Tuberculosis Case Finding With Combined Rapid Point-of-Care Assays (Xpert MTB/RIF and Determine TB LAM) in HIV-Positive Individuals Starting Antiretroviral Therapy in Mozambique

Floridia, Marco; Ciccacci, Fausto; Andreotti, Mauro; Hassane, Archa; Sidumo, Zita; Magid, Nurja Abdul; Sotomane, Horacio; David, Muhlavasse; Mutemba, Elsa; Cebola, Junia; Mugunhe, Remigio Josè; Riccardi, F; Marazzi, Maria Cristina; Giuliano, Marina; Palombi, Leonardo; Mancinelli, Sandro

doi:10.1093/cid/cix641

Cited by 45 publications

(54 citation statements)

References 32 publications

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“…Some studies of pre-ART patients have found LAM useful for diagnosing TB. 7,8,11,13 In our study, half of the LAMpositive patients were on ART, and ART-naive patients did not have a higher likelihood of being LAM positive than those on ART, suggesting systematic LAM's utility for diagnosing TB in severely immunosuppressed patients, regardless of their ART status. A South African study of patients under HIV care found very low LAM positivity, 6 although high degrees of immunosuppression in our study population (median CD4 was 31 cells/μL compared with 111 cells/μL in Hanifa et al study) may partially explain this difference.…”

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confidence: 53%

“…4,5 Diagnostic accuracy studies of LAM for TB diagnosis of HIV-positive patients irrespective of signs and symptoms have provided inconsistent results. [6][7][8][9][10][11][12][13] In a recent systematic review, the sensitivity and specificity of LAM in outpatients, irrespective of their TB symptoms, was 31% and 95%, respectively, 14 and the just published WHO TB-LAM revised guidelines recommend the use of LAM in HIV-positive patients with CD4 count les than 100 cells/μL, irrespective of signs and symptoms of TB 15 We assessed LAM results and TB diagnosis in ambulatory, severely immunosuppressed HIV patients, who had LAM systematically performed at new or regular HIV consultations. We also assessed the association between LAM results and mortality at 6 months.…”

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confidence: 99%

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Systematic, Point-of-Care Urine Lipoarabinomannan (Alere TB-LAM) Assay for Diagnosing Tuberculosis in Severely Immunocompromised HIV-Positive Ambulatory Patients

Huerga¹,

Cossa²,

Manhiça

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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Point-of-care urine-lipoarabinomannan (LAM) Alere Determine TB-LAM assay has shown utility diagnosing tuberculosis (TB) in HIV-positive, severely immunocompromised, TB-symptomatic patients. We assessed LAM results in severely immunocompromised patients, who had LAM systematically performed at new or follow-up HIV consultations. This was a prospective, observational study on consecutive ambulatory, > 15-year-old HIV-positive patients with CD4 < 100 cells/μL in Mozambique. Clinical assessments and LAM were performed for all and microscopy, Xpert, sputum culture, and chest X-ray for LAM-positive participants. Patients were followed up for 6 months. Of 360 patients, half were ART-naive. Lipoarabinomannan positivity was 11.9% (43/360), higher among symptomatic patients compared with asymptomatic: 18.5% (30/162), and 6.6% (13/198), respectively, P = 0.001. Tuberculosis was bacteriologically confirmed in 6/35 LAM-positive patients (2 of them asymptomatic). Lipoarabinomannan positivity was associated with higher risk of mortality (adjusted odds ratio [aOR]: 4.6, 95% CI: 1.3-15.6, P = 0.015). Systematic urine-LAM allows for rapid TB treatment initiation in severely immunocompromised HIV ambulatory patients and identifies patients at a higher risk of death.

