Xpert MTB/RIF test cost in India

Cost-effectiveness of Xpert MTB/RIF for tuberculosis

In 2010 a new diagnostic test for tuberculosis, Xpert MTB/RIF, received a conditional programmatic recommendation from WHO. Several model-based economic evaluations predicted that Xpert would be cost-effective across sub-Saharan Africa. We investigated the cost-effectiveness of Xpert in the real world during national roll-out in South Africa Laboratories in IPAQT offer Xpert at a fixed price of INR 2000 ($30·26), compared with an average of $52·82 in the rest of the private sector in India. By January, 2016, IPAQT had consolidated 110 accredited private laboratories that receive concessional pricing for Xpert, LPA, and liquid cultures Xpert MTB/RIF in India Dr K S Sachdeva Addl. DDG (TB), Government of India - Transportation cost covered under the project • Quality assurance - Panel testing using GLI Xpert MTB-Rif panel . Rapid Scale Up 235 3 sites 785 5 sites1000 1917 13 sites 3423 15 sites 4046 16 sites 4397 18 sites 529 The company also announced its 'Make in India' initiative by announcing plans to establish their manufacturing footprint in the country for Xpert® MTB/RIF test cartridges which run on the GeneXpert® System. More than 1,200 Cepheid's GeneXpert Systems have been installed in the last 2 years at various Revised National Tuberculosis. Before IPAQT was launched, the price of Xpert MTB/RIF in the private sector was in excess of Rs.3,000, and less than 500 tests were done in the private sector in all of India. After IPAQT was..

Xpert MTB/RIF remained less costly than IGRA testing until the average cost of MDR treatment exceeded US$5100 (298,000 INR) per person, near the highest average cost of MDR treatment in India from 2008-2013 (US$5500) [ 31] (322,000 INR) Xpert MTB/RIF diagnosis and decentralised management of drug-resistant tuberculosis in rural South Africa (H Hausler et al, S328) Triage test characteristics for increasing the cost-effectiveness of Xpert MTB/RIF in the diagnosis of tuberculosis: a decision analytical model (A Van't Hoog et al, S345 Truenat MTB-RIF test for knowing the resistance has 93% sensitivity and 95% specificity. According to WHO, the accuracy of Truenat and Truenat MTB Plus is comparable with Xpert and Xpert Ultra

Cost. Some concerns have been raised about the Xpert MTB/RIF, including minor operational issues and cost. The concessional price for a GeneXpert system is currently 32,000 USD for a four module instrument. As of 6 August 2012, the cost of a test cartridge in countries eligible for concessional pricing is 9.98 USD The Xpert MTB/RIF assay is a new test that is revolutionizing tuberculosis (TB) control by contributing to the rapid diagnosis of TB disease and drug resistance. The test simultaneously detects Mycobacterium tuberculosis complex (MTBC) and resistance to rifampin (RIF) in less than 2 hours. In comparison, standard cultures can take 2 to 6 weeks. Background:Xpert MTB/RIF is an automated cartridge-based nucleic acid amplification test that has demonstrated its potential to detect tuberculosis and rifampicin resistance with high accuracy. To assist scale-up decisions in India, a feasibility assessment of Xpert MTB/RIF implementation was conducted within microscopy centres of 18 RNTCP TB. New Delhi: US-based leading molecular diagnostics company, Cepheid Inc. (a wholly owned subsidiary of Danaher) unveiled its newest configuration in the GeneXpert family of systems, the GeneXpert Edge, in India recently. The company also announced its 'Make in India' initiative by announcing plans to establish their manufacturing footprint in the country for Xpert MTB/RIF test cartridges. The test is a molecular TB test which detects the DNA in TB bacteria. It uses a sputum sample and can give a result in less than 2 hours. The Genexpert can also detect the genetic mutations associated with resistance to the drug Rifampicin. 1Two hour detection of MTB and resistance to rifampicin, Cepheid International, 2011, www.

The price of the Truelab system, which includes the sample preparation device and the 4-module PCR analyzer device (capable of testing four specimens simultaneously), is $14,150. We used this cost in the base case for comparison with the 4-module Xpert system (assumed to be the standard in India) Xpert MTB/RIF is an automated cartridge-based nucleic acid amplification test that has demonstrated its potential to detect tuberculosis and rifampicin resistance with high accuracy. To assist scale-up decisions in India, a feasibility assessment of Xpert. The Xpert per-person test cost included costs for equipment, maintenance, labour and overheads that are country specific and were maintained from the original model, but were adjusted to accommodate the US$9.98 subsidized cartridge cost resulting in a per-person test cost ranging from $14.01 in India to $19.23 in Uganda (Table S1) GeneXpert MTB/RIF is currently the only rapid molecular test recommended by WHO for the rapid diagnosis of tuberculosis [2, 8]. GeneXpert MTB/RIF can detect both the presence of the Mycobacterium tuberculosis complex genome in patient specimens and the presence of genomic sequences of the main mutations responsible for Rifampicin resistance. Background: Xpert MTB/RIF (Xpert) is a promising new rapid diagnostic technology for tuberculosis (TB) that has characteristics that suggest large-scale roll-out. However, because the test is expensive, there are concerns among TB program managers and policy makers regarding its affordability for low- and middle-income settings

