Analytical evaluation of the performances of Diazyme and BRAHMS procalcitonin applied to Roche Cobas in comparison with BRAHMS PCT-sensitive Kryptor

Ceriotti, Ferruccio; Marino, Irene; Motta, Andréa; Carobene, Anna

doi:10.1515/cclm-2017-0159

Cited by 24 publications

(16 citation statements)

References 15 publications

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“…The results of our analytical evaluation of the newly commercialized Beckman Coulter Access PCT chemiluminescent immunoassay demonstrate the reliability and robustness of this fully automated technique. The values of LoB, LoD and functional sensitivity were considerably low (all ≤0.003 µg/L), in line with those claimed by the manufacturer and aligned with those of the most sensitive chemiluminescent immunoassays such as Fujirebio Lumipulse BRAHMS PCT [14], but were even better than those of other fully-automated techniques [13,17], including the currently considered reference method BRAHMS PCT-sensitive Kryptor [16]. The total imprecision of the assay was also globally acceptable, being between 3.1% and 4.3% and thus mirroring the performance characteristics of other comparable fully automated chemiluminescent immunoassays [13,14,17].…”

Section: Discussionsupporting

confidence: 82%

“…The results of the comparison study with BRAHMS PCT-sensitive Kryptor were especially surprising and favorable. Overall, the correlation coefficient was excellent (i.e., r = 0.999; p < 0.001) and the bias extremely limited, lower than 5% (i.e., 3.2%), and thus even better than those frequently observed when comparing other methods using the same BRAHMS anti-PCT monoclonal antibodies [12,13,16,17]. Identical conclusions can be made for diagnostic agreement at the three clinical decision thresholds, whereby global agreement between Access PCT and BRAHMS PCT-sensitive Kryptor was always ≥98%, again, better than comparative methods based on BRAHMS anti-PCT monoclonal antibodies.…”

Section: Discussionmentioning

confidence: 71%

“…This second test is a homogeneous immunoassay based on the sandwich principle and using TRACE (time resolved amplified cryptate emission) technology. According to the manufacturer's specifications, the functional sensitivity of BRAHMS PCT-sensitive Kryptor is 0.06 µg/L, the assay is linear between 0.02 and 5000 µg/L with automatic dilution (direct measuring range is 0.02-50 µg/L), whilst inter-and intra-assay imprecision was recently reported as being between 1.66-3.28% and 0-0.46%, respectively [16]. The main characteristics of the two assays (BRAHMS PCT-sensitive Kryptor vs. Beckman Coulter Access PCT) are as follows: type of assay: homogeneous immunoassay using TRACE technology vs. paramagnetic, chemiluminescent immunoassay; incubation time: 19 vs. 20 min; calibration stability: 15 vs. 42 days; throughput: up to 155 vs. up to 400 tests per hour (with UniCel DxI 800).…”

Section: Methods Comparisonmentioning

confidence: 99%

“…The well-established value of PCT measurement in many infectious conditions and across a kaleidoscope of healthcare settings has strongly contributed to development of analytical techniques for its measurement [11]. More specifically, a large number of fully-automated immunoassays have become commercially available during the past decade, employing different assay formats (i.e., enzymatic, luminescent, fluorescent, chemiluminescent and turbidimetric immunoassays) [12][13][14][15][16][17][18][19]. Since the clinical management of patients with severe infections and/or sepsis is always critical and time-dependent, the availability of fully-automated PCT immunoassays is now virtually unavoidable, and these techniques enable an excellent balance between high throughput, short turnaround time, low sample volume (which is always crucial in critical patients needing repeated blood collections) and reasonable costs.…”

Section: Introductionmentioning

confidence: 99%

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Analytical Evaluation of the New Beckman Coulter Access Procalcitonin (PCT) Chemiluminescent Immunoassay

et al. 2020

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This study was designed to evaluate the analytical performance of the recently commercialized Beckman Coulter Access procalcitonin (PCT) chemiluminescent test on the Access immunoassay system. The analytical assessment encompassed the estimation of limit of blank (LoB), limit of detection (LoD), functional sensitivity (i.e., PCT value with ≤10% imprecision), linearity, imprecision and comparability of values with BRAHMS PCT-sensitive Kryptor. LoB, LoD and functional sensitivity were 0.002 μg/L, 0.003 μg/L and 0.003 μg/L, respectively. Intra-assay, inter-assay and total imprecision for plasma pools with low, medium and high PCT values were 1.8–2.1%, 2.4–3.7% and 3.1–4.3%, respectively. The assay exhibited excellent linearity between 0.02 and 84.0 μg/L. Excellent correlation (r = 0.999; p < 0.001) and negligible bias (3.2%) were found by comparing values obtained in paired plasma samples with BRAHMS PCT-sensitive Kryptor. Diagnostic agreement at 0.5, 2.0 and 10 μg/L PCT values ranged between 98%-100%. The results of this study confirm that Access PCT displays excellent analytical performance and high comparability with BRAHMS PCT-sensitive Kryptor.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 71%

