The Accuracy and Precision of the Diazyme SMART 700-300 Analyzer for HbA1c and hs-CRP
DOI:
https://doi.org/10.14288/hfjc.v10i2.233Keywords:
Cardiovascular Disease, Accuracy, Precision, Clinical Research.Abstract
PURPOSE: To assess the accuracy and precision of the Diazyme SMART analyzer through testing glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP). METHODS: Forty-five whole blood samples were collected from 15 subjects (4/11m/f, 63±8yrs). Two samples were used to determine precision by comparing repeated tests for both hsCRP and HbA1c. Accuracy was examined by comparing the analyzer results to the third sample measured by standard procedure in a hospital laboratory. RESULTS: Test-retest revealed a mean difference of 0.07 ±0.44% (p=0.6), ICC= 0.72 for HbA1C, and 0.1 ±0.7mg/L (p=0.5), ICC=0.99 for hs-CRP. Comparison of Diazyme SMART results with the lab results for HbA1C resulted in a mean difference of 1.6±0.1%, p=0.3; r=0.75 and1.9 ±4.8mg/L, p=0.2; r= 0.98 for hs-CRP. CONCLUSION: The Diazyme SMART analyzer provides precise and accurate measures of hs-CRP while HbA1c values were less precise. The system may offer acceptable accuracy and precision for select screening in a research laboratory or clinic setting.
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