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

Akbas, Neval; Schryver, Patricia G.; Algeciras‐Schimnich, Alicia; Baumann, N; Block, Darci R.; Budd, Jeffrey R.; Gaston, Steven; Klee, George G.

doi:10.1016/j.clinbiochem.2014.08.005

Cited by 10 publications

(6 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Therefore, it is important to choose an appropriate curve-fitting model for calibration curves and to consider all calibration curve-related factors, including quality and stability of reference standards, quality and stability of reagents, and statistical validity of the calibration curve [ 10 11 ]. Although various CEA assays with different principles, including chemiluminescence immunoassay (CLIA), enzyme immunoassay, radioimmunoassay, fluorescence immunoassay, and lateral flow immunoassay have been introduced, currently, automated CLIA analyzers with high sensitivity and high throughput are the most widely used [ 12 13 14 ]. Despite ongoing standardization efforts, CEA concentrations from different manufacturers can vary owing to the lack of accurate calibration as well as differences in assay principle, the epitope used, antibody specificities, and the reagents used.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Four Automated Carcinoembryonic Antigen Immunoassays: ADVIA Centaur XP, ARCHITECT I2000sr, Elecsys E170, and Unicel Dxi800

et al. 2018

View full text Add to dashboard Cite

BackgroundCarcinoembryonic antigen (CEA) is one of the tumor markers available for evaluating disease progression status after initial therapy and monitoring subsequent treatment modalities in colorectal, gastrointestinal, lung, and breast carcinoma. We evaluated the correlations and differences between widely used, automated CEA immunoassays at four different medical laboratories.MethodsIn total, 393 serum samples with CEA ranging from 3.0 to 1,000 ng/mL were analyzed on ADVIA Centaur XP (Siemens Diagnostics, Tarrytown, NY, USA), ARCHITECT i2000sr (Abbott Diagnostics, Abbott Park, IL, USA), Elecsys E170 (Roche Diagnostics, Indianapolis, IN, USA), and Unicel DxI800 (Beckman Coulter, Fullerton, CA, USA), and the results were compared. Deming regression, Passing-Bablok regression, and Bland-Altman analyses were performed to evaluate the data correlation and % differences among these assays.ResultsDeming regression analysis of data from Elecsys E170 and UniCel DxI800 showed good correlation (y=3.1615+0.8970x). According to Bland-Altman plot, no statistically significant bias (−1.78 ng/mL [95% confidence interval: −4.02 to 0.46]) was observed between Elecsys E170 and UniCel DxI800. However, the relative differences of CEA concentrations between assays exceeded the acceptable limit of 30%. Regarding the agreement of positivity with cut-off value 5.0 ng/mL, ARCHITECT i2000sr and Elecsys E170 showed the highest agreement (95.2%), whereas ADVIA Centaur XP and ARCHITECT i2000sr showed the lowest agreement (70.7%).ConclusionsAgreements between automated CEA immunoassays are variable, and individual CEA concentrations may differ significantly between assays. Standardization of serum CEA concentrations and further harmonization are needed.

show abstract

Section: Introductionmentioning

confidence: 99%

Comparison of Four Automated Carcinoembryonic Antigen Immunoassays: ADVIA Centaur XP, ARCHITECT I2000sr, Elecsys E170, and Unicel Dxi800

et al. 2018

View full text Add to dashboard Cite

show abstract

“…Eleven thousand eight hundred ninety three records were obtained from the search strategy depicted in Table 1 . From 252 records extracted, 187 studies were included in the qualitative analysis [ 8 , 10 , 15 – 199 ] and 148 in the meta-analysis [ 8 , 10 , 15 , 17 , 18 , 22 , 23 , 26 , 28 , 30 – 32 , 34 – 56 , 58 – 64 , 66 – 68 , 72 , 73 , 75 , 77 – 80 , 82 – 85 , 87 – 92 , 94 – 98 , 100 – 102 , 106 – 109 , 111 – 116 , 120 – 137 , 139 – 143 , 145 , 146 , 148 – 151 , 153 – 157 , 159 – 164 , 166 – 175 , 177 , 179 – ...…”

Section: Resultsmentioning

confidence: 99%

“…As shown in S1 Table (supplementary material), some of the studies report calibrating the assays to WHO or other international reference materials, although calibration data is not presented in the articles [ 8 , 10 , 18 , 36 , 38 , 45 , 54 , 62 , 78 , 79 , 85 , 95 , 112 , 115 , 116 , 126 , 131 , 136 , 137 , 139 , 140 , 142 , 148 , 155 , 156 , 158 , 162 , 164 , 168 , 171 , 187 , 190 ]. There were no studies reporting the use of these materials on a laboratory routine basis.…”