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confidence: 53%

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confidence: 99%

Systematic, Point-of-Care Urine Lipoarabinomannan (Alere TB-LAM) Assay for Diagnosing Tuberculosis in Severely Immunocompromised HIV-Positive Ambulatory Patients

Huerga¹,

Cossa²,

Manhiça

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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“…In a previous study [ 10 ], a TB-diagnosis algorithm based on combined rapid POC assays was evaluated in 972 HIV+ patients in Mozambique. In the present study, to evaluate the cost-effectiveness of the different screening protocols, a simulation was performed on a sample of 1,000 HIV+ patients, with an average age of 35 years at the time of the positive HIV test, as in the previous study.…”

Section: Methodsmentioning

confidence: 99%

“…True-positive-, true-negative-, false-positive- and false-negative-cases were derived on the basis of sensitivity and specificity of tests. Sensitivity and specificity of 4SS was considered 77.5% and 70.4% respectively as described by Floridia et al [ 10 ]. This specificity value differed from that reported by the WHO of 50% [ 1 ], but data regarding performance of 4SS is widely heterogeneous among studies [ 14 – 16 ]; individual performance assessments for SMEAR, MTB/RIF and LF-LAM were derived from previous studies or international guidelines where all test were compared with gold standard culture tests [ 17 – 19 ].…”

Section: Methodsmentioning

confidence: 99%

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Delayed diagnosis and treatment of tuberculosis in HIV+ patients in Mozambique: A cost-effectiveness analysis of screening protocols based on four symptom screening, smear microscopy, urine LAM test and Xpert MTB/RIF

et al. 2018

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BackgroundTuberculosis (TB) represents the ninth leading cause of death worldwide. In 2016 are estimated 1.3 million TB deaths among HIV negative people and an additional 374,000 deaths among HIV positive people. In 2016 are estimated 1.4 million new cases of TB in people living with HIV (PLHIV), 74% of whom were living in Africa. In light of these data, the reduction of mortality caused by TB in PLHIV is strongly required specially in low-income countries as Mozambique. According to international guidelines, the initial TB screening in HIV+ patients should be done with the four symptoms screening (4SS: fever, current cough, night sweats and weight loss). The diagnostic test more used in resource-limited countries is smear microscopy (SMEAR). World Health Organization (WHO) recommended Lateral Flow urine LipoArabinoMannan assay (LF-LAM) in immunocompromised patients; in 2010 WHO endorsed the use of Xpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) test for rapid TB diagnosis but the assay is not used as screening test in all HIV+ patients irrespectively of symptoms due to cost and logistical barriers. The paper aims to evaluate the cost-effectiveness of three screening protocols: standard (4SS and SMEAR in positive patients to 4SS); MTB/RIF; LF-LAM / MTB/RIF.MethodsWe developed a model to assess the cost-effectiveness of the MTB/RIF protocol versus the common standard and LF-LAM / MTB/RIF protocol. The model considered a sample of 1,000 HIV+ antiretroviral treatment naïve patients in Mozambique. We evaluated disability-adjusted life year (DALY) averted for each protocol, cost per DALY, and incremental cost-effectiveness ratio (ICER), over 1-year, assuming a national healthcare system perspective. The model considered the delayed diagnosis as the time elapsed between a false negative test and the diagnosis and treatment of TB. Additional health system organization delay is defined as the time interval between positive test and treatment initiation caused by a delay in the delivery of results due organization of services. We conducted a sensitivity analysis on more relevant variables.ResultsThe MTB/RIF protocol was cost-effective as compared to the standard protocol with an ICER of $56.54 per DALY saved. In a cohort of 1,000 patients MTB/RIF and LF-LAM / MTB/RIF protocol generated 1,281 and 1,254 DALY’s saved respectively, with a difference of 174 and 147 DALY respect to the standard protocol. The total cost of MTB/RIF protocol was lower ($92,263) than the standard ($147,226) and the LF-LAM / MTB/RIF ($113,196). Therefore, the cost per DALY saved including new infections due to delayed diagnosis with the standard protocol was $79.06, about 5 fold higher than MTB/RIF and LF-LAM / MTB/RIF protocols. The cost of additional TB infections due to delays in diagnosis plus health system delay seemed the more relevant costs. The low sensibility and sensitivity of the standard protocol led to a high number of false negatives, thus delayed TB diagnoses and treatment lead to the development of newly transmitted TB infectio...

