2017
DOI: 10.1515/cclm-2017-0159
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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

Abstract: Background: Procalcitonin (PCT) is a recognized marker of sepsis, and its use is expanding to antibiotic stewardship. The aim of this study was the evaluation of two methods: Diazyme PCT on Roche Cobas c702 (PCT-D) and BRAHMS PCT on Roche Cobas e602 analyzers (PCT-BR) in comparison with BRAHMS PCT-sensitive Kryptor (PCT-BK). Methods: Imprecision was assessed at six critical concentrations following the CLSI EP5-A3; limits of detection (LoDs) were checked according to CLSI EP17-A2; linearity was tested, and met… Show more

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Cited by 24 publications
(16 citation statements)
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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%
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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%
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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%