Diagnostic accuracy of interleukin-6 (IL-6) as a significant biomarker in late-onset neonatal sepsis: an updated systematic review and meta-analysis

<p dir="ltr">Late-onset neonatal sepsis (LONS) remains a leading cause of morbidity and mortality in neonates, particularly among preterm and low birth weight infants. Interleukin-6 (IL-6) has emerged as a promising biomarker for early detection of LONS, yet the diagnostic performanc...

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محفوظ في:
التفاصيل البيبلوغرافية
المؤلف الرئيسي: Amani N. Alansari (19743643) (author)
مؤلفون آخرون: Mohamed Sayed Zaazouee (10576593) (author), Alaa Ahmed Elshanbary (11967181) (author), Salma Mani (22047860) (author), Marwa Messaoud (22827959) (author)
منشور في: 2025
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author Amani N. Alansari (19743643)
author2 Mohamed Sayed Zaazouee (10576593)
Alaa Ahmed Elshanbary (11967181)
Salma Mani (22047860)
Marwa Messaoud (22827959)
author2_role author
author
author
author
author_facet Amani N. Alansari (19743643)
Mohamed Sayed Zaazouee (10576593)
Alaa Ahmed Elshanbary (11967181)
Salma Mani (22047860)
Marwa Messaoud (22827959)
author_role author
dc.creator.none.fl_str_mv Amani N. Alansari (19743643)
Mohamed Sayed Zaazouee (10576593)
Alaa Ahmed Elshanbary (11967181)
Salma Mani (22047860)
Marwa Messaoud (22827959)
dc.date.none.fl_str_mv 2025-09-02T03:00:00Z
dc.identifier.none.fl_str_mv 10.1007/s00431-025-06409-w
dc.relation.none.fl_str_mv https://figshare.com/articles/journal_contribution/Diagnostic_accuracy_of_interleukin-6_IL-6_as_a_significant_biomarker_in_late-onset_neonatal_sepsis_an_updated_systematic_review_and_meta-analysis/30971722
dc.rights.none.fl_str_mv CC BY 4.0
info:eu-repo/semantics/openAccess
dc.subject.none.fl_str_mv Biomedical and clinical sciences
Clinical sciences
Paediatrics
Biomarker
Diagnostic accuracy
Interleukin-6
IL-6
Late-onset neonatal sepsis
dc.title.none.fl_str_mv Diagnostic accuracy of interleukin-6 (IL-6) as a significant biomarker in late-onset neonatal sepsis: an updated systematic review and meta-analysis
dc.type.none.fl_str_mv Text
Journal contribution
info:eu-repo/semantics/publishedVersion
text
contribution to journal
description <p dir="ltr">Late-onset neonatal sepsis (LONS) remains a leading cause of morbidity and mortality in neonates, particularly among preterm and low birth weight infants. Interleukin-6 (IL-6) has emerged as a promising biomarker for early detection of LONS, yet the diagnostic performance of IL-6 remains inconsistent across studies. This meta-analysis aimed to evaluate the overall diagnostic accuracy of IL-6 in detecting LONS and to assess the certainty of evidence using the GRADE approach. A comprehensive search of five databases was conducted up to July 15, 2025. Twenty-two studies were eligible for inclusion, of which 20 (<i>n</i> = 3527 neonates) were included in the meta-analysis. A bivariate random-effects model was used to estimate pooled sensitivity and specificity, and the area under the SROC curve was used to assess overall diagnostic accuracy. Pooled sensitivity and specificity were 85.2% (95% CI: 80.0–89.3%) and 84.1% (95% CI: 77.5–89.0%), respectively. The positive and negative likelihood ratios were 5.43 and 0.18, with a diagnostic odds ratio of 31.4. The AUC was 0.91, indicating excellent diagnostic accuracy. Subgroup and sensitivity analyses confirmed the robustness of the findings, and no significant threshold effect was detected. However, suspected publication bias was noted. The GRADE assessment rated the certainty of evidence as moderate. Conclusion: IL-6 demonstrates high diagnostic accuracy for LONS and may serve as a valuable tool for early identification, though standardization of cutoff thresholds and further validation studies are warranted. What is Known:• IL-6 is an early-rising biomarker for late-onset neonatal sepsis (LONS), but its diagnostic accuracy varies across studies. What is New:• This meta-analysis used a bivariate model to estimate IL-6 performance, yielding high pooled sensitivity (85.2%) and specificity (84.1%).</p><h2 dir="ltr">Other Information</h2><p dir="ltr">Published in: European Journal of Pediatrics<br>License: <a href="https://creativecommons.org/licenses/by/4.0" target="_blank">https://creativecommons.org/licenses/by/4.0</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1007/s00431-025-06409-w" target="_blank">https://dx.doi.org/10.1007/s00431-025-06409-w</a></p>
eu_rights_str_mv openAccess
id Manara2_d976dcf9f1f465d0262f9963b1418026
identifier_str_mv 10.1007/s00431-025-06409-w
network_acronym_str Manara2
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oai_identifier_str oai:figshare.com:article/30971722
