Clinical Impact and Cost-Effectiveness of Xpert MTB/RIF Testing in Hospitalized Patients with Presumptive Pulmonary Tuberculosis in the United States

Cowan, James; Chandler, Aldine S; Kracen, Elizabeth; Park, David R.; Wallis, Carolyn K.; Liu, Emelline; Song, Changcheng; Persing, David H.; Fang, Ferric C.

doi:10.1093/cid/ciw803

Cited by 30 publications

(56 citation statements)

References 34 publications

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“…Our study result demonstrated that GeneXpert testing among patients with suspected TB is very cost-effective. This cost estimate is in line with a study in China [32] and the United States [33] that found incorporating GeneXpert in the TB diagnostic algorithms was highly cost-effective.…”

Section: Discussionsupporting

confidence: 87%

Cost-effectiveness of GeneXpert Compared to Smear Microscopy for Diagnosis of Tuberculosis in Ethiopia

Kaso¹,

Hailu²

2020

Preprint

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Background Early diagnosis is one of the pillars of the TB (TB) control, and there are strong efforts to detect and treat cases in Ethiopia. Smear microscopy testing has been a routine test for the diagnosis of pulmonary TB in resource-constrained settings for a long time. Recently, many countries, including Ethiopia, are scaling up the use of GeneXpert without a precise evaluation of the cost and cost-effectiveness of this technology. Therefore, this study aimed to evaluate the cost-effectiveness of GeneXpert compared to smear microscopy tests for the diagnosis of TB patients in Ethiopia. Methods We develop a decision tree model using TreeAge Pro 2020 software. The model accounts for the prevalence and incidence of TB in the study area. The costs were estimated from the health providers' perspective in one year (in 2017/18). We applied an ingredients-based costing approach to identify, measure, and evaluate the smear microscopy cost and GeneXpert. We employed the 'proportion of cases detected' as an outcome measure of effectiveness. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the changes in cost and change effectiveness. One way and probabilistic sensitivity analysis were done by varying different input parameters. All costs and ICER are reported in 2018 US$. Results The unit cost per test for GeneXpert and smear microscopy testing was US$12.9 and $3.1, respectively. The average cost of testing using GeneXpert was $113.0 and $3.3 for smear microscopy. The cost of the cartridge ($10.7) was the primary (83%) parameter influencing the overall cost of GeneXpert, while it was the cost of reagent and consumables $1.28 (41%) for the smear microscopy. The ICER for GeneXpert strategy was $729.8 per new TB cases detected compared to smear microscopy. The sensitivity analysis indicates that TB prevalence was the most influential parameter on the ICER. Conclusion The present study indicates that testing all individuals with suspected TB using GeneXpert is a very cost-effective strategy compared to smear microscopy, and therefore, it can be part of the routine diagnostic testing strategy in Ethiopia.

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Section: Discussionsupporting

confidence: 87%

Cost-effectiveness of GeneXpert Compared to Smear Microscopy for Diagnosis of Tuberculosis in Ethiopia

Kaso¹,

Hailu²

2020

Preprint

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“…Data on cost and cost-effectiveness of Xpert in diverse settings had been reported. Xpert was more sensitive, comparably specific, and more cost-effective than smear microscopy in intermediate and low burden areas (16,17). Xpert was superior over microscopic determination of drug susceptibility (MODS) in high TB/HIV prevalence setting (18).…”

Section: Discussionmentioning

confidence: 99%

“…Theoretically, Ultra would be more cost-effective comparing with 2 Xpert tests for smear-negative PTB diagnosis. Cowan et al (21) reported that the two Xpert tests strategy was more expensive but still cost-effective compared with 3 smears. Due to the unavailable of Ultra in most of countries nowadays, our results suggested that two Xpert tests can benefit the poor diagnosis of smear-negative TB.…”

Section: Discussionmentioning

confidence: 99%

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Incremental cost-effectiveness of the second Xpert MTB/RIF assay to detect Mycobacterium tuberculosis

