Commercial Fully Automated Procalcitonin Immunoassay Compared

Procalcitonin (PCT), a 13-kDa peptide precursor of calcitonin, has gained widespread acceptance as an early and specific biomarker for the presence of systemic bacterial infection. In particular, PCT monitoring has demonstrated value in guiding antibiotic use for bacterial infections.

Based on high plasma levels of PCT during systemic bacterial and fungal infections that decrease on recovery and low concentrations during infections of viral origin or nonspecific causes, the use of PCT assays can be used to assist the clinical management of different patient groups in a range of clinical settings.

An international team of scientists working with the Abbott Laboratories (Abbott Park, IL, USA) using de-identified 1,116 plasma or serum samples from patients tested at nine clinical laboratories in Australia, France, Germany, Italy, South Africa, Turkey, Vietnam and Wales. Plasma or serum samples were tested either fresh or following storage of the serum fraction at 2–8 °C for a maximum of 24 hours.

The team evaluated the ARCHITECT B.R.A.H.M.S PCT assay, which is a two-step immunoassay using chemiluminescent microparticle immunoassay (CMIA) technology, with a 29-minute assay completion time. The ARCHITECT B.R.A.H.M.S PCT assay was evaluated on Abbott Laboratories’ ARCHITECT i2000SR immunoanalyzers. The ARCHITECT B.R.A.H.M.S PCT assay was compared with the Roche Cobas (Basel, Switzerland), Diasorin LIAISON (Saluggia, Italy); bioMérieux VIDAS (‎Marcy-l'Étoile, France), and widely accepted B.R.A.H.M.S Kryptor systems (Hennigsdorf, Germany).

The scientists reported that using Deming regression analysis of the plasma or serum samples with PCT results detected across a dynamic assay range of 0.02–100 μg/L using the ARCHITECT B.R.A.H.M.S PCT assay yielded results of r = 0.989 versus. Roche Cobas, r = 0.986 versus Kryptor B.R.A.H.M.S, r = 0.987 versus BioMérieux VIDAS and r = 0.972 versus Diasorin LIAISON respectively. Concordance at cut-offs of 0.25 μg/L and 0.50 μg/L were 96.9% and 98.1% with Roche Cobas, 95.4% and 96.1% with B.R.A.H.M.S Kryptor, 93.8% and 98.4% with bioMérieux VIDAS, and 92.7% and 93.9% with Diasorin LIAISON.

The authors concluded that independent observations at nine different clinical laboratory sites confirmed the analytical characteristics of the ARCHITECT B.R.A.H.M.S PCT immunoassay. Compared with other assays, ARCHITECT B.R.A.H.M.S PCT offers excellent precision and low-end sensitivity. The study was published on November 9, 2018, in the journal Practical Laboratory Medicine.