AccuSure™ Insti

AccuSure™ Insti

Specifications

  • Based upon most widely used GOD/POD method
  • Individual Foil Strip Packing
  • Gives Plasma Equivalent Results
  • Just ~1µL Sample Required
  • Electrochemical Method, Five Electrodes
  • Results within 10 Seconds
  • No Interference from other sugars like galactose, maltose etc.
  • Highly Accurate & Reliable
  • Measurement Range: 20-600mg/dL
  • Acceptable Hematocrit upto 60%
  • 250 Groups Memory Positions
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System Accuracy & Precision

The data resulted from AccuSure Insti blood glucose test strips tested by AccuSure Insti blood glucose meter
  • Fingertips: System accuracy when blood glucose concentration is below 5.55 mmol/L (100 mg/dL)
    • Within + 0.83 mmol/L (Within + 15 mg/dL)
    • 192/192(100%)
  • Fingertips: System accuracy when blood glucose concentration is above or equal to 5.55 mmol/L (100mg/dL)
    • Within + 15%
    • 436/444 (99.3%
Performance assessment by the user:

A study evaluating glucose values from fingertip capillary blood samples showed the following results:

  • For glucose concentrations less than 5.55 mmol/L(100mg/dL), 100% the test results were within +0.83 mmol/L(15mg/dL) of the results obtained through laboratory testing.
  • For glucose concentrations equal to or greater than 5.55 mmol/L(100mg/dL), 99.3% the test results were within +15% of the results obtained through laboratory testing.
Repeatability

The data resulted from AccuSure Insti blood glucose test strips tested by AccuSure Insti blood glucose meter.

Sr. No. Mean (mg/dL)(mmol/L) Standard deviation (mg/dL)(mmol/L) or coefficient of variation
1. 44.3(2.5) 1.66(0.09)
2. 85.1(4.7) 2.28(0.13)
3. 129.2(7.2) 3.7%
4. 190.3(10.6) 3.1%
5. 314.2(17.5) 3.6%
Intermediate precision

The data resulted from AccuSure Insti blood glucose test strips tested by AccuSure Insti blood glucose meter.

Sr. No. Control solution level Mean(mg/dL)/(mmol/L) Standard deviation (mg/dL)/(mmol/L) or coefficient of variation
1. Low 32.9(1.8) 1.05(0.06)
2. Medium 119.9(6.7) 2.6%
3. High 346.7(19.3) 2.9%

Evaluation Report National Institute of Biologicals

Sr No. Test(s) Conducted Specifications/limits Results
1 INTERMEDIATE PRECISION %CV at Normal Control Level<=7.1 %CV=2.9
(at Normal Control)
%CV at Pathological Control <=7.1 (WHO: Laboratory Diagnosis and Monitoring of Diabetes Mellitus, 2002) %CV=2.6
(at Pathological Control)
REPEATABILITY %CV at 51-110mg/dL glucose<=7.1 %CV=2.6 (at 51-110mg/dL glucose)
%CV at 111-150mg/dL glucose<=7.1 %CV=2.7 (at 111-150mg/dL glucose)
2 SYSTEM ACCURACY AND
BIAS EVALUATION		 %CV at 151-250mg/dL glucose<=7.1 (WHO: laboratory Diagnosis and Monitoring of Diabetes Mellitus, 2002) %CV=2.8 (at 151-250mg/dL glucose)
System Accuracy requirement: 95% of the individual Glucometer results shall fall within +/- 15mg/dL of the results of the 'Reference Method' at glucose concentrations <100mg/dL and within +/- 15% at glucose concentrations >=100mg/dL (**ISO15197 :2013**) 100% of individual glucometer results are within +/- 15mg/dL of the results of the 'Reference Method' at glucose concentration <100mg/dL

100% of individual glucometer results are within +/- 15% of the results of the 'Reference Method' at glucose concentration >=100mg/dL
Maximum allowable deviation should be <= 15% (WHO: Laboratory Diagnosis and Monitoring of Diabetes Mellitus, 2002) % Inaccuracy obtained-3.4 (lower limit) and-0.8(Upper limit) at 95% confidence interval.