The Beckman Coulter DxI 9000 Immunoassay Analyzer* includes new technologies that improve assay sensitivity capabilities. The technological advancements include the Lumi-Phos PRO chemiluminescent substrate, a new luminometer, and improved low-volume pipetting capabilities. These enhancements afford opportunities to develop immunoassays using reduced sample and reagent volumes, minimizing the carbon footprint of plastic packaging, increasing the number of tests per reagent pack, and importantly, conserving precious patient samples, which is especially significant for those with challenging blood draws such as pediatric, geriatric, and cancer patients.

In this study, Access TSH (3rd IS), Access Total βhCG (5th IS), and Access Hybritech PSA assays were evaluated to determine analytical performance when using decreased sample/reagent volumes on the DxI 9000 analyzer as compared with standard volumes on the Access 2 or UniCel DxI analyzers.

The study demonstrated:

• Maximum observed limit of quantitation (LoQ) improved up to 3-fold on DxI 9000 analyzer relative to Access 2 analyzer
• Improved accuracy and precision on the DxI 9000 analyzer relative to Access 2 or UniCel DxI analyzers
• Reducing volumes of samples and reagents for these three assays on the DxI 9000 analyzer does not sacrifice analytical performance.

The novel Lumi-Phos PRO substrate on the DxI 9000 analyzer has shown the capability to develop increasingly sensitive and clinically relevant assays, by improving signal to noise ratio. In these three assays—Access TSH (3rd IS), Access Total βhCG (5th IS), and Access Hybritech PSA—Lumi-Phos PRO's increased signal production was shown to allow for the reduction of sample and reagent volumes while retaining sensitivity.

At Beckman Coulter, we are committed to revolutionizing the next generation in immunoassay testing with precision and sensitivity to drive innovations, advance medical insights, and enhance diagnostic availability.

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*Full name: DxI 9000 Access Immunoassay Analyzer

NOTE: Access Hybritech Total PSA assay is pending clearance by the United States Food and Drug Administration; not yet available for in vitro diagnostic use in the US.