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GeneXpert MTB/RIF

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specificity 99%. In a clinical study conducted the sensitivity of the MTB/RIF test on just 1 sputum sample was 92.2% for culture-positive TB; 98.2% for smear+ and culture-positive cases; and 72.5% for smear-negative, culture-positive cases, with a specificity of 99.2%. Sensitivity and higher specificity were slightly higher when 3 samples were tested.
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Boehme, Catharina C.; Nabeta, Pamela; Hillemann, Doris; Nicol, Mark P.; Shenai, Shubhada; Krapp, Fiorella; Allen, Jenny; Tahirli, Rasim; Blakemore, Robert; Rustomjee, Roxana; Milovic, Ana; Jones, Martin; O'Brien, Sean M.; Persing, David H.; Ruesch-Gerdes, Sabine; Gotuzzo, Eduardo; Rodrigues, Camilla;
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Helb, Danica; Jones, Martin; Story, Elizabeth; Boehme, Catharina; Wallace, Ellen; Ho, Ken; Kop, Joann; Owens, Michelle R.; Rodgers, Richard; Banada, Padmapriya; Safi, Hassan; Blakemore, Robert; Lan, N. T. Ngoc; Jones-LĂłPez, Edward C.; Levi, Michael; Burday, Michele; Ayakaka, Irene; Mugerwa, Roy D.;
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Some concerns have been raised about the Xpert MTB/RIF, including 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 $
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A review to assess the diagnostic accuracy of Xpert TB found that when used as an initial test to replace smear microscopy it had pooled sensitivity of 89% and specificity of 99% . However, when Xpert TB was used as an add-on for cases of negative smear microscopy the sensitivity was only 67% and
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genome in a real time format using fluorescent probes called molecular beacons. Results are obtained from unprocessed sputum samples in 90 minutes, with minimal biohazard and very little technical training required to operate. This test was developed as an on-demand near patient technology which
276:. According to Nguyen Viet Nhung, director of the National Lung Hospital in Hanoi, the test is similar to RT-PCR, gives accurate results within 35–45 minutes for both COVID-19 and tuberculosis, and could work automatically. It is also used for COVID-19 testing at six sites across 235:
from sputum samples, isolates genomic material from the captured bacteria by sonication and subsequently amplifies the genomic DNA by PCR. The process identifies most of the clinically relevant Rifampicin resistance inducing mutations in the RNA polymerase beta (rpoB) gene in the
338:(lists creators, also states "Gene-based test developer Cepheid of Sunnyvale said Tuesday it has devised a rapid, sensitive diagnostic test for tuberculosis and will make it available at reduced cost in developing countries where the life-threatening disease is widespread.") 1529: 590:
Horne, David J.; Kohli, Mikashmi; Zifodya, Jerry S.; Schiller, Ian; Dendukuri, Nandini; Tollefson, Deanna; Schumacher, Samuel G.; Ochodo, Eleanor A.; Pai, Madhukar; Steingart, Karen R. (7 June 2019).
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Rie, Annelies Van; Page-Shipp, Liesl; Scott, Lesley; Sanne, Ian; Stevens, Wendy (2010). "XpertMTB/RIF for point-of-care diagnosis of TB in high-HIV burden, resource-limited countries: Hype or hope?".
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9.98 USD. As of 30 June 2013, 1,402 GeneXpert systems (comprising 7553 modules) and >3 million Xpert MTB/RIF cartridges had been procured in 88 of the 145 countries under concessional pricing.
76:). The difference between a GeneXpert MTB/RIF test and a GeneXprt test for anything else is swapping out a single reagent, so it would be repetitive to have a separate article for each one (see 1519: 1509: 186:(WHO) endorsed the Xpert MTB/RIF for use in tuberculosis (TB) endemic countries. The announcement followed 18 months of assessing its field effectiveness in tuberculosis, MDR-TB, and TB/ 1494: 699: 197:(CDC) in 2015, the Xpert MTB/RIF test was "revolutionizing TB control by contributing to the rapid diagnosis of TB disease and drug resistance. The test simultaneously detects 164: 815: 1175: 451: 746: 1464: 784: 931:
Cepheid Announces European Release of First On-Demand Molecular Test for Simultaneous Detection of Mycobacterium tuberculosis (TB) and Resistance to Rifampicin
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McMillan, Bill; Winn-Deen, Emily; Christel, Lee; Dailey, Peter; Perkins, Mark D.; Persing, David H.; Alland, David (2010).