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Patient Preferences for Strategies to Improve Tuberculosis Diagnostic Services in Zambia

et al. 2022

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IMPORTANCE Delayed engagement in tuberculosis (TB) services is associated with ongoing transmission and poor clinical outcomes. OBJECTIVE To assess whether patients with TB have differential preferences for strategies to improve the public health reach of TB diagnostic services. DESIGN, SETTING, AND PARTICIPANTSA cross-sectional study was undertaken in which a discrete choice experiment (DCE) was administered between September 18, 2019, and January 17, 2020, to 401 adults (>18 years of age) with microbiologically confirmed TB in Lusaka, Zambia. The DCE had 7 attributes with 2 to 3 levels per attribute related to TB service enhancements. Latent class analysis was used to identify segments of participants with unique preferences. Multiscenario simulations were used to estimate shares of preferences for different TB service improvement strategies. MAIN OUTCOMES AND MEASURESThe main outcomes were patient preference archetypes and estimated shares of preferences for different strategies to improve TB diagnostic services. Collected data were analyzed between January 3, 2022, to July 2, 2022. RESULTS Among 326 adults with TB (median [IQR] age, 34 [27-42] years; 217 [66.8%] male; 158 [48.8%] HIV positive), 3 groups with distinct preferences for TB service improvements were identified. Group 1 (192 participants [58.9%]) preferred a facility that offered same-day TB test results, shorter wait times, and financial incentives for testing. Group 2 (83 participants [25.4%])preferred a facility that provided same-day TB results, had greater privacy, and was closer to home. Group 3 (51 participants [15.6%]) had no strong preferences for service improvements and had negative preferences for receiving telephone-based TB test results. Groups 1 and 2 were more likely to report at least a 4-week delay in seeking health care for their current TB episode compared with group 3 (29 [51.3%] in group 1, 95 [35.8%] in group 2, and 10 [19.6%] in group 3; P < .001). Strategies to improve TB diagnostic services most preferred by all participants were same-day TB test results alone (shares of preference, 69.9%) and combined with a small financial testing incentive (shares of preference, 79.3%), shortened wait times (shares of preference, 76.1%), or greater privacy (shares of preference, 75.0%). However, the most preferred service improvement strategies differed substantially by group. CONCLUSIONS AND RELEVANCEIn this study, patients with TB had heterogenous preferences for TB diagnostic service improvements associated with differential health care-seeking behavior.Tailored strategies that incorporate features most valued by persons with undiagnosed TB, including same-day results, financial incentives, and greater privacy, may optimize reach by overcoming key barriers to timely TB care engagement.

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Tuberculosis Case Finding With Combined Rapid Point-of-Care Assays (Xpert MTB/RIF and Determine TB LAM) in HIV-Positive Individuals Starting Antiretroviral Therapy in Mozambique

Cited by 45 publications

References 32 publications

Systematic, Point-of-Care Urine Lipoarabinomannan (Alere TB-LAM) Assay for Diagnosing Tuberculosis in Severely Immunocompromised HIV-Positive Ambulatory Patients

Systematic, Point-of-Care Urine Lipoarabinomannan (Alere TB-LAM) Assay for Diagnosing Tuberculosis in Severely Immunocompromised HIV-Positive Ambulatory Patients

Delayed diagnosis and treatment of tuberculosis in HIV+ patients in Mozambique: A cost-effectiveness analysis of screening protocols based on four symptom screening, smear microscopy, urine LAM test and Xpert MTB/RIF

Patient Preferences for Strategies to Improve Tuberculosis Diagnostic Services in Zambia

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