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. TEXT. In December 2010, the World Health Organization endorsed the use of GeneXpert MTB/RIF (Xpert; Cepheid, Sunnyvale, CA), an automated nucleic acid amplification test for detection of tuberculosis and rifampin resistance for regions with high rates of HIV-tuberculosis coinfection or multidrug-resistant tuberculosis (MDR-TB) ().The South African National Minister of Health announced a plan. Background: Accurate and rapid detection of tuberculosis (TB) and drug resistance are critical for improving patient care and decreasing the spread of TB. Xpert® MTB/RIF assay (Xpert) is a rapid, automated test that can detect both TB and rifampicin resistance, within two hours after starting the test, with minimal hands-on technical time, but is more expensive than conventional sputum.
The Xpert MTB/RIF test was performed on the portion of the clinical sample using G4 cartridges as per manufacturer's instruction. All sample results data were entered into an online database and analyzed using SAS, version 9.3. RESULTS Although the evidence base regarding the use of the Xpert MTB/RIF assay for diagnosis of pulmonary tuberculosis (TB) when testing respiratory samples is well established, the evidence base for its diagnostic accuracy for extrapulmonary and sputum-scarce pulmonary TB when testing non-respiratory samples is less clearly defined. A systematic literature search of 7 electronic databases (Medline. To estimate the diagnostic accuracy of Xpert MTB/RIF for rifampicin resistance in different regions, a meta-analysis was carried out. Several databases were searched for relevant studies up to March 3, 2019. A bivariate random-effects model was used to estimate the diagnostic accuracy. We identified 97 studies involving 26,037 samples for the diagnosis of rifampicin resistance
The Xpert MTB/RIF (Xpert) assay offers rapid and accurate diagnosis of tuberculosis (TB) but still suffers from imperfect sensitivity. The newer Xpert MTB/RIF Ultra cartridge has shown improved sensitivity in recent field trials, but at the expense of reduced specificity IMPORTANCE The Xpert MTB/RIF assay (Xpert), the first point-of-care assay for tuberculosis (TB), was endorsed by the World Health Organization in December 2010. Since then, 23 million Xpert tests have been procured in 130 countries. Although Xpert showed high overall sensitivity and specificity with pulmonary samples, its sensitivity has been lower with smear-negative pulmonary samples and. The Xpert MTB/RIF assay has also been used successfully in a small pilot study of active case finding in household contacts of smear-positive index cases in Tanzania. 57 In a large tuberculosis prevalence survey in a South African gold mine, 58 the sensitivity was substantially higher than that of smear microscopy, but much lower (62·6%, 95%. WHO report on performance of Xpert MTB/RIF version G4 assay reported detection load of 300 copies/run for wild type and mutant MTB strains except 533 ccg (500 copies/run) If this is true, is some way in which I can use Xpert to quantify TB bacillary load for research pourpuses (diluted sputum until negativize, etc? Introduction: Xpert MTB/RIF (Cepheid, USA) is an automated real-time PCR system that simultaneously detects TB and resistance to rifampicin. The test has excellent accuracy when performed on sputum and is endorsed by the World Health Organisation (WHO) and the USA Federal Drug Administration. Aims: To measure the diagnostic yield of bronchoalveolar lavage gene Xpert and compare it with.
