Abstract
ObjectivesTo assess the performance of LIAISON® BRAHMS PCT® 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. MethodsDiagnostic 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® KRYPTOR; b) prospective samples: 150 apparently healthy specimens obtained from a blood bank, 161 hospitalized patients (not with specific pathologies), 243 apparently healthy children. ResultsThe comparison of LIAISON® BRAHMS PCT® 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 0.5ng/mL cut-off. Moreover, the results obtained using prospective samples showed: (i) no samples with PCT concentration >0.5ng/mL (cut-off) for the apparently healthy adults (highest value=0.033ng/mL, 95th percentile and 97.5th percentile <0.02ng/mL); (ii) 2 samples >0.5ng/mL for hospitalized patients (highest value=0.715ng/mL, 95th percentile: 0.054ng/mL; 97.5th percentile: 0.088ng/mL); (iii) 3 samples >0.5ng/mL for the healthy children population (highest value=0.713ng/mL, 95th percentile: 0.155ng/mL; 97.5th percentile: 0.275ng/mL). ConclusionThe fully automated LIAISON® BRAHMS PCT® II GEN agrees well with the reference method and is suitable for early diagnosis of sepsis, severe bacterial infection and guiding antibiotic therapy.
Highlights
Over the last two decades, an increasing number of studies have evidenced the diagnostic and prognostic role of procalcitonin (PCT) in discriminating between bacterial, viral or other non-bacterial infection, sepsis and systemic inflammation [1] across a variety of clinical scenarios, in both adult and pediatric populations [2].PCT concentrations increase at the onset of bacterial infection and correlate with the severity of infection
The diagnostic performance of LIAISONs BRAHMS PCTs in measuring PCT level was assessed in comparison with the reference method
This study compared the performance of the LIAISONs BRAHMS PCTs II GEN system, a chemiluminescence immunoassay (CLIA) technology, with the reference method BRAHMS PCTs KRYPTOR assay which is based on TRACE technology, and highlights the quality of LIAISONs BRAHMS PCTs II GEN system in terms of sensitivity and specificity, both in adults and children populations
Summary
Over the last two decades, an increasing number of studies have evidenced the diagnostic and prognostic role of procalcitonin (PCT) in discriminating between bacterial, viral or other non-bacterial infection, sepsis and systemic inflammation [1] across a variety of clinical scenarios, in both adult and pediatric populations [2]. PCT concentrations increase at the onset of bacterial infection and correlate with the severity of infection. Plasma PCT concentrations generally remain below 0.05 ng/mL and rapidly increase within 2–4 h in case of systemic bacterial infection ( o0.25 to o0.5 ng/mL), sepsis (40.5 to 42 ng/mL) and some non-infectious conditions (including trauma, surgery, burns, hyperthermia and neoplasms), remaining high until recovery (Table 1) [3,4,5].
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