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Open Access TB testing in HIV-positive patients prior to antiretroviral treatment

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BACKGROUND: TB diagnosis in patients with HIV is challenging due to the lower sensitivities across tests. Molecular tests are preferred and the Xpert® MTB/RIF assay has limitations in lower-income settings. We evaluated the performance of loop-mediated isothermal amplification (LAMP) and the lipoarabinomannan (LAM) test in HIV-positive, ART-naïve clinic patients.

METHODS: A total of 783 eligible patients were enrolled; three spot sputum samples of 646 patients were tested using TB-LAMP, Xpert, smear microscopy and culture, while 649 patients had TB-LAM testing. Sensitivity, specificity, and negative and positive predictive values were estimated with 95% confidence intervals.

RESULTS: Sensitivities for smear microscopy, TB-LAMP and Xpert were respectively 50%, 63% and 74% compared to culture, with specificities of respectively 99.2%, 98.5% and 97.5%. An additional eight were positive on TB-LAM alone. Seventy TB patients (9%) were detected using standard-of-care testing, an additional 27 (3%) were detected using study testing. Treatment was initiated in 57/70 (81%) clinic patients, but only in 56% (57/97) of all those with positive TB tests; 4/8 multidrug-resistant samples were detected using Xpert.

CONCLUSION: TB diagnostics continue to miss cases in this high-burden setting. TB-LAMP was more sensitive than smear microscopy, and if followed by culture and drug susceptibility testing as required, can diagnose TB in HIV-positive patients. TB-LAM is a useful add-in test and both tests at the point-of-care would maximise yield.

Keywords: ART-naïve; POCT; TB-LAM; TB-LAMP; Xpert® MTB/RIF

Document Type: Research Article

Affiliations: 1: Department of Paediatrics and Child Health, University of KwaZulu-Natal, Durban, South Africa, HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa 2: South African Medical Research Council, Durban, South Africa 3: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa 4: Biostatistics Unit, South African Medical Research Council, Durban, South Africa 5: School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa, Medical Microbiology Department, National Health Laboratory Services, Durban, South Africa, Centre for AIDS Programme Research in South Africa, Durban, South Africa 6: School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa, Medical Microbiology Department, National Health Laboratory Services, Durban, South Africa 7: Medical Microbiology Department, National Health Laboratory Services, Durban, South Africa 8: EThekwini Health Unit, EThekwini Municipality, Durban, South Africa 9: Occupational Health, Durban, South Africa 10: Department of Paediatrics and Child Health, University of KwaZulu-Natal, Durban, South Africa

Publication date: March 1, 2022

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