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Diagnostic sensitivity of SILVAMP TB-LAM (FujiLAM) point-of-care urine assay for extra-pulmonary tuberculosis in people living with HIV.

Kerkhoff AD, Sossen B, Schutz C, Reipold EI, Trollip A, Moreau E, Schumacher SG, Burton R, Ward A, Nicol MP, Meintjes G, Denkinger CM, Broger T.

Eur Respir J. 2019 Nov 7. pii: 1901259. doi: 10.1183/13993003.01259-2019. [Epub ahead of print] No abstract available.


Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in people living with HIV.

Bjerrum S, Schiller I, Dendukuri N, Kohli M, Nathavitharana RR, Zwerling AA, Denkinger CM, Steingart KR, Shah M.

Cochrane Database Syst Rev. 2019 Oct 21;10:CD011420. doi: 10.1002/14651858.CD011420.pub3. [Epub ahead of print] Review.


Guidance for Studies Evaluating the Accuracy of Tuberculosis Triage Tests.

Nathavitharana RR, Yoon C, Macpherson P, Dowdy DW, Cattamanchi A, Somoskovi A, Broger T, Ottenhoff THM, Arinaminpathy N, Lonnroth K, Reither K, Cobelens F, Gilpin C, Denkinger CM, Schumacher SG.

J Infect Dis. 2019 Oct 8;220(Supplement_3):S116-S125. doi: 10.1093/infdis/jiz243.


Guidance for Studies Evaluating the Accuracy of Rapid Tuberculosis Drug-Susceptibility Tests.

Georghiou SB, Schumacher SG, Rodwell TC, Colman RE, Miotto P, Gilpin C, Ismail N, Rodrigues C, Warren R, Weyer K, Zignol M, Arafah S, Cirillo DM, Denkinger CM.

J Infect Dis. 2019 Oct 8;220(Supplement_3):S126-S135. doi: 10.1093/infdis/jiz106.


Guidance for Studies Evaluating the Accuracy of Biomarker-Based Nonsputum Tests to Diagnose Tuberculosis.

Drain PK, Gardiner J, Hannah H, Broger T, Dheda K, Fielding K, Walzl G, Kaforou M, Kranzer K, Joosten SA, Gilpin C, Weyer K, Denkinger CM, Schumacher SG.

J Infect Dis. 2019 Oct 8;220(Supplement_3):S108-S115. doi: 10.1093/infdis/jiz356.


Guidance for Studies Evaluating the Accuracy of Sputum-Based Tests to Diagnose Tuberculosis.

Schumacher SG, Wells WA, Nicol MP, Steingart KR, Theron G, Dorman SE, Pai M, Churchyard G, Scott L, Stevens W, Nabeta P, Alland D, Weyer K, Denkinger CM, Gilpin C.

J Infect Dis. 2019 Oct 8;220(Supplement_3):S99-S107. doi: 10.1093/infdis/jiz258.


Guidance for the Evaluation of Tuberculosis Diagnostics That Meet the World Health Organization (WHO) Target Product Profiles: An Introduction to WHO Process and Study Design Principles.

Denkinger CM, Schumacher SG, Gilpin C, Korobitsyn A, Wells WA, Pai M, Leeflang M, Steingart KR, Bulterys M, Schünemann H, Glaziou P, Weyer K.

J Infect Dis. 2019 Oct 8;220(Supplement_3):S91-S98. doi: 10.1093/infdis/jiz097.


Estimating the impact of a novel drug regimen for treatment of tuberculosis: a modeling analysis of projected patient outcomes and epidemiological considerations.

Kendall EA, Malhotra S, Cook-Scalise S, Denkinger CM, Dowdy DW.

BMC Infect Dis. 2019 Sep 9;19(1):794. doi: 10.1186/s12879-019-4429-x.


Tuberculosis Diagnosis in Children Using Xpert Ultra on Different Respiratory Specimens.

Zar HJ, Workman LJ, Prins M, Bateman LJ, Mbhele SP, Whitman CB, Denkinger CM, Nicol MP.

Am J Respir Crit Care Med. 2019 Aug 5. doi: 10.1164/rccm.201904-0772OC. [Epub ahead of print]


Novel lipoarabinomannan point-of-care tuberculosis test for people with HIV: a diagnostic accuracy study.

