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Xpert MTB/RIF assay G4

GeneXpert MTB/RIF Version G4 for Identification of

  1. 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 week
  2. The Xpert Ultra detected more RIF resistance than the Xpert G4 and the LPA, which supports one of the reasons the Xpert Ultra assay was developed i.e., to overcome the limitations of the old Xpert.
  3. 4. Davis JL, et al. Impact of GeneXpert MTB/RIF on patients and tuberculosis programs in a low-burden setting. a hypothetical trial. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1551-9. 5. Lippincott CK, et al. Xpert MTB/RIF Assay Shortens Airborne Isolation for Hospitalized Patients With Presumptive Tuberculosis in the United States
  4. 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.
  5. Significant reduction of non-reportable results for Xpert MTB/RIF G4 assay (G4). No 5011 errors seen for G4. Accuracy of G4 Assay Maintained Overall Accuracy of Xpert MTB/Rif G3 assay versus G4 assay Sensitivity in C+ Specificity in S-C-Rif-R Sensitivity Rif-S Specificity G3 82.6% (142/172) [76 -87] 98.8% (242/245) [96 -100] 100.0

A Comparative Evaluation of the New Genexpert MTB/RIF

The Xpert MTB/RIF test was performed using the G4 version of cartridges as per the manufacturer's instruction (Cepheid, Sunnyvale, CA). Unprocessed samples were used directly for performing the test and no frozen samples were used in the study. The samples were processed for Xpert MTB/RIF as per the manufacturer's instructions A recent Cochrane review estimated GeneXpert MTB/RIF specificity for rifampin resistance as 98% (95% confidence interval [CI], 97 to 99), based on results from earlier test versions. The measured positive predictive value of the new generation test from programmatic implementation in Cape Town, South Africa, was 99.5% (95% CI, 98.5 to 100), confirming excellent specificity

Cepheid MTB/RIF Molecular Test - Xpert MTB/RI

  1. ated sample. • The cartridges should be processed within 4 hours once sample added to the cartridge
  2. BACKGROUND: The Xpert(R) 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. METHODS: An analytical study was performed to assess Xpert detection of.
  3. The G3 version of the Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA) was available in our laboratory until the end of January 2013, with a cartridge expiration date of 7 July 2013. The case described in our paper was diagnosed in December 2012

Fact Sheets Testing and Diagnosis A New ToolXpert

The assay was performed using the version G3 of the Xpert MTB/RIF assay until 7 April 2012 and the version G4 thereafter following manufacturer's instructions (Cepheid, Sunnyvale, CA, USA). The GeneXpert MTB/RIF uses molecular beacons in five overlapping regions of the rpoB DNA region CASE REPORT. The Xpert MTB/RIF G4 assay ([Cepheid] hereafter referred to as Xpert) has greatly improved diagnosis of tuberculosis (TB) and its resistance to rifampicin [1, 2].Many TB control programs rely on its results for rapid diagnosis of rifampicin-resistant (RR) and initiation of appropriate treatment [].Xpert amplifies an 81-base pair region of the rpoB gene [], using 5 probes. 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

Molecular detection of Mycobacterium tuberculosis in blood

It is pertinent to remember here that the current version (Xpert MTB/RIF Version G4) is the product of changes in significant delta C T (The difference between the highest C T and the lowest C T) from 3.5 cycles (Xpert MTB/RIF Version G1) to 4.0 cycles (version G2) and subsequent fine tuning of other parameters in the later versions (G3 and G4) IN CASE OF TEST UPDATE In case of test update, before running a test, you need to import the Assay definition of the test (ADF) from the CD-ROM provided in the kit. 1- Click on DEFINE ASSAYS 2- Click on the import button 3- Locate the CD-ROM from the D drive location 4- Import your file Xpert MTB-RIF G4_5. gxa from the blue CD-ROM 2

Video: Comparison of Xpert MTB/RIF (G4) and Xpert Ultra

METHODS:We evaluated the relative accuracy of Xpert-MTB/RIF and Xpert-Ultra in 272 selected but well-characterized archived sputum samples. Of these, 168 were culture-positive (64/168 smear-positive and 104/168 smear-negative), and 104 were culture-negative (102/104 from patients with previous TB and 2/104 from patients without a TB history) The Cochrane Library appears to be unavailable to you at the moment. This could be due to maintenance activity or an unexpected issue. Please contact Customer Support for assistance