1625: 1469: 1454: 462: 1479: 269: 1615: 998: 776: 207:(RIF) in less than 2 hours. In comparison, standard cultures can take 2 to 6 weeks for MTBC to grow and conventional 1590: 1413: 1109: 950: 918: 155: 1438: 1378: 1055: 1028: 272:
had approved the use of GeneXpert, that has been used in Vietnam tuberculosis prevention network since 2012, for
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This article contains a lot of positive statements with no indication that most of them apply to all automated
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co-infection. The test may enable the diagnosis of TB in patients likely to be missed by traditional tests.
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Public-Private Partnership Announces Immediate 40 Percent Cost Reduction for Rapid TB Test
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Small, Peter M.; Pai, Madhukar (2010). "Tuberculosis Diagnosis — Time for a Game Change".
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Please help update this article to reflect recent events or newly available information.
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WHO Roadmap for rolling out Xpert MTB/RIF for rapid diagnosis of TB and MDR-TB
163:(RIF). It was co-developed by the laboratory of Professor David Alland at the 160: 615: 1297: 1221: 1195: 1185: 1168: 780: 874: 685: 633: 576: 526: 422: 384: 667: 558: 1595: 508: 376: 204: 1530:
Phipps Institute for the Study, Treatment and Prevention of Tuberculosis
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and Rifampin Resistance by Use of On-Demand, Near-Patient Technology"
652:"Rapid molecular detection of tuberculosis and rifampin resistance" 543:"Rapid Molecular Detection of Tuberculosis and Rifampin Resistance" 939: 935: 452:"A New Tool to Diagnose Tuberculosis: The Xpert MTB/RIF Assay" 187: 54: 18: 1475:
European and Developing Countries Clinical Trials Partnership
808:"Stigma and weak systems hamper the Somali COVID-19 response" 700:"Negotiated prices for Xpert® MTB/RIF and FIND country list" 241:
could be performed even in a doctor's office if necessary.
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Mycobacterium Tuberculosis Structural Genomics Consortium
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International Union Against Tuberculosis and Lung Disease
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Cepheid inks deals to sell TB test in developing nations
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The Global Fund to Fight AIDS, Tuberculosis and Malaria
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Tuberculosis disgnostic and antibiotic sensitivity test
231:(NAAT). The Xpert® MTB/RIF purifies and concentrates 219:
The Xpert MTB/RIF detects DNA sequences specific for
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World Health Organisation. Retrieved on 1 Sept 2013
310:"Frequently asked questions on Xpert MTB/RIF assay" 897:VIDEO: CNN features use of Xpert MTB/RIF in Uganda 165:University of Medicine and Dentistry of New Jersey 1176:Microscopic Observation Drug Susceptibility assay 892:Frequently Asked Questions on Xpert MTB/RIF assay 442: 440: 80:). The omission of this context means that it 1465:Center for Global Infectious Disease Research 951: 650:, Nabeta P, Hillemann D, et al. (2010). 