Costs and Consequences of Using Interferon-γ Release Assays for the Diagnosis of Active Tuberculosis in India

Little, Kristen; Pai, Madhukar; Dowdy, David W.

doi:10.1371/journal.pone.0124525

Cited by 15 publications

(9 citation statements)

References 27 publications

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“…14,35 Furthermore, a recent cost analysis suggests that using IGRAs for diagnosis of active TB in a setting such as India results in overtreatment, with tremendous incremental costs. 36 Our study results are in line with these previous studies, demonstrating that neither the TST nor ELISpot assays can be used to rule in or rule out TB with reasonable certainty.…”

Section: Discussionsupporting

confidence: 90%

Novel interferon-gamma assays for diagnosing tuberculosis in young children in India

Shaikh

Gupte

Dharmshale

et al. 2017

int j tuberc lung dis

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SUMMARY SETTING The tuberculin skin test (TST) and interferon-gamma release assays (IGRAs) are used as supportive evidence to diagnose active tuberculosis (TB). Novel IGRAs could improve diagnosis, but data are lacking in young children. DESIGN Children (age ≤ 5 years) with suspected TB were prospectively screened at a tertiary hospital in Pune, India; the children underwent TST, and standard (early secretory antigenic target 6 and culture filtrate protein 10) and enhanced (five additional novel antigens) enzyme-linked immunospot (ELISpot) assays. RESULTS Of 313 children (median age 30 months) enrolled, 92% had received bacille Calmette-Guérin vaccination, 53% were malnourished and 9% were coinfected with the human immunodeficiency virus (HIV); 48 (15%) had TB, 128 (41%) did not, and TB could not be ruled out in 137 (44%). The sensitivity of enhanced (45%) and standard (42%) ELISpot assays for diagnosing TB was better than that of TST (20%) (P ≤ 0.03); however, enhanced ELISpot was not more sensitive than the standard ELISpot assay (P= 0.50). The specificity of enhanced ELISpot, standard ELISpot and TST was respectively 82% (95%CI 74–89), 88% (95%CI 81–94) and 98% (95%CI 93–100). Rv3879c and Rv3615c, previously reported to be promising antigens, failed to improve the diagnostic performance of the ELISpot assay. CONCLUSION The TST and the standard and novel ELISpot assays performed poorly in diagnosing active TB among young children in India.

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Section: Discussionsupporting

confidence: 90%

Novel interferon-gamma assays for diagnosing tuberculosis in young children in India

Shaikh

Gupte

Dharmshale

et al. 2017

int j tuberc lung dis

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“…Most studies (78%) were performed in high burden TB settings, i.e. Brazil, [ 34 , 35 , 38 , 47 , 48 ] India, [ 36 , 40 , 42 , 50 , 52 , 53 ] several countries in Southern Africa (Botswana, Lesotho, Namibia, South Africa and Swaziland), [ 31 , 35 , 43 , 51 – 53 ] and East Africa (Kenya, Malawi, Uganda, Tanzania and Zambia). [ 30 , 35 , 41 , 44 , 46 , 49 , 51 – 53 , 55 ] One study performed analysis in a high burden region, i.e.…”

Section: Resultsmentioning

confidence: 99%

“…Two studies evaluated the negative impact of serology based testing for active disease diagnosis in high burden settings. [ 36 , 42 ]…”

Section: Resultsmentioning

confidence: 99%

“…Exceptions were found in three studies assessing NAAT (e.g. Xpert and Mycobacterium Tuberculosis Direct Test or MTD) in low-burden settings, [ 33 , 39 , 45 ] two studies evaluating serology based testing in high burden setting, [ 36 , 42 ] and one study investigating TB diagnosis in private and public health sector. [ 50 ]…”

Section: Resultsmentioning

confidence: 99%

“…Around half of the studies failed to report structural assumptions and their justification. [ 29 – 34 , 36 – 38 , 40 , 42 , 44 , 46 – 49 , 51 ] Moreover, none of the studies performed adequate structural uncertainty analysis. All studies also failed to report adequately the synthesis process of the diagnostic tools’ accuracy.…”