Xpert MTB/RIF for tuberculosis testing: access and price

Background: Rapid and specific diagnosis of tuberculous meningitis (TBM) is of paramount importance to decrease morbidity and mortality. Therefore, the present study was undertaken to compare the efficacy of Xpert MTB/RIF assay (GXpert) and multiplex PCR (MPCR) using three targets (IS6110, MPB64 and protein B) for diagnosing tuberculous meningitis
Xpert MTB/RIF versus sputum microscopy as the initial diagnostic test for tuberculosis: a cluster-randomised trial embedded in South African roll-out of Xpert MTB/RIF Lancet Glob Health , 3 ( 2015 ) , pp. e450 - e45
A 7.2% increase in the diagnostic yield when using Xpert MTB/RIF for TB case finding compared to smear microscopy was found in a feasibility and impact study of using the test at decentralised laboratories in India, as reported by Dr Naraj Raizada, Project Manager of Xpert MTB/RIF projects for FIND in India.
in a project assessing the cost-effectiveness of Xpert MTB/RIF and was co-author of the cost-effectiveness analysis by Langley et al. Lancet Glob Health, 2014, 2; 10, e581-591. Thomas Shinnick declared that he was a former employee of the United States Centres for Disease Control and Prevention (CDC) until January 2016
The Xpert MTB/Rif, with a detection limit of 131 CFU/ml, plays a valuable role in the diagnosis of extrapulmonary tuberculosis, both susceptible and resistant. This study aims at evaluating the Xpert MTB/Rif for the same, at a tertiary care centre in south India, assessing it against both culture and a composite gold standard (CGS). Method
Results The intervention resulted in an estimated 60 additional Xpert cartridges ordered per lab-month in the intervention group, which yielded an estimated increase of 11 500 tests over the post-intervention period, at an additional cost of US$13.3-US$17.63 per test. Further, we found that investing in this intervention would increase the IRR from 4.8% to 5.5% for hospital labs but yield a.
*9.98 USD is concessional cost. Market price is 50 -150 USD. Item Unit Cost (USD) Shipping Cost (USD) GeneXpert 2 Module with: Laptop / Desktop 12,280 / 11,780 600 • Same test platform as Xpert MTB/Rif • Single-module • Battery powered • Robust, for use in remote settings • Cost of unit = $5315 • Surcharge of $1.50 / cartridge.

4. Discussion. With 130,000 new cases in 2015, India had the highest population of RR-TB in the world [].Although two-thirds of the Indian population live in rural areas [], diagnosis of RR-TB in rural settings is difficult because of the scarcity of qualified technicians and sophisticated laboratories.Our results demonstrate that the Xpert MTB/RIF assay can be used to diagnose RR-TB in rural.
The GeneXpert System is available in a 2, 4 or 16-module configuration. All have our proven GeneXpert module at their analytic heart, and use the same patented cartridge technology for every Xpert ® test. CE-IVD. In Vitro Diagnostic Medical Devise
Sputum samples from 249 patients with suspected PTB were subjected to smear, culture, Xpert MTB/RIF (Cepheid, USA) and EasyNAT assay testing. Of the 169 PTB patients, EasyNAT detected more PTB patients than Xpert (72.19% vs. 61.54%, P＜0.05, χ 2 = 4.326)
Xpert MTB/Rif Ultra is scheduled for Q2-Q3 2016 and will cost $9.98 ex-works, the same as the current Xpert MTB/Rif. Once import licences have been obtained, it should be available in India shortly afterwards
The average price of the Xpert test at private laboratories in the other six countries ranged from $30.26 Footnote 1 in IPAQT Footnote 2 member laboratories in India to $155.44 in the Philippines (mean $68.73). The test was available in the public sector in each of these countries at no cost

