Genedrive MT-RNR1 ID Kit for detecting a genetic variant to guide antibiotic use and prevent hearing loss in babies: early value assessment

Time to antibiotic treatment

Using the Genedrive MT-RNR1 ID Kit in specialist neonatal intensive care (the PALOH study, McDermott et al. 2022) did not affect time to antibiotic treatment. But there is no evidence in smaller centres, such as a labour or postnatal ward. Evidence is needed to check whether using the test in smaller centres delays antibiotic treatment in babies with suspected infection, which could have severe consequences.

Antibiotic prescribing decisions

Babies with a positive Genedrive MT-RNR1 test result would have an alternative antibiotic to gentamicin. If the false positive rate with the Genedrive System is low, it is likely that only a few additional babies would also have an alternative antibiotic. Experts were not concerned that this would lead to increased antibiotic resistance. But generating further evidence on how the test might affect antibiotic use is essential.

Failure rate

The failure rate of the current Genedrive MT-RNR1 ID Kit is uncertain, so further evidence is needed. This is because failed tests could delay antibiotics, or result in an alternative antibiotic (in line with NICE's guideline on neonatal infection and local protocols) being used unnecessarily.

Diagnostic accuracy

Further evidence on the diagnostic accuracy of the Genedrive MT-RNR1 ID Kit is needed to reduce the uncertainty about the current test, which was changed during development.

Use in smaller non-specialist centres

Using the Genedrive MT-RNR1 ID Kit outside of neonatal intensive care is essential to check whether the time to antibiotic treatment, test failure rate and diagnostic accuracy estimates reported in PALOH are generalisable to other settings. It will also show how the test affects antibiotic prescribing decisions in different centres.

Use in centres with babies from diverse ethnic backgrounds

For equality, it is important to collect data on the ethnicity of babies who have the Genedrive MT-RNR1 test because the prevalence of the m.1555A>G variant varies.

PharmGKB's allele frequency table includes frequencies of the m.1555A>G variant by ethnicity. These are 0.11% (Central or South Asian), 1.81% (East Asian), 0.11% (European), 0.14% (Near Eastern) and 0.3% (Sub-Saharan African).

Use in a wide range of geographical regions

Implementing the Genedrive MT-RNR1 ID Kit in a wide range of geographical regions would support babies from different socioeconomic groups having access to the test. It would also generate evidence for services with differences in practice.