Centre for Infectious Disease Research in Zambia
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Diagnostic value of serological scores for the detection of liver steatosis in people with HIV in low- and middle-income countries.
(2026-May-01) Plaisy MK; Mondoka C; Moreira R; Samala N; Borse R; Kuniholm MH; Minga A; Wandeler G; Lopez-Iñiguez A; Michael D; Ross J; Shumbusho F; Mensah E; Shamu T; Crabtree-Ramirez BE; Byakwaga H; Rupasinghe D; Murenzi G; Mureithi F; Diero L; Mivumbi JP; Nguyen DTH; Maruri F; Jaquet A; Perazzo H
BACKGROUND: The accuracy of Fatty Liver Index (FLI) and Hepatic Steatosis Index (HSI) to predict liver steatosis in people with HIV (PWH) remains poorly studied in low- and middle-income countries (LMICs). We assessed their diagnostic performances in a multiregional cohort.
METHODS: This cross-sectional analysis included PWH aged ≥40 years on antiretroviral therapy for ≥6 months at enrolment (2020-2023) in the Sentinel Research Network (SRN) of IeDEA consortium, across 12 HIV clinics in Asia-Pacific, Americas, and central, East, southern, and West Africa regions. Liver steatosis was defined based on Controlled Attenuation Parameter (CAP) ≥248 dB/m using vibration-controlled transient elastography. HSI was evaluated in the overall population, while FLI was assessed and compared to HSI in a subset of participants with available data. Model discrimination was assessed using area under the receiver operating characteristic curve (AUROC) and model calibration with calibration plots. A decision curve analysis was performed to compare their clinical utility.
RESULTS: Among 2195 PWH assessed using CAP, 624 (28.4%) presented with liver steatosis. HSI showed acceptable discriminative ability (AUROC = 0.74) but poor calibration, generally overestimating the risk, except in Asia-Pacific region. FLI performed better than HSI (AUROC = 0.80, P < 0.001), and demonstrated good calibration except in sub-Saharan Africa. Both scores showed high clinical utility, with FLI demonstrating a greater net benefit when compared with HSI.
CONCLUSION: FLI demonstrated higher accuracy and clinical utility within a subgroup of regions. However, the limited performance of FLI and HSI in sub-Saharan populations highlights the need to adapt existing tools or develop new predictive models tailored to regional contexts.
Pulmonary Tuberculosis Detection with MiniDock MTB Using Swab Samples.
(2026-Apr-30) Yerlikaya S; Chirwa M; Ajide B; Castro MDM; Ha H; Kato-Maeda M; Kisakye E; Marcelo D; Mochizuki T; Rockman L; Steadman A; Thangakunam B; Bimba JS; Christopher DJ; Muyoyeta M; Phan H; Theron G; Yu C; Kremer K; Phillips PPJ; Nahid P; Denkinger CM; Cattamanchi A; Andama A
BACKGROUND: Improved diagnostic tools for tuberculosis that are suitable for use in peripheral health centers are essential for reducing the persistent gap between estimated and notified cases. The diagnostic accuracy and usability of the MiniDock MTB test for detecting pulmonary tuberculosis is unknown.
METHODS: We conducted a prospective, cross-sectional study at outpatient centers in India, Nigeria, the Philippines, South Africa, Uganda, Vietnam, and Zambia. Patients 12 years of age or older with presumptive pulmonary tuberculosis were enrolled between September 12, 2024, and March 31, 2025. Assessment with MiniDock MTB was performed with sputum swabs and tongue swabs. Diagnostic accuracy was evaluated against a sputum-culture-based reference and as compared with sputum-smear microscopy and Xpert MTB/RIF Ultra assay. Usability was assessed with a system usability scale and direct observation.
RESULTS: A total of 1380 participants were enrolled; 255 (18.5%) had human immunodeficiency virus infection and 226 (16.4%) had culture-confirmed tuberculosis. MiniDock MTB sensitivity was 85.7% (95% confidence interval [CI], 80.4 to 90.0) with sputum and 79.6% (95% CI, 73.8 to 84.7) with tongue swabs; specificity was greater than 97.5% for both. Results of sputum tests with MiniDock MTB closely matched those with Xpert MTB/RIF Ultra for sensitivity (difference, -2.8 percentage points; 95% CI, -6.0 to 0.5). MiniDock MTB had greater sensitivity than smear microscopy for tests of sputum (difference, 24.3 percentage points; 95% CI, 17.9 to 30.7) and tongue swabs (difference, 18.3 percentage points; 95% CI, 12.0 to 24.7). The test showed diagnostic accuracy that was consistent with World Health Organization (WHO) accuracy targets for near-point-of-care tuberculosis diagnostics (≥85% sensitivity for sputum and ≥75% for nonsputum and ≥98% specificity for both). The median score on the system usability scale (range, 0 to 100, with higher scores indicating better perceived usability) was 75 (interquartile range, 65 to 80), which indicated good usability. No adverse events related to the index test were reported.