Section: Resultsmentioning

confidence: 99%

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Disparities in model-based cost-effectiveness analyses of tuberculosis diagnosis: A systematic review

et al. 2018

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BackgroundStructural approach disparities were minimally addressed in past systematic reviews of model-based cost-effectiveness analyses addressing Tuberculosis management strategies. This review aimed to identify the structural approach disparities in model-based cost-effectiveness analysis studies addressing Tuberculosis diagnosis and describe potential hazards caused by those disparities.MethodsA systematic search to identify studies published before October 2015 was performed in five electronic databases. After removal of duplication, studies’ titles and abstracts were screened based on predetermined criteria. The full texts of potentially relevant studies were subsequently screened and excluded when they did not address active pulmonary Tuberculosis diagnosis. Quality of the studies was assessed using the “Philips’ checklist.” Various data regarding general information, cost-effectiveness results, and disease modeling were extracted using standardized data extraction forms. Data pertaining to models’ structural approaches were compared and analyzed qualitatively for their applicability in various study settings, as well as their potential influence on main outcomes and cost-effectiveness conclusion.ResultsA total of 27 studies were included in the review. Most studies utilized a static model, which could underestimate the cost-effectiveness of the diagnostic tools strategies, due to the omission of indirect diagnosis effects, i.e. transmission reduction. A few structural assumption disparities were found in the dynamic models. Extensive disparities were found in the static models, consisting of varying structural assumptions regarding treatment outcomes, clinical diagnosis and empirical treatment, inpatient discharge decision, and re-diagnosis of false negative patients.ConclusionIn cost-effectiveness analysis studies addressing active pulmonary Tuberculosis diagnosis, models showed numerous disparities in their structural approaches. Several structural approaches could be inapplicable in certain settings. Furthermore, they could contribute to under- or overestimation of the cost-effectiveness of the diagnosis tools or strategies. They could thus lead to ambiguities and difficulties when interpreting a study result. A set of recommendations is proposed to manage issues related to these structural disparities.

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Rethinking Tuberculosis Morbidity Quantification: A Systematic Review and Critical Appraisal of TB Disability Weights in Cost-Effectiveness Analyses

Tomeny,

Hampton,

Tran

et al. 2024

PharmacoEconomics

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Background The disability-adjusted life year (DALY), a key metric for health resource allocation, encompasses morbidity through disability weights. Widely used in tuberculosis cost-effectiveness analysis (CEAs), DALYs play a significant role in informing intervention adopt/reject decisions. This study reviews the values and consistency of disability weights applied in tuberculosis-related CEAs. Methods We conducted a systematic review using the Tufts CEA database, updated to July 2023 with searches in Embase, Scopus and PubMed. Eligible studies needed to have included a cost-per-DALY ratio, and additionally either evaluated a tuberculosis (TB) intervention or included tuberculosis-related weights. We considered all tuberculosis health states: with/without human immunodeficiency virus (HIV) coinfection, TB treatments and treatment side effects. Data were screened and extracted independently by combinations of two authors. Findings A total of 105 studies spanning 2002–2023 across 50 countries (mainly low- and middle-income countries) were extracted. Disability weights were sourced primarily from the Global Burden of Disease (GBD; 100/165; 61%), with 17 non-GBD studies additionally referenced, along with primary derivation. Inconsistencies in the utilisation of weights were evident: of the 100 usages of GBD-sourced weights, only in 47 instances (47%) had the weight value been explicitly specified with an appropriate up-to-date reference cited (constituting 28% of all weight usages, 47/165). Sensitivity analyses on weight values had been conducted in 30% of studies (31/105). Twelve studies did not clearly specify weights or their sources; nine further calculated DALYs without morbidity. The review suggests methodological gaps in current approaches for representing important aspects of TB, including TB–HIV coinfection, treatment, drug-resistance, extrapulmonary TB and psychological impacts. We propose a set of best practice recommendations. Interpretation There is a need for increased rigour in the application, sensitivity testing and reporting of TB disability weights. Furthermore, there appears a desire among researchers to reflect elements of the tuberculosis experience beyond those allowed for by GBD disability weights. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-024-01410-x.

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Costs and Consequences of Using Interferon-γ Release Assays for the Diagnosis of Active Tuberculosis in India

Cited by 15 publications

References 27 publications

Novel interferon-gamma assays for diagnosing tuberculosis in young children in India

Novel interferon-gamma assays for diagnosing tuberculosis in young children in India

Disparities in model-based cost-effectiveness analyses of tuberculosis diagnosis: A systematic review

Rethinking Tuberculosis Morbidity Quantification: A Systematic Review and Critical Appraisal of TB Disability Weights in Cost-Effectiveness Analyses

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