Broger T, Sossen B, du Toit E, Kerkhoff AD, Schutz C, Ivanova Reipold E, Ward A, Barr DA, Macé A, Trollip A, Burton R, Ongarello S, Pinter A, Lowary TL, Boehme C, Nicol MP, Meintjes G, Denkinger CM.

Lancet Infect Dis. 2019 Aug;19(8):852-861. doi: 10.1016/S1473-3099(19)30001-5. Epub 2019 May 30.


Whole-genome and targeted sequencing of drug-resistant Mycobacterium tuberculosis on the iSeq100 and MiSeq: A performance, ease-of-use, and cost evaluation.

Colman RE, Mace A, Seifert M, Hetzel J, Mshaiel H, Suresh A, Lemmer D, Engelthaler DM, Catanzaro DG, Young AG, Denkinger CM, Rodwell TC.

PLoS Med. 2019 Apr 30;16(4):e1002794. doi: 10.1371/journal.pmed.1002794. eCollection 2019 Apr. Erratum in: PLoS Med. 2019 Jun 3;16(6):e1002823.


Addressing critical needs in the fight to end tuberculosis with innovative tools and strategies.

Hatherill M, Chaisson RE, Denkinger CM.

PLoS Med. 2019 Apr 30;16(4):e1002795. doi: 10.1371/journal.pmed.1002795. eCollection 2019 Apr.


Sensitive electrochemiluminescence (ECL) immunoassays for detecting lipoarabinomannan (LAM) and ESAT-6 in urine and serum from tuberculosis patients.

Broger T, Tsionksy M, Mathew A, Lowary TL, Pinter A, Plisova T, Bartlett D, Barbero S, Denkinger CM, Moreau E, Katsuragi K, Kawasaki M, Nahid P, Sigal GB.

PLoS One. 2019 Apr 18;14(4):e0215443. doi: 10.1371/journal.pone.0215443. eCollection 2019.


Author Correction: A systematic review of biomarkers to detect active tuberculosis.

MacLean E, Broger T, Yerlikaya S, Fernandez-Carballo BL, Pai M, Denkinger CM.

Nat Microbiol. 2019 May;4(5):899. doi: 10.1038/s41564-019-0452-3.


Diagnostic Accuracy of Stool Xpert MTB/RIF for Detection of Pulmonary Tuberculosis in Children: a Systematic Review and Meta-analysis.

MacLean E, Sulis G, Denkinger CM, Johnston JC, Pai M, Ahmad Khan F.

J Clin Microbiol. 2019 May 24;57(6). pii: e02057-18. doi: 10.1128/JCM.02057-18. Print 2019 Jun.


Cost and operational impact of promoting upfront GeneXpert MTB/RIF test referrals for presumptive pediatric tuberculosis patients in India.

Sarin S, Huddart S, Raizada N, Parija D, Kalra A, Rao R, Salhotra VS, Khaparde SD, Boehme C, Denkinger CM, Sohn H.

PLoS One. 2019 Apr 1;14(4):e0214675. doi: 10.1371/journal.pone.0214675. eCollection 2019.


New TB Tools Need to be Affordable in the Private Sector: The Case Study of Xpert MTB/RIF.

Ponnudurai N, Denkinger CM, Van Gemert W, Pai M.

J Epidemiol Glob Health. 2018 Dec;8(3-4):103-105. doi: 10.2991/j.jegh.2018.04.005. No abstract available.


A systematic review of biomarkers to detect active tuberculosis.

MacLean E, Broger T, Yerlikaya S, Fernandez-Carballo BL, Pai M, Denkinger CM.

Nat Microbiol. 2019 May;4(5):748-758. doi: 10.1038/s41564-019-0380-2. Epub 2019 Feb 25. Erratum in: Nat Microbiol. 2019 Apr 11;:.


Deriving the optimal limit of detection for an HCV point-of-care test for viraemic infection: Analysis of a global dataset.

Freiman JM, Wang J, Easterbrook PJ, Horsburgh CR, Marinucci F, White LF, Kamkamidze G, Krajden M, Loarec A, Njouom R, Nguyen KV, Shiha G, Soliman R, Solomon SS, Tsertsvadze T, Denkