Clinical Performance of a New Soluble CD14-Subtype Immunochromatographic Test for Whole Blood Compared with Chemiluminescent Enzyme Immunoassay: Use of Quantitative Soluble CD14-Subtype Immunochromatographic Tests for the Diagnosis of Sepsis

PLOS ONE, Dec 2019

We previously reported that a soluble CD14-subtype (sCD14-ST) immunochromatographic test (ICT) for plasma is more convenient than chemiluminescent enzyme immunoassay (CLEIA), but plasma separation makes bedside measurements difficult. We developed a new sCD14-ST ICT for whole blood and investigated whether quantitative determinations of sCD14-ST by ICT were useful for diagnosing sepsis and severe sepsis/septic shock. We studied 20 patients who fulfilled two or more systemic inflammatory response syndrome (SIRS) criteria and 32 patients who had been diagnosed with sepsis or severe sepsis/septic shock. Whole blood was collected on day 0 (on admission) and day 7, and the sCD14-ST concentration was quantitatively measured by CLEIA and ICT for whole blood. The patients’ Acute Physiology and Chronic Health Evaluation (APACHE) II, Sequential Organ Failure Assessment (SOFA), and Mortality in Emergency Department Sepsis (MEDS) scores were also calculated. The cut-off values obtained by the quantitative measurements made by ICT were 464.5 pg/mL for sepsis and 762.7 pg/mL for severe sepsis/septic shock (P < 0.0001). A Bland–Altman plot showed that no fixed bias or proportional bias was detected between CLEIA and quantitative ICT for whole blood. sCD14-ST concentrations were significantly correlated with APACHE II, SOFA, and MEDS scores (P < 0.0001). These results suggest that the new sCD14-ST ICT for whole blood may be a useful tool for the convenient, rapid bedside diagnosis and treatment of sepsis.

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Clinical Performance of a New Soluble CD14-Subtype Immunochromatographic Test for Whole Blood Compared with Chemiluminescent Enzyme Immunoassay: Use of Quantitative Soluble CD14-Subtype Immunochromatographic Tests for the Diagnosis of Sepsis

December Clinical Performance of a New Soluble CD14- Subtype Immunochromatographic Test for Whole Blood Compared with Chemiluminescent Enzyme Immunoassay: Use of Quantitative Soluble CD14-Subtype Immunochromatographic Tests for the Diagnosis of Sepsis Masayuki Sato 0 1 Gaku Takahashi 0 1 Shigehiro Shibata 0 1 Makoto Onodera 0 1 Yasushi Suzuki 0 1 Yoshihiro Inoue 0 1 Shigeatsu Endo 0 1 0 Department of Critical Care Medicine, Iwate Medical University , Uchimaru, Morioka, Iwate , Japan 1 Editor: Sachin Yende, University of Pittsburgh, UNITED STATES We previously reported that a soluble CD14-subtype (sCD14-ST) immunochromatographic test (ICT) for plasma is more convenient than chemiluminescent enzyme immunoassay (CLEIA), but plasma separation makes bedside measurements difficult. We developed a new sCD14-ST ICT for whole blood and investigated whether quantitative determinations of sCD14-ST by ICT were useful for diagnosing sepsis and severe sepsis/septic shock. We studied 20 patients who fulfilled two or more systemic inflammatory response syndrome (SIRS) criteria and 32 patients who had been diagnosed with sepsis or severe sepsis/septic shock. Whole blood was collected on day 0 (on admission) and day 7, and the sCD14-ST concentration was quantitatively measured by CLEIA and ICT for whole blood. The patients' Acute Physiology and Chronic Health Evaluation (APACHE) II, Sequential Organ Failure Assessment (SOFA), and Mortality in Emergency Department Sepsis (MEDS) scores were also calculated. The cut-off values obtained by the quantitative measurements made by ICT were 464.5 pg/mL for sepsis and 762.7 pg/mL for severe sepsis/septic shock (P < 0.0001). A Bland-Altman plot showed that no fixed bias or proportional bias was detected between CLEIA and quantitative ICT for whole blood. sCD14-ST concentrations were significantly correlated with APACHE II, SOFA, and MEDS scores (P < 0.0001). These results suggest that the new sCD14-ST ICT for whole blood may be a useful tool for the convenient, rapid bedside diagnosis and treatment of sepsis. - Data Availability Statement: All relevant data are within the paper and its Supporting Information files. Funding: These authors have no support or funding to report. Competing Interests: The authors have declared that no competing interests exist. Introduction Sepsis is a toxic systemic response to infection that progresses to the even more serious conditions of severe sepsis and septic shock accompanied by organ dysfunction [ 1 ]. According to the Surviving Sepsis Campaign Guidelines 2012 (SSCG 2012), mortality rates are higher when antimicrobial agents have been administered after septic shock has developed. Targets that should be completed within 3 h and within 6 h have also been clearly identified, and rapid diagnosis and treatment of sepsis has been emphasized [ 2 ]. Procalcitonin (PCT), interleukin-6 (IL-6), and tumor necrosis factor-α have previously been used as diagnostic markers for sepsis. PCT, in particular, has been reported to be superior to endotoxin, β-D-glucan, IL-6, and C-reactive protein for differentiating between bacterial infections, including sepsis, and non-bacterial infections [ 3 ]. Conversely, PCT is known to be increased in non-infectious systemic inflammatory response syndrome (SIRS) [ 4–7 ], and differentiating between non-infectious SIRS and infectious SIRS can be difficult [8]. In recent years, soluble CD14-subtype (sCD14-ST) has been highlighted as a specific marker in infections. In 2005, we reported that quantitatively determined sCD14-ST using a sandwich enzyme-linked immunosorbent assay (ELISA) that showed elevated sCD14-ST levels (specifically increased in sepsis) was a better diagnostic marker than PCT, IL-6, or endotoxin and was strongly correlated with Sequential Organ Failure Assessment (SOFA) scores [ 9 ]. However, the assay method is complicated, and because it takes approximately 5–6 h, the time required to make a diagnosis is a disadvantage. In 2011, we quantitatively analyzed sCD14-ST concentrations in only 17 min using the PATHFAST1 Presepsin assay system, which is based on a completely automated chemiluminescent enzyme immunoassay (CLEIA) [ 10 ]. We previously reported a sCD14-ST immunochromatographic test (ICT) for plasma that allows measurements to be made more conveniently and in 15 min—a shorter time than by CLEIA [ 11–14 ]. However, the plasma needs to be separated by centrifugation, and ICT for plasma lacks speed, making bedside measurements difficult. Moreover, the complexity of the assay procedure is a problem. To resolve these issues, we developed a new sCD14-ST ICT for whole blood that can be used to make quantitative determinations using an optical reader. In this study, we investigated whether quantitative determinations of sCD14-ST by ICT for whole blood would be useful for diagnosing sepsis and severe sepsis/septic shock and whether its quantitative capacity is similar to that provided by CL (...truncated)


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Masayuki Sato, Gaku Takahashi, Shigehiro Shibata, Makoto Onodera, Yasushi Suzuki, Yoshihiro Inoue, Shigeatsu Endo. Clinical Performance of a New Soluble CD14-Subtype Immunochromatographic Test for Whole Blood Compared with Chemiluminescent Enzyme Immunoassay: Use of Quantitative Soluble CD14-Subtype Immunochromatographic Tests for the Diagnosis of Sepsis, PLOS ONE, 2015, Volume 10, Issue 12, DOI: 10.1371/journal.pone.0143971