Evaluation of a turbidimetric C-reactive protein assay to monitor early-onset neonatal sepsis in South Kivu (Democratic Republic of the Congo)

Abstract

ObjectivesNeonatal sepsis, a condition defined as bacteremia within the first month of life accompanied by signs of systemic infection, is the most preventable cause of infant mortality in sub-Saharan Africa. Despite the development of new infection markers, C-reactive protein (CRP) is the most extensively studied acute phase reactant so far and the preferred index in many neonatal intensive care units (NICUs). The aim of the present study was to evaluate an affordable, non-commercial turbidimetric CRP assay for monitoring early-onset neonatal sepsis (EOS).MethodsA total of 148 neonates admitted at the NICU of the Hôpital Provincial Général de Référence de Bukavu to diagnose and to monitor EOS were enrolled in the study. CRP was assayed using a functional turbidimetric assay based on the interaction of CRP with phosphocholine containing particles (Intralipid®).ResultsIn total, 62/148 (41.9%) cases were identified as blood culture-proven EOS. Different serum CRP slopes were observed among the different birth weight categories. Moreover, the serum (CRP 48 h–CRP 12 h) difference and the birth weight predicted the outcome of these septic newborns.ConclusionsOur turbidimetric CRP assay is a potential novel tool that can be used in the management of EOS in sub-Saharan Africa. The simplicity of the assay and the extremely low price make the CRP method very well suited for developing countries.

Early-Onset Neonatal Sepsis in Low- and Middle-Income Countries: Current Challenges and Future Opportunities

“…Most of the literature define EOS being within the first 72h of life, especially for pre-term neonates, 20 however there are studies that use the value of the metric at either 48h, 21 , 22 or <7 days, 23 especially for term neonates. 20 , 24 Neonates born at term have a lower risk of neonatal sepsis compared to premature (<37 weeks gestational age), very low birth weight (VLBW, <1500g), or extremely low birth weight (ELBW) neonates. 25–27 A lack of clarity with neonatal sepsis definitions may bias and cloud data comparisons.…”

“… 31 Many global estimates are limited to inclusion of data from a relatively small number of countries, not an accurate representation of global incidence, more a biased reflection on available data, with scarcity of data from a large quantity of LMICs. However, from the data available, the incidence of EOS (and all neonatal sepsis; some studies include pooled metrics and/or variations in the definition of EOS) is considerably lower in HICs compared to LMICs; the NeonIN study collated data from 30 neonatal units in the UK and reported an EOS incidence of 0.7 cases per 1000 live births, 24 similar to EOS rates reported from studies in America between 0.5–0.8 cases per 1000 live births. 32–35 Comparably, a study from Norway reported EOS incidence of 0.97/1000 live births between 1996–2018.…”

“…Studies have discussed the benefits of serum assays and biomarkers to aid the diagnosis of sepsis, however access to the assays, requirement for training and equipment, prognostic accuracy of reliability these assays are still a contested topic. A low-cost sustainable serum C-reactive protein (CRP) assay has been shown to be useful in monitoring EOS, 24 although it has limited sensitivity and specificity, 111 particularly during the in early phase of the infection (>12h after presentation of clinical symptoms). 112 There is likely no single biomarker or assay to diagnose neonatal sepsis, 113 and studies have shown diagnostic value for a combined assay of CRP, tumour necrosis factor-α (TNF-α) and interleukin −1 and −6.…”

Exploration of the relationship between anemia and iron and zinc deficiencies in children under 5 years of age living in the malaria endemic area of South Kivu/Democratic Republic of Congo

“…Submicroscopic Plasmodium parasitemia was defined as a negative thick smear with a positive LAMP illumigene malaria assay. C-reactive protein (CRP) was measured by turbidimetric method as described elsewhere [24,25] using UVmini-1240 UV-VIS spectrophotometer (Shimadzu corporation, Japan). A direct colorimetric test without deproteinization of sample based on the 5-Br-PAPS method was used to measure serum zinc with the CYANSmart® spectrophotometer using zinc Spinreact color 5 Br-PAPS (Santa Coloma, Spain).…”

Consistency Analysis of 3 Detection Systems for Measuring Serum C-Reactive Protein

“…Clinical chemistry analyzers based on turbidimetric principles are used in large clinical settings, while commercially approved ELISA kits are preferred in dispersed and remote settings [ 9 ]. In the present study, the Mindray BC-5390, Mindray BC-6800, and Johnson Vitros5600 analyzers were based on the principle of the turbidimetric method to detect CRP value [ 10 , 28 ]. The difference was that the Mindray analyzers used immunity transmission turbidity, while the Johnson Vitros5600 analyzer used immune scatter turbidity.…”