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2015 ; 2
(ä): 22-28
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Multicenter comparison of automated procalcitonin immunoassays
#MMPMID28932801
Dipalo M
; Guido L
; Micca G
; Pittalis S
; Locatelli M
; Motta A
; Bianchi V
; Callegari T
; Aloe R
; Da Rin G
; Lippi G
Pract Lab Med
2015[Aug]; 2
(ä): 22-28
PMID28932801
show ga
OBJECTIVES: A multicenter study to compare results of BRAHMS Kryptor PCT with
those obtained using four BRAHMS-partnered procalcitonin (PCT) automated
immunoassays (DiaSorin Liaison, BioMérieux Vidas, Roche Cobas E601 and Siemens
Advia Centaur) and the Diazyme immunotubidimetric assay implemented on four
clinical chemistry platforms (Abbott Architect c16000, Siemens Advia 2400, Roche
Cobas C501 and Beckman Coulter AU5800). DESIGN AND METHODS: One hundred serum
samples from in-patients with PCT values between 0.10 and 58.7 ng/mL were divided
into aliquots and tested with the nine different reagents and analyzers. BRAHMS
PCT Kryptor results were used as reference. RESULTS: Compared to BRAHMS PCT
Kryptor, significant differences in results were observed on Vidas, Advia
Centaur, Architect, Cobas C501 and AU5800. However, the correlation coeffiecients
(r) with BRAHMS PCT Kryptor were between 0.899 and 0.988. The mean bias was less
than ±1.02 ng/mL, except for Vidas (2.70 ng/mL). The agreement at three
clinically relevant cut-offs was optimal: between 83-98% at 0.50 ng/mL, 90-97% at
2.0 ng/mL, and 98% at 10 ng/mL. The comparison of Diazyme PCT across the four
clinical chemistry analyzers yielded high correlation coefficients (r between
0.952 and 0.976), a mean bias less than ±0.9 ng/mL, acceptable agreement at
0.5 ng/mL (>82%), and high concordance at the 2.0 ng/mL (>97%) and 10 ng/mL
(>98%) cut-offs. CONCLUSIONS: The methods and applications evaluated in this
multicenter study are aligned with BRAHMS PCT Kryptor and can be used for
predicting the risk of progression to systemic inflammation in patients with
bacterial infections using the conventional PCT diagnostic thresholds.