Glucose Biosensors and Need for Accuracy

In a previous post I talked about the need for reproducibility and accuracy in multiplexed bioassays but report in today’s NY Times made clear the enormity of the problem even when a single analyte is measured. The key points from the report “Standards Might Rise on Monitors for Diabetics” are

  • In United States 18 million peoples have Diabetes and another 6 million are expected to have it without knowing
  • More than 11 million diabetic in Unites States use Glucose monitors
  • Tight control of blood glucose level resulted in 76, 54 and 60% reduction in the risk for retinopathy, albuminuria and clinical neuropathy respectively
  • International Standard Organization (ISO) allows 20% variation in strip based blood glucose monitor when glucose values are >75mg/dl and values must be within 15mg/dl when Glucose values are less than 75mg/dl. ISO Document#15197 “In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus”
  • FDA analysis has however showed that stricter standards of 15% variation can be met by most manufacturer
  • Strip based glucose monitors can give erroneous results under various conditions including
    • In presence of Tylenol, vitamin C or sugar such as Xylose or mannose
    • At high temperature, humidity, altitude
    • When blood is taken from alternate site like thigh or forearm
    • Mishandling of strip or instrument
  • A study by government researchers found that when comparing tests from five different popular monitors, results varied by as much as 32 percent
  • A stricter requirement on quality control will increase the price of the testing and may discourage regular testing and hence increase the risk.
  • FDA however agrees that testing of Glucose as biomarkers for diagnosis in ICUs and hospital environment should be done by non-strip based systems with accuracy approaching laboratory based systems
  • Continuous training and awareness is required for proper use of glucose monitoring devices


Though FDA/ISO guidelines and specific need for meeting quality standards may be common knowledge for diagnostic companies it is important that research/academic laboratories developing Biosensing technologies, IVDs and POCs must be aware of these requirements early on to ensure translation of research into practice.


One response to “Glucose Biosensors and Need for Accuracy

  1. Pingback: Glucose Measurement in the Operating Room: More Complicated than It Seems « All About Biosensors

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