Wang

Jiang

et al. 2018

J. Thorac. Dis.

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Background: Due to the non-homogeneity of specimens collected from tuberculosis (TB) suspects, repeated Xpert MTB/RIF (Xpert) may have potential clinical benefits. Incremental cost-effectiveness was analyzed for the second Xpert assay to detect Mycobacterium tuberculosis (Mtb) and rifampicin (RIF) resistance. Methods: Specimens were collected from 1,063 pulmonary TB (PTB) and 398 extrapulmonary TB (EPTB) suspects, who had two Xpert tests sequentially within one week. The specimens were subjected to smear, culture, Xpert and drug susceptibility testing. Incremental cost-effectiveness of the serial Xpert assays was evaluated. Results: Among 813 Xpert-positive TB patients, 755 (92.87%) were identified by the first assay whereas the additional 58 (7.13%) were identified by the second assay. The second Xpert assay had higher incremental yield for smear-negative than for smear-positive specimens (12.07% vs. 1.84%, P<0.001), and higher incremental yield for EPTB than for PTB (10.71% vs. 4.65%, P=0.003). About 94.48% (137/145) of the RIF-resistant patients were identified by the first Xpert assay and 5.52% (8/145) were identified by the second Xpert assay. After the first assay, the incremental cost of performing a second Xpert was huge:US$22.82 vs. US$467.72 (P<0.001) and US$35.02 vs. US$291.87 (P<0.001) for PTB and EPTB, respectively.The incremental cost of performing a second Xpert is lower in smear-negative than in smear-positive group in both PTB and EPTB. Conclusions: One Xpert assay is sufficient for smear-positive cases, and a second Xpert assay is beneficial not only for Mtb detection but also for RIF-resistant diagnosis for smear-negative TB suspects, whereas the incremental cost for the second Xpert is huge.

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“…Both methods, however, have low clinical sensitivity for paucibacillary TB cases, which account for >60% of new TB cases each year in emerging TB-endemic areas such as China (1, 4, 5). The PCR-based Xpert MTB/RIF assay can increase the diagnosis speed and clinical sensitivity in multibacillary TB, but it still requires sputum or invasive biopsy specimens, exhibits moderate clinical sensitivity in patients with paucibacillary TB (e.g., Mycobacterium tuberculosis ( Mtb ) culture- or smear-negative TB cases), and cannot differentiate between live and nonviable Mtb bacilli to monitor response to anti-TB therapy (6–10). Blood-based IFN- γ release assays measure ex vivo immune responses to assay-introduced Mtb antigens and cannot distinguish between active TB and latent TB infection (11, 12).…”

mentioning

confidence: 99%

Clinical Evaluation of a Blood Assay to Diagnose Paucibacillary Tuberculosis via Bacterial Antigens

Liu

Lyon

et al. 2018

Clinical Chemistry

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BACKGROUND The diagnosis of active tuberculosis (TB)10 cases primarily relies on methods that detect Mycobacterium tuberculosis (Mtb) bacilli or their DNA in patient samples (e.g., mycobacterial culture and Xpert MTB/RIF assays), but these tests have low clinical sensitivity for patients with paucibacillary TB disease. Our goal was to evaluate the clinical performance of a newly developed assay that can rapidly diagnose active TB cases by direct detection of Mtb-derived antigens in patients’ blood samples. METHODS Nanoparticle (NanoDisk)-enriched peptides derived from the Mtb virulence factors CFP-10 (10-kDa culture factor protein) and ESAT-6 (6-kDa early secretory antigenic target) were analyzed by high-throughput mass spectrometry (MS). Serum from 294 prospectively enrolled Chinese adults were analyzed with this NanoDisk-MS method to evaluate the performance of direct serum Mtb antigen measurement as a means for rapid diagnosis of active TB cases. RESULTS NanoDisk-MS diagnosed 174 (88.3%) of the study’s TB cases, with 95.8% clinical specificity, and with 91.6% and 85.3% clinical sensitivity for culture-positive and culture-negative TB cases, respectively. NanoDisk-MS also exhibited 88% clinical sensitivity for pulmonary and 90% for extrapulmonary TB, exceeding the diagnostic performance of mycobacterial culture for these cases. CONCLUSIONS Direct detection and quantification of serum Mtb antigens by NanoDisk-MS can rapidly and accurately diagnose active TB in adults, independent of disease site or culture status, and outperform Mycobacterium-based TB diagnostics.

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Clinical Impact and Cost-Effectiveness of Xpert MTB/RIF Testing in Hospitalized Patients with Presumptive Pulmonary Tuberculosis in the United States

Cited by 30 publications

References 34 publications

Cost-effectiveness of GeneXpert Compared to Smear Microscopy for Diagnosis of Tuberculosis in Ethiopia

Cost-effectiveness of GeneXpert Compared to Smear Microscopy for Diagnosis of Tuberculosis in Ethiopia

Incremental cost-effectiveness of the second Xpert MTB/RIF assay to detect Mycobacterium tuberculosis

Clinical Evaluation of a Blood Assay to Diagnose Paucibacillary Tuberculosis via Bacterial Antigens

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