Cepheid to establish manufacturing footprint for Xpert MTB

Cost of XpertMTB/RIF test for TB varies between countries. Abstract. PharmacoEconomics & Outcomes News 746, p17 - 13 Feb 2016 Cost of Xpert MTB/RIF test for TB varies between countries The price of Cepheid's Xpert MTB/RIF test for the diagnosis of tuberculosis (TB) varies between countries, according to the findings of an analysis published in The Lancet Global Health The Xpert® MTB/RIF assay (Cepheid, Sunnyvale, CA, USA) is a real-time nucleic acid auto-amplification technique and a design-locked and all-within-cartridge test to quickly and synchronously measure mycobacterium tuberculosis (MTB) and rifampin (RIF) resistance within 2 h (Boehme et al., 2010) The commercial prices of the Xpert MTB/RIF cartridges ($22.22 per cartridge) and the 4-Cartridge Xpert instrument ($31 811.27) were indicated by sales agencies in Thailand, whereas the process of the solid culture ($8.25 per test) and DST ($6.35 per test) were equal to the charge rates indicated by the Department of Central Chest Institute of. The Xpert MTB/RIF Assay What is the Xpert MTB/RIF Assay? The Xpert MTB/RIF assay is a new test that is revolutionizing tuberculosis (TB) control . by contributing to the rapid diagnosis of TB disease and drug resistance. The test simultaneously detects . Mycobacterium tuberculosis. complex (MTBC) and resistance to rifampin (RIF) in less than 2.

Manjula Kanakaraju, Sharath Burugina Nagaraja, Srinath Satyanarayana, Yella Ramesh Babu, Akshaya Kibballi Madhukeshwar, Somashekar Narasimhaiah, Chest Radiography and Xpert MTB/RIF® Testing in Persons with Presumptive Pulmonary TB: Gaps and Challenges from a District in Karnataka, India , Tuberculosis Research and Treatment,. vol. 2020, Article ID 5632810, 10 pages, 2020. https://doi.org. Xpert MBT/ Rif pooled sensitivity and specificity when used as initial test for TB detection, as an add-on test for TB detection following a smear-negative microscopy result and as initial test for rifampicin-resistance Xpert MTB/Rif usage %Sensitivity %Specificity As an initial test for TB detection 88 (83-92) 98 (97-99) replacing microscop The first such test was the Xpert MTB/RIF assay for use on the Genexpert platform. This test became available in 2010. An updated WHO policy was published in 2013. In 2017 WHO recommended Xpert Ultra, the next generation of Xpert MTB/RIF as the initial TB diagnostic test for adults and children, regardless of HIV status, over smear microscopy. Nearly 3 Million Xpert MTB/RIF Tests Run in Support of HBDC Programs South Africa, India, China, and Brazil, Among Others, have Xpert -Based Programs at Various Stages . it has the potential to revolutionize TB care, and WHO will treat it as a top priority. Dr. Mario Raviglione, World Health Organizatio Challenges in Rolling-out the GeneXpert MTB/RIF Diagnostic Test in Resource-Limited Settings - May 9-20 By Sophie Beauvais | 09 May, 2011 Last edited by Sophie Beauvais on 29 Dec 2011. Dear colleagues, Starting today, May 9, and running until May 20, GHDonline is pleased to host an expert panel discussion on the challenges of rolling-out the Xpert MTB/RIF diagnostic test, especially in.

Xpert MTB/RIF (Xpert) has been recommended by WHO as the initial diagnostic test for TB and rifampicin-resistance detection. Existing evidence regarding its uptake is limited to public health systems and corresponding resource and infrastructure challenges. It cannot be readily extended to private providers, who treat more than half of India's TB cases and demonstrate complex diagnostic. Full replacement of microscopy by Xpert MTB/RIF saves €449.98. In probabilistic Monte-Carlo simulation, adding Xpert MTB/RIF is less costly in 46.4% and 76.2% of smear-positive TB and MDR-TB suspects, respectively, but 100% less expensive in all smear-negative suspects. Full replacement by Xpert MTB/RIF is also consistently cost-saving Objectives We aim to define the burden of rifampicin monoresistant tuberculosis (TB) at a tertiary care centre in northern India as well as determine the second-line drug susceptibilities (SL-DST) in a subset of patients. Methods A total of 3045 pulmonary (n=1883) and extrapulmonary (n=1162) samples from likely patients with TB were subjected to microscopy, culture and the Xpert MTB/RIF assay.

