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#Beckman coulter dxi verification

Vitamin D is a prohormone that plays a key role in bone and mineral metabolism, and it is also essential for maintenance of health. The Access Total 25(OH) Vitamin D immunoassay method has acceptable analytical performance, and the results are in concordance with the LC-MS/MS results. The intra-assay, inter-assay and total coefficient of variation (CV%) for the Unicel DXI 800 vitamin D immunoassay were 3.3%, 5.3% and 8.3%, respectively, at 31.7 ng/mL concentration, and 2.1%, 3.2% and 7%, respectively, at 66.8 ng/mL concentration. The concordance correlation coefficient (CCC) between the two methods was 0.916. When compared to LC-MS/MS, the Access Total 25(OH) Vitamin D immunoassay on the Beckman Coulter Unicel DXI 800 analyzer had an R-value of 0.957 (intercept: −3.938, slope: 1.185) and a mean bias of 9.5%. Additionally, imprecision, interference, limit of blank (LOB), recovery, linearity and carry-over studies were performed for the Beckman Coulter Unicel DXI 800 analyzer. The concordance of the results was evaluated with Passing-Bablok regression analysis and Bland-Altman plot. Every sample was analyzed with both Unicel DXI 800 immunoassay analyzer and LC-MS/MS. The study was conducted with 148 patient samples which were sent to Ankara Numune Training and Research Hospital for routine vitamin D testing. In this study, we aimed to evaluate the analytical performance of the Access Total 25(OH) Vitamin D immunoassay on the Beckman Coulter Unicel DXI 800 analyzer, through comparison with the reference method, liquid chromatography/tandem mass spectrometry (LC-MS/MS). Several manufacturers have developed new automated immunoassays for this purpose. Vitamin D deficiency is quite prevalent, and detection of this condition is important.

#Beckman coulter dxi verification

Analytical Performance Verification of the Beckman Coulter AU5800 Clinical Chemistry Analyser Against Recognized Quality Specifications Reveals Relevance of Method Harmonization.As vitamin D has recently been implicated in various diseases, vitamin D testing has gained a lot more significance.

Evaluation of the analytical performance of Unicel DXI 800 for the Total 25 (OH) Vitamin D measurements.

Evaluation of Beckman Coulter DxI 800 immunoassay system using clinically oriented performance goals.

Analytical Performance of the VIDAS® High-Sensitivity Troponin I Assay and the Beckman Coulter Unicel® DXI AccuTnI+3 Assay in a Stat Laboratory.

Laboratory evaluation of the UniCel DxI 800 analyser (Beckman Coulter) for detecting HBV and HCV serological markers.

Robustness of the Beckman Coulter Access TSH (3rd IS) assay.

Challenges in harmonizing integrated healthcare network laboratories: multi-center evaluation of the hCG5 assay.

Challenges in harmonizing integrated healthcare network laboratories: Multi-center evaluation of the AccuTnI+3 troponin assay.

Multicenter evaluation of the new immunoassay method for TSH measurement using the automated DxI platform.

Performance characteristics of the Beckman Coulter total βhCG (5th IS) assay.

The assay is acceptable for clinical testing. CONCLUSIONS: The TSH3 assay for UniCel DxI 800, is precise, highly sensitive and comparable to the previous generation assay. Variable bias was observed for the TSH3 assay when evaluated against the previous generation assay and other platforms, but overall TSH3 gave comparable results. RESULTS: Intra-day and inter-day CVs were <10% at all concentrations evaluated. Inter-assay variability was assessed across 5 different platforms (n=47 patient specimens).

Linearity, reportable range, stability, sensitivity and susceptibility to common inferences were determined using pooled patient specimens. METHODS: Intra-day and inter-day precision was evaluated using 3 concentrations of commercial quality control material. An extensive evaluation of the performance characteristics for this assay was completed.

N2 - INTRODUCTION: Beckman Coulter recently reformulated their commercial TSH assay with primary calibration to the World Health Organization 3rd TSH international standard. JF - Clinica chimica acta international journal of clinical chemistry T1 - Performance characteristics of the Beckman Coulter UniCel DxI 800 TSH (3rd IS) assay.