Case report of a false positive result of the Xpert ® MTB

Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children Xpert MTB/RIF implementation manual: technical and operational 'how-to'; practical considerations Expert Group meeting report (20-21 May, 2013 Xpert MTB-RIF Assay G4 was performed and reported as MTB DETECTED LOW (low levels of mycobacterium tuberculosis) with Rif RESISTANCE NOT DETECTED (no resistance to Rifampicin). Sample which was cultured showed Streptococcus Pneumoniae. Patient was referred to Chest- TB Physician. She was put on AKT regime. The development of the Xpert MTB/RIF assay has been the most important breakthrough for the diagnosis of tuberculosis in decades. David L. Cohn. This molecular-based test provides a rapid and. 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 Next-generation Xpert® MTB/RIF Ultra assay recommended by WHO. 24 March 2017 - The World Health Organization (WHO) today recommended the use in all settings of a next-generation Xpert® MTB/RIF assay (called Xpert® MTB/RIF Ultra) as a replacement for the current Xpert MTB/RIF® cartridge. The Ultra cartridge, that has been developed by Cepheid (Sunnyvale, USA), showed significantly better.

reported using GeneXpert MTB/RIF version G4 on sputum samples; however, this has not been investigated for urine samples in HIV-associated tuberculosis (TB). Objectives: We sought to determine the proportion of false rifampicin resistant results using Xpert MTB/RIF version G4 on urine samples among HIV-infected inpatients investigated for TB The Xpert MTB/RIF Much lower RIF monoresistance levels were reported from an- version G4 assay was developed by the manufacturers to increase other high-TB-burden country (South Africa [13.5%]) and a low- the assay's robustness and mitigate against potential false RIF- TABLE 2 Mutations detection by LPA and Xpert MTB/RIF in rifampin-resistant. 4.1.4 usinG Xpert mtB/rif tO detect smear-neGatiVe culture-pOsitiVe tB 12 4.1.5 usinG Xpert mtB/rif tO detect pulmOnary tB in HiV-neGatiVe and HiV- pOsitiVe indiViduals 12 4.1.6 usinG Xpert mtB/rif tO detect rifampicin resistance 14 4.1.7 effect Of tHe VersiOn Of tHe Xpert mtB/rif assay 15 4.1.8 accuracy Of tHe Xpert mtB/rif G4 cartridGe 1

Xpert MTB/RIF assay, a real-time PCR assay designed to detect Mycobacterium tuberculosis, has proven sensitive and specific when performed on respiratory samples in a high prevalence setting. However, it was suggested as less accurate in a low-incidence environment. We evaluated the accuracy of the Xpert for the diagnosis of tuberculosis (TB) on pulmonary and extrapulmonary samples in Geneva. The New Xpert MTB/RIF Ultra: 1. The New Xpert MTB/RIF Ultra: Improving Detection of Mycobacterium tuberculosis and Resistance to Rifampin in an Assay Suitable for Point-of-Care Testing Soumitesh Chakravorty,a Ann Marie Simmons,b Mazhgan Rowneki,a Heta Parmar,a Yuan Cao,a Jamie Ryan,b Padmapriya P. Banada,a Srinidhi Deshpande,a Shubhada Shenai,a Alexander Gall,c Jennifer Glass,b Barry. 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 Xpert MTB/RIF specificity was 100% (99.7-100%) among 1164 specimens from 892 children in whom TB was excluded, strongly suggesting all Xpert MTB/RIF positives are true positives Xpert detects mutations in the M. tuberculosis rpoB gene, which is responsible for >95% of rifampicin resistance, with a well-established 98% specificity [3, 7]. Compared with the earlier version [3, 7], the latest generation (G4) assay has a reduced risk of false positive results for rifampicin resistance [8]

