Listing a study does not mean it has been evaluated by the u. Xpert mtbrif may be used as a followon test to microscopy xpert mtbrif may be used as a followon test to microscopy in adults suspected of havingtb who are not at risk of mdrtb or hivassociated tb, especially when further testing of smearnegative specimens is necessary conditional recommendation acknowledging resource implications, high. Together, the strengthened icf intervention and xpert activation are referred to as the xpert package. Xpert mtb rif versus sputum microscopy as the initial diagnostic test for tuberculosis. Planning for country transition to xpert mtbrif ultra cartridges. Tb diagnosis in people living with hiv plhiv is complicated by the high proportion who are smearnegative andor have extrapulmonary disease 2. Currently, data on the effect of the xpert mtbrif assay on. Laboratory considerations for use of cepheid xpert mtbrif.
It is imperative that all users read the genexpert operator. Xpert mtbrif or xpert ultra as initial diagnostic test for tb in children bacteriological culture as reference standard data assessed for xpert mtbrif. In december 2010, who first recommended the use of the xpert mtbrif assay. In comparison, standard cultures can take 2 to 6 weeks. Xpert mtb rif medical equipment pdf manual download. Implementation of xpert mtbrif for routine pointofcare. It helps to avoid injudicious use of antituberculosis drug. Cepheid, sunnyvale, ca as the initial diagnostic test for individuals being investigated for hivassociated tuberculosis tb 1. Effect of xpert mtbrif on clinical outcomes in routine.
Mar 14, 2012 cepheids xpert mtbrif delivers results in less than 2 hours, without making demands on expertise, infrastructure or biosafety measures beyond what can be expected in most peripheral. Quality of care for patients evaluated for tuberculosis in. Following world health organization endorsement in 2010, xpert mtbrif has helped improve tb programs in over countries and counting. We aim to analyze the impact of these changes on linkage to care and drtb treatment outcomes. A sputum sample processing method for community and mobile. Implementation guideline for xpert mtb rif mtb rif assay, ethiopia mohephi, june 2014 5. Hivinfected children aged 12 years or less enrolled in a randomized controlled trial nct02063880 comparing urgent to poststabilization antiretroviral therapy initiation in kenya underwent tb evaluation. A sample processing control spc and a probe check control pcc are also included in the cartridge. June, 2019 xpert mtb xdr page 3 of 190 3006081, rev. To assess 3year trends of market penetration of xpert mtbrif in the public sector, smear and xpert mtbrif volumes for the year 2016 were evaluated and policies from 20142016 within 22 highburden countries hbcs were studied. Our search identified 387 studies, of which five rcts were eligible for analysis. A sputum sample processing method for community and mobile tuberculosis diagnosis using the xpert mtb rif assay harriet d. Insufficient sample for testing in the xpert mtbrif assay 4. Work plan template for xpert mtbrif implementation and.
At enrollment, sputum or gastric aspirates were collected for tb culture and xpert, stool for xpert, and urine for lipoarabinomannan lam. Xpert mtb rif may be used as a followon test to microscopy xpert mtb rif may be used as a followon test to microscopy in adults suspected of havingtb who are not at risk of mdrtb or hivassociated tb, especially when further testing of smearnegative specimens is necessary conditional recommendation acknowledging resource implications, high. Xpert mtb rif may be considered as an additional test. Diagnostic accuracy of quantitative pcr xpert mtbrif for tuberculous pericarditis compared to adenosine deaminase and unstimulated interferon.
The xpert mtbrif assay includes singleuse disposable cartridges and sample reagent for sample preparation. Pdf the xpert mtbrif assay xpert is a rapid test for tuberculosis tb and rifampin resistance rifr suitable for pointofcare testing. Yes, the same set of equipment genexpert platform, computer, monitor, keypad, barcode reader can be used for ultra. Xpert mtbrif performance to diagnose tuberculosis and. Xpert mtb rif has demonstrated excellent accuracy in clinical evaluation studies, but has reduced sensitivity for detection of smearnegative tuberculosis. Update implementation and rollout of xpert mtbrif may 2012 this document provides an update on the global rollout of the xpert mtbrif assay, the whoendorsed test for the rapid and simultaneous detection of tb and rifampicin resistance. Ac hazard statements flammable liquid and vapour causes severe skin burns and eye damage. Assessing the utility of xpert mtbrif as a screening tool.
