Cost-effectiveness of GeneXpert and LED-FM for diagnosis of pulmonary tuberculosis: A systematic review

Sagili, Karuna D.; Muniyandi, Malaisamy; Nilgiriwala, Kayzad; Shringarpure, Kalpita; Satyanarayana, Srinath; Kirubakaran, Richard; Chadha, Sarabjit; Tharyan, Prathap

doi:10.1371/journal.pone.0205233

Cited by 20 publications

(12 citation statements)

References 25 publications

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“…The WHO initially recommended this technology in early 2011 [67]; the organization is monitoring the global rollout of this method to promote coordination [107]. In the past 3 years, one systematic and four literature reviews of the performance of GeneXpert MTB/RIF for the diagnosis of TB in several settings have been published [108–112]. Because comprehensive reviews on the diagnostic accuracy of the GeneXpert MTB/RIF system were published in 2013 [113], 2014 [114] and 2019 [103], we have not focused on this topic here.…”

Section: Detection Of M Tuberculosismentioning

confidence: 99%

Revisiting the methods for detecting Mycobacterium tuberculosis: what has the new millennium brought thus far?

Campelo

Sousa

Nogueira

et al. 2021

Access Microbiology

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Tuberculosis (TB) affects around 10 million people worldwide in 2019. Approximately 3.4 % of new TB cases are multidrug-resistant. The gold standard method for detecting Mycobacterium tuberculosis , which is the aetiological agent of TB, is still based on microbiological culture procedures, followed by species identification and drug sensitivity testing. Sputum is the most commonly obtained clinical specimen from patients with pulmonary TB. Although smear microscopy is a low-cost and widely used method, its sensitivity is 50–60 %. Thus, owing to the need to improve the performance of current microbiological tests to provide prompt treatment, different methods with varied sensitivity and specificity for TB diagnosis have been developed. Here we discuss the existing methods developed over the past 20 years, including their strengths and weaknesses. In-house and commercial methods have been shown to be promising to achieve rapid diagnosis. Combining methods for mycobacterial detection systems demonstrates a correlation of 100 %. Other assays are useful for the simultaneous detection of M. tuberculosis species and drug-related mutations. Novel approaches have also been employed to rapidly identify and quantify total mycobacteria RNA, including assessments of global gene expression measured in whole blood to identify the risk of TB. Spoligotyping, mass spectrometry and next-generation sequencing are also promising technologies; however, their cost needs to be reduced so that low- and middle-income countries can access them. Because of the large impact of M. tuberculosis infection on public health, the development of new methods in the context of well-designed and -controlled clinical trials might contribute to the improvement of TB infection control.

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Section: Detection Of M Tuberculosismentioning

confidence: 99%

Revisiting the methods for detecting Mycobacterium tuberculosis: what has the new millennium brought thus far?

Campelo

Sousa

Nogueira

et al. 2021

Access Microbiology

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“…The reporting quality of the three published studies was assessed against 24 checkpoints using the CHEERS statement 22. The risk of bias for the three published studies was assessed using the 20-item CHEC-extended checklist 24 32. A risk of bias assessment using the CHEC-extended checklist was not performed for the ACSQHC report; rather, the quality of the ACSQHC report was assessed against 14 checkpoints using the AACODS checklist 23.…”

Section: Resultsmentioning

confidence: 99%

“…Out of a maximum total score of 20, Woolley et al scored 16 (80%) and both Hollenbeak et al and Thanh et al had reported 17 (85%) of items in the CHEC-extended checklist (see online supplementary appendix table S4). Overall, the risk of bias across the three studies as appraised using the CHEC-extended list ranged from moderate to low 24 32…”

