Cost utility of lateral-flow urine lipoarabinomannan for tuberculosis diagnosis in HIV-infected African adults

Sun, Di; Dorman, Susan E.; Shah, Maunank; Manabe, Yukari C.; Moodley, Mischka; Nicol, Mark P.; Dowdy, David W.

doi:10.5588/ijtld.12.0627

Cited by 37 publications

(37 citation statements)

References 15 publications

(16 reference statements)

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“…A cost-utility analysis restricted to hospitalized, severely immunocompromised, HIV-infected African adults showed that the addition of lateral flow urine LAM testing to standard tuberculosis diagnostics detected additional TB cases at an incremental cost in US dollars per disability-adjusted life year averted of USD $86 in Uganda and USD $353 in South Africa, and was therefore likely to be cost-effective in those populations. 36 Finally, while we purposefully sought diversity within our study population, our findings may not apply to all other populations, especially those with less advanced immunosuppression and/or less severe tuberculosis.…”

Section: Discussionmentioning

confidence: 97%

Diagnostic Accuracy of a Rapid Urine Lipoarabinomannan Test for Tuberculosis in HIV-Infected Adults

Nakiyingi

Moodley

Manabe

et al. 2014

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Objective In settings of high HIV prevalence, tuberculosis control and patient management are hindered by lack of accurate, rapid tuberculosis diagnostic tests that can be performed at point-of-care. The Determine TB LAM Ag (‘TB LAM’) test is a lateral flow immunochromatographic test for detection of mycobacterial lipoarabinomannan (LAM) in urine. Our objective was to determine sensitivity and specificity of the TB LAM test for tuberculosis diagnosis. Design Prospective diagnostic accuracy study. Setting Hospital and outpatient settings in Uganda and South Africa. Participants HIV-infected adults with tuberculosis symptoms and/or signs. Methods Participants provided a fresh urine specimen for TB LAM testing, blood for mycobacterial culture, and two respiratory specimens for smear microscopy and mycobacterial culture. Main outcome measures For the TB LAM test, sensitivity in participants with culture-positive tuberculosis and specificity in participants without tuberculosis. Results 1013 participants were enrolled. Among culture-positive tuberculosis patients, the TB LAM test identified 136/367 (37.1%) overall and 116/196 (59.2%) in the group with CD4≤100 cells/mm3. The test was specific in 559/573 (97.6%) of patients without tuberculosis. Sensitivity of the urine TB LAM test plus sputum smear microscopy was 197/367 (53.7%) overall and 133/196 (67.9%) among those with CD4≤100. CD4≤50 (adjusted odds ratio [AOR] 6.2, P<0.001) or 51–100 (AOR 7.1, P<0.001), mycobacteremia (AOR 6.1; P<0.01) and hospitalization (AOR 2.6, P=0.03) were independently associated with a positive TB LAM test. Conclusions In HIV-positive adults with CD4≤100, the TB LAM urine test detected over half of culture-positive tuberculosis patients, in less than 30 minutes and without the need for equipment or reagents.

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Section: Discussionmentioning

confidence: 97%

Diagnostic Accuracy of a Rapid Urine Lipoarabinomannan Test for Tuberculosis in HIV-Infected Adults

Nakiyingi

Moodley

Manabe

et al. 2014

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…Key parameters including disease prevalence and diagnostic test performance are summarized in Table 1 and Supplemental Digital Content 1, http://links.lww.com/QAD/A400 [3,9,10,12,14,16–37]. Data were collected during a prospective study comparing the sensitivity and specificity (stratified by CD4 + cell count) of the urine LF-LAM assay, Xpert MTB/Rif, and combinations of tests among HIV-infected patients presenting with signs or symptoms of TB [12] [NCT01525134].…”

Section: Methodsmentioning

confidence: 99%

“…Sun et al [14] recently showed that usage of LF-LAM for hospitalized patients with low CD4 + cell count in South Africa was considered highly cost-effective compared with smear-microscopy alone. The cost-effectiveness of incorporating LF-LAM testing as part of diagnostic algorithms with or without Xpert for a broader population of HIV-infected individuals, including outpatients and those with less immunosuppression, is unknown.…”