The cartridges should be processed within 4 hours once sample added to the cartridge. We also created a database of contacts, primarily laboratory technicians and tb treatment nurses at each facility, table 1 comparison of three remote monitoring tools for xpertw mtbrif features cepheid remote xpert monitoring tool xpertsms gxalert secure data transmission and storage yes yes yes location of data server cepheid secure. Impact of xpert mtbrif and decentralized care on linkage. Pdf xpert mtbrif ultra for detection of mycobacterium. A proportionate number of nrp cases are having llf tb and a high index of suspicion is a must while evaluating these cases to have successful treatment outcome. Xpert mtbrif is the most technologically advanced test for tb ever developed, yet it is. At the same time, the south african national tb program adopted a policy decentralized, outpatient treatment for drug resistant dr tb. A total of 145 samples were subjected to xpert mtbrif retesting. Earlier and improved tuberculosis tb case detection including smearnegative disease, often associated with hiv coinfection as well as expanded capacity to diagnose multidrugresistant tuberculosis mdrtb are global priorities for tb control. Despite substantial increased sensitivity for mtb detection compared with smear microscopy, xpert mtb rif test sensitivity is nevertheless suboptimal, particularly with. Apr 26, 2018 hanifa y, fielding kl, chihota vn et al. Add 2ml of the sample mixture directly to the xpert mtbrif cartridge 3. The cepheid xpert mtbrif test is considered by many as a revolution the diagnostics of tuberculosis in providing a platform that is accurate, fast and easy to use directly from a patients sputum sample. We excluded studies of patients with extrapulmonary tuberculosis, and studies in which.
However, little is known about routine pointofcare poc use in high tbhiv burden settings. Sensitivity in smear negatives and hiv associated tb low 6070% suboptimal sensitivity for rif resistance determination limitations. The world health organization recommends use of the xpert mtbrif assay as the initial diagnostic test in adults and children with presumptive hivassociated tb or multidrugresistant tb. The xpert mtb rif assay is an automated molecular test that has improved the detection of tuberculosis and rifampicin resistance, but. Xpert is a semiautomated, cartridgebased molecular assay for diagnosis of pulmonary tb and detection of rifampicin resistance, and it is more sensitive than sputum smear.
A sputum sample is collected from the patient with suspected tb. View and download genexpert xpert mtb rif user manual online. Since 2011 the world health organization who has recommended xpert mtbrif xpert. Before starting the test, ensure that the genexpert dx system is.
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. Page 3 xpert mtb rif assay ntended the xpert mtb rif assay for use with the cepheid genexpert system is a semiquantitative, nested realtime pcr invitro diagnostic test for the detection of. We prospectively enrolled consecutive patients with suspected pulmonary tb from two tertiary hospitals. More than 9 million new m tuberculosis mtb cases and 1. The xpert mtbrif assay is an automated molecular test that has improved the detection of tuberculosis and rifampicin. There must be a sufficient potential number of specimens to be tested using xpert mtb rif in the facility where the technology will be placed to justify implementation of the test and to ensure that utilization of the new technology will be optimal the capacity of the genexpert iv instrument is 1216 a day or 30004000 tests annually. Among three patients with negative culture and positive xpert mtb rif and afb there were two cases with m. Frequently asked questions about the who technical expert.
Apr 06, 2016 effect of xpert mtbrif on patient outcomes the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The xpert mtbrif assay is a new test that is revolutionizing tuberculosis tb control. Performance of xpert mtbrif ultra and xpert mtbrif for the diagnosis of tuberculosis through testing of formalinfixed paraffinembedded tissues. The utility of repeat xpert mtbrif testing to diagnose tuberculosis in hivpositive adults with initial negative result version 1. Results from the xpert mtbrif assay indicate whether or not mtbc was detected in the sample. The xpert mtbrif assay cartridges contain reagents for the detection of mtbcomplex dna and rif resistance associated mutations. The adoption of the xpert mtbrif test rollout and implementation plan by the ministry of health and social welfare mohsw marks a big step forward because it underscores the programmes commitment to providing the latest technology in rapid testing for tuberculosis tb in tanzania. Diagnosis of tuberculosis from smearnegative presumptive tb. The xpert mtbrif assay what is the xpert mtbrif assay. Du wei li 1, song jing 1, wang jian guo 2,3, liu zi chen 1, li kun 1, wang yu xuan 1, dong yu jie 1, che nan ying 1, corresponding author. Xpert and conventional dst method for detection of mdrtb. It was codeveloped by the laboratory of professor david. Causes serious eye damage suspected of causing genetic defects.