. For Xpert, G4 cartridges were used; for pDST, the commercial microdilution method was conducted to assess in vitro susceptibility using RIF concentrations 1.0, 2.0, 4.0, and 8.0 mg/L A new molecular diagnostic test called Xpert MTB/RIF assay detects M. tuberculosis complex within 2 hours, with an assay sensitivity that is much higher than that of smear microscopy. 34 In HIV-infected patients, the test has a rate of case detection that is increased by 45%, as compared with smear microscopy Containment of bioaerosol infection risk by the Xpert MTB/ RIF assay and its applicability to point-of-care settings. J Clin Microbiol. 2010;48:3551-3557. 6. World Health Organization. Using the Xpert MTB/RIF Assay to Detect Pulmonary and Extrapulmonary Tuberculosis and Rifampicin Resistance in Adults and Children: Expert Grou
Wide introduction of new molecular diagnostic tests, such as through the TB Xpert project, is the best way we have today to ensure early and accurate TB diagnosis. Until recently, the high cost of GeneXpert® TB cartridges was a barrier to the test's introduction in low- and middle-income countries Performance of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis and rifampin resistance in a low-incidence, high-resource setting. Rapid molecular assays for detection of tuberculosis Rapid molecular assays for detection of tuberculosis
All studies performing Xpert used G4 cartridges, and all urine LAM testing used Alere Determine TB LAM Ag test (Alere, Waltham, MA, USA). The pooled summary diagnostic yield of urine LAM was 52% (95% CI 35-69) and of sputum was 77% (63-87); the composite diagnostic yield (urine LAM plus sputum) was highest at 89% (95% CI 80-94, appendix p. The Xpert MTB/RIF assay (Xpert; Cepheid, Sunnyvale, CA, USA) is a rapid, World Health Organization (WHO) endorsed, automated PCR test optimised for respiratory specimens that can detect both Mycobacterium tuberculosis (MTB) and rifampicin resistance [3, 4]. Given the limitations of available tests for the diagnosis of pleural TB, several.
The Xpert MTB/Rif test is already being rolled out as the first-line diagnostic test in South Africa. It can provide rapid results, and can also show whether a patient has resistance to rifampicin, a marker for multi-drug resistant TB. Evidence from South Africa shows that the test is already increasing the number of TB and MDR-TB cases. Le test Xpert MTB/RIF était sensible pour le diagnostic de la tuberculose ganglionnaire. Pour les enfants chez qui on suspecte une méningite tuberculeuse, les décisions de traitement devraient être basées sur l'ensemble des informations cliniques et le traitement ne devrait pas être refusé uniquement sur la base d'un résultat Xpert MTB. Performance of Xpert MTB/RIF RUO Assay and IS6110 Real Time PCR for Mycobacterium tuberculosis Detection in Clinical Samples Limitations of this study include the retrospective design, which was necessary due to the low prevalence of M. tubercu- losis in our community
TB-PCR assay requires sample manipulation which inhibits amplification reaction of specimens by decreasing proteins and enzymes and takes more amount of time as compared to the Xpert MTB/RIF assay. All these can lead to unrecognized errors such as cross-contamination and sample dilution Table 3 Overview of early Xpert MTB/RIF testing approaches in nine countries Country Xpert MTB/RIF testing strategy Point-of-care (POC) or referral for treatment Laboratory process for requesting Xpert test Time from initial screen to Xpert + result Time from submission of sputum for Xpert MTB/RIF test to result Bangladesh A - Direct to Xpert.
An important emerging challenge, given the wide global rollout of Xpert ® MTB/RIF for use on pulmonary specimens, is to demonstrate how access to this assay can impact on patient outcomes, as the existing paradigm in high TB‐burden settings is to institute TB therapy for cases of clinically suspected TBM even in the absence of. This review demonstrates that Xpert® is accurate in diagnosing pulmonary TB as well as detecting rifampicin resistance. None of the studies were done in the primary health care setting where the public health benefits are likely to be maximum. The studies used the older generations of Xpert®. It is that the performance of current Xpert G4, will be different 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. . In this review Karen Steingart and co-authors examine the diagnostic accuracy of Xpert, where Xpert was used as an initial test replacing microscopy, or where it was used as an add-on test following a negative smear microscopy. 33. Mustapha G, Jumoke O, Nwadike P, Emeka E, Akang G, Eneogu R, et al. Assessment of Gene-xpert MTB RIF program implementation and the challenges for enhanced tuberculosis diagnosis in Nigeria. SAARC Journal of Tuberculosis, Lung Diseases and HIV/AIDS. 2015;12(2):1-7. 34. FIND Report., Performance of Xpert MTB/RIF version G4 assay
Readout of Xpert MTB/RIF assay for a tuberculosis positive, rifampicin-susceptible specimen. Courtesy: Karin Weyer, the WHO Global TB Programme. Since Xpert MTB/RIF was released, there have been four gener-ations (G1, G2, G3, and G4) of the test involving different soft-ware and cartridge combinations. G4 contains modifications that improved. The introduction of the Xpert MTB/RIF (Xpert) test replaces the two sputum smears in the initial diagnoses of TB. All cases detected as having rpoB mutations on this assay are initiated on MDR TB treatment while a second sample is sent for culture and drug susceptibility testing (DST) to confirm these results [ 5 ] The GeneXpert MTB/RIF Assay In December 2010, WHO endorsed the use of GeneXpert MTB/RIF (Xpert; Cepheid, Sunnyvale, CA), a rapid, automated, cartridge-based nucleic acid amplification test that can simultaneously detect M. tuberculosis complex and resistance to RIF In a 2014 meta-analysis, the sensitivity of the assay for detection of rifampin resistance was 95% (95% CI, 90% to 97%) and the specificity was 98% (95% CI, 97% to 99%). 98 False-positive results for rifampin resistance with the Xpert MTB/RIF assay can occur, and sequence-based testing should be done to confirm results. 119 However, the.