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spelling Diagnostic accuracy of interleukin-6 (IL-6) as a significant biomarker in late-onset neonatal sepsis: an updated systematic review and meta-analysisAmani N. Alansari (19743643)Mohamed Sayed Zaazouee (10576593)Alaa Ahmed Elshanbary (11967181)Salma Mani (22047860)Marwa Messaoud (22827959)Biomedical and clinical sciencesClinical sciencesPaediatricsBiomarkerDiagnostic accuracyInterleukin-6IL-6Late-onset neonatal sepsis<p dir="ltr">Late-onset neonatal sepsis (LONS) remains a leading cause of morbidity and mortality in neonates, particularly among preterm and low birth weight infants. Interleukin-6 (IL-6) has emerged as a promising biomarker for early detection of LONS, yet the diagnostic performance of IL-6 remains inconsistent across studies. This meta-analysis aimed to evaluate the overall diagnostic accuracy of IL-6 in detecting LONS and to assess the certainty of evidence using the GRADE approach. A comprehensive search of five databases was conducted up to July 15, 2025. Twenty-two studies were eligible for inclusion, of which 20 (<i>n</i> = 3527 neonates) were included in the meta-analysis. A bivariate random-effects model was used to estimate pooled sensitivity and specificity, and the area under the SROC curve was used to assess overall diagnostic accuracy. Pooled sensitivity and specificity were 85.2% (95% CI: 80.0–89.3%) and 84.1% (95% CI: 77.5–89.0%), respectively. The positive and negative likelihood ratios were 5.43 and 0.18, with a diagnostic odds ratio of 31.4. The AUC was 0.91, indicating excellent diagnostic accuracy. Subgroup and sensitivity analyses confirmed the robustness of the findings, and no significant threshold effect was detected. However, suspected publication bias was noted. The GRADE assessment rated the certainty of evidence as moderate. Conclusion: IL-6 demonstrates high diagnostic accuracy for LONS and may serve as a valuable tool for early identification, though standardization of cutoff thresholds and further validation studies are warranted. What is Known:• IL-6 is an early-rising biomarker for late-onset neonatal sepsis (LONS), but its diagnostic accuracy varies across studies. What is New:• This meta-analysis used a bivariate model to estimate IL-6 performance, yielding high pooled sensitivity (85.2%) and specificity (84.1%).</p><h2 dir="ltr">Other Information</h2><p dir="ltr">Published in: European Journal of Pediatrics<br>License: <a href="https://creativecommons.org/licenses/by/4.0" target="_blank">https://creativecommons.org/licenses/by/4.0</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1007/s00431-025-06409-w" target="_blank">https://dx.doi.org/10.1007/s00431-025-06409-w</a></p>2025-09-02T03:00:00ZTextJournal contributioninfo:eu-repo/semantics/publishedVersiontextcontribution to journal10.1007/s00431-025-06409-whttps://figshare.com/articles/journal_contribution/Diagnostic_accuracy_of_interleukin-6_IL-6_as_a_significant_biomarker_in_late-onset_neonatal_sepsis_an_updated_systematic_review_and_meta-analysis/30971722CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/309717222025-09-02T03:00:00Z
spellingShingle Diagnostic accuracy of interleukin-6 (IL-6) as a significant biomarker in late-onset neonatal sepsis: an updated systematic review and meta-analysis
Amani N. Alansari (19743643)
Biomedical and clinical sciences
Clinical sciences
Paediatrics
Biomarker
Diagnostic accuracy
Interleukin-6
IL-6
Late-onset neonatal sepsis
status_str publishedVersion
title Diagnostic accuracy of interleukin-6 (IL-6) as a significant biomarker in late-onset neonatal sepsis: an updated systematic review and meta-analysis
title_full Diagnostic accuracy of interleukin-6 (IL-6) as a significant biomarker in late-onset neonatal sepsis: an updated systematic review and meta-analysis
title_fullStr Diagnostic accuracy of interleukin-6 (IL-6) as a significant biomarker in late-onset neonatal sepsis: an updated systematic review and meta-analysis
title_full_unstemmed Diagnostic accuracy of interleukin-6 (IL-6) as a significant biomarker in late-onset neonatal sepsis: an updated systematic review and meta-analysis
title_short Diagnostic accuracy of interleukin-6 (IL-6) as a significant biomarker in late-onset neonatal sepsis: an updated systematic review and meta-analysis
title_sort Diagnostic accuracy of interleukin-6 (IL-6) as a significant biomarker in late-onset neonatal sepsis: an updated systematic review and meta-analysis
topic Biomedical and clinical sciences
Clinical sciences
Paediatrics
Biomarker
Diagnostic accuracy
Interleukin-6
IL-6
Late-onset neonatal sepsis