Performance of the G4 Xpert MTB/RIF assay for the detection of and rifampin resistance: a retrospective case-control study of analytical and clinical samples from high- and low-tuberculosis prevalence setting BACKGROUND: The Xpert(R) 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 We read the study by Jean Claude Semuto Ngabonziza and colleagues 1 in The Lancet Microbe, in which the authors identified an association between false-positive rifampicin-resistant Xpert MTB/RIF (Xpert; G4 cartridge; Cepheid, Sunnyvale, CA, USA) results and a very low bacillary load. 1 This association has previously been described, 2-4 and. We read the study by Jean Claude Semuto Ngabonziza and colleagues1 in The Lancet Microbe, in which the authors identified an association between false-positive rifampicin-resistant Xpert MTB/RIF (Xpert; G4 cartridge; Cepheid, Sunnyvale, CA, USA) results and a very low bacillary load.1 This association has previously been described,2-4 and Xpert rifampicin-resistant results associated with a. We are not allowed to display external PDFs yet. You will be redirected to the full text document in the repository in a few seconds, if not click here.click here

(PDF) A Comparative Evaluation of the New Genexpert MTB

Monitoring quality indicators for the Xpert MTB/RIF

The Xpert MTB/RIF assay (Xpert, Cepheid, Sunnyvale, California), an automated, rapid nucleic acid amplification test (NAAT) endorsed by the World Health Organization in 2010 and authorized for marketing by the US Food and Drug Administration in 2013 , can expedite the diagnostic process given its sensitive and specific ability to diagnose. Performance of the G4 Xpert® 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 . By Nila J. Dharan, Robert Blakemore, Alex Sloutsky, Devinder Kaur,. Key message: Xpert® MTB/RIF is a diagnostic test which can quickly detect TB in adults with a high degree of accuracy and without the need for laboratory facilities. It can accurately detect rifampicin resistance in adults thought to have multi-drug resistant TB, allowing treatment to be started quickly. It may be useful, too, as an add-on tes Xpert MTB/RIF The Xpert MTB/RIF test was performed using the G4 version of cartridges as per the manufacturer's instruction (Cepheid, Sunnyvale, CA). Unprocessed samples were used directly for performing the test and no frozen samples were used in the study. The sample was mixed with the sample reagen

Enter the password to open this PDF file: Cancel OK. File name: 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 In this context for Xpert MTB/RIF, a panel must require intact Mycobacterium tuberculosis that can be processed outside a biosafety level 3 (BSL3) (or even BSL2) laboratory infrastructure.Currently, no EQA program exists for the Xpert MTB/RIF test, which represents a paradigm shift in molecular testing for TB Test Results Overall Results. Over the first 12 months of implementation the nine projects consumed 47,973MTB/RIF tests (range 1,428-11,472). MTB/RIF testing resulted in a positive test for 15.0. 3 Steingart KR, Schiller I, Horne DJ, et al. Xpert1 MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev 2014; 1: CD009593. 4 Pantoja A, Fitzpatrick C, Vassall A, et al. Xpert MTB/RIF for diagnosis of tuberculosis and drug-resistant tuberculosis: a cost and affordability analysis

[Diagnostic Test Accuracy Protocol] Xpert® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance MikashmiKohli1,IanSchiller2,NandiniDendukuri2,HannahRyan3,KeertanDheda4,ClaudiaMDenkinger5,SamuelGSchumacher 5, Karen R Steingart6 1All India Institute of Medical Sciences (AIIMS), New Delhi, India. 2Division of Clinical Epidemiology, McGill University Healt 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. A thorough preclinical assessment of analytic performance and biosafety of the Xpert MTB/RIF assay was done. 17 By spiking defined numbers of M tuberculosis bacilli into clinical sputum samples from patients without tuberculosis, the limit of detection (95% reliability for detection) of the assay was 131 colony forming units (cfu)/mL (95% CI 106-176) of sputum. 22 This result contrasts with. This indicated that Xpert MTB/RIF has an added value in detecting MTB and drug resistance that facilitated and supported the community-based intervention in the study site. This is also supported by a study entitled The implementation of Xpert MTB/RIF assay for diagnosis of tuberculosis conducted in Nepal [ 15 , 20 ] The Xpert® MTB/RIF assay (Cepheid, Sunnyvale, CA, USA) has been in routine use in Odessa Oblast, a region with the highest tuberculosis (TB) incidence in Ukraine, since 2013. We assessed the performance of the assay in routine settings and evaluated its effect on treatment outcomes

