Moving Toward PCT Harmonization

Consistency in diagnostic testing is the backbone of clinical confidence. We are pleased to announce that our latest contribution regarding Procalcitonin (PCT) assay variation has been published in the Annals of Clinical Biochemistry.

Our "Letter to the Editor" tackles a critical challenge in modern diagnostics: the significant differences in results between various immunoassays, particularly at the low concentrations where critical clinical decisions are made.

The Core Findings

The importance of evidence-based thresholds: In their original paper, Richardson et al. suggested that different PCT assays may require different cut-offs due to the well-known lack of standardization. The DiaSys letter, by contrast, emphasizes the importance of achieving harmonized measurements between different immunoassays following the IFCC approach (see the IFCC Working Group on Standardization of Procalcitonin Assays). This is essential to avoid creating uncertainty in laboratories regarding well established PCT algorithms.
The Standardization Challenge: Much of this variation is linked to the use of non commutable quality assurance or working calibrator materials, which do not always behave like native patient samples. The DiaSys letter explicitly states, for the first time, that the use of recombinant Procalcitonin results in clearly non commutable materials and consequently in larger inter assay differences, making it unsuitable for standardization purposes.

A Path Forward

At DiaSys, we advocate for the use of commutable materials and the standardization efforts led by the IFCC to ensure that PCT measurements remain a reliable tool across all laboratory platforms.

Access the Full Insights

You can find the official version via the DOI below, or download the original submission letter directly from our dedicated procalcitonin microsite.

Official Journal Link (DOI): https://doi.org/10.1177/00045632261420649

Download Accepted Manuscript: https://www.procalcitonin.de/