Authors' objectives: Neonates with suspected sepsis are commonly treated with gentamicin, an aminoglycoside. These antibiotics are associated with high risk of ototoxicity, including profound bilateral deafness, in people with the m.1555A>G mitochondrial genetic variant. This early value assessment summarised and critically assessed the clinical effectiveness and cost-effectiveness of the Genedrive MT-RNR1 ID Kit for identifying the gene m.1555A>G variant in neonates and mothers of neonates needing antibiotics or anticipated to need antibiotics. Following feedback from the scoping workshop and specialist assessment subgroup meeting, we also considered the Genedrive MT-RNR1 ID Kit for identifying the m.1555A>G variant in mothers prior to giving birth. Sepsis and bacterial infections are a significant cause of mortality and morbidity in neonates (up to and including a corrected gestational age of 28 days). Expert opinion suggests that the incidence of culture-confirmed neonatal infection is around 1 in 2000 deliveries. But a larger proportion of babies will go on to receive precautionary antibiotic treatment for suspected infection [e.g. 30–60 in 1000 for those admitted to neonatal intensive care units (NICUs)]. Treatment for suspected infection or sepsis is commonly conducted using gentamicin, an antibiotic of the aminoglycoside family. This antibiotic is associated with a high risk of ototoxicity in those with a genetic variation of the mitochondrial MT-RNR1 gene, specifically m.1555A>G. The purpose of this assessment was to investigate the use of the Genedrive MT-RNR1 ID Kit for identifying the m.1555A>G variant in neonates with suspected infection or sepsis. This technology has the potential to identify those at most risk of ototoxicity from aminoglycoside antibiotics and inform treatment decisions within the time frame recommended by National Institute for Health and Care Excellence (NICE) guidance.
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