Tuberculosis (TB) remains a global health concern in the 21st century. It has been estimated that in the year 2015, there were around 10.4 million new cases and 1.8 million deaths attributable to TB.1 The ambitious global End TB strategy led by the World Health Organization, aims to achieve 90% reduction in TB incidence and 95% reduction in TB mortality by 2035.2 This will not be possible. Introduction: Xpert MTB/RIF (Cepheid, USA) is an automated real-time PCR system that simultaneously detects TB and resistance to rifampicin.The test has excellent accuracy when performed on sputum and is endorsed by the World Health Organisation (WHO) and the USA Federal Drug Administration
Similar to Cochrane review, however current G4 version, launched in Dec 2011might differ in performance •G4 version in Africa- Specificity of 99.5%-Chang K, J Infect 2012; 64: 580-88 - Muhammad Osman et al. JCM, Nov 2013 Xpert in Diagnosis of PT Fibreoptic bronchoscopy showed normal airway anatomy without extrinsic airway compression. Bronchoalveolar lavage (BAL) specimens were obtained from multiple sites. Three specimens of gastric lavage and the BAL were negative for TB by Ziehl-Neelsen staining, Xpert MTB RIF assay (GeneXpert), and Mycobacterium Growth Indicator Tube (MGIT) culture 130 Armand S, Vanhuls P, Delcroix G, Courcol R, Lemaître N. Comparison of the Xpert MTB/RIF test with an IS6110-TaqMan real-time PCR assay for direct detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. J Clin Microbiol 2011; 49 (5) 1772-177 POLICY UPDATE PERFORMANCE ACCURACY ACCURACY RECOMMENDATIONS MOLECULAR DIAGNOSTICS TUBERCULOSIS DRUG-RESISTANCE NEW DIAGNOSTIC TEST
GeneXpert-MTB/RIF assay was highly recommended as an initial diagnostic platform in high burden countries for early and quick detection of TB cases. Until date, very few studies have evaluated the performance of this brilliant assay in pericardial effusion cases, thus, more studies are required to address the unanswered questions left so far The WHO recommends that GeneXpert test could be used as a follow on test to microscopy, especially in smear-negative specimens. Objectives: To assess percentage of Tuberculosis cases and Multi Drug Resistant (MDR) case detection at diagnosis using Xpert MTB/RIF assay in smear-negative pulmonary cases The updated assay under investigation was the Xpert MTB/RIF G4 assay (Cepheid, Sunnyvale, CA, USA; www.cepheid.com). In the analytical study, culture-positive isolates were confirmed to be MTBc. NAA testing (either the Xpert MTB/RIF Version G4 or the Amplified Mycobacterium Tuberculosis Direct test [MTD]) is believed to be highly sensitive for the detection of TB in respiratory specimens, with a sensitivity somewhere between sputum smear and culture For example, it has been estimated that in India, providing the MTB/RIF test to only 15% of the suspected cases of TB would consume the annual budget for the entire TB control program. References Andrews JR et al. Cost-effectiveness of routine tuberculosis screening with Xpert MTB/RIF prior to initiation of antiretroviral therapy in South Africa
Xpert ® Mycobacterium tuberculosis/rifampin (MTB/RIF) assay and bronchoscopy are useful in this direction. Xpert ® MTB/RIF assay (Xpert, Cepheid, Sunnyvale, CA, USA) is a hemi-nested real-time PCR test that simultaneously identifies MTB/RIF resistance. Its diagnostic accuracy is comparable to culture in sputum samples and provides results. 1. rapid test cannot exclude TB (low sensitivity) 2. need (very) good quality of samples: tissue better than fluid, •RRDR is the target for Xpert MTB/RIF and GenoType MTBDRplus LPA. Trouble shooting Xpert MTB/RIF: False-positive rifampicin resistance (G4 cartridge). Urine Xpert testing for both studies was performed at the Groote Schuur Hospital National Health Laboratory Service laboratory using Xpert MTB/RIF Assay G4 version 5. All specimens were processed using standardised protocols and quality assurance procedures as previously described. 