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

Med Princ Pract. 2024 Feb 6. doi: 10.1159/000536678. Online ahead of print.

Abstract

Objective: Sepsis often prompts clinicians to start empirical antibiotics in suspected neonates while awaiting diagnosis. The next-generation testing with point-of-care 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 point-of-care (POC) testing of C-reactive protein (CRP), interleukin-6 (IL-6), and procalcitonin with standard laboratory methods was performed.

Results: The mean gestation age and birth weight of the neonates were 33.17 ± 4.25 weeks and 1695.4 ± 700.74 grams respectively. Most neonates were preterm (75%) with nearly equal proportions of early (51.22%) and late-onset (48.78%) sepsis. The point-of-care CRP correlated well with standard CRP (r = 0.8001, 95% CI: 0.706 - 0.867, p < 0.0001). Amongst the three biomarkers, CRP had the maximum diagnostic accuracy (AUC - 0.73) followed by procalcitonin (AUC - 0.65) and IL-6 (0.55). There was no significant difference in the diagnostic accuracy of CRP (p = 0.46), procalcitonin (p = 0.29), and IL-6 (p = 0.60) in early and late-onset sepsis. The mean time for point-of-care estimation of IL-6, PCT, and CRP was 12 ± 3 minutes which was significantly less compared to 366 ± 61 minutes for standard techniques. (p < 0.001).

Conclusion: Point-of-care CRP correlates well with standard techniques of estimation, and CRP alone and in combination with procalcitonin has good diagnostic accuracy in neonatal sepsis.