Section: Resultsmentioning

confidence: 99%

Performance and comparability of laboratory methods for measuring ferritin concentrations in human serum or plasma: A systematic review and meta-analysis

et al. 2018

View full text Add to dashboard Cite

BackgroundDifferent laboratory methods are used to quantify ferritin concentrations as a marker of iron status. A systematic review was undertaken to assess the accuracy and comparability of the most used methods for ferritin detection.Methods and findingsNational and regional databases were searched for prospective, retrospective, sectional, longitudinal and case-control studies containing the characteristics and performance of at least one method for serum/plasma ferritin determinations in humans published to date. The analysis included the comparison between at least 2 methods detailing: sensitivity, precision, accuracy, predictive values, inter-methods adjustment, and use of international reference materials. Pooled method performance was analyzed for each method and across methods.OutcomesSearch strategy identified 11893 records. After de-duplication and screening 252 studies were assessed, including 187 studies in the qualitative analysis and 148 in the meta-analysis. The most used methods included radiometric, nonradiometric and agglutination assays. The overall within-run imprecision for the most reported ferritin methods was 6.2±3.4% (CI 5.69–6.70%; n = 171), between-run imprecision 8.9±8.7% (CI 7.44–10.35%; n = 136), and recovery rate 95.6% (CI 91.5–99.7%; n = 94). The pooled regression coefficient was 0.985 among all methods analyzed, and 0.984 when comparing nonradiometric and radiometric methods, without statistical differences in ferritin concentration ranging from 2.3 to 1454 μμg/L.ConclusionThe laboratory methods most used to determine ferritin concentrations have comparable accuracy and performance. Registered in PROSPERO CRD42016036222.

show abstract

“…Serum sample levels of 25(OH) vitamin D Total (D2 and D3) were determined by enzyme immunoassay (UniCel DxI 800 Immunoassay System, Beckman Coulter, Inc., Brea, CA), with a sensitivity of 2 ng/ml and intra‐ and inter‐assay coefficients of variation <10%, which is considered a valid methodology of analysis (Akbas et al, 2014). Blood samples were drawn at the time of hospitalization.…”

Section: Methodsmentioning

confidence: 99%

Relation between vitamin D and impulse behaviours in patients with eating disorder: a pilot observational study

Todisco¹,

Meneguzzo

Vogazianos

et al. 2020

Euro Eating Disorders Rev

View full text Add to dashboard Cite

Objective There is growing evidence that vitamin D levels have a role not only in bone health and energy metabolism, but also for supporting nervous system and brain functions, including impulsivity. Impulsive behaviours are considered characteristics of great relevance in patients with Eating Disorders (ED) both for the course of the illness and for the treatment. The aim of this study is to examine the relationship between impulsive behaviours and vitamin D in patients with ED. Method 236 patients with a diagnosis of ED, consecutively recruited at an ED ward between 2014 and 2018, were enrolled. Patients were classified as impulsive or non‐impulsive based on the presence of clinically relevant impulsive behaviours. Results Impulsive patients were found to have statistically significant lower levels of vitamin D than non‐impulsive (p = .007). A threshold value of 20.4 ng/ml for discriminating impulsive from non‐impulsive patients was found. Discussion This hypothesis generating study partially confirmed a relationship between vitamin D deficiency and impulsive behaviours in ED spectrum mediated by body weight, even if results were not confirmed after corrected by obesity. No definitive conclusion may be taken on whether the effect is reduced due to the loss of power. Future directions are discussed.

show abstract

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

Cited by 10 publications

References 12 publications

Comparison of Four Automated Carcinoembryonic Antigen Immunoassays: ADVIA Centaur XP, ARCHITECT I2000sr, Elecsys E170, and Unicel Dxi800

Comparison of Four Automated Carcinoembryonic Antigen Immunoassays: ADVIA Centaur XP, ARCHITECT I2000sr, Elecsys E170, and Unicel Dxi800

Performance and comparability of laboratory methods for measuring ferritin concentrations in human serum or plasma: A systematic review and meta-analysis

Relation between vitamin D and impulse behaviours in patients with eating disorder: a pilot observational study

Contact Info

Product

Resources

About