24 In brief, for the GF Jooste Hospital study, Xpert testing of. The Xpert MTB/RIF test was performed using the G4 version of cartridges according to the manufacturer's instructions (Cepheid, Sunnyvale, USA) as described previously. The samples were subsequently inoculated into Mycobacterium Growth Indicator Tube (MGIT 960), a non-radiometric automated isolation system (Becton Dickinson, USA) Among culture-positive samples, Xpert MTB/RIF assay detected Mycobacterium tuberculosis (Mtb) in 97.3% (364/374) of AFB smear-positive samples and 76.5% (13/17) among smear-negative samples, and the corresponding values for LPA test (valid results with Mtb control band) were 97.9% (366/374) and 58.8% (10/17), respectively. For detection of RR among Mtb positive molecular results, the.
tuberculosis (MTB) by PCR (Xpert MTB RIF assay G4). There was a slight improvement in the posterior segment inflammation as well as media clarity after the surgical procedure, with examination revealing optic disc edema, as well as macular folds on fundus photograph (Fig. 2) as well as on OCT. When the patient starte Two studies used the Xpert MTB/RIF G4 assay and provided data for specificity determinations. One study observed a specificity of 100% (10/10) (95% CI 69% - 100%) while the second study reported a specificity of 95% (42/44) (95% CI 85% - 99%) (Figure 5) The Xpert MTB/RIF test is probably the most known of rapid molecular tests for tuberculosis diagnosis. Its principle is based on heminested PCR assay to amplify sequences from the rpoB genes with specific probes to target mutations within the rifampicin-resistance determining region [ 62 ] У пацієнта виключався туберкульоз: кванті-фероновий тест мав негативний результат, тестом Xpert MTB- RIF Assay G4 у промивних водах бронхів мікобактерій туберкульозу не виявлено study of diagnostic utility of xpert mtb/rif test on pleural fluid in the evaluation of patients presenting with pleural tuberculosis in nepal the correlation between xpert mtb/rif level category with sputum culture conversion time in drug resistant tuberculosis (tb) patients clinical course and outcome of immunoglobulin g4 related lung.
mtb/rif and a thin layer agar mdr/xdr-tb colour test g4. latent tuberculosis infection treatment completion with self-administered, once weekly isoniazid-rifapentine under programmatic conditions performance of the xpert® hiv-1 viral load assay: a systematic review an Effective testing for pulmonary tuberculosis using Xpert MTB/RIF assay for stool specimens in immunocompetent Pakistani children p. 8 Zahra Hasan, Fehmina Arif, Sadia Shakoor, Aisha Mehnaz, Alnoor Akber, Akbar Kanji, Mussarat Ashraf, Rumina Hasa The successful management of tuberculosis (TB) requires efficient diagnosis and treatment. Further, the increasing prevalence of drug-resistant TB highlights the urgent need to develop novel inhibitors against both drug-susceptible and drug-resistant forms of disease. Malate synthase (MS), an enzyme of the glyoxylate pathway, plays a vital role in mycobacterial persistence, and therefore it is. Comparison of the new HIV VL XC Assay with the established Alinity m in HIV-1 viral load measurement Using QIAstat-Dx® Respiratory SARS-CoV-2 Panel as a tool for diagnosis of zoonotic strains and the G4 Eurasian avian-like H1N1 influenza A and for differentiation from the seasonal influenza A viruses Evaluation of Xpert MTB/RIF Ultra. 20 Dharan NJ, Blakemore R, Sloutsky A, Kaur D, Alexander RC, Ghajar M, et al. Performance of the G4 Xpert(r) MTB/RIF assay for the detection of Mycobacterium tuberculosis and rifampin resistance: a retrospective case-control study of analytical and clinical samples from high- and low-tuberculosis prevalence settings
Esmail, Aliasgar; Tomasicchio, Michele; Meldau, Richard; Makambwa, Edson; Dheda, Keertan; (2020) Comparison of Xpert MTB/RIF (G4) and Xpert Ultra, including trace readouts, for the diagnosis of pulmonary tuberculosis in a TB and HIV endemic setting 300-6252 Rev D Xpert MTB RIF CE-IVD PI MultiLang. Ghdonline.org DA: 17 PA: 35 MOZ Rank: 55. D, September 2010 1 English In Vitro Diagnostic Medical Device Proprietary Name Xpert® MTB/RIF Common or Usual Name MTB/RIF Assay Intended Use The Xpert MTB/RIF test for use with the Cepheid GeneXpert® System is a semi-quantitative nested real-time PCR in-vitro diagnostic test for: 1) the detection of. Results obtained by the Xpert MTB/RIF assay were in agreement with GenoType MTBDRplus results on rifampicin resistance, with an exception of 2/43 (4.7%), which were sensitive on the GenoType MTBDRplus but rifampicin resistant on Xpert MTB/RIF. Ct values of 18.5 and 24.4 on Xpert MTB/RIF, both on probe B, were interpreted as rifampicin resistant
The Xpert MTB/RIF is a cartridge-based nucleic acid amplification test (NAAT) for simultaneous rapid tuberculosis diagnosis and rapid antibiotic sensitivity U4 spliceosomal RNA (1,642 words) [view diff] case mismatch in snippet view article find links to articl Evidence of TB diagnosis either confirmed bacteriologically by Xpert MTB/RIF Version G4 assay (Cepheid, Sunnyvale, CA, USA) or clinically diagnosed. 2. Evidence of a personally signed and dated informed consent document that indicates that the participant (or a legal representative) has been informed of all pertinent aspects of the study Results: The pooled sensitivity of GeneXpert MTB/Rif assay, smear microscopy and culture against a composite reference standard was found to be 78.64%, 24.27% and 50.49% respectively. The individual sensitivity of the Gene Xpert MTB/Rif assay for biopsy, body fluids, csf and pus samples was found to be 84.62%, 50%, 71.43% and 95.45% respectively
The new and improved GeneXpert Ultra assay was more sensitive than GeneXpert G4 and LPA in both pulmonary and extra pulmonary samples, albeit with lower specificity than the GeneXpert G4. The auramine and LPA tests were also highly sensitive, although the LPA was less specific Background: The Xpert MTB/RIF (Xpert) assay is a rapid PCR-based assay for the detection of Mycobacterium tuberculosis complex DNA (MTBc) and mutations associated with rifampin resistance (RIF). An updated version introduced in 2011, the G4 Xpert, included modifications to probe B and updated analytic software
53. Theron G, Peter J, Pai M, Dheda K. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Resp Crit Care Med 2011; 184(1):132-40. 54 Objectives: This study was designed to apply GeneXpert MTB/RIF assays for the detection of rifampicin resistant tuberculosis and validation of assays by comparing with conventional standard drug proportion method. Additionally, to explore whether the assay can be utilized in treatment of Multidrug Resistant T NIT for Procurement of Aspergillus Galactomannan Lateral Flow Assay Kit, Make: Immuno-Mycologics, Inc. (IMMY) - Vallabhbhai Patel Chest Institute posted on Jun 8, 2021 NIT for Procurement of Xpert-TB (Xpert MTB/RIF-Ultra) Cartridges & Xpert - TB Xpert -MTB/RIF - MII, Make: Cepheid - Vallabhbhai Patel Chest Institut The Transactions of the Royal Society of Tropical Medicine and Hygiene Journal Impact IF 2020-2021 is 1.868. More IF Analysis, Trend, Ranking & Prediction