Additional 42 MTB cases (9.2% of the total cases) were detected among unsuccessful results by follow-up tests. Sixty-four percent of the initial test results were released within the turnaround time (TAT) ≤24 hours. Conclusion. Most of the quality indicators for the Xpert MTB/RIF molecular assay were maintained within the targets Of the two collected sputum specimens, one was tested using the Xpert MTB/RIF assay (version G4 cartridges) (Cepheid, Sunnyvale, CA, USA) according to the manufacturer's instructions and the other decontaminated and concentrated using the NaLC-NaOH method 21; sediments were used to prepare smears for light microscopy by Ziehl-Neelsen staining. Xpert® MTB/RIF assay vs culture What happens No of studies Comparison to other TB tests Xpert® MTB/ RIF assay as initial test (replacing sputum smear Sensitivity 89% Specificity 99% Xpert® MTB/RIF assay diagnoses TB in 89 out of 100 people who have TB. Xpert assay diagnoses TB in 1 in a 100 people who do not have TB based on culture results. sequencing was dependent on results from the Xpert MTB/ RIF assay (software version G4). DNA was extracted from corresponding MGIT cultures if rifampicin resistance was detected by Xpert MTB/RIF. Xpert MTB/RIF assay Samples (n = 995) were processed as per the manufacturer's instructions. A sample reagent buffer was added to 500 µL o The MTBDRplus Version 2.0, Xpert® MTB/RIF (GXP) (G3 cartridge) and the Anyplex™ MTB/NTM (Anyplex) were performed according to manufacturer's instructions. For the GXP 1 ml of cultured isolate was used and sample reagent buffer added in a 2:1 ratio

Background: U.S. guidelines recommend respiratory isolation during evaluation of suspected pulmonary tuberculosis (TB) until demonstration of serial negative acidfast bacilli(AFB) sputa. We evaluated the strategies of 1 vs. 2 rapid nucleic acid GeneXpert MTB/RIF(Xpert) tests in comparison to AFB smear for the initial diagnostic evaluation, including in persons with HIV, for whom prompt TB. family of systems have set a new standard in workflow flexibility, 24/7 testing accuracy, and user-friendly design — delivered in an astonishingly beautiful and compact package. GeneXpert® Omni System. A portable near-patient testing molecular diagnostic system that delivers lab-quality results when and where they are needed most Abstract. MTB/RIF (Xpert) is an automated molecular test for simultaneous detection of tuberculosis (TB) and rifampicin resistance, recommended by the World Health Organization as the preferred diagnostic method for individuals presumed to have multi-drug resistant TB (MDR-TB) or HIV-associated TB The CSF and a lymph node aspirate were both analysed with Xpert MTB/RIF assay version G4 (Cepheid, Sunnyvale, California, USA) to detect MTB and test for resistance to rifampicin. MTB was detected in both samples with discordance in the rifampicin resistance result, being rifampicin resistant in the lymph node sample and rifampicin susceptible. the Xpert MTB/RIF assay version G4 (Cepheid, Sunny-vale, CA, USA) at the end of the study on specimens from all children treated for confirmed, highly probable, or pos-sible TB as well as from children for whom a TB diagnosis had been excluded. Laboratory procedures were externall

GeneXpert MTB/RIF version G4 for identification of

However, the Xpert MTB/RIF assay endorsed by WHO in 2010 has high sensitivity for rifampicin resistance . When used to screen patients pre-ART in South Africa , all cases of MDR-TB were diagnosed after a mean of 2 days compared to 21 days using culture and line-probe assay and 43 days using culture and phenotypic drug-susceptibility testing [28] In a head-to-head comparison of the MTBDR plus version 2.0 (Hain Lifescience), the Xpert MTB/RIF (Cepheid), and the Anyplex MTB/NTM (Seegene) assays, we demonstrated equal sensitivity (59/61; 96.7%) and specificity (53/54; 98.1%) for detecting rifampin resistance with further analysis of discordances. The Xpert assay does not detect isoniazid resistance while the Anyplex assay showed high. Xpert MTB/RIF assay (version G4 cartridges) (Cepheid, Sunnyvale, CA, USA) according to the manufacturer's instructions and the other decontaminated and concentrated using the NaLC-NaOH method [21]; sedi-ments were used to prepare smears for light microscop 58 These findings warn that by using the Xpert MTB/RIF testing we might be underestimating the 59 burden of drug-resistant tuberculosis and country sp ecific probes need to be designed to increase 60 the sensitivity of Xpert MTB/RIF. 61 62 Key words: Rifampicin, line probe assay, Xpert MT B/RIF, Xpert MTB/RIF, mutation, drug 63 resistance

