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

immunoassay infection procalcitonin sepsis

Journal

Diagnostics (Basel, Switzerland)
ISSN: 2075-4418
Titre abrégé: Diagnostics (Basel)
Pays: Switzerland
ID NLM: 101658402

Informations de publication

Date de publication:
26 Feb 2020
Historique:
received: 27 11 2019
revised: 01 02 2020
accepted: 25 02 2020
entrez: 1 3 2020
pubmed: 1 3 2020
medline: 1 3 2020
Statut: epublish

Résumé

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;

Identifiants

pubmed: 32111028
pii: diagnostics10030128
doi: 10.3390/diagnostics10030128
pmc: PMC7151122
pii:
doi:

Types de publication

Journal Article

Langues

eng

Déclaration de conflit d'intérêts

The authors declare no conflicts of interest.

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Auteurs

Giuseppe Lippi (G)

Section of Clinical Biochemistry, University of Verona, 37134 Verona, Italy.

Gian Luca Salvagno (GL)

Section of Clinical Biochemistry, University of Verona, 37134 Verona, Italy.

Matteo Gelati (M)

Section of Clinical Biochemistry, University of Verona, 37134 Verona, Italy.

Mairi Pucci (M)

Section of Clinical Biochemistry, University of Verona, 37134 Verona, Italy.

Davide Demonte (D)

Section of Clinical Biochemistry, University of Verona, 37134 Verona, Italy.

Diego Faggian (D)

Department of Laboratory Medicine, University Hospital of Padova, 35128 Padova, Italy.

Mario Plebani (M)

Department of Laboratory Medicine, University Hospital of Padova, 35128 Padova, Italy.

Classifications MeSH