IPAQT: subsidised Xpert TB test in private labs gets

Assessing the cost of the molecular tests, the ABC of the Xpert ® MTB/RIF was US$ 9.89, while the mean cost was US$ 11.53. These results were similar to those of another Brazilian study where the ABC cost was US$ 11.11 14, as well as those reported by Rupert et al. in India (US$ 12.29) 21
Simon Walusimbi, Brendan Kwesiga, Rashmi Rodrigues, Melles Haile, Ayesha de Costa, Lennart Bogg, Achilles Katamba, Cost-effectiveness analysis of microscopic observation drug susceptibility test versus Xpert MTB/Rif test for diagnosis of pulmonary tuberculosis in HIV patients in Uganda, BMC Health Services Research, 10.1186/s12913-016-1804-9.
ations, if negative followed by Xpert on a single sputum Xpert MTB/RIF assay (referred to as Xpert in this article), is a specimen (''in addition to''); (2) Xpert instead of smear real-time PCR assay that is a design-locked, all-within-cartridge exa
GeneXpert instruments as those for Xpert MTB/RIF and Ultra testing; it is being expedited for large-scale production and deployment. Consequently, TB-test-ing capacity, already limited by the availability of necessary staff, testing modules, and Xpert MTB/RIF and Ultra cartridges, may be further reduced by the increased demand for GeneXpert for.
The latest endorsement of Xpert MTB/RIF by WHO (2) and its inclusion in the RNTCP guideline (9), while justified, the practi cal applicability is limited due to financial constraints in resource limited settings like India. Also, Xpert MTB/RIF though an excel lent diagnostic test cannot replace liquid culture and drug-sensi tivity test.
Background: World Health Organization (WHO) recommends the use of Xpert MTB/RIF assay for rapid diagnosis of tuberculosis (TB) and detection of rifampicin resistance. This systematic review was done to know about the diagnostic accuracy and cost-effectiveness of the Xpert MTB/RIF assay. Methods: A systematic literature search was conducted in following databases: Cochrane Central Register of.

Recommandations 2010 de l'OMS sur Xpert • Xpert MTB/RIF devrait être utilisé comme test initial de diagnostic chez les patients suspects de TB-MR ou de TB associée au VIH (Forte recommandation) • Xpert MTB/RIF peut être considéré comme test de second niveau après la microscopie là où la TB-MR et le VIH sont pe The Xpert diagnostic test has been endorsed by the World Health Organization.But there are fears that it won't be cost-effective in the low- and middle-income countries that have the highest TB. Xpert MTB/RIF is a rapid test to diagnose tuberculosis (TB) and rifampicin-resistant TB. Cost and affordability will influence its uptake. We assessed the cost, globally and in 36 high-burden countries, of two strategies for diagnosing TB and multidrug-resistant (MDR)-TB: Xpert with follow-on diagnostics, and conventional diagnostics. Costs were compared with funding available for TB care and. Research & Development Xpert MTB/RIF Ultra • The current Xpert MTB/RIF test has a limit of detection (LOD) of 130 cfu/ml. • New innovations, including a larger DNA reaction chamber in the cartridge, will bring the LOD down ten-fold, to approximately10 cfu/ml (across all strains) — a level similar to or potentially better than liquid culture Background Outreach and promotion programs are essential to ensuring uptake of new public health interventions and guidelines. We assessed the costs and operation dynamics of outreach and promotion efforts for up front Xpert MTB/RIF (Xpert) testing for pediatric presumptive tuberculosis (TB) patients in four major Indian cities. Methods Xpert test costs were assessed as weighted average per.

Costs and Consequences of Using Interferon-γ Release

guidelines for implantation of Gene Xpert® MTB/RIF test for diagnosis of TB and drug resistance. Keywords- extrapulmonary tuberculosis, Gene Xpert® MTB/RIF, rifampicin, drug resistance, WHO. 1. Introduction India has the world's largest burden of tuberculosis (TB), accounting for one-forth (24%) of the global TB incidence. Th
The GeneXpert System is available in a 2, 4 or 16-module configuration. All have our proven GeneXpert module at their analytic heart, and use the same patented cartridge technology for every Xpert ® test. CE-IVD. In Vitro Diagnostic Medical Devise
Significant improvements have been made in the diagnosis of TB since the WHO updated its recommendation to use the rapid test called the Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA, USA, referred.
Xpert MTB/RIF (US$67-US$33) and Hain Line Probe Assay (US$58-US$27) and approximately 15% lower for MGIT Liquid Culture (US$18-US$15). demand-side activities IPAQT implemented several strategies to increase demand for quality TB tests among private providers. These were copyright. on July 15, 2021 at MSN Academic Search. Protected b