Can the equipment to perform the xpert mtb rif test be used for ultra. The xpert mtbrif assay does not replace the need for smear with microscopy for acidfast bacilli, culture for mycobacteria, and growthbased drug susceptibility testing, in addition to genotyping for early discovery of outbreaks. This study showed the yield of genexpert mtbrif in gl was comparable to bal to. Rapid implementation of the xpert mtb rif diagnostic test 6 p a g e 2. The sputum is mixed with the reagent that is provided with the assay, and a cartridge containing this mixture is placed in the genexpert machine. For detailed instructions, see the genexpert dx system operator manual.
Xpert mtb rif may be used as a followon test to microscopy in adults suspected of having tb but not at risk of mdrtb or hiv associated tb, especially in further testing of smearnegative specimens conditional recommendation acknowledging resource implications, highquality evidence. An updated version introduced in 2011, the g4 xpert, included modifications to probe b and updated analytic software. Xpert mtbrif ultra newer technology diagnosis of tuberculosis. Can the equipment to perform the xpert mtbrif test be used for ultra. Performance of xpert mtbrif ultra and xpert mtbrif for. Using xpert mtb rif ultra has the potential to reduce the number of missed smearnegative tb patients and may lead to a decrease in total costs of patient care due to the detection of mtb in patient specimens and rifresistance in a single test. Comparison of xpert mtbrif with line probe assay for. Xpert mtb rif xpert offers rapid detection of mycobacterium tuberculosis and rifampicin resistance. Rapid implementation of the xpert mtbrif diagnostic test 6 p a g e 2. Rapid implementation of the xpert mtbrif diagnostic test. Gene xpert mtbrif in bronchial wash samples is found to be the best diagnostic modality in evaluating llf tb and should be used routinely as current gold standard. Diagnosing pulmonary tuberculosis with the xpert mtb rif test. The xpert mtbrif xpert assay is a rapid pcrbased assay for the detection of mycobacterium tuberculosis complex dna mtbc and mutations associated with rifampin resistance rif.
The xpert mtbrif assay is an automated molecular test that has improved the detection of tuberculosis and rifampicin resistance, but. The considerations are based on experiences reported to who, and reports from countries and partners that were presented and discussed in a series of implementers meetings. Abstract the global rollout of xpert mtbrif cepheid inc. Because of the greater sensitivity of the xpert mtbrif assay for the detection of.
The xpert mtb rif test cartridge can simultaneously identify mycobacterium tuberculosis complex bacteria mtb and resistance to rifampicin in less than two hours, using the automated genexpert platform. In 2012, as a pilot for botswanas national xpert mtbrif xpert rollout plans, intensified tuberculosis tb case finding icf activities were strengthened at 22 hiv treatment clinics prior to phased activation of xpert instruments. Laboratory considerations for use of cepheid xpert mtbrif assay. Xpert mtb rif ultra compared to xpert mtb rif who report concluded the following. Evaluation of automated molecular testing rollout for. Xpert mtb rif is an automated realtime polymerase chain reaction test for simultaneous detection of tuberculosis and rifampicin resistance. This part of the document presents practical considerations for introducing the xpert mtbrif assay.
The xpert mtbrif test was performed by using the newer version g4 of cartridges per the manufacturers instruction cepheid, sunnyvale, ca. Comparison of genexpert mtbrif assay in broncho alveolar. Introduction the global burden of tb remains enormous. The updated manual reiterated the need for countries to. A structured questionnaire was sent to representatives of 22 hbcs. While this technology is simple to implement, the quality of the final results ultimately depends on the quality of preanalytic steps.
