AccuSure® Soul+

AccuSure® Soul+

Specifications

  • No Coding Technology
  • Gives Plasma Equivalent Results
  • Just 0.5µL Sample Required
  • Electrochemical Method
  • Results within 5 Seconds
  • Highly Accurate & Reliable
  • No Interference from other sugars like galactose, maltose etc.
  • Measurement Range: 20~600mg/dL
  • Acceptable Hematocrit upto 65%
  • With Strip Ejector
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CodeSens Technology

It is the most accurate system among the different kinds of no-coding technology available in the world. CodeSens allows glucose meter to automatically recognize the code number of each glucose strip so that users can get the most reliable and accurate results.

Most of the popular coding meters require the user to input a specific code number to the meter whenever a new pack of strips is used. According to a study published, 1 out of 6 users miscode. Therefore, if the meters are coded incorrectly, it can cause the meters to display inaccurate blood glucose readings which could lead patients to inject larger doses of insulin than needed.

Now, with more convenient and accurate CodeSens technology, Dr. Gene AccuSure Soul meters will automatically code to match the test strips while reducing the risk of calculating the incorrect insulin dose.

System Accuracy

AccuSure Soul+ BGM System are calibrated to yield results equivalent to plasma glucose concentrations. The accuracy of the AccuSure Soul+ BGM System was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument. the following results were obtained by 122 diabetic patients at clinic centers.

  • Slope: 1.02
  • y-intercept -7.38 mg/dL
  • Correlation Coefficient(r) 0.992
  • Number of Sample 122
  • Range Tested 40-577 mg/dL
1. System accuracy results for glucose concentration <100mg/dL (Compared with YSI-2300
Sr. No. Difference Fingertips
1. within ±5mg/dL 100% 11/11
2. within ±10mg/dL 100% 11/11
3. within ±15mg/dL 100% 11/11
4. within ±10 % 80% 89/111
5. within ±15 % 98% 109/111

Assessments: AccuSure pro shows excellent precision. The CV was less than 5%. The three lots of test strips that were used showed no variation from this evaluation.

System Precision

Sr. No. Controlav Total Precision
1. Controlav 36.2 mg/dL (2.0 mmol/L) SD = 1.3 mg/dL (0.07 mmol/L)
2. Controlav 117.0 mg/dL (6.5 mmol/L) CV = 2.3%
3. Controlav 321.8 mg/dL (17.9 mmol/L) CV = 2.4%

Assessments: AccuSure pro shows excellent precision. The CV was less than 5%. The three lots of test strips that were used showed no variation from this evaluation

Evaluation Report - National Institute of Biologocals
Sr. No. Test Specifications/limits Results
1 Precision Evaluation Value of %CV obtained between ≤ 7.1 (WHO: Laboratory Diagnosis and Monitoring of Diabetes Mellitus, 2002) **Intermediate precision:**
%CV = 1.5 (With Normal Control)
%CV = 1.7 (With Path Control)
**Repeatability:**
%CV = 2.0 (at 51-100 mg/dL Glu)
%CV = 1.8 (at 111-150 mg/dL Glu)
%CV = 1.2 (at 151-250 mg/dL Glu)
2 System Accuracy
and Bias Evaluation		 * System Accuracy Requirement: 95% of the individual glucometer results shall fall within ±15mg/dL of the results of the "Reference Method" at Glucose concentrations < 100 mg/dL and within ± 15% at Glucose concentrations ≥ 100 mg/dL (**ISO15197:2013**)
* Maximum allowable deviation_should be ≤ 15% (WHO: Laboratory Diagnosis and Monitoring of Diabetes Mellitus, 2002)		 * 100% of individual glucometer results are within ±15 mg/dL of the results of the "Reference Method" at Glucose concentrations < 100 mg/dL
* 100% of individual glucometer results are within ± 15% of the results of the "Reference Method" at Glucose concentrations ≥ 100 mg/dL

% Inaccuracy obtained:
1.2% (LL at 95% confidence interval)
1.0% (UL at 95% confidence interval)