Diagnostic Accuracy of Point-of-Care Testing of C-Reactive Protein, Interleukin-6, and Procalcitonin in Neonates with Clinically Suspected Sepsis: A Prospective Observational Study

• Published in: Medical principles and practice Vol. 33; no. 3; pp. 291 - 298
• Main Authors: Goyal, Medha, Mascarenhas, Dwayne, RR, Prashanth, Haribalakrishna, Anitha
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland S. Karger AG 06.02.2024
• Subjects: Accuracy; Antibiotics; Antibodies; Antigens; Automation; Bacterial infections; Biomarkers; Biomarkers - blood; Blood tests; C-reactive protein; C-Reactive Protein - analysis; Cytokines; Female; Gestational Age; Humans; Infant, Newborn; Intensive Care Units, Neonatal; Interleukin-6 - blood; Laboratories; Leukocytes; Male; Medical diagnosis; Neonatal care; Neonatal Sepsis - blood; Neonatal Sepsis - diagnosis; Neutrophils; Newborn babies; Observational studies; Original Paper; Point of care testing; Procalcitonin - blood; Prospective Studies; Proteins; Sample size; Sensitivity and Specificity; Sensors; Sepsis; Sepsis - blood; Sepsis - diagnosis; Viral infections; Diagnosis; Biological markers; Neonatal intensive care units; Bedside testing
• ISSN: 1011-7571; 1423-0151; 1423-0151
• DOI: 10.1159/000536678

Abstract Objective: Sepsis often prompts clinicians to start empirical antibiotics in suspected neonates while awaiting diagnosis. The next-generation testing with point-of-care (POC) techniques offers a lead-time advantage that could bridge the gap by providing a timely diagnosis. Materials and Methods: We conducted a prospective diagnostic study in 82 neonates enrolled between May and October 2022 in a level III neonatal intensive care unit. All neonates with a new episode of clinically suspected sepsis were included. Diagnostic accuracy of POC testing of C-reactive protein (CRP), interleukin-6 (IL-6), and procalcitonin (PCT) with standard laboratory methods was performed. Results: The mean gestation age and birth weight of the neonates were 33.17 ± 4.25 weeks and 1,695.4 ± 700.74 grams, respectively. Most neonates were preterm (75%) with nearly equal proportions of early (51.22%) and late-onset (48.78%) sepsis. The POC CRP correlated well with standard CRP (r = 0.8001, 95% CI: 0.706–0.867, p < 0.0001). Among the three biomarkers, CRP had the maximum diagnostic accuracy (area under the curve [AUC] – 0.73) followed by PCT (AUC – 0.65) and IL-6 (0.55). There was no significant difference in the diagnostic accuracy of CRP (p = 0.46), PCT (p = 0.29), and IL-6 (p = 0.60) in early- and late-onset sepsis. The mean time for POC estimation of IL-6, PCT, and CRP was 12 ± 3 min which was significantly less compared to 366 ± 61 min for standard techniques (p < 0.001). Conclusion: POC CRP correlates well with standard techniques of estimation, and CRP alone and in combination with PCT has good diagnostic accuracy in neonatal sepsis. Highlights of the StudyPoint-of-care (POC) C-reactive protein (CRP) levels correlate well with standard laboratory estimation.CRP alone and in combination with procalcitonin (PCT) has maximum diagnostic accuracy in neonatal sepsis.POC testing can be used in both early- and late-onset sepsis with similar diagnostic accuracy.The mean time required for POC estimation of interleukin-6, PCT, and CRP is nearly 12 min which is significantly less than standard techniques.