It was codeveloped by the laboratory of professor david alland at the university of medicine and dentistry. Laboratory name standard operating procedure sop version. Studies evaluated sputum specimens, gastric specimens. The current who recommendations for the use of the xpert mtb rif assay also apply to the use of the ultra assay as the initial diagnostic test for all adults and children with. Bronchial wash gene xpert mtbrif in lower lung field. The prompt diagnosis of active tuberculosis atb is still a challenge in clinical practice, especially in tbendemic countries. Load the cartridge into the genexpert instrument as per manufacturers instructions less than 0. Who should use the xpert mtb rif work plan template the xpert mtb rif assay work plan template is intended for use by individuals responsible for planning implementation and scaleup at the national level e. Xpert mtb rif should be used as the initial diagnostic test in individuals suspected of having mdrtb or hivassociated tb, and may be used in all children suspected of having tb.
Update implementation and rollout of xpert mtbrif may 2012. Acidfast staining afs, xpert mtbrif xpert, mycobacterium tuberculosis culture, and tspot. The genexpert mtbrif of bal fluid was positive on 35 48. This section lists the basic steps of running the test. Mycobacterium tuberculosis complex dna in sputum samples or concentrated sediments prepared. The xpert mtb rif is a cartridgebased nucleic acid amplification test naat for simultaneous rapid tuberculosis diagnosis and rapid antibiotic sensitivity test. The xpert mtbrif is a cartridgebased nucleic acid amplification test naat for simultaneous rapid tuberculosis diagnosis and rapid antibiotic sensitivity test. Effect of xpert mtbrif on patient outcomes full text view. Why was mtbrif ultra developed mtbrif assay challenges. Cepheid xpert mtbrif assay november 20 3 all mtb isolates, including those that are rif sensitive, should receive additional dst by culturebased methods to determine the susceptibility patterns of other drugs used to treat tb. Cepheid, sunnyvale, california is an automated nucleic acid amplification test for sputum specimens that can detect both mycobacterium tuberculosis and rifampin resistance within 2 hours, and requires minimal handson time.
Xpert mtbrif xpert offers rapid detection of mycobacterium tuberculosis and rifampicin resistance. Cepheid enabling access to molecular diagnostic testing. The mtbrif test is a simple method, and routine staff with minimal training can use the system. Stool xpert mtbrif and urine lipoarabinomannan for the. Practical considerations xpert mtbrif implementation. Diagnostic accuracy of quantitative pcr xpert mtbrif for tuberculous. Dec 31, 2014 the xpert mtb rif xpert assay cepheid inc. A july 20 genprobe amplified mtb users guide in0014 rev.
This document was prepared by a writing group under the coordination of the. Resuspend the csf to a final volume of 2 ml with xpert mtbrif sample reagent. Hayward, alistair story erj open research feb 2019, 5 1 001652018. Diagnosing pulmonary tuberculosis with the xpert mtbrif test.
Xpert mtbrif assay is a new rapid pointofcare test that can in 2 hours, simultaneously detect, mycobacterium. The test simultaneously detects mycobacterium tuberculosis complex mtbc and resistance to rifampin rif in less than 2 hours. The sensitivity of the xpert mtbrif assay for detecting. We describe our experiences of launching xpert as the poc, initial diagnostic for all tb suspects at a primary healthcare clinic in johannesburg. It is an automated diagnostic test that can identify mycobacterium tuberculosis mtb dna and resistance to rifampicin rif.
Development, rollout and impact of xpert mtbrif for. In 2011, south africa improved its ability to test for rifampicinresistant tb rrtb by introducing genexpert mtbrif. Xpert mtbrif revolutionized the management of mycobacterium tuberculosis mtb infections by providing faster and more accurate mtb diagnosis that detects mtb and rifampicin rif resistance simultaneously. Xpert mtbrif testing in a low tuberculosis incidence, high. Remote monitoring of xpertw mtbrif testing in mozambique. Evaluation of cepheids xpert mtbrif test on pleural fluid in the diagnosis. The xpert mtb rif assay is a nucleic acid amplification naa test that uses a disposable. The ultra assay can be used as an alternative to the xpert mtb rif assay in all settings. A negative result from the xpert mtb rif assay never rules out active tb disease in a child.
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