Assessing the effect of Mycobacterium tuberculosis bacterial load on Xpert MTB/RIF accuracy for detecting rifampicin resistance in bronchoalveolar lavage fluid 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

Evaluating the Diagnostic Accuracy of Xpert MTB/RIF Assay

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 Hired at the verge of the WHO endorsement of the Xpert MTB/RIF test by the WHO in Dec 2010 Played a central role in managing the upgrading of the MTB assay (to G4 version) during the very fast. Xpert MTB/RIF Mark Nicol Indirect line probe assay If Rif R -culture and 2nd line DST If Rif R 2nd line DST Variable implementation. 20/03/2012 11 Current algorithm for MDR detection New G4 cartridge: redesigned probes, fluidics software changes. 20/03/2012 1 mL equivalents. The Xpert assay was performed using the G4 version of cartridges with sediment protocol according to the The Xpert MTB/RIF assay (Xpert assay; Cepheid, Sunny-vale, CA, USA) is a fully automated, real-time polymerase chain reaction assay that is designed to detect the presence of Mycobacterium tuberculosis (MTB) and rifampin (RFP

Performance of the G4 Xpert(R) MTB/RIF assay for the

Xpert MTB/RIF Assay G4 Version 5 We measured the DNA concentration of the thermolysates through an Invitrogen Qubit 2.0 Fluorometer (Thermo Fisher Scientific, Waltham, MA, USA) following the manufacturer's instructions. The calculated weight of DNA per M tuberculosi The average MTB detection rate was 18.5%, 22.3%, and 11.6% for the three different strategies respectively. Analysis of the results on samples tested in parallel showed that using Xpert as add-on test to microscopy would have increased laboratory TB confirmation by 49.7%, versus 42.3% for Xpert replacing microscopy Comparison of the Xpert MTB/RIF test with an IS6110-TaqMan real-time PCR assay for direct detection of Mycobacterium tuberculosisin respiratory and non-respiratory specimens. J Clin Microbiol 2011; 50: 1772-1776. 14 Chang K, Lu W, Wang J, et al. Rapid and effective diagnosis of tuberculosis and rifampicin resistance with Xpert MT/RI

The flow-chart of the study is reported in Fig 1: out of 5170 Xpert tests performed (883 with G3 assay version and 4287 with G4 version), 143 (2.8%) had an invalid result and were excluded from the analysis. Similar proportion of invalid results were obtained with the two assay versions (2.3% with G3 and 2.9% with G4) Performance of Xpert MTB/RIF version G4 assay. Geneva, Switzerland: Foundation for Innovative New Diagnostics; 2011. 26. Creswell J, Codlin AJ, Andre E, Micek MA, Bedru A, Cater EJ, et al. Results from early programmatic implementation of Xpert MTB/RIF testing in nine countries subjected them to RDTs, namely Xpert MTB/RIF, GenoType MTBDRplusv2.0, and Genoscholar NTM + MDRTB II. Xpert MTB/RIF Assay G4 Version 5 We measured the DNA concentration of the thermolysates through an Invitrogen Qubit 2.0 Fluorometer (Thermo Fisher Scientific, Waltham, MA, USA) following the manufacturer's instructions Prinsip : Bakteri dalam sputum dilisiskan dan DNA bakteri diisolasi. Fragmen DNA spesifik M.tb diamplifikasi jutaan kali dengan Real Time Polymerase Chain Reaction.Primer dalam assai Xpert MTB/RIF memperbanyak bagian dari gen rpoB yang mengandung 81 pasangan basa core. Probes dapat membedakan conserved wild-type sequence dan mutasi pada core yang berhubungan dengan resistensi terhadap RIF

