Assay performance data was collected using a pre-prototype system to assay clinical samples and control materials.
- The clinical sample assay results (ratios) wer proportional to the NGSP reference method and could be harmonized with the DCCT
- The Scripps method met NGSP certification criteria for agreement with reference methods
- The twenty-day precision study showed CV's of ≤ 4% for HbA1c at 5% and at 11% and thus met NGSP certification criteria for precision
The agreement of the Scripps method to the NGSP Primus reference method is shown below. There was no difference between days in the correlation.