Section: Introductionmentioning

confidence: 99%

Cost-effectiveness of novel algorithms for rapid diagnosis of tuberculosis in HIV-infected individuals in Uganda

Shah

Dowdy

Joloba³

et al. 2013

Aids

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Objective Xpert MTB/RIF (‘Xpert’) and urinary lateral-flow lipoarabinomannan (LF-LAM) assays offer rapid tuberculosis (TB) diagnosis. This study evaluated the cost-effectiveness of novel diagnostic algorithms utilizing combinations of Xpert and LF-LAM for the detection of active TB among people living with HIV. Design Cost-effectiveness analysis using data from a comparative study of LF-LAM and Xpert, with a target population of HIV-infected individuals with signs/symptoms of TB in Uganda. Methods A decision-analysis model compared multiple strategies for rapid TB diagnosis:sputum smear-microscopy; sputum Xpert; smear-microscopy combined with LF-LAM; and Xpert combined with LF-LAM. Primary outcomes were the costs and DALY’s averted for each algorithm. Cost-effectiveness was represented using incremental cost-effectiveness ratios (ICER). Results Compared with an algorithm of Xpert testing alone, the combination of Xpert with LF-LAM was considered highly cost-effective (ICER $57/DALY-averted) at a willingness to pay threshold of Ugandan GDP per capita. Addition of urine LF-LAM testing to smear-microscopy was a less effective strategy than Xpert replacement of smear-microscopy, but was less costly and also considered highly cost-effective (ICER $33 per DALY-averted) compared with continued usage of smear-microscopy alone. Cost-effectiveness of the Xpert plus LF-LAM algorithm was most influenced by HIV/ART costs and life-expectancy of patients after TB treatment. Conclusion The addition of urinary LF-LAM to TB diagnostic algorithms for HIV-infected individuals is highly cost-effective compared with usage of either sputum smear-microscopy or Xpert alone.

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“…59,79,80 Integrating TB screening methods (e.g., Xpert MTB/RIF or urine LAM) when initiating ART for PLHIV can be cost-effective in South Africa, as compared to symptom screening and sputum smear or sputum culture. 81-83 Point-of-care tests that improve linkage to care could outweigh limitations in test characteristics, such as reduced sensitivity or specificity, when compared with a laboratory-based test. 84 Isoniazid preventive therapy among PLHIV offers another example of how integrating an aspect of TB prevention into HIV services can be cost-effective.…”

Section: Search Strategy and Selection Criteriamentioning

confidence: 99%

HIV, Tuberculosis, and Noncommunicable Diseases

Hyle

Naidoo

et al. 2014

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Unprecedented investments in health systems low- and middle-income countries (LMICs) have resulted in more than eight million individuals on antiretroviral therapy (ART). Such individuals experience dramatically increased survival, but are increasingly at risk of developing common non-communicable diseases (NCDs). Integrating clinical care for HIV, other infectious diseases, and NCDs could make health services more effective and provide greater value. Cost-effectiveness analysis is a method to evaluate the clinical benefits and costs associated with different healthcare interventions and offers guidance for prioritization of investments and scale-up, especially as resources are increasingly constrained. We first examine tuberculosis and HIV as one example of integrated care already successfully implemented in several LMICs; we then review the published literature regarding cervical cancer and depression as two examples of NCDs for which integrating care with HIV services could offer excellent value. Direct evidence of the benefits of integrated services generally remains scarce; however, data suggest that improved effectiveness and reduced costs may be attained by integrating additional services with existing HIV clinical care. Further investigation into clinical outcomes and costs of care for NCDs among people living with HIV (PLHIV) in LMICs will help to prioritize specific healthcare services by contributing to an understanding of the affordability and implementation of an integrated approach.

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Cost utility of lateral-flow urine lipoarabinomannan for tuberculosis diagnosis in HIV-infected African adults

Cited by 37 publications

References 15 publications

Diagnostic Accuracy of a Rapid Urine Lipoarabinomannan Test for Tuberculosis in HIV-Infected Adults

Diagnostic Accuracy of a Rapid Urine Lipoarabinomannan Test for Tuberculosis in HIV-Infected Adults

Cost-effectiveness of novel algorithms for rapid diagnosis of tuberculosis in HIV-infected individuals in Uganda

HIV, Tuberculosis, and Noncommunicable Diseases

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