5. TESTING AND MANAGING PATIENTS 10 5.1. selecting individuals to be tested 10 5.2. test Performance 12 5.3. interPreting results from XPert mtb/rif 14 5.4. diagnostic algoritHms 16 5.5. monitoring Patients during treatment 18 5.6. using XPert mtb/rif in drug resistance surveys 18 5.7. using XPert mtb/rif in tb Prevalence surveys 19 6 Xpert MTB/RIF Ultra. 1. Xpert® MTB/RIF Ultra Information. 2. Why was MTB/RIF Ultra developed MTB/RIF assay challenges: • Sensitivity in smear negatives and HIV associated TB low • 60-70% - sub-optimal • Sensitivity for Rif resistance determination • Limitations: May miss some Rifs. 3 Approximately 10 to 15% of tuberculosis (TB) cases in India are estimated to have extrapulmonary disease, and due to a lack of diagnostic means, they often remain untreated. The early detection of Mycobacterium tuberculosis and multidrug resistance is a priority in TB diagnosis to improve the successful treatment rate of TB and reduce transmission. The Xpert MTB/RIF (Xpert) test, recently. However, nucleic acid amplification testing (NAAT) with the Xpert MTB/RIF assay (Xpert) may be more efficient and less costly. Methods. This prospective observational cohort study enrolled a consecutive sample of 318 AII-eligible inpatients from a public hospital in Seattle, Washington, from March 2012 to October 2013

TB diagnostic test developed in India has high accuracy

Rapid diagnosis of tuberculosis with the Xpert MTB/RIF assay in high burden countries: A cost-effectiveness analysis Anna Vassall, Sanne van Kampen, Hojoon Sohn , Joy S. Michael, K. R. John, Saskia den Boon, J. Lucian Davis, Andrew Whitelaw, Mark P. Nicol, Maria Tarcela Gler, Anar Khaliqov, Carlos Zamudio, Mark D. Perkins, Catharina C. Boehme.
The Xpert MTB/RIF is a closed cartridge based system that is easy to operate and gives results in approximately 2 h. Xpert MTB/RIF test was approved by WHO in 2010, for diagnosis of pulmonary TB [ 6 ]. In 2013 WHO has recommended the use of Xpert MTB/RIF for the use in children and in extra pulmonary form [ 7 ]
Under routine conditions, Xpert MTB/RIF provided 99.1% valid results in TB suspects with low overall failure rates (7.2% initial failure, 0.9% final failure); devices provided valuable real-time.
Unit cost of decentralized Xpert testing. Bars show the estimated unit cost (in 2015 US dollars) of decentralized Xpert testing as a function of the mean daily number of tests performed (x-axis), with the annual test volume shown in parenthesis under each scenario and the cost per test shown above each bar.Blue bars indicate two representative scenarios chosen for the cost-effectiveness analysis
The new Xpert MTB/RIF Ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing. MBio . 2017 ; 8 : e00812 - 7

The GeneXpert MTB/RIF assay (Cepheid, Sunnyvale, CA), has been suggested as a test fulfilling these criteria [1]. The test received a shot in the arm when the World Health Organization (WHO) recently recommended [2,3] that it may (note emphasis) be used as the initial test in children with suspected tuberculosis instead of attempting to. However, concern has been expressed that a ramp-up of COVID-19 testing on the GeneXpert system may come at the expense of TB testing in LMICs that rely on Xpert MTB/RIF (3, 68). Abbott and Roche also have released COVID-19 assays to run on their centralized testing platforms, namely, RealTime ( 71 ) and Cobas 6800 ( 72 ), respectively

GeneXpert MTB/RIF - Wikipedi

When exploring triage algorithms with lower sensitivity, the use of an example triage test with 95% sensitivity relative to Xpert, 75% specificity and test costs $5 resulted in similar cost reduction, and was cost-effective by the WHO willingness-to-pay threshold compared to Xpert for all in Uganda, but not in India and South Africa GeneXpert MTB/Rif to Diagnose Tuberculous Meningitis: Perhaps the First Test but not the Last Nathan C. Bahr , 1 Suzaan Marais , 2 Maxine Caws , 3 Reinout van Crevel , 4 Robert J. Wilkinson , 2, 5, 6 Jaya S. Tyagi , 7 Guy E. Thwaites , 8, 9 and David R. Boulware 1 , for the Tuberculous Meningitis International Research Consortium Consequently, TB-testing capacity, already limited by the availability of necessary staff, testing modules, and Xpert MTB/RIF and Ultra cartridges, may be further reduced by the increased demand for GeneXpert for COVID-19 testing . There is an urgent need to develop laboratory testing approaches to expand TB diagnostic and case-finding services. In general, Xpert MTB/RIF had a high diagnostic accuracy in diagnosing TB pericarditis. The diagnostic test sensitivity and specificity forest plot of Xpert MTB/RIF for TB pericarditis were shown in Figure 4. Xpert MTB/RIF had an overall sensitivity of 0.676 (95% CI: 0.580-0.759), and the overall specificity was 0.994 (95% CI: 0.919-1.000) In contrast, fully automated polymerase chain reaction (PCR) testing with Xpert MTB/RIF (Xpert) testing using the GeneXpert platform (Cepheid, Sunnyvale, CA) can generate results in under 2 hours and, if positive, includes rifampicin resistance prediction