175:, with additional financial support from the 8: 255:Cepheid (company) § Pricing controversy 72:tests, not just this proprietary brand (see 843:Journal of Family Medicine and Primary Care 596:The Cochrane Database of Systematic Reviews 1460:Campaign for Access to Essential Medicines 958: 944: 936: 448:Centers for Disease Control and Prevention 350:8 December 2010. Retrieved on 12 June 2012 348:"WHO endorses new rapid tuberculosis test" 195:Centers for Disease Control and Prevention 909:WHO Xpert technical and operational guide 864: 854: 764:"WHO monitoring of Xpert MTB/RIF rollout" 675: 623: 566: 516: 173:Foundation for Innovative New Diagnostics 121:Learn how and when to remove this message 541:Alland, David; Perkins, Mark D. (2010). 396: 394: 1331:Extensively drug-resistant tuberculosis 358: 356: 302: 1505:International Congress on Tuberculosis 787:from the original on 21 September 2020 403:Expert Review of Molecular Diagnostics 330:Cepheid unveils fast, low cost TB test 82:contains content that is written like 777:"Vietnam to use TB test for Covid-19" 7: 818:from the original on 24 January 2021 706:. FIND. October 2013. Archived from 328:Tansey, Bernadette (25 March 2009). 1336:Totally drug-resistant tuberculosis 233:Mycobacterium tuberculosis bacilli 200:Mycobacterium tuberculosis complex 14: 837:Singh, H.; Dhibar, D. P. (2020). 1500:Global Plan to Stop Tuberculosis 1326:Multidrug-resistant tuberculosis 1069: 806:Jerving, Sara (13 August 2020). 497:Journal of Clinical Microbiology 177:US National Institutes of Health 59: 23: 656:New England Journal of Medicine 547:New England Journal of Medicine 365:New England Journal of Medicine 229:nucleic acid amplification test 139:nucleic acid amplification test 1159:Interferon gamma release assay 1061:Post-tuberculosis lung disease 608:10.1002/14651858.CD009593.pub4 1: 1626:Tuberculosis in human culture 1470:Cure Cottages of Saranac Lake 1455:Adirondack Cottage Sanitarium 736:, Retrieved 15 September 2023 223:and rifampicin resistance by 159:(MTB) DNA and resistance to 1616:Tuberculosis classification 999:Extrapulmonary tuberculosis 856:10.4103/jfmpc.jfmpc_1289_20 147:antibiotic sensitivity test 1678: 1591:List of tuberculosis cases 1110:Mycobacterium tuberculosis 491:Mycobacterium tuberculosis 270:Vietnam Ministry of Health 264:Using for COVID-19 testing 252: 238:Mycobacterium tuberculosis 221:Mycobacterium tuberculosis 156:Mycobacterium tuberculosis 1480:Glen Lake Children's Camp 1439:Edward Livingston Trudeau 1379:Friedrich Franz Friedmann 1067: 1056:Giant multinucleated cell 1029:Tuberculous lymphadenitis 319:Retrieved on 12 June 2012 225:polymerase chain reaction 203:(MTBC) and resistance to 184:World Health Organization 32:This article needs to be 1561:Tuberculosis elimination 1140:Löwenstein–Jensen medium 919:Cepheid website on Xpert 78:Cepheid (company)#System 1566:2007 tuberculosis scare 1346:History of tuberculosis 1149:Chest photofluorography 1089:Mycobacterium africanum 335:San Francisco Chronicle 211:can add 3 more weeks." 1641:World Tuberculosis Day 1631:Tuberculosis radiology 1525:National Jewish Health 1121:Tuberculosis diagnosis 1034:Tuberculous meningitis 983:Pulmonary tuberculosis 182:In December 2010, the 143:tuberculosis diagnosis 1621:Tuberculosis in China 1515:Millennium Foundation 1227:4-Aminosalicylic acid 1134:Auramine phenol stain 1080:Mycobacterium species 976:associated conditions 668:10.1056/nejmoa0907847 559:10.1056/NEJMoa0907847 209:drug resistance tests 149:. It is an automated 137:is a cartridge-based 103:neutral point of view 1571:Baumgarten-Tangl law 1485:Glen Lake Sanatorium 1103:Mycobacterium caprae 1039:Miliary tuberculosis 1014:Canga's bead symptom 974:Symptoms, signs and 509:10.1128/jcm.01463-09 489:"Rapid Detection of 377:10.1056/NEJMe1008496 1535:Stop TB Partnership 1490:Glenn Dale Hospital 1129:Ziehl–Neelsen stain 1096:Mycobacterium bovis 1046:Latent tuberculosis 95:promotional content 1389:Philip D'Arcy Hart 924:2011-02-10 at the 902:2011-10-06 at the 315:2020-08-20 at the 292:(the manufacturer) 153:that can identify 97:and inappropriate 1649: 1648: 1154:GeneXpert MTB/RIF 849:(11): 5822–5823. 