s on commercially available POCD, with respected to price and sustainablesupply of test strips were collected by pre-tested questioner, from March 1 to March 30, 2015 inAddis Ababa. A total of 170 importers and wholesalers were interviewed during the studyperiod. Then hospital based cross-sectional study was conducted from April 2015 to June 2016,to assess accuracy sensocard PoCGD compared with conventional Clinical chemistry testanalyzer-Humastar80 at mettu karl hospital, southwest Ethiopia. A total 50 Diabetic patients wasparticipated in the study. Glucose value was determined by glucose oxidase methods in bothSensoCard glucose meter and the glucose oxidase HumaStar80 as a reference in the presentstudy. The data was entered and analyzed by SPSS version 20.The minimum accuracy ofSensocard was determined in both based on ISO 15197:2003 and ISO 15197:2013 criteria.Correlation coefficient and bias was calculated to observe the agreement of the glucose meterresult with the comparative method.
Result: From 148 of importers only 12 of them import glucose meters from different countrieslike India, Thailand, Singapore and Turkey. Of the available PoCGD, “sensocard” was relativelycheapest and had sustainable supply by the importers. On the accuracy assessment of“sensocard” PoCGD versus conventional human star80 clinical chemistry glucose test results,Twenty three (46%) participants were females. The mean age of the study participants were49.29 ±12.96.The mean serum glucose value measured by reference method was 242.96 ± 102.4mg/dl and where as that of SensoCard glucose meter was 236.76 ± 92.6 mg/dl. There was nostatistically significant difference between the means of SensoCard glucose meter and referencemethod glucose value (p-value=0.084). The correlation coefficient between the two methods was0.862. The SensoCard glucose meter underestimated the overall glucose value from the referencemethod glucose value by a bias of 6.22. Moreover, SensoCard test result compared withreference method, were expected to be within 95-100% ranges, nevertheless this cant’shappened. Therefore SensoCard test measurements did not fulfill the minimum accuracyrequirements of ISO 15197:2003 and ISO15197:2013.
Conclusion and recommendation: Although “sensoCard PoCGD was cheap and had moresupplies in the market, its measurement lack accuracy as compared with reference conventionalchemistry methods. Further study should be undertaken including hypoglycemic andnormoglycemic individuals in addition to DM patients to justify the present findings.
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Keywords
Point of care glucose meter, Sensocard, Humastar80