Fact Sheets Testing and Diagnosis A New ToolXpert

Xpert MTB/RIF for tuberculosis testing: access and price in highly privatised health markets Xpert MTB/RIF (Cepheid, Sunnyvale, CA, USA) is the biggest recent advance in tuberculosis diagnosis, and since 2010 more than 15 million cartridges have been procured through concessional pricing ($9·98 per cartridge in 2015).1 However, eve
Chest Radiography and Xpert MTB/RIF® Testing in Persons with Presumptive Pulmonary TB: Gaps and Challenges from a District in Karnataka, India Manjula Kanakaraju ,1 Sharath Burugina Nagaraja ,2 Srinath Satyanarayana,3 Yella Ramesh Babu,4 Akshaya Kibballi Madhukeshwar,5 and Somashekar Narasimhaiah6 1Taluka Health Oﬃce, Chikkaballapur.
Mycobacterium tuberculosis Using the GeneXpert MTB/RIF Assay from a Rural Setting in India usually underprivileged. In our setting, the high cost of the cartridges, compared with the standard AFB staining, programmatic implementation of Xpert MTB/RIF testing i
Tuberculosis Research and Treatment (2020-01-01) . Chest Radiography and Xpert MTB/RIF® Testing in Persons with Presumptive Pulmonary TB: Gaps and Challenges from a District in Karnataka, India
Our 'Make in India' plans are a testimony to our commitment towards supporting the Indian Government's vision of TB eradication by 2025. With this announcement, we aim to establish a manufacturing footprint for Xpert ® MTB/RIF test cartridges, thus bringing our global expertise in TB diagnostics to India. Today, we also unveil our latest.
Abstract: Background: Use of Xpert MTB/RIF is being scaled up throughout South Africa for improved diagnosis of tuberculosis (TB). A large proportion of HIV-infected patients with possible TB are Xpert-negative on their initial test, and the existing diagnostic algorithm calls for these patients to have sputum culture (Xpert followed by culture (X/C)). We.
Xpert MTB/RIF for diagnosis of tuberculosis: evaluating impact and cost-effectiveness in the routine roll-out in South Africa Xpert for TB: Evaluating a New Diagnostic (XTEND) trial Background South Africa is rolling out Xpert MTB/RIF, a new diagnostic test with improved sensitivity for detection of active tuberculosis combined with simultaneous detection of rifampicin resistance. The.

Cepheid launches 'GeneXpert Edge' test for MTB, reveals

Peter Farrell, Cepheid's Executive Vice-President (Worldwide Commercial Operations), said that they would manufacture in India Xpert® MTB/RIF test cartridges which run on the GeneXpert® System Recently, GeneXpert MTB/RIF (GeneXpert), a fully automated real time hemi-nested PCR system, has been developed to rapid diagnosis of TB and rifampin (RIF) resistance in under 3 hours 17, 18 More information: David J Horne et al. Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults, Cochrane Database of Systematic Reviews (2019).DOI: 10.

Genexpert Cepheid test - Test for drug resistant TB - TBFact

Prevalent TB was diagnosed in 24 of 1001 (2.4%) individuals enrolled in clinics randomized to Xpert, compared with 10 of 841 (1.2%) in clinics randomized to LED-FM. All-cause mortality was 22% lower in the Xpert arm than in the LED-FM arm (6.7 vs 8.6 per 100 person-years; RR, 0.78 [95% confidence interval {CI}, .58-1.06])
Abstract. Background: Xpert MTB/RIF (Xpert) is a promising new rapid diagnostic technology for tuberculosis (TB) that has characteristics that suggest large-scale roll-out
Xpert MTB/RIF is an automated rapid nucleic acid amplification test (NAAT) that can simultaneously identify M. tuberculosis DNA in a sputum sample and detect resistance to rifampin (rifampicin) in as little as 2 h. The Xpert MTB/RIF is more sensitive than sputum smear microscopy and about as sensitive as culture for diagnosing TB
This test, initially evaluated in sputum samples for pulmonary TB, has been tested with success in a few small studies for diagnosing pulmonary TB from bronchoalveolar lavage fluid (BALF).5-8 When it comes to extra-pulmonary sites, recent studies from Italy,9 Germany10 and India11 demonstrate the impressive yield of the Xpert MTB/RIF from a variety of extra-pulmonary sites

Rapid, point-of-care diagnosis of tuberculosis with novel

This was meant to facilitate access to Xpert MTB/RIF and reduce the cost of use. The funds were supposed to be used to roll out Xpert-based programs in 20 countries and bring down the price of. One study from India has used peritoneal tissue that was obtained by ultrasound-guided biopsy, and hence, was not sufficient to define the exact role of Xpert® MTB/RIF assay on peritoneal tissue . Therefore, the present study aimed to analyze the role of Xpert® MTB/RIF assay in the diagnosis of PTB on peritoneal tissue obtained by peritoneoscopy

