Diagnosis of neonatal and adult sepsis using a Serum Amyloid A lateral flow test

Sepsis is the overwhelming immunological response to infection, which if not treated can lead to multi-organ failure, shock and death. Specifically, neonatal sepsis results in 225,000 neonatal deaths globally per annum. Moreover, Uganda experiences one of the highest materno-fetal death rates (62,00...

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Vydáno v:PLOS ONE Ročník 20; číslo 2; s. e0314702
Hlavní autoři: Nowak, Julia, Ssanyu, Jacquellyn Nambi, Namiiro, Flavia, Mountford, Nicola, Parducci, Avery, Domijan, Katarina, Daly, Mandy, O'Brien, Deirdre, Barden, Eithne, Walshe, Kieran, Doyle, Sean, Waiswa, Peter
Médium: Journal Article Publikace
Jazyk:angličtina
Vydáno: United States Public Library of Science 12.02.2025
Public Library of Science (PLoS)
Témata:
Adult
Adults
Analysis
Antibiotics
Antimicrobial agents
Biology and Life Sciences
Biomarkers
Biomarkers - blood
Births
Blood
C-reactive protein
Care and treatment
Complications and side effects
Death
Diagnosis
Economic aspects
Fatalities
Female
Fetuses
Health aspects
Health surveys
Humans
Immune response
Immunology
Infant mortality
Infant, Newborn
Infants
Infants (Newborn)
Infection
Infections
Inflammation
Laboratories
Male
Medical diagnosis
Medicine and Health Sciences
Middle Aged
Multiple organ failure
Nanoparticles
Neonatal Sepsis - blood
Neonatal Sepsis - diagnosis
Neonates
Patient outcomes
Patients
Prevention
Proteins
Risk factors
Sensitivity
Sensitivity analysis
Sensitivity and Specificity
Sepsis
Sepsis - blood
Sepsis - diagnosis
Serum Amyloid A Protein - analysis
Serum Amyloid A Protein - metabolism
Signs and symptoms
Sustainable development
Tumor necrosis factor-TNF
Uganda
Uganda
Ireland
ISSN:1932-6203, 1932-6203
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Shrnutí:Sepsis is the overwhelming immunological response to infection, which if not treated can lead to multi-organ failure, shock and death. Specifically, neonatal sepsis results in 225,000 neonatal deaths globally per annum. Moreover, Uganda experiences one of the highest materno-fetal death rates (62,000 p.a.), with neonatal sepsis deaths at approximately 6,500 p.a.. The difficulty in diagnosing neonatal sepsis lies in the non-specific signs and symptoms associated with sepsis and an absence of definitive sepsis-specific biomarkers. However, serum amyloid A (SAA) detection has potential as a superior biomarker for the diagnosis of probable neonatal sepsis. Herein, in ethically-approved studies we have deployed a competitive lateral flow test (NeoSep-SAA (research-use only)) to detect SAA in whole blood at patient bedside in a resource-limited environment. Results are available within 10 minutes and test format is compatible with small blood volumes available from neonates (5 μl). NeoSep-SAA exhibited a high sensitivity and specificity for diagnosis of adult sepsis, and in neonates showed a sensitivity and specificity of 92% (89%, 95%) and 73% (68%, 77%) with PPV and NPV of 78% (75%, 81%) and 90% (86%, 93%), respectively (n = 714 individuals; 95% CI). NeoSep-SAA showed superior sensitivity for neonatal sepsis over C-Reactive Protein detection (sensitivity: 37%), albeit with some sacrifice of specificity. NeoSep-SAA enabled rapid diagnosis, which combined with minimally-invasive blood withdrawal, was less stressful for neonates. Overall, NeoSep-SAA can readily identify infection/inflammation and has the potential to enable rapid and informed clinical decisions to combat sepsis. This approach has potential to improve neonatal sepsis detection and reduce neonatal mortality in line with United Nations Sustainable Development Goal (SDG) 3.2 objectives.
Bibliografie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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Competing Interests: The authors have declared that no competing interests exist, except Kieran Walshe who is Chief Technology Officer of Accuplex Diagnostics Limited.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0314702