Abstract
Strengthening tuberculosis diagnosis is an international priority and the advocacy for multi-disease testing devices raises the possibility of improving laboratory efficiency. However, the advantages of centralized platforms might not translate into real improvements under operational conditions. This study aimed to evaluate the field use of the Abbott RealTime MTB (RT-MTB) and Xpert MTB/RIF assays, in a large cohort of HIV-positive and TB presumptive cases in Southern Mozambique. Over a 6-month period, 255 HIV-positive TB presumptive cases were consecutively recruited in the high TB/HIV burden district of Manhiça. The diagnostic performance of both assays was evaluated against two different reference standards: a microbiological gold standard (MGS) and a composite reference standard (CRS). Results from the primary analysis (MGS) showed improved sensitivity (Se) and reduced specificity (Sp) for the Abbott RT-MTB assay compared to the Xpert MTB/RIF (RT-MTB Se: 0.92 (95% CI: 0.75;0.99) vs Xpert Se: 0.73 (95% CI: 0.52;0.88) p value = 0.06; RT-MTB Sp: 0.80 (0.72;0.86) vs Xpert Sp: 0.96 (0.92;0.99) p value < 0.001). The lower specificity may be due to cross-reactivity with non-tuberculous mycobacteria (NTMs), the detection of non-viable MTBC, or the identification of true TB cases missed by the gold standard.
Highlights
Tuberculosis (TB) remains one of the leading causes of death and disease worldwide
The median age was calculated as 27 years [IQR 23;35], with 51.4% of them (111/216) identified as female and 58.3% (126/216) were on antiretroviral therapy (ART)
All of them tested negative for TB at the initial visit, and based on National Tuberculosis Programme (NTP) records, they did not start treatment during the study period
Summary
Tuberculosis (TB) remains one of the leading causes of death and disease worldwide. The World Health Organization (WHO)’s End TB Strategy has set ambitious goals to be achieved by 2035: 90% reduction in TB incidence and 95% reduction in mortality compared with levels in 2 0151. The endorsement of the Xpert MTB/RIF (hereinafter Xpert) as an initial test for TB investigation has radically changed the landscape of TB d iagnosis[5]. This cartridge-based molecular assay was designed for the Cepheid’s GeneXpert System (module-based), which allows the rapid detection of the MTBC. Through the release of rapid communication, WHO made new recommendations on the use of molecular assays as initial tests for TB diagnosis (Xpert MTB/RIF, Xpert Ultra, and TrueNat MTB have shown to have good performance for the detection of TB and rifampicin resistance d etection[9]). The advocacy for high-capacity, multi-disease testing devices, mainly in settings with limited resources, provides the option of improving laboratory efficiency and cost-saving
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