Abstract
Procalcitonin (PCT) is a current, frequently-used marker for severe bacterial infection. The aim of this study was to develop a cost-effective detection kit for rapid quantitative and on-site detection of PCT. To develop the new PCT quantitative detecting kit, a double-antibody sandwich immunofluorescent assay was employed based on time-resolved immunofluorescent assay (TRFIA) combined with lateral flow immunoassay (LFIA). The performance of the new developed kit was evaluated in the aspects of linearity, precision, accuracy, and specificity. Two-hundred thirty-four serum samples were enrolled to carry out the comparison test. The new PCT quantitative detecting kit exhibited a higher sensitivity (0.08 ng/mL). The inter-assay coefficient of variation (CV) and the intra-assay CV were 5.4%–7.7% and 5.7%–13.4%, respectively. The recovery rates ranged from 93% to 105%. Furthermore, a high correlation (n = 234, r = 0.977, p < 0.0001) and consistency (Kappa = 0.875) were obtained when compared with the PCT kit from Roche Elecsys BRAHMS. Thus, the new quantitative method for detecting PCT has been successfully established. The results indicated that the newly-developed system based on TRFIA combined with LFIA was suitable for rapid and on-site detection for PCT, which might be a useful platform for other biomarkers in point-of-care tests.
Highlights
Procalcitonin (PCT) is a non-hormonal precursor of the propeptide calcitonin which consists of 114 to 116 amino acids [1]
Fast and accurate detection and monitoring of PCT are very important for antibiotic treatment decision-making, especially in intensive care units (ICU) [7,8,9,10,11,12,13]
PCT reflects the effectiveness of antibiotics and may be used to guide antibiotic treatment, reduce the abuse of antibiotics which may benefit the reduction of the waste of treatment and avoid bacterial drug resistance [7,8]
Summary
Procalcitonin (PCT) is a non-hormonal precursor of the propeptide calcitonin which consists of 114 to 116 amino acids [1]. Recent studies showed that serum PCT levels are significantly elevated in bacterial infection and this has been extensively applied for diagnosis of infection [2,3]. The physiological PCT serum level is below 0.5 ng/mL, but a rise to a value higher than 2 ng/mL is indicative of sepsis [4]. Detectable levels of PCT rise in bacterial infections, but do not increase in most other inflammatory reactions, such as viral infections [5], autoimmune disease, and trauma, making. Fast and accurate detection and monitoring of PCT are very important for antibiotic treatment decision-making, especially in intensive care units (ICU) [7,8,9,10,11,12,13].
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