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 medical
care and ongoing patient self-management. SensoCard is one of pocket Glucose meter devices
used 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 available
POCGD SensoCard glucose meter by comparing with conventional clinical chemistry analyzer
HumaStar80 at Mettu Karl hospital.
Methods: Data’s on commercially available POCD, with respected to price and sustainable
supply of test strips were collected by pre-tested questioner, from March 1 to March 30, 2015 in
Addis Ababa. A total of 170 importers and wholesalers were interviewed during the study
period. Then hospital based cross-sectional study was conducted from April 2015 to June 2016,
to assess accuracy sensocard PoCGD compared with conventional Clinical chemistry test
analyzer-Humastar80 at mettu karl hospital, southwest Ethiopia. A total 50 Diabetic patients was
participated in the study. Glucose value was determined by glucose oxidase methods in both
SensoCard glucose meter and the glucose oxidase HumaStar80 as a reference in the present
study. The data was entered and analyzed by SPSS version 20.The minimum accuracy of
Sensocard 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 meter
result with the comparative method.
Result: From 148 of importers only 12 of them import glucose meters from different countries
like India, Thailand, Singapore and Turkey. Of the available PoCGD, “sensocard” was relatively
cheapest 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 were
49.29 ±12.96.The mean serum glucose value measured by reference method was 242.96 ± 102.4
mg/dl and where as that of SensoCard glucose meter was 236.76 ± 92.6 mg/dl. There was no
statistically significant difference between the means of SensoCard glucose meter and reference
method glucose value (p-value=0.084). The correlation coefficient between the two methods was
0.862. The SensoCard glucose meter underestimated the overall glucose value from the reference
method glucose value by a bias of 6.22. Moreover, SensoCard test result compared with
reference method, were expected to be within 95-100% ranges, nevertheless this cant’s
happened. Therefore SensoCard test measurements did not fulfill the minimum accuracy
requirements of ISO 15197:2003 and ISO15197:2013.
Conclusion and recommendation: Although “sensoCard PoCGD was cheap and had more
supplies in the market, its measurement lack accuracy as compared with reference conventional
chemistry methods. Further study should be undertaken including hypoglycemic and
normoglycemic individuals in addition to DM patients to justify the present findings.
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Keywords
Point of care glucose meter, Sensocard, Humastar80