Missed opportunities for integrated testing of HIV and tuberculosis on the GeneXpert platform in Lesotho.

Background: Integrated testing, treatment and care are key strategies for addressing the dual burdens of tuberculosis and HIV. The GeneXpert instrument allows simultaneous HIV and tuberculosis testing, but its utilisation for integrated testing remains suboptimal. Objective: The study determined the extent to which tuberculosis testing and HIV early infant detection (EID) were integrated on the GeneXpert platform, or the potential for integration at selected health facilities. Methods: A mixed methods evaluation was conducted using retrospective secondary data analysis of laboratory records from 2017 to 2019, and semi-structured interviews. Data were collected between January 2020 and March 2020 in Lesotho. Results: Forty-four health staff were interviewed across 13 health facilities: one regional, nine district, and three clinic level. Six were government facilities, six were mission hospitals, and one was a non-profit clinic. All facilities selected had at least one GeneXpert instrument used for tuberculosis or HIV testing; none included simultaneous testing for tuberculosis and HIV. In 2017, the average utilisation rate for the GeneXpert instrument for tuberculosis and EID testing was 63% and 24%, while in 2019, the average utilisation rate was 61% for tuberculosis testing and 27% for EID. Conclusion: Except for three sites where the testing rates were high, utilisation rates were sufficiently low that all the HIV EID and tuberculosis tests undertaken in 2017 and 2019 could have been performed using only the instruments currently dedicated to tuberculosis testing. There is a missed opportunity for the integration of testing for tuberculosis and HIV on the GeneXpert instrument. What this study adds: This study adds to the body of evidence on the need for integration of testing and highlights some practical and technical considerations for successful implementation of integrated tuberculosis and HIV testing.

Strategic site selection for placement of HIV early infant diagnosis point-of-care technology within a national diagnostic network in Lesotho.

BACKGROUND: New technologies for rapid point-of-care (POC) diagnostic tests hold great potential for improving the health outcomes of HIV-exposed infants. POC testing for HIV early infant diagnosis (EID) was introduced in Lesotho in late 2016. Here we highlight critical requirements for selecting routine POC EID sites to ensure a sustainable and optimised EID diagnostic network. INTERVENTION: Lesotho introduced POC EID in a phased approach that included assessments of national databases to identify sites with high test volumes, the creation of local networks of sites to potentially increase access to POC EID, and a standardised capacity assessment to determine site readiness. Potential site networks comprising 'hub' testing sites and 'spoke' specimen referring sites were created. LESSONS LEARNT: After determining optimal placement, a total of 29 testing facilities were selected for placement of POC EID to potentially increase access to 189 facilities through the use of a hub-and-spoke model. Site capacity assessments identified vital human resources and infrastructure capacity gaps that needed to be addressed before introducing POC EID and informed appropriate POC platform selection. RECOMMENDATIONS: POC placement involves more than just purchasing the testing platforms. Considering the relatively small proportion of sites that can be eligible for placement of a POC platform, utilising a hub-and-spoke model can maximise the number of health facilities served by a POC platform while reducing the necessary capacity building and infrastructure investments to fewer sites.

Host urine immunological biomarkers as potential candidates for the diagnosis of tuberculosis.

OBJECTIVE: To investigate the potential of host urinary biomarkers as diagnostic candidates for tuberculosis (TB). METHODS: Adults self-presenting with symptoms requiring further investigation for TB were enrolled in Cape Town, South Africa. Participants were later classified as having TB or other respiratory diseases (ORD) using results from TB confirmatory tests. The concentrations of 29 analytes were evaluated in urine samples from participants using the Luminex platform, and their diagnostic potential was assessed using standard statistical approaches. RESULTS: Of the 151 study participants, 34 (22.5%) were diagnosed with TB and 26 (17.2%) were HIV-positive. Seven biomarkers showed potential as TB diagnostic candidates, with accuracy improving (in HIV-positives) when stratified according to HIV status (area under the receiver operating characteristics curve; AUC ≥0.80). In HIV-positive participants, a four-marker biosignature (sIL6R, MMP-9, IL-2Ra, IFN-γ) diagnosed TB with AUC of 0.96, sensitivity of 85.7% (95% confidence interval (CI) 42.1-99.6%), and specificity of 94.7% (95% CI 74.0-99.9%). In HIV-negatives, the most promising was a two-marker biosignature (sIL6R and sIL-2Ra), which diagnosed TB with AUC of 0.76, sensitivity of 53.9% (95% CI 33.4-73.4%), and specificity of 79.6% (95% CI 70.3-87.1%). CONCLUSIONS: Urinary host inflammatory biomarkers possess TB diagnostic potential but may be influenced by HIV infection. The results of this study require validation in larger studies.