CONCLUSIONS: MiniDock MTB met WHO targets for diagnostic accuracy and usability for tuberculosis detection across diverse clinical settings. (Funded by the National Institutes of Health and others; Rapid Research in Diagnostics Development for TB Network and Assessing Diagnostics at Point-of-Care for Tuberculosis ClinicalTrials.gov numbers, NCT04923958 and NCT05941052.).
Diagnostic Yield of Tongue Swab- Compared to Sputum-Based Molecular Testing for Tuberculosis in Four High-Burden Countries.
(2026-Apr-30) Moe CA; Luswata RK; Barrameda AJ; Le H; Muzazu S; Crowder R; Andama AO; Denkinger CM; Muyoyeta M; Phan H; Cattamanchi A; Yu C
BACKGROUND: Tongue swabs are a promising alternative specimen for tuberculosis (TB) diagnosis. Although test specificity exceeds 98%, sensitivity is lower than sputum-based molecular testing. We investigated whether the use of tongue swabs could increase sample availability, resulting in similar diagnostic yield.
METHODS: In this cross-sectional study (July 2024-January 2025), we screened consecutive people with presumptive TB at health centers in the Philippines, Vietnam, Uganda, and Zambia. Participants were asked to provide tongue swabs and referred for routine sputum collection. Tongue swabs were tested in research laboratories using the MiniDock MTB Test (Guangzhou Pluslife Biotech Co., Ltd., China); sputum was tested using WHO-recommended molecular testing per national guidelines. We compared diagnostic yield, defined as proportion of positive test results among all participants, between tongue swab- and sputum-based molecular testing with a prespecified 3.0% non-inferiority margin.
RESULTS: Of 1639 participants, 851 (51.9%) were female, 415 (25.3%) were diagnosed with HIV, and 132 (8.1%) were children <5 years. All provided tongue swabs, but only 1389 (84.7%) produced sputum. Diagnostic yield was 3.8% (63/1639) for tongue swabs and 4.1% (68/1639) for sputum-based (68/1639, 4.1%) molecular testing. The difference (0.3%, 95% CI -0.6 to +1.2) was within the prespecified non-inferiority margin. Results were consistent across countries and key subgroups (age, sex, and HIV status).
CONCLUSIONS: Tongue swab-based molecular testing with MiniDock MTB achieved non-inferior diagnostic yield compared with sputum-based molecular testing. These findings support scale-up of swab-based platforms as a cost-efficient alternative, particularly where sputum collection is challenging or smear microscopy remains the primary diagnostic method.
Tongue swab Xpert MTB/RIF Ultra testing for TB using a revised consensus protocol.
(2026-Apr-27) Ajide B; Moe CA; Barrameda J; Chirwa M; Rockman L; de Haas P; de Vos M; Kato-Maeda M; Tasca B; Bimba J; Yu C; Denkinger CM; Kremer K; Nahid P; Cattamanchi A; Theron G; Muyoyeta M
BACKGROUNDTongue swabs are a promising specimen type for TB diagnosis. In a previous study, using a consensus protocol, tongue swabs tested with Xpert MTB/RIF Ultra outperformed sputum smear microscopy, but a substantial proportion (6.1%) of results were non-actionable (e.g., invalid/error). We evaluated a revised protocol for tongue swab Xpert Ultra testing in four high-burden countries.METHODSParticipants aged ≥12 years with presumptive TB were enrolled from outpatient clinics in the Philippines, South Africa, Nigeria, and Zambia. Tongue swabs were processed using Sample Reagent (SR, Cepheid, USA) diluted 2:1 with phosphate buffer or phosphate-buffered saline and tested with Xpert Ultra. Diagnostic performance was assessed against culture-based microbiological reference standard and compared to sputum tests.RESULTSFrom March to November 2024, 1,168 participants were enrolled (median age 37 [IQR: 28-48] years; 46.7% female; 21.8% living with HIV; 18.5% culture-confirmed TB). The proportion of non-actionable tongue swab results was 5.6% overall, but <4% in all countries except South Africa (15.4%). Tongue swab sensitivity was 66.0% (95% CI: 59.0-72.5); specificity was 99.6% (95% CI: 98.9-99.9).CONCLUSIONThe revised protocol yielded low error rates at most sites and moderate sensitivity, supporting tongue swabs as an alternative specimen for Xpert Ultra testing when sputum is unavailable..
Burden of Enteric Viral Infections Among United States Children in the Post-Rotavirus Vaccine Era.
(2026-May-01) Laban NM; Lee B