Development of nanodevice for the detection of pro-inflammatory markers for the diagnosis of sepsis
We aim to develop and field test (limited) a rapid diagnostic test using a nanodevice for detecting bacterial sepsis in neonates and young children. This test will identify inflammatory and bacterial surface markers of bacterial sepsis in the blood. The goal is its use in the field by community health workers (CHWs) to assist in the safe management of neonatal sepsis. It is cheap (<$1 per test), rapid (<30 minutes), and since the readout is visual, its use will not require specialized training. The nanodevice will be designed to detect elevations in pro-inflammatory markers (CRP, IL-6, TNF-α, procalcitonin) with/without detectable LPS of Gram negative bacilli and TSST-1 of Staphyloccus aureus in the blood of the neonate indicating septicemia (The major organisms causing neonatal septicemia in developing countries). By varying the concentrations of the primary and secondary antibodies, the nanodevice will initially be titrated to detect only elevated levels of CRP ( >5 mg/dl) IL-6 (> 5pg/ml) PCT (>5 ng/ml) and TNF-α (>150pg/ml), and any LPS/TSST-1. After standardization its sensitivity and specificity will be assessed in neonates and young children with sepsis (at least 550 with suspected sepsis) and 450 healthy controls in whom standard methods of detection of the markers of inflammation and (LPS/TSST-1) in the blood will be used. If successful, it has the potential to transform the community based management of sepsis in the newborn. The device will be developed and tested in India, and if successful will be manufactured with a company based in India.