GeneXpert MTB/RIF (Xpert), a novel, semiautomated TB nucleic-acid amplification test, has renewed interest in this technology, but data from low-burden countries are limited. Objectives: We sought to estimate Xpert's potential clinical and public health impact on empiric treatment, contact investigation, and housing in patients undergoing TB. Xpert® MTB/RIF assay . The development of the Xpert MTB/RIF assay, a fully automated nucleic acid amplification test that can simultaneously detect TB and rifampicin resistance directly from sputum and other extrapulmonary samples with minimal hands-on time in less than 2 hours, is considered a revolution in the diagnosis of TB The MTB/RIF test was indeterminate in 192 of 5190 tests performed (3.7%), a rate that was lower than the overall culture-contamination rate (5.5%) in 381 of 6920 MGIT and Löwenstein-Jensen. more drugs (Xpert XDR, RealTime MTB RIF/INH, and FluoroType MDR). These and other advances are described below. ADVANCES IN TB DIAGNOSIS AND DRUG-SUSCEPTIBILITY TESTING GeneXpert Ultra Perhaps the biggest advance so far this year in TB diagnostics has been the launch of the Xpert MTB/ RIF Ultra assay (Ultra).7 A WHO expert consultation found.

A study led by Frank Cobelens of the Amsterdam Institute of Global Health and Development, Amsterdam, the Netherlands, and colleagues reports on the cost-effectiveness of implementing the Xpert. of Xpert MTB/RIF testing in Mongolia based on their experiences. These are summarised inTable 2, and described below according to the following themes: (1) guidelines and organisational structures, (2) equipment, (3) training, (4) communication systems, (5) diagnostic algorithms, case finding for Xpert MTB/RIF and clinical management

Feasibility of Decentralised Deployment of Xpert MTB/RIF

Care in India [15]. Testing for multidrug-resistant TB (MDR-TB) is rarely undertaken in either the public or private sector [1,21]. Xpert MTB/RIF (Xpert, Cepheid Inc, Sunnyvale, CA, USA) is a novel molecular test for active TB that uses semi-automated PCR to amplify mycobacterial DNA [22,23]. It has a highe
Xpert MTB/RIF: a New Pillar in Diagnosis of Extrapulmonary Tuberculosis? 6 1 0 1
Xpert MTB/RIF Ultra (Xpert Ultra) and Xpert MTB/RIF are World Health Organization (WHO)-recommended rapid nucleic acid amplification tests (NAATs) widely used for simultaneous detection of Mycobacterium tuberculosis complex and rifampicin resistance in sputum. To extend our previous review on extrapulmonary tuberculosis (Kohli 2018), we performed this update to inform updated WHO policy (WHO.
Xpert MTB/RIF assay is a new rapid molecular test that asserted that it was able to overcome many of the current operational difficulties in TB diagnosis. WHO endorsed Xpert MTB/RIF assay in 2010 for use in TB prevalent resource limited countries as a first line diagnos-tic test for rapid diagnosis of TB in HIV infected patient
One patient each with pre-XDR TB, polyresistant TB (rifampicin and streptomycin resistance) and MDR-TB had a negative Xpert MTB/RIF result. Sensitivity of Xpert MTB/RIF to pick up drug resistant TB as compared to conventional DST was 72.7% and specificity was 83.3%. The study area has a high background resistance rate [5]
g. The Xpert MTB/RIF Assay has the capacity to revolutionize the diagnosis of TB because of its speed, sensitivity and specificity
Feasibility of Decentralised Deployment of Xpert MTB/RIF Test at Lower Level of Health System in India

