RT Journal Article SR Electronic T1 Unlocking the health system barriers to maximise the uptake and utilisation of molecular diagnostics in low-income and middle-income country setting JF BMJ Global Health JO BMJ Global Health FD BMJ Publishing Group Ltd SP e005357 DO 10.1136/bmjgh-2021-005357 VO 6 IS 8 A1 Ntinginya, Nyanda Elias A1 Kuchaka, Davis A1 Orina, Fred A1 Mwebaza, Ivan A1 Liyoyo, Alphonce A1 Miheso, Barbara A1 Aturinde, Augustus A1 Njeleka, Fred A1 Kiula, Kiula A1 Msoka, Elizabeth F A1 Meme, Helen A1 Sanga, Erica A1 Mwanyonga, Simeon A1 Olomi, Willyhelmina A1 Minja, Linda A1 Joloba, Moses A1 Mmbaga, Blandina T A1 Amukoye, Evans A1 Gillespie, Stephen Henry A1 Sabiiti, Wilber YR 2021 UL http://gh.bmj.com/content/6/8/e005357.abstract AB Background Early access to diagnosis is crucial for effective management of any disease including tuberculosis (TB). We investigated the barriers and opportunities to maximise uptake and utilisation of molecular diagnostics in routine healthcare settings.Methods Using the implementation of WHO approved TB diagnostics, Xpert Mycobacterium tuberculosis/rifampicin (MTB/RIF) and Line Probe Assay (LPA) as a benchmark, we evaluated the barriers and how they could be unlocked to maximise uptake and utilisation of molecular diagnostics.Results Health officers representing 190 districts/counties participated in the survey across Kenya, Tanzania and Uganda. The survey findings were corroborated by 145 healthcare facility (HCF) audits and 11 policy-maker engagement workshops. Xpert MTB/RIF coverage was 66%, falling behind microscopy and clinical diagnosis by 33% and 1%, respectively. Stratified by HCF type, Xpert MTB/RIF implementation was 56%, 96% and 95% at district, regional and national referral hospital levels. LPA coverage was 4%, 3% below culture across the three countries. Out of 111 HCFs with Xpert MTB/RIF, 37 (33%) used it to full capacity, performing ≥8 tests per day of which 51% of these were level five (zonal consultant and national referral) HCFs. Likewise, 75% of LPA was available at level five HCFs. Underutilisation of Xpert MTB/RIF and LPA was mainly attributed to inadequate—utilities, 26% and human resource, 22%. Underfinancing was the main reason underlying failure to acquire molecular diagnostics. Second to underfinancing was lack of awareness with 33% healthcare administrators and 49% practitioners were unaware of LPA as TB diagnostic. Creation of a national health tax and decentralising its management was proposed by policy-makers as a booster of domestic financing needed to increase access to diagnostics.Conclusion Our findings suggest higher uptake and utilisation of molecular diagnostics at tertiary level HCFs contrary to the WHO recommendation. Country-led solutions are crucial for unlocking barriers to increase access to diagnostics.Data are available on reasonable request. Data available at School of Medicine Division of Infection and Global Health, WS, ws31@st-andrews.ac.uk. Requests will be reviewed by the ethics Committee to assess their compliance to confidentiality and limits of consent given by study participants.