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Paper-Based Interleukin-6 Test Strip for Early Detection of Wound Infection.

ABSTRACT: The early stage of wound infection is always non-specific. Prompt intervention may help to prevent the wound from worsening. We developed a new protocol, based on previous research, that employs a paper-based IL-6 test strip used in combination with a spectrum-based optical reader to detect IL-6 in normal tissue (n = 19), acute wounds (n = 31), and chronic wounds (n = 32). Our data indicated the presence of significantly higher levels of IL-6 in acute wound tissues, but no significant difference in serum CRP. Receiver operating characteristics were used to determine clinical sensitivity and specificity of tissue IL-6 and systemic CRP. The area under the curve values were 0.87 and 0.63, respectively. The cut-off value of 30 pg/mL for IL-6 provided good sensitivity (75.0%) and superior specificity (88.9%). We found a high correlation between the IL-6 test strip and conventional ELISA results (R² = 0.85, p < 0.001), and good agreement was also observed according to Bland-Altman analysis. We showed a promising role of tissue IL-6 to help early diagnosis of wound infection when clinical symptoms were non-specific. The advantages of this wound detection protocol included minimal invasiveness, small sample requirements, speed, sample preparation ease, and user-friendliness. This methodology could help care providers quickly clarify wound infection status and implement timely, optimal management.

SUBMITTER: Pan SC

PROVIDER: S-EPMC9313325 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Introduction: Community-acquired pneumonia (CAP) is lethal in elderly individuals who are more vulnerable to respiratory failure and require more emergency ventilation support than younger individuals. Interleukin-6 (IL-6) plays a crucial role and has predictive value in CAP; high serum IL-6 concentrations in adults are associated with high respiratory failure and mortality rates. Early detection of IL-6 concentrations can facilitate the timely stratification of patients at risk of acute respiratory failure. However, conventional enzyme-linked immunosorbent assay (ELISA) IL-6 measurement is laborious and time-consuming. Methods: The IL-6 rapid diagnostic system combined with a lateral flow immunoassay-based (LFA-based) IL-6 test strip and a spectrum-based optical reader is a novel tool developed for rapid and sequential bedside measurements of serum IL-6 concentrations. Here, we evaluated the correlation between the IL-6 rapid diagnostic system and the ELISA and the efficacy of the system in stratifying high-risk elderly patients with CAP. Thirty-six elderly patients (median age: 86.5 years; range: 65-97 years) with CAP were enrolled. CAP diagnosis was established based on the Infectious Diseases Society of America (IDSA) criteria. The severity of pneumonia was assessed using the CURB-65 score and Pneumonia Severity Index (PSI). IL-6 concentration was measured twice within 24 h of admission. Results: The primary endpoint variable was respiratory failure requiring invasive mechanical or non-invasive ventilation support after admission. IL-6 rapid diagnostic readouts correlated with ELISA results (p < 0.0001) for 30 samples. Patients were predominantly male and bedridden (69.4%). Ten patients (27.7%) experienced respiratory failure during admission, and five (13.9%) died of pneumonia. Respiratory failure was associated with a higher mortality rate (p = 0.015). Decreased serum IL-6 concentration within 24 h after admission indicated a lower risk of developing respiratory failure in the later admission course (Receiver Operating Characteristic [ROC] curve = 0.696). Conclusion: Sequential IL-6 measurements with the IL-6 rapid diagnostic system might be useful in early clinical risk assessment and severity stratification of elderly patients with pneumonia. This system is a potential point-of-care diagnostic device for sequential serum IL-6 measurements that can be applied in variable healthcare systems.

Project description:Influenza virus infection is a major worldwide public health problem. Influenza virus infections are associated with a high hospitalization rate in children between the ages of 5 and 14. The predominant reason for poor influenza prognosis is the lack of any effective means for early diagnosis. Early diagnosis of severe illness is critical to improving patient outcome, and could be especially useful in areas with limited medical resources. Accurate, inexpensive, and easy-to-use diagnostic tools could improve early diagnosis and patient outcome, and reduce overall healthcare costs. We developed an interleukin-6 paper-based test strip that used colloidal gold-conjugated antibodies to detect human interleukin-6 protein. These complexes were captured on a paper-based test strip patterned with perpendicular T lines that were pre-coated with anti-human interleukin-6 antibodies. Applied serum samples interacted with these antibodies and presented as colored bands that could be read using a spectrum-based optical reader. The full-spectrum of the reflected light interleukin-6 protein signal could be obtained from the spectral optics module, and the standard could be used to quantitatively analyze interleukin 6 level in serum. We retrospectively evaluated 10 children (23 serum samples) with severe influenza virus infections, 26 children (26 serum samples) with mild influenza virus infections, and 10 healthy children (10 serum samples). Our system, the combined use of a paper-based test strip and a spectrum-based optical reader, provided both qualitative and quantitative information. When used with the optical reader, the detection limit was improved from a qualitative, naked-eye level of 400 pg/ml to a quantitative, optical reader level of 76.85 pg/ml. After monitoring serum interleukin-6 level via our system, we found a high correlation between our system results and those obtainable using a conventional sandwich enzyme-linked immunosorbent assay method (Rho = 0.706, p < 0.001). The sensitivity and specificity for differentiating between severe and mild influenza using our combined method (test strip coupled with optical reader) were 78.3 and 50.0%, respectively. When interleukin-6 was combined with serum C-reaction protein, the sensitivity and specificity were 85.7 and 95.5%, and the receiver operating characteristic area-under-the-curve was quite high (AUC = 0.911, p < 0.001). The potential advantages of our system, i.e., a paper-based test strip coupled with a spectrum-based optical reader, are as follows: 1) simple user operation; 2) rapid turnaround times-within 20 min; 3) high detection performance; and, 4) low-cost fabrication.

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Paper-Based Interleukin-6 Test Strip for Early Detection of Wound Infection.

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