The Urgent Need for Accurate Neonatal Sepsis Diagnostics
Each year, an estimated 2.3 million neonates die within their first month of life, with sepsis being a major contributor to this devastating statistic. Sepsis alone is responsible for 7.3% of all neonatal deaths worldwide, with a disproportionate burden falling on low- and middle-income countries (LMICs).
The challenge lies in the non-specificity of sepsis symptoms, which can include fever, respiratory distress, feeding difficulties, and lethargy, among others. The absence of a definitive, affordable, and readily accessible diagnostic test for neonatal sepsis presents a critical gap, leading to both underdiagnosis and overdiagnosis. Both scenarios can have severe consequences for vulnerable newborns and their families.
Early intervention with antibiotics and supportive care can be life-saving, yet the lack of accurate diagnostic tools often compels clinicians to trigger sepsis protocols even when the suspicion is low. This overuse of antibiotics inevitably contributes to the growing crisis of antimicrobial resistance (AMR), further undermining the effectiveness of these critical medications in treating neonatal infections.
Addressing the Diagnostic Gap: Key Priorities and Emerging Solutions
To address this urgent public health challenge, the development of affordable and accurate diagnostic tests that can detect neonatal sepsis at or near the point of care is a high priority. Such diagnostics could significantly contribute to reducing sepsis-related mortality rates in LMICs, support the United Nations Sustainable Development Goal to reduce neonatal deaths to less than 12 per 1,000 live births by 2030, and protect new and existing antibiotics through improved antimicrobial stewardship.
Two key diagnostic solutions have been identified as high priorities:
1. Screening Test for Primary Healthcare Settings
In LMICs, a considerable proportion of neonatal sepsis deaths occur outside of hospital settings. Due to the non-specific nature of sepsis signs, healthcare workers in primary care clinics often struggle to accurately identify these cases. Additionally, logistical challenges, such as transportation costs and distance, frequently prevent timely referrals to higher levels of care, even when neonatal sepsis is recognized.
A neonatal sepsis screening test for use in primary healthcare facilities could increase the number of correct referrals, potentially saving lives, while also decreasing unnecessary referrals that can expose vulnerable newborns to the risk of healthcare-associated infections and impose a financial burden on families and healthcare systems.
2. In-Hospital Diagnostic Test
At the hospital level, a diagnostic test for neonatal sepsis is the highest priority. While clinical judgment remains paramount, an objective test could provide valuable information to guide treatment decisions. By reducing the risk of missed cases and enabling clinicians to identify patients who do not require antibiotics, such a test could improve outcomes for neonates who do not need life-saving treatment while limiting the adverse effects of antibiotic overuse.
This diagnostic test could also serve as a triage tool to identify patients who would benefit from downstream microbiology testing, such as blood culture, pathogen identification, and antibiotic sensitivity testing. This would be particularly beneficial for patients in the “diagnostic grey zone,” where it is unclear from clinical signs alone whether sepsis treatment is warranted.
Key Attributes for Successful Neonatal Sepsis Diagnostics in LMICs
To be effective in LMICs, the diagnostic tests described above must possess several critical attributes:
- Accuracy: The tests must be highly sensitive and specific, with the ability to reliably detect sepsis and differentiate it from other conditions.
- Affordability: The tests must be priced within the reach of healthcare systems and families in resource-limited settings.
- Accessibility: The tests should be easy to use, require minimal infrastructure, and be available at or near the point of care.
- Rapidity: Results must be available quickly to enable timely clinical decision-making and intervention.
- Usability: The tests should be simple to operate, with minimal training required for healthcare workers.
- Heat Stability: The tests must be able to withstand the high temperatures and variable environmental conditions often encountered in LMICs.
- Low Sample Volume: The tests should be able to deliver accurate results with small sample volumes, as obtaining sufficient blood from neonates can be challenging.
Importantly, the diagnostic tests must also demonstrate a tangible impact on clinical outcomes, such as reduced mortality and morbidity, as well as support for antimicrobial stewardship efforts.
Collaborative Efforts to Bridge the Diagnostic Gap
Achieving the ambitious but realistic goal of developing effective diagnostics for neonatal sepsis will require a concerted effort involving various stakeholders, including researchers, product developers, healthcare providers, policymakers, and funders.
The World Health Organization (WHO), in collaboration with organizations such as FIND and UNICEF, is taking steps to address this critical gap. They are working to develop a target product profile that will outline the minimum and optimal attributes of neonatal sepsis diagnostics that are well-suited to the needs of LMIC settings.
Additionally, the Neonatal Sepsis Diagnostic Working Group, a multidisciplinary team of experts, is providing valuable technical insights to guide the development and implementation of these crucial diagnostic solutions.
Conclusion: A Call to Action
Bridging the diagnostic gap for neonatal sepsis is essential to reducing preventable deaths and improving health outcomes for the world’s most vulnerable population. Diagnostic tests that can accurately detect sepsis and guide appropriate treatment decisions have the potential to save countless lives, while also supporting antimicrobial stewardship and the preservation of life-saving antibiotics.
Through collaborative efforts, innovative thinking, and a steadfast commitment to addressing this public health challenge, we can work towards a future where every newborn has access to the care and support they deserve. The time to act is now, and the Joint Action for Water community stands ready to contribute to this vital endeavor.
