Clinical evaluation of the FreeStyle Precision Pro system

Area of Science:

• Clinical Chemistry
• Medical Devices
• Point-of-Care Testing

Background:

• New international (ISO 15197) and CLSI (POCT12) standards for blood glucose monitoring systems (BGMS) are imminent, featuring enhanced accuracy criteria.
• The FreeStyle Precision Pro system is a novel BGMS developed to improve accuracy in point-of-care testing (POCT).

Purpose of the Study:

• To evaluate the performance of the FreeStyle Precision Pro system against the upcoming ISO 15197 and POCT12 standards.
• Assess the system's precision, interference, and accuracy using diverse blood sample types.

Main Methods:

• A multicenter study involving 503 blood samples from capillary, venous, and arterial sources was conducted.
• System performance was evaluated for precision (CV <5%) and interference from various substances and hematocrit levels.
• Accuracy was assessed against laboratory analyzer values, adhering to the final draft ISO 15197 and POCT12 specifications.

Main Results:

• The FreeStyle Precision Pro system exhibited excellent precision (CV <5%) and minimal interference.
• No significant interference was observed across a hematocrit range of 15-65% and from 24 of 25 common interfering substances.
• The system met all accuracy criteria, with 97.3-98.9% of results aligning with laboratory values within specified glucose concentration limits.

Conclusions:

• The FreeStyle Precision Pro system successfully meets the stringent accuracy requirements of the new ISO 15197 and POCT12 guidelines.
• This BGMS offers a reliable solution for enhancing accuracy in point-of-care blood glucose monitoring.