Section: Resultsmentioning

confidence: 99%

Economic evaluation of clinical quality registries: a systematic review

et al. 2019

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ObjectivesThe objective of this systematic review was to examine the existing evidence base for the cost-effectiveness or cost-benefit of clinical quality registries (CQRs).DesignSystematic review and narrative synthesis.Data sourcesNine electronic bibliographic databases, including MEDLINE, EMBASE and CENTRAL, in the period from January 2000 to August 2019.Eligibility criteriaAny peer-reviewed published study or grey literature in English which had reported on an economic evaluation of one or more CQRs.Data extraction and synthesisData were screened, extracted and appraised by two independent reviewers. A narrative synthesis was performed around key attributes of each CQR and on key patient outcomes or changes to healthcare processes or utilisation. A narrative synthesis of the cost-effectiveness associated with CQRs was also conducted. The primary outcome was cost-effectiveness, in terms of the estimated incremental cost-effectiveness ratio (ICER), cost savings or return-on-investment (ROI) attributed to CQR implementation.ResultsThree studies and one government report met the inclusion criteria for the review. A study of the National Surgical Quality Improvement Programme (NSQIP) in the USA found that the cost-effectiveness of this registry improved over time, based on an ICER of US$8312 per postoperative event avoided. A separate study in Canada estimated the ROI to be US$3.43 per US$1.00 invested in the NSQIP. An evaluation of a post-splenectomy CQR in Australia estimated that registry cost-effectiveness improved from US$234 329 to US$18 358 per life year gained when considering the benefits accrued over the lifetime of the population. The government report evaluating five Australian CQRs estimated an overall return of 1.6–5.5 times the cost of investment.ConclusionsAvailable data indicate that CQRs can be cost-effective and can lead to significant returns on investment. It is clear that further studies that evaluate the economic and clinical impacts of CQRs are necessary.PROSPERO registration numberCRD42018116807.

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“…GeneXpert MTB/RIF has been widely deployed in a range of LMIC settings and appears to be cost-effective in at least some of them. [29][30][31] However, even this system shares the challenge presented by low copy number bacteria, which may certainly be the case in paucibacillary mycobacterial disease. Potential solutions to insensitivity include new technologies and applications of nucleic acid-based methods such as single-cell whole genome sequence Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-based detection 32 as well as free DNA capture as applied in fetal abnormality and cancer screening tests.…”

Section: Promises and Pitfalls Of Nucleic Acid Amplification Testsmentioning

confidence: 99%

Leapfrogging laboratories: the promise and pitfalls of high-tech solutions for antimicrobial resistance surveillance in low-income settings

et al. 2020

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The scope and trajectory of today’s escalating antimicrobial resistance (AMR) crisis is inadequately captured by existing surveillance systems, particularly those of lower income settings. AMR surveillance systems typically collate data from routine culture and susceptibility testing performed in diagnostic bacteriology laboratories to support healthcare. Limited access to high quality culture and susceptibility testing results in the dearth of AMR surveillance data, typical of many parts of the world where the infectious disease burden and antimicrobial need are high. Culture and susceptibility testing by traditional techniques is also slow, which limits its value in infection management. Here, we outline hurdles to effective resistance surveillance in many low-income settings and encourage an open attitude towards new and evolving technologies that, if adopted, could close resistance surveillance gaps. Emerging advancements in point-of-care testing, laboratory detection of resistance through or without culture, and in data handling, have the potential to generate resistance data from previously unrepresented locales while simultaneously supporting healthcare. Among them are microfluidic, nucleic acid amplification technology and next-generation sequencing approaches. Other low tech or as yet unidentified innovations could also rapidly accelerate AMR surveillance. Parallel advances in data handling further promise to significantly improve AMR surveillance, and new frameworks that can capture, collate and use alternate data formats may need to be developed. We outline the promise and limitations of such technologies, their potential to leapfrog surveillance over currently available, conventional technologies in use today and early steps that health systems could take towards preparing to adopt them.

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Cost-effectiveness of GeneXpert and LED-FM for diagnosis of pulmonary tuberculosis: A systematic review

Cited by 20 publications

References 25 publications

Revisiting the methods for detecting Mycobacterium tuberculosis: what has the new millennium brought thus far?

Revisiting the methods for detecting Mycobacterium tuberculosis: what has the new millennium brought thus far?

Economic evaluation of clinical quality registries: a systematic review

Leapfrogging laboratories: the promise and pitfalls of high-tech solutions for antimicrobial resistance surveillance in low-income settings

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