Background: The production of YSI 2300 STAT (YSI 2300), a widely used Class II in-vitro diagnostics medical device for calibrating blood glucose monitoring systems, has been discontinued and replaced by new generation analyzers such as the YSI 2900D Biochemistry Analyzer (YSI 2900). The aim of this study was to evaluate the analytical performance of the YSI 2900D (YSI 2900) laboratory instrument using the validated YSI 2300 STAT Plus™ (YSI 2300) medical device as the reference method.
Methods: Serum controls (YSI and NIST SRM 965b) and blood and plasma samples were used to assess precision, accuracy (bias) and linearity of both analyzers for glucose concentration measurements. Human blood (n= 4 subject) was collected to prepare blood and plasma samples with low (1-70 mg/dL), mid (70-125 mg/dL) and high (125-900 mg/dL) glucose concentrations. Both analyzers employed a glucose oxidase amperometric biosensor and were configured with the same parameters. Daily membrane integrity and linearity checks were performed prior to conducting sample analyses. Results: Both instruments passed the daily performance checks prior to sample analyses. The YSI 2900 analyzer demonstrated similar within-run precision as the YSI 2300 (CV < 2% for each analyzer and each serum control tested). A total of 80 blood samples (range: 3.7-766.3 mg/dL) and 80 plasma samples (range: 4.7-880.7 mg/dL) were analyzed in triplicate on both analyzers. Paired results from the YSI 2900 and YSI 2300 showed a high correlation coefficient (R2 > 0.99) and similar regression statistics for both blood and plasma samples. Both the YSI 2900 and the YSI 2300 analyzers met accuracy (bias) criteria and Clarke error grid analysis demonstrated clinical accuracy with 100% of blood and 100% of plasma results in zone A.
Conclusion: Results from this study demonstrates that the YSI 2900 analyzer is analytically comparable to the YSI 2300 for a wide range of blood and plasma glucose concentrations.
M. Hernandez: None. C. Beysen: Employee; Self; ProSciento. M. Hompesch: Board Member; Self; ProSciento. Employee; Self; ProSciento. Stock/Shareholder; Self; ProSciento. L. Morrow: Employee; Spouse/Partner; Lilly Diabetes. Employee; Self; ProSciento.