A new sensitive automated assay for procalcitonin detection: LIAISON

Objectives: To assess the performance of LIAISON s BRAHMS PCT s II GEN (DiaSorin, Saluggia, Italy) in procalcitonin (PCT) determination by comparing it to the assay reference method B R A H M S PCT KRYPTOR (Thermo Fisher Scientific Clinical Diagnostics, Hennigsdorf, Germany) and assessing its ability to discriminate between healthy subjects and patients with suspected infection. Methods: Diagnostic performance was evaluated on: a) 193 selected samples covering the assay range, whose procalcitonin levels were already evaluated with the B R A H M S PCT s KRYPTOR; b) prospective samples: 150 apparently healthy specimens obtained from a blood bank, 161 hospitalized patients (not with specific pathologies), 243 apparently healthy children. Results: The comparison of LIAISON s BRAHMS PCT s II GEN to the reference method B R A H M S PCT KRYPTOR yielded high correlation coefficients: slope of Deming fit equal to 1.04 (95% CI: 0.99–1.09) with an intercept equal to 0.05 (95% CI: 0.09 to 0.19) and a high concordance (98.4% (95% CI: 95.5–99.7%)) at the 0.5 ng/mL cut-off. Moreover, the results obtained using prospective samples showed: (i) no samples with PCT concentration 40.5 ng/mL (cut-off) for the apparently healthy adults (highest value1⁄40.033 ng/mL, 95th percentile and 97.5th percentile o0.02 ng/mL); (ii) 2 samples 40.5 ng/mL for hospitalized patients (highest value1⁄40.715 ng/mL, 95th percentile: 0.054 ng/mL; 97.5th percentile: 0.088 ng/mL); (iii) 3 samples 40.5 ng/mL for the healthy children population (highest value1⁄40.713 ng/mL, 95th percentile: 0.155 ng/mL; 97.5th percentile: 0.275 ng/mL). Conclusion: The fully automated LIAISON s BRAHMS PCT s II GEN agrees well with the reference method and is suitable for early diagnosis of sepsis, severe bacterial infection and guiding antibiotic therapy. & 2016 Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).