783:. 8 August 2020. 745:(8 August 2012). 728:(6 August 2012). 662:(11): 1005–1015. 553:(11): 1005–1015. 415:10.1586/erm.10.67 371:(11): 1070–1071. 193:According to the 141:(NAAT) for rapid 131: 130: 123: 74:Cepheid (company) 53: 52: 1669: 1419:Mario Raviglione 1073: 1019:Prosector's wart 1004:Caseous necrosis 960: 953: 946: 937: 879: 878: 868: 858: 834: 828: 827: 825: 823: 803: 797: 796: 794: 792: 773: 767: 761: 755: 743: 737: 734:Gates Foundation 726: 720: 719: 717: 715: 710:on April 7, 2014 704:FIND Diagnostics 696: 690: 689: 679: 644: 638: 637: 627: 587: 581: 580: 570: 537: 531: 530: 520: 483: 477: 476: 474: 473: 467: 461:, archived from 456: 444: 435: 434: 398: 389: 388: 360: 351: 345: 339: 326: 320: 307: 274:COVID-19 testing 268:In August 2020, 126: 119: 115: 112: 106: 84:an advertisement 63: 62: 55: 48: 45: 39: 27: 26: 19: 1677: 1676: 1672: 1671: 1670: 1668: 1667: 1666: 1652: 1651: 1650: 1645: 1636:Tygerberg score 1549: 1443: 1409:Charles Mantoux 1399:George M. Heath 1369:Christopher Dye 1364:Albert Calmette 1359:Hermann Brehmer 1354:Manuel de Abreu 1340: 1314: 1276: 1210: 1202: 1115: 1074: 1065: 975: 969: 964: 926:Wayback Machine 904:Wayback Machine 888: 883: 882: 836: 835: 831: 821: 819: 805: 804: 800: 790: 788: 775: 774: 770: 762: 758: 744: 740: 727: 723: 713: 711: 698: 697: 693: 646: 645: 641: 602:(6): CD009593. 589: 588: 584: 539: 538: 534: 485: 484: 480: 471: 469: 465: 454: 446: 445: 438: 400: 399: 392: 362: 361: 354: 346: 342: 327: 323: 317:Wayback Machine 308: 304: 299: 286: 266: 257: 251: 217: 151:diagnostic test 127: 116: 110: 107: 88: 64: 60: 49: 43: 40: 37: 28: 24: 17: 12: 11: 5: 1675: 1673: 1665: 1664: 1654: 1653: 1647: 1646: 1644: 1643: 1638: 1633: 1628: 1623: 1618: 1613: 1608: 1603: 1598: 1593: 1588: 1583: 1578: 1573: 1568: 1563: 1557: 1555: 1551: 1550: 1548: 1547: 1542: 1537: 1532: 1527: 1522: 1517: 1512: 1507: 1502: 1497: 1492: 1487: 1482: 1477: 1472: 1467: 1462: 1457: 1451: 1449: 1445: 1444: 1442: 1441: 1436: 1431: 1426: 1421: 1416: 1414:Richard Morton 1411: 1406: 1401: 1396: 1391: 1386: 1381: 1376: 1374:Marcos Espinal 1371: 1366: 1361: 1356: 1350: 1348: 1342: 1341: 1339: 1338: 1333: 1328: 1322: 1320: 1316: 1315: 1313: 1312: 1311: 1310: 1305: 1300: 1292: 1286: 1284: 1278: 1277: 1275: 1274: 1269: 1264: 1259: 1254: 1249: 1244: 1239: 1234: 1229: 1224: 1218: 1216: 1204: 1203: 1201: 1200: 1199: 1198: 1193: 1188: 1178: 1173: 1172: 1171: 1166: 1156: 1151: 1146: 1136: 1131: 1125: 1123: 1117: 1116: 1114: 1113: 1106: 1099: 1092: 1084: 1082: 1076: 1075: 1068: 1066: 1064: 1063: 1058: 1053: 1048: 1043: 1042: 1041: 1036: 1031: 1026: 1024:Lupus vulgaris 1021: 1016: 1011: 1006: 996: 995: 994: 992:Ghon's complex 979: 977: 971: 970: 965: 963: 962: 955: 948: 940: 934: 933: 928: 916: 911: 906: 894: 887: 886:External links 884: 881: 880: 829: 798: 768: 756: 738: 721: 691: 639: 582: 532: 503:(1): 229–237. 478: 436: 409:(7): 937–946. 