Unlocking the health system barriers to maximise the uptake and utilisation of molecular diagnostics in low-income and middle-income country setting

Abstract

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.

Keywords: diagnostics and tools; health systems evaluation; tuberculosis.

Figure 1

The Xpert MTB/RIF coverage in the surveyed districts and counties in Uganda, Kenya and Tanzania. The highest coverage was 3, 4 and 9 per district or county in Uganda, Tanzania and Kenya, respectively. Orange strip shading denotes districts or counties surveyed. The size of the blue circles denotes the number of the Xpert MTB/RIF machines starting from zero or no Xpert MTB/RIF machine (smallest blue circle).

Figure 2

Xpert MTB/RIF coverage. (A) Percentage HCFs with Xpert MTB/RIF proportional to the total number of HCFs in possession of Xpert MTB/RIF (n=111). (B) Xpert MTB/RIF coverage in proportion to the HCF type. HCFs, healthcare facilities.

Figure 3

Utilisation of Xpert MTB/RIF at different HCF level. (A) The number of Xpert MTB/RIF tests conducted per HCF. (B) The number of HCFs that performed 240 and above tests per month or eight tests per day recommended by WHO for full capacity use of Xpert MTB/RIF. In both level, five hospitals performed more tests than lower level HCFs. HCFs, healthcare facilities.

Figure 4

Availability, utilisation, calibration and procurement issues of Xpert MTB/RIF machines. Participants answered yes (blue bars) or no (orange bars) to (A) possession of Xpert MTB/RIF test instruments, (B) use of the instrument at point-of-care, (C) instrument calibration, (D) prescription of Xpert MTB/RIF test to all presumptive MTB/RIF cases, (E) stable supply of Xpert MTB/RIF reagent cartridges and (F) if these cartridges were delivered on time. There was a trend to better performances in all parameters at higher healthcare facility levels. HCFs, healthcare facilities.

Figure 5

Healthcare facilities that referred samples for (A) culture (black bars) and drug sensitivity testing (grey bars). (B) Time to culture result across different healthcare facilities. Level 5 HCFs performed substantially more DST than lower level HCFs. The less median time-to-result by level 2 HCFs is because there were only two HCFs that referred samples for culture, insufficient to compute meaningful median. DST, drug sensitivity testing; HCFs, healthcare facilities.