Optimal performance relative to EFLM specifications
for imprecision

 

 

 

In 2023, Mayo University Hospital (MUH), Ireland, installed the country’s first DxI 9000 Immunoassay Analyzer.* In this study, they evaluated the DxI 9000 analyzer in accordance with Clinical & Laboratory Standards Institute (CLSI) guidelines using eight immunoassay tests: Total β HCG (5th IS), Access Free T4, Access Ferritin, Access Folate, Access Vitamin B12, Access PCT, Access hsTnI, and Access TSH 3rd IS.

Results obtained on the DxI 9000 analyzer correlated well with those on the DxI 800 [95% Confidence Interval (CI) = 0.93-1.08; R = 0.91-1.00].

The study demonstrated:

  • Within-run percent coefficient of variation (%CV) and within laboratory %CV met manufacturers published claims for precision and detection for all analytes
  • 88% of within-laboratory CVs below 4%, meeting precision specifications of the European Federation of Laboratory Medicine (EFLM)
  • Detection claims were met for limit of blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity, and carryover for all analytes

Further, the authors found that the DxI 9000 immunoassay analyzer required no daily maintenance and less than 15 minutes of weekly and monthly maintenance.



At a Glance

8 %
Assays currently in use in the MUH biochemistry lab. Verified
88 %
Within-laboratory CVs
below 4%
100 %
Of assays met or exceeded manufacturer’s claims

 

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*Full name: DxI 9000 Access Immunoassay Analyzer