Assessing the performance of a point-of-need diagnostic algorithm in rapid detection of peripheral lymph node tuberculosis (Mobile-TB-Lab): a diagnostic evaluation study protocol
Abstract
Introduction: Early and accurate diagnosis of tuberculosis (TB) is central to ensuring the proper treatment and curbing the transmission of the disease. Despite the significant burden, the diagnosis of peripheral lymph node(LN)TB, the most prevalent form of extra pulmonary tuberculosis (EPTB), has been challenging in low resource settings. To meet the existing needs, the Mobile-TB-Lab study set out to evaluate two innovative approaches, including thermal imaging and recombinase-aided amplification assay (RAA) in Minoo for point-of-need diagnosis of LNTB. The synergy of these index tests is expected to pave the way for rapid detection of EPTB in resource-constrained settings.
Methods and analysis: Mobile-TB-Lab is a multicountry diagnostic evaluation study to be performed in Bangladesh and Uganda. Under this protocol, a total of 200 suspected EPTB patients with cervical lymphadenitis will be enrolled from tertiary healthcare facilities in Bangladesh and Uganda. Each participant will be subjected to laboratory investigations including microscopy, real-time PCR, cytology, culture and Xpert MTB/RIF Ultra with the tissue sample following fine-needle aspiration (FNA). As the index tests, thermal imaging will be performed before performing the FNA, and the leftover aspirate will be used to perform RAA in the Minoo device. The diagnostic efficiency of the index tests will be determined against a composite reference standard based on the laboratory methods. Besides, latent class…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 200 participants or records.
Read the paper
Related studies
- Understanding the factors influencing fall armyworm (Spodoptera frugiperda J.E. Smith) damage in African smallholder maize fields and quantifying its impact on yield. A case study in Eastern Zimbabwe
- Alarming situation of emerging H5 and H7 avian influenza and effective control strategies
- Livestock and food security: vulnerability to population growth and climate change
- Atmosphere–ocean oxygen and productivity dynamics during early animal radiations
- Characterization of the global distribution and diversified plasmid reservoirs of the colistin resistance gene mcr-9
- The global seroprevalence of Toxoplasma gondii in pigs: A systematic review and meta-analysis
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.