Section: Methods Comparisonmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Analytical Evaluation of the New Beckman Coulter Access Procalcitonin (PCT) Chemiluminescent Immunoassay

et al. 2020

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“…The functional assay sensitivity was 0.045 μg/L for B·R·A·H·M·S PCT and <0.035 μg/L for B·R·A·H·M·S PCT sensitive KRYPTOR. B·R·A·H·M·S PCT and B·R·A·H·M·S PCT sensitive KRYPTOR was linear up to 68.7 μg/L and up to 43 μg/L, respectively . Analytical characteristics of the ADVIA Centaur® B·R·A·H·M·S PCT were similar…”

Section: Methodsmentioning

confidence: 75%

Improve Management of acute heart failure with ProcAlCiTonin in EUrope: results of the randomized clinical trial IMPACT EU Biomarkers in Cardiology (BIC) 18

Möckel

Boer

Slagman

et al. 2019

European J of Heart Fail

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Aim To determine whether initiation of antibiotic therapy (ABX) by procalcitonin (PCT) within 8 h of admission in patients presenting to the emergency department with symptoms and signs of acute heart failure (AHF) and elevated natriuretic peptides would improve clinical outcomes. Methods and results The study was a randomized multicentre clinical trial conducted at 16 sites in Europe. Patients were randomized to either a PCT‐guided strategy or standard care. Patients with PCT‐guided strategy (n = 370) had ABX initiated if PCT was > 0.2 μg/L. Patients with standard care (n = 372) had AHF care in accordance with published guidelines without PCT. The primary endpoint was 90‐day all‐cause mortality. Pre‐specified secondary endpoints included 30‐day all‐cause mortality and readmission and rate of pneumonia. The Data Safety and Review Committee recommended stopping the study for futility when 762 of the planned 792 patients had been enrolled. A total of 742 patients could be analysed. Patients were elderly (median age: 77 years), 38% were women, and had typical signs and symptoms of AHF. All‐cause mortality at 90 days was 10.3% in the PCT‐guided group vs. 8.2% in standard care (P = 0.316). Thirty‐day readmission was significantly higher in the PCT‐guided group vs. standard care but the difference vanished until day 90. The rate of pneumonia was overall low (7.5%) and not different between groups. Conclusions In patients with AHF, a strategy of PCT‐guided initiation of ABX was not more effective than a standard care strategy in improving clinical outcomes.

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Performance evaluation of the XPEN60 CRP&SAA, a novel automated hematology analyzer, in detecting complete blood count, C‐reactive protein, and serum amyloid A

Zong

Kan

Luo

et al. 2020

Clinical Laboratory Analysis

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Background The XPEN60 CRP&SAA (hereafter XPEN60) is a new automated hematology analyzer that can rapidly detect C‐reactive protein (CRP), serum amyloid A (SAA), and blood cell counts (CBC), including the 5‐part differential of white blood cells (5‐DIFF). The aim of this study was to evaluate the analytical performance of XPEN60. Methods The analytical performance of XPEN60 was evaluated on the basis of several parameters, including the limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ), precision, accuracy, carryover, linearity, clinical reportable range (CRR), and interference test. In addition, method comparisons between CBC and 5‐DIFF, CRP, and SAA were performed on several systems. Results Total imprecision and accuracy for all parameters fell within acceptable criteria, and excellent measurements were observed in the dilution linearity (coefficient of determination, R2 > .99). LoBs and LoDs (0 and 0.21 mg/L for CRP, 1.1 and 2.27 mg/L for SAA) satisfy the manufacturer's statement. LoQs were 0.61 and 3.62 mg/L for CRP and SAA, respectively. No significant carryover or interference tests (<10%) were observed in this study. The comparison analysis demonstrated strong agreement between XPEN60 results and those of Sysmex–XN1000 (XN1000), except for basophils (Bas) and eosinophils (Eos). The data correlated well with E601 and Mindray CRP‐M100 for CRP. Conclusion XPEN60 was demonstrated satisfactory analytical performance, which made it well‐suited for use in clinical laboratories, emergency departments, and community hospitals.

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Analytical evaluation of the performances of Diazyme and BRAHMS procalcitonin applied to Roche Cobas in comparison with BRAHMS PCT-sensitive Kryptor

Cited by 24 publications

References 15 publications

Analytical Evaluation of the New Beckman Coulter Access Procalcitonin (PCT) Chemiluminescent Immunoassay

Analytical Evaluation of the New Beckman Coulter Access Procalcitonin (PCT) Chemiluminescent Immunoassay

Improve Management of acute heart failure with ProcAlCiTonin in EUrope: results of the randomized clinical trial IMPACT EU Biomarkers in Cardiology (BIC) 18

Performance evaluation of the XPEN60 CRP&SAA, a novel automated hematology analyzer, in detecting complete blood count, C‐reactive protein, and serum amyloid A

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