• Xpert MTB/RIF in 207 smear microscopy laboratories • ~10.7% MTBC detected, ~6% Rif resistant (proxy for MDR) • Liquid culture (16 labs): 0.56million tests for diagnosis in HIV+/Xpert- 1500000and DST/LPA for MDR/XDR confirmation • Smear microscopy (1.0million tests) for treatment monitoring: 78% reduction in test volumes since 4 year Gen xpert MTB-RIF Assay G4 MTB not detected Sputum BTA SPS Negatif IGRA Positif Tabel 1. Hasil Pemeriksaan Penunjang Diagnosis TB A B Gambar 3. Kondisi pasien pada follow-up 1 bulan. Pada gambar A dan B tampak edema papil dan sheating pada pembuluh darah Gambar 2. Hasil pemeriksaan USG У пацієнта виключався туберкульоз: кванті-фероновий тест мав негативний результат, тестом Xpert MTB- RIF Assay G4 у промивних водах бронхів мікобактерій туберкульозу не виявлено

Evidence of TB diagnosis-either confirmed bacteriologically by Xpert MTB/RIF Version G4 assay (Cepheid, Sunnyvale, CA, USA) or clinically diagnosed by health worker. Evidence of a personally signed and dated informed consent document indicating that the participant (or a legal representative) has been informed of all pertinent aspects of the study The Xpert MTB/RIF assay has recently replaced sputum microscopy as the investigation of choice in People living with HIV (PLHIV). The present study aims to compare two methods for the diagnosis of TB in PLHIV: Microscopy, and Xpert MTB/RIF. and to compare with CD4 count Objective of the Study 1 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

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 assay is a fully automated molecular diagnostic test for TB disease, developed in partnership with Cepheid Inc, the foundation for innovative new diagnostics (FIND); the university of medicine and dentistry of New Jersey (UMDNJ) and the national institutes of health (NIH). It ca The Xpert MTB/RIF assay is now being widely implemented around the world and, in 2011, South Africa took the bold decision to implement this nationwide as a replacement for sputum smear microscopy. Although the Xpert MTB/RIF assay is a substantial advance, it is an imperfect solution 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

Performance of the G4 Xpert ® 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. Nila J. Dharan, Robert Blakemore, Alex Sloutsky, Devinder Kaur,. 4.1.6 иСпольЗоВание Xpert MtB/rIF для ВыяВления уСтойчиВоСти к Рифампицину 16 4.1.7 Влияние ВеРСии аналиЗа Xpert MtB/rIF 17 4.1.8 точноСть каРтРиджа G4 СиСтемы Xpert MtB/rIF 18 4.1.9 точноСть Эталонных СтандаРтоВ 1

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) Each sample was divided for diagnosis using microscopy, GeneXpert MTB/RIF assays, and LPA; these were all comparatively evaluated, using the MGIT 960 culture as a gold standard. The sensitivity and specifcity of microscopy, Xpert Ultra, Xpert G4 and MTBDRplus (ver 2) in pulmonary samples were respectively: 82.00% and 90.28%; 88.00% and 58.57%. All specimens were processed as per standard Xpert MTB/RIF protocol by addition of Sample Reagent (SR) buffer in a 3:1 or 2:1 ratio to take the final volume to 2 mL (Cepheid, USA). The on-site result obtained from the Xpert MTB/RIF assay was reported to the treating clinicians. Statistical analysi Implementation and roll-out of Xpert MTB/RIF February 2012 This document provides an update on the global roll-out of Xpert MTB/RIF, the WHO-endorsed test for the rapid and simultaneous detection of TB and rifampicin resistance. For background and guidance on use of the test, including the WH 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. •Xpert: Sensitivity of 85.9% (Smear-: 72.7%); Specificity: 99.0% •RIF on Ultra: -4 FP: 3 with disputed mutations or heteroresistance -3 FN: G4 and Ultra are WT, likely mutation outside of rpoB Ongoing: 10 sites; 8 country study •Reference standard: 4-6 cultures •Direct comparison to Xpert