High Sensitivity Assay Performance



The DxI 9000 Access Immunoassay Analyzer addresses the laboratory’s demands for speed, reliability, reproducibility, quality and menu expansion. Its novel Lumi-Phos Pro substrate has compared with previous substrates, and along with its unique ZeroDaily Maintenance, saves time to results and for laboratory staff. PrecisionVIsion Technology helps to safeguard against flawed data reports.

In this study, the Limit of Blank (LoB) was evaluated for twelve analytes using the CLSI EP17-A2 guidelines1 with three levels of quality control and five measurements per quality control sample. Results were compared against results obtained on competitor analyzers (Siemens, Hoffman-La Roche, and Thermo Fisher Scientific) and with desired minimal coefficient of variation (CV%).

The study found:

  • The Limit of Blank for the 12 analytes fully met or exceeded the manufacturer’s claims for assay sensitivity
  • Assay performance on the DxI 9000 Immunoassay Analyzer was excellent and met manufacturer claims and specifications from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)2
  • All 15 investigated assays showed good correlation between the DxI 9000 Immunoassay Analyzer and other commercially available immunoassay platforms, with coefficients of regression (r) from 0.95-0.998 and slopes from 0.85-1.28.

At a Glance

100 %
Of tested analytes fully met or exceeded manufacturer’s claims
100 %
Of tested analytes showed good correlation with competitor platforms
100 %
Of analytes met the precision (CV%) requirements of the EFLM relative to biological variation

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1. CLSI EP17-A2 Verification of detection capability for clinical laboratory measurement procedures; 2nd edition

2. EFLM database: https://biologicalvariation.eu

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