390: 352: 340: 321: 301: 300: 298: 295: 294: 293: 285: 282: 265: 262: 253:Main article: 250: 247: 216: 213: 129: 128: 99:external links 67: 65: 58: 51: 50: 31: 29: 22: 15: 13: 10: 9: 6: 4: 3: 2: 1674: 1663: 1662:Medical tests 1660: 1659: 1657: 1642: 1639: 1637: 1634: 1632: 1629: 1627: 1624: 1622: 1619: 1617: 1614: 1612: 1609: 1607: 1604: 1602: 1599: 1597: 1594: 1592: 1589: 1587: 1584: 1582: 1579: 1577: 1574: 1572: 1569: 1567: 1564: 1562: 1559: 1558: 1556: 1552: 1546: 1543: 1541: 1538: 1536: 1533: 1531: 1528: 1526: 1523: 1521: 1518: 1516: 1513: 1511: 1508: 1506: 1503: 1501: 1498: 1496: 1493: 1491: 1488: 1486: 1483: 1481: 1478: 1476: 1473: 1471: 1468: 1466: 1463: 1461: 1458: 1456: 1453: 1452: 1450: 1448:Organizations 1446: 1440: 1437: 1435: 1432: 1430: 1427: 1425: 1422: 1420: 1417: 1415: 1412: 1410: 1407: 1405: 1402: 1400: 1397: 1395: 1394:F. R. G. 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Retrieved 811: 801: 789:. Retrieved 771: 759: 750: 741: 733: 724: 712:. Retrieved 708:the original 703: 694: 659: 655: 642: 599: 595: 585: 550: 546: 535: 500: 496: 490: 481: 470:, retrieved 463:the original 458: 406: 402: 368: 364: 343: 333: 324: 305: 290:Cepheid Inc. 267: 258: 243: 237: 232: 220: 218: 198: 192: 181: 169:Cepheid Inc. 154: 134: 132: 117: 108: 93:by removing 89:Please help 81: 41: 33: 1540:TB Alliance 1404:Robert Koch 1290:BCG vaccine 1262:Bedaquiline 1242:Cycloserine 1237:Capreomycin 1164:QuantiFERON 1138:Culture on 459:CDC website 215:Description 1606:Sanatorium 1424:Carl RĂĽedi 1384:Max Gerson 1319:Resistance 1247:Rifampicin 1232:Ethambutol 1208:Management 1181:Tuberculin 1051:Paronychia 988:Ghon focus 822:26 January 472:2018-05-25 297:References 161:rifampicin 145:and rapid 91:improve it 1298:M72/AS01E 1222:Isoniazid 1196:Tine test 1186:Heaf test 1169:T-SPOT.TB 781:VnExpress 648:Boehme CC 616:1469-493X 167:(UMDNJ), 1656:Category 1596:Plombage 1282:Vaccines 922:Archived 900:Archived 875:33532451 816:Archived 791:8 August 785:Archived 686:20825313 634:31173647 577:20825313 527:19864480 450:(2015), 431:28312109 423:20964612 385:20825320 313:Archived 284:See also 205:rifampin 111:May 2022 44:May 2020 1545:Unitaid 1272:Rifater 1142:and/or 866:7842456 752:Reuters 714:6 April 677:2947799 625:6555588 568:2947799 518:2812290 278:Somalia 179:(NIH). 34:updated 1581:ESAT-6 1576:CFP-10 1308:RBCG30 1303:MVA85A 873:  863:  684:  674:  632:  622:  614:  575:  565:  525:  515:  429:  421:  383:  1554:Other 812:Devex 466:(PDF) 455:(PDF) 427:S2CID 1144:MGIT 871:PMID 824:2021 793:2020 716:2014 682:PMID 630:PMID 612:ISSN 573:PMID 523:PMID 419:PMID 381:PMID 249:Cost 171:and 133:The 861:PMC 851:doi 672:PMC 664:doi 660:363 620:PMC 604:doi 563:PMC 555:doi 551:363 513:PMC 505:doi 411:doi 373:doi 369:363 188:HIV 1658:: 990:/ 869:. 859:. 845:. 841:. 814:. 810:. 779:. 749:, 732:, 702:. 680:. 670:. 658:. 654:. 628:. 618:. 610:. 598:. 594:. 571:. 561:. 549:. 545:. 521:. 511:. 501:48 499:. 495:. 457:, 439:^ 425:. 417:. 407:10 405:. 393:^ 379:. 367:. 355:^ 332:, 1215:) 1211:( 959:e 952:t 945:v 877:. 853:: 847:9 826:. 795:. 718:. 688:. 666:: 636:. 606:: 600:6 579:. 557:: 529:. 507:: 475:. 433:. 413:: 387:. 375:: 124:) 118:( 113:) 109:( 105:. 87:. 46:) 42:( 36:.

Index

real-time PCR
Cepheid (company)
Cepheid (company)#System
an advertisement
improve it
promotional content
external links
neutral point of view
Learn how and when to remove this message
nucleic acid amplification test
tuberculosis diagnosis
antibiotic sensitivity test
diagnostic test
Mycobacterium tuberculosis
rifampicin
University of Medicine and Dentistry of New Jersey
Cepheid Inc.
Foundation for Innovative New Diagnostics
US National Institutes of Health
World Health Organization
HIV
Centers for Disease Control and Prevention
Mycobacterium tuberculosis complex
rifampin
drug resistance tests
polymerase chain reaction
nucleic acid amplification test
Cepheid (company) § Pricing controversy
Vietnam Ministry of Health
COVID-19 testing

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