Performance evaluation of presepsin using a Sysmex HISCL‐5000 analyzer and determination of reference interval

BACKGROUND: Analytical evaluation of newly developed presepsin by a Sysmex HISCL‐5000 (Sysmex, Japan) automated immune analyzer was performed. METHODS: For evaluation, sepsis patient samples were collected before treatment in an emergency department. Precision, linearity, limit of blank/limit of detection, method comparisons, and reference intervals were evaluated. Method comparisons were performed using a PATHFAST immune analyzer (LSI Medience Corporation, Japan). RESULTS: Precision using a 20x2x2 protocol for low (306 pg/mL) and high (1031 pg/mL) levels resulted in within‐laboratory standard deviation (95% confidence interval [CI]) and coefficient of variation (CV) %, which were as follows: 15.3 (13.1–18.7), 5.5% and 47.7, (40.5–58.1), 6.4%, respectively. Linearity using patient samples and calibrators were measured from 201 to 16,177 and 188 to 30,000 pg/mL, respectively. The regression equation was y = −23.2 + 1.008x (SE = 162.4) for low levels and y = 779.9 + 1.006x (SE = 668) for high levels. Method comparison by Passing–Bablock analysis was as follows: y = −209.77 + 1.047x (S(yx) = 335.3). The correlation coefficient (95% CI) was 0.869 (0.772–0.927) with statistical significance (p < 0.001). Reference intervals from 120 normal healthy subjects showed that 300 pg/mL was the cut off. Presepsin tended to show a higher value at higher ages and in males. Presepsin showed correlation with some parameters, and the correlation coefficient (p value) were as follows: hematocrit, 0.198 (0.03); eGFR (CKD‐EPI), −0.240 (0.0129); MDRD‐eGFR, −0.194 (0.048), respectively. CONCLUSION: Presepsin measurement by HISCL‐5000 showed reliable performance. Further clinical studies are required for the diagnosis and prognosis of sepsis.