Multicenter comparison of automated procalcitonin immunoassays

Mariella Dipalo, Lorena Guido, Gianmatteo Micca, Salvatore Pittalis, Massimo Locatelli, Andrea Motta, Vincenza Bianchi, Tiziana Callegari, Rosalia Aloe, Giorgio Da Rin, Giuseppe Lippi

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)22-28
Number of pages7
JournalPractical Laboratory Medicine
Volume2
DOIs
Publication statusPublished - Aug 1 2015

Fingerprint

Calcitonin
Immunoassay
Clinical Chemistry
Multicenter Studies
Bacterial Infections
Assays
Inflammation
Serum

Keywords

  • Bacterial infections
  • Immunoassay
  • Multicenter study
  • Procalcitonin
  • Sepsis

ASJC Scopus subject areas

  • Radiological and Ultrasound Technology
  • Clinical Biochemistry

Cite this

Dipalo, M., Guido, L., Micca, G., Pittalis, S., Locatelli, M., Motta, A., ... Lippi, G. (2015). Multicenter comparison of automated procalcitonin immunoassays. Practical Laboratory Medicine, 2, 22-28. https://doi.org/10.1016/j.plabm.2015.07.001

Multicenter comparison of automated procalcitonin immunoassays. / Dipalo, Mariella; Guido, Lorena; Micca, Gianmatteo; Pittalis, Salvatore; Locatelli, Massimo; Motta, Andrea; Bianchi, Vincenza; Callegari, Tiziana; Aloe, Rosalia; Da Rin, Giorgio; Lippi, Giuseppe.

In: Practical Laboratory Medicine, Vol. 2, 01.08.2015, p. 22-28.

Research output: Contribution to journalArticle

Dipalo, M, Guido, L, Micca, G, Pittalis, S, Locatelli, M, Motta, A, Bianchi, V, Callegari, T, Aloe, R, Da Rin, G & Lippi, G 2015, 'Multicenter comparison of automated procalcitonin immunoassays', Practical Laboratory Medicine, vol. 2, pp. 22-28. https://doi.org/10.1016/j.plabm.2015.07.001
Dipalo M, Guido L, Micca G, Pittalis S, Locatelli M, Motta A et al. Multicenter comparison of automated procalcitonin immunoassays. Practical Laboratory Medicine. 2015 Aug 1;2:22-28. https://doi.org/10.1016/j.plabm.2015.07.001
Dipalo, Mariella ; Guido, Lorena ; Micca, Gianmatteo ; Pittalis, Salvatore ; Locatelli, Massimo ; Motta, Andrea ; Bianchi, Vincenza ; Callegari, Tiziana ; Aloe, Rosalia ; Da Rin, Giorgio ; Lippi, Giuseppe. / Multicenter comparison of automated procalcitonin immunoassays. In: Practical Laboratory Medicine. 2015 ; Vol. 2. pp. 22-28.
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abstract = "Objectives: A multicenter study to compare results of BRAHMS Kryptor PCT with those obtained using four BRAHMS-partnered procalcitonin (PCT) automated immunoassays (DiaSorin Liaison, BioM{\'e}rieux 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.",
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AU - Locatelli, Massimo

AU - Motta, Andrea

AU - Bianchi, Vincenza

AU - Callegari, Tiziana

AU - Aloe, Rosalia

AU - Da Rin, Giorgio

AU - Lippi, Giuseppe

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N2 - 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.

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KW - Sepsis

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