Optimal Triage Test Characteristics to Improve the Cost

The second, on early experience in the use of the Xpert MTB/RIF assay to improve diganosis, was published in May 2012. Introduction. The second part of this series looked at the introduction of the Xpert MTB/RIF test. It identified a number of barriers to the adoption of the test for TB diagnosis in low- and middle-income countries
Xpert MTB/RIF may require high upfront and running costs, however it has been shown in India (a high burden MDR-TB country) that the mean total costs (per MDR case initiated on treatment) are lower when using Xpert MTB/RIF for all presumptive TB patients, compared to solely using it for those at risk of DR-TB 7. This is particularly relevant.
Xpert MTB/RIF testing. Cost-effectiveness modeling indicated that the use of Xpert MTB-RIF significantly increased TB case-finding (by roughly 30%) when used as a replacement or add-on test to microscopy. Use of Xpert MTB/RIF as replacement for conventional culture and DST also significantly increased MDR case-finding (roughly three-fold)
Shipping costs added to the test cost and ranged from 0.33 USD to 1.44 USD per test. As increasing Xpert MTB/RIF testing occurs, the demand for competent in-country services will also increase.
The Xpert MTB/XDR assay will be evaluated for INH and second-line resistance detection, and to recommend its use in diverse clinical settings. The focus of this protocol is the multicentre clinical evaluation. RIF-resistance MTB Group. An anticipated 316 additional RIF-resistant patients, as detected by Xpert MTB
The Xpert MTB/RIF® test was positive in 35 of the 103 samples. In 5.6% (6) of the cases the test was positive with negative culture while 2.9% (3) were culture-positive PCR-negative cases . The overall sensitivity of the Xpert MTB/RIF® test was 91%, specificity, 92%, PPV, 83% and NPV, 96%
By Anna Vassall, Sanne van Kampen, Hojoon Sohn, Joy S Michael, K R John, Saskia den Boon, J Lucian Davis, Andrew Whitelaw, Mark P Nicol, Maria Tarcela Gler, Anar Khaliqov, Carlos Zamudio, Mark D Perkins, Catharina C Boehme and Frank Cobelens; Abstract: A cost-effectiveness study by Frank Cobelens and colleagues reveals that Xpert MTB/RIF is a cost-effective method o

(PDF) Bottom-up or top-down: Unit cost estimation of

Evaluation of GeneXpert MTB/RIF system performances in the

Among presumptive TB patients with HIV, both sputum smear microscopy and Xpert testing are done simultaneously, and based on the results, the appropriate treatment is initiated. In the Mandalay Region, there are a total of 62 microscopy centres. Of these, eight laboratories also perform Xpert® MTB/RIF assay. In 2016, a total of 4186.
N2 - Xpert® MTB/RIF offers new and important possibilities for the diagnosis of sputum smear-negative tuberculosis (TB) and/or rifampicin (RMP) resistance, and many are encouraging rapid and widespread implementation. This simple test can be implemented almost everywhere, and it provides results within a few hours
In a meta-analysis, the use of GenXpert-Mtb/Rif in EPTB has been reported to have a sensitivity of 77% and specificity of 97%. 7 However, the studies on the use of Xpert-Mtb/Rif in setting of ITB are limited to a few retrospective studies which have reported the positivity of this test to be 8-28% in patients with ITB. 8,9 However, none of.
Xpert MTB/RIF testing on smear-negative individuals, the general approach used here, expends significantly more resources and time, as all individuals are tested using smear microscopy and 80-90.

with the Xpert MTB/RIF test. Here is the new diagnostic test for TB that the phys-ician in the developing world has been waiting for. It does two things, and does them both well. It diagnoses TB with a higher sensitivity than a sputum smear examination: a single Xpert MTB/RIF test diagnoses 98% of sputum smear positive cases and around 70% of. Table 1: The patient's gender, HIV status and reason for testing represented in percentage. The performance of the xpert/MTB Rif assay method among the study population is as shown in Table 2; 116% of the 586 patients had MTB positive results while 470% had MTB negative results.A total of 8 (6.9%) of the 116 MTB positive patients had rifampicin resistant TB

Data collection procedure during the study, Chhattisgarh

The Xpert MTB/RIF assay has greatly shortened the time to diagnosis of TB and rifampicin-resistant TB. 17 Since its endorsement by the WHO, many high-burden TB countries have started scaling-up use of this innovative assay; however, concerns about Xpert specificity for assessing RIF resistance have arisen due to silent mutations detected in the. test. 3. Results In comparison of GeneXpert with LED-FM, all 25 smear positive samples were GeneXpert positive. In addition, GeneXpert detected 10 of the smear negative cases. Of the 110 specimens that yielded a valid GeneXpert MTB/RIF result, 10 (9%) positive GeneXpert isolates showed resistance to Rifampicin of the sputum isolates The authors evaluated the costs of centralized and decentralized testing for tuberculosis with Xpert MTB/RIF (Xpert), a WHO-endorsed test. They used an agent-based simulation of TB transmission in a hypothetical representative region in India to assess the impact and cost-effectiveness of various strategies to provide universal access to. The authors evaluated the costs of centralized and decentralized testing for tuberculosis with Xpert MTB/RIF (Xpert), a WHO-endorsed test. They used an agent-based simulation of TB transmission in a hypothetical representative region in India to assess the impact and cost-effectiveness of various strategies to provide universal access to diagnosis and drug susceptibility testing (DST) for.

Sarang DEO | Associate Professor | BTech, MBA, PhD