Medisense Precision Qid User Manual
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Abstract The Precision Quantum-in-dium (Q.I.D.)TMGiucometer was used to determine the.glucose concentrations of 38 human blood samples. The same samples were also run on the OPERA Chemistry Autoanalyzer 2010 system.More than 44% of the glucometer reports had a difference of greater than 15% from the respective autoanalyzer reports. The calibration of the glilcometer could be the source of the error and an improvement is recommended (JPMA 48: 114, 1998). Introduction Diabetes Mellitus is a common disease in Pakistan 1,2. It manifests in two forms: Insulin Dependent Diabetes Mellitus (I.D.D.M.) and Non-Insulin Dependent Diabetes Mellitus (N.I.D.D.M.).
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Periodical blood glucose monitoring is mandatory for both I.D.D.M. And N.I.D.D.M. In seine I.D.D.M. Eases, the insulin dose determination may require knowledge of the blood glucose concentration. Glucometers were introduced in the market to help the Health Professionals and people with diabetes. Initially such instruments worked on reflectance photometry.
Lately more advanced Sensor Type Glueonicters have appeared on the scene. They use the change in the electromotive force (e.m.f.) generated by the movement of electrons between electrodes because of the glucose oxidasc reaction 3. These glucometers provide a rapid and relatively convenient way of detennining the blood glucose level, though their accuracy has often been questioned. Livesugations were taken up at the Biochemistry Department. Shaikh Zayed Hospital, Lahore 1 to determine the accuracy of the Precision Q.I.D,TM giucorneter. Materials, Methods and Results The sensor gIucolneter works on semi-automatic glucose ainlvzing system.
It consists of thin film glucose sensors and a flow injection system with a computerized data processing unit. Glucose oxidase is immobilized into a network of epoxy on the electrude strip together with potassium ferricyanide. This acts as an electron mediator for reducing the operation voltage of the sensor 4. The glucometer calibration system uses a Standard Calibration Electrode Strip. One end of this is inserted into the Test Port Terminal of the sensor.
It is designed to conduct a certain number of electrons to the sensor. The data processing unit reads this signal current and expresses it as a standard glucose concentration of 298 mg/dl (16.54 mmoI/l) on the screen display. The Test Electrode consists of adisposable strip inserted at the same terminal. One drop of blood (5-50 ul) 5 is applied to the “Target Area” on the electrode. The glucose oxidasc reaction generates electrons, which cause a flow of current. The sensor compares this current with that from the Calibration strip and the glucose concentration relative to the standard 298 mg/dl (16.54 mmoLfl) is displayed within 20 seconds 4. Thirty-eight subjects were chosen randomly from the Medicine ward (4), Surgical ward (4), Outpatients Department (13), EarNose and Throat Ward (2), Eye Ward (3), Urology Ward (2), Orthopedics Ward (3) and Biochemistry Laboratory (7) of the Shaikh Zayed Hospital, Lahore.
From each subject, 1.50 nil venous blood was drawn. The identity of each subject was recorded for future reference. Within 5 minutes 5 of drawing the blood, the first drop of each sample was applied to the glucomcter electrode strip.
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The remaining sample was placed in a collecting tube. The glucometer reading was recordcd.
The collecting tubes had been prepared containing I mg Sodium Fluoride (NaF) and 3mg Ethylene Diamine Tetra Acetate (EDTA-Sodiurn). The sample in each tube was centrifuged to separate the plasma from the blood cells.
The plasma was run on the “OPERA” Chemistry Autoanalyzer 2010 system. This system employs the Hexokinase reaction. The reported glucose concentration was recorded for the comparison with the glucometer reports. It may be clarified here that quality-control standard solutions were run repeatedly on the Opera Autoanalyzer. The accurate results proved that the system was working efficiently and properly. Figure 1 shows the graphical comparison of the reports. The regression analysis6 of the sample comparisons revealed: Slope (b)=0.705±0.0623 (1 SE) Y-intercept= +35.47 mg/dl (1.97 mmol/l) Sy.x,(S.E.E.) 29.31 mg/dl (1.63 mmol/1) The r-value (as compared to the perfect 1.0) shows a relatively strong positive correlation between the glucometer and autoanlyzer results.
However, the slope (see appendix-B) was significantly different from 1.0 (t=4.74, p15%from the autoanalyzcr results. Discussion The results show that the performance of the glucometer was not satisfactory.
The large proportion of results showing a considerable difference (15%) from the autoanalyzer is evidence that the device failed to meet the requirements of the American Diabetes Association standards 3. Although the device is relatively technique-independent, the possibility of faults in the operating technique may not be ruled out 3. The handling and storage of the equipment by the importers and distributors should also have followed the temperature range (4°C to 30°C) specified by the manufacturers 5. This is essential for the ideal svorking of the enzyme system. If the strips were exposed to extreme temperatures, the enzymes of the system would have been altered explaining why about 40% of glucometer results were lower than the autoanalyzer results.
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Improper calibration of the glucometer could create problems at two fronts: The first is the built-in calibration by the manufacturer utilized to convert the results on the whole blood to equivalent values for semm. Any error in this regard would obviously create an error in the glucometcr results. This would require stricter control on the part of the manufacturers 3,4.
The second fault could be the result of the Calibration Electrode (strip) system. If the strips were mishandled during storage or transport, the number of electrons (therefore the current) it conducts to the sensor would be altered. The sensor is designed to interpret whatever the magnitude of the current from the Electrode, as the standard 298 mg/dl (16.54 mmol/l) for this device. When the test strip is inserted and if it is giving a faulty current, the sensor would compare the “test” current from the (blood glucose) with the altered calibratorcurrent and give a faulty reading. This appears to be a logical explanation of the problem of inaccuracy and can be tested using, electronic measurements. Better control on the calibration is recommended.
If the Calibration Electrode is sending an altered current, the sensor should be able to detect these alterations. It should then adjust the screen display, eliminating this error. This would require changes in structure and designof the sensoronpartofthe manufacturers. Changes should also be made in the Calibration Electrode to tty to keep the current within narrow and detectable limits. Acknowledgement We would like to add that the kind cooperation of ProfessorS. Shah Jahan (Department of Biochemistiy, Shaikh Zayed Hospital, Lahore) is gratefully acknowledged. His guidance was extremely helpful.
References 1. Shera,A.S., Rafique. Pakistan national diabetes survey: Prevalence of glucose intolerance and associated factors in Shikarpur. Sindh Province. Med., 1 995;12: 1116-21.
Hameed, K., Kadir, M. The frequency of known diabetes, Hypertension and ischaemic heart disease in affluent and poor urban populations ofKarachi, Pakistan. Med., 1995; 12:500-3. Innanen, VT., Barqueira-de-Compos. Point of care glucose testing: Cost savings and ease of use with the Ames Glucometer, Elite. 1995;4 1: 153 7-8. Sriyudthsak, M.
Cholaprance, T.,.Sawadsaringkarn, M. Enzyme-epoxy membrane based glucose analyzing system and medical applications. Biosens Bioelectron. 1996;1 1:735-42.
Precision, Q.I.D,Tm Blood glucose testing system. User’s Manual. MediSense Inc., 1996. Basic Statistics for the Health Sciences, In: Kuzma, J.W. Mayfield Publishing Company, 1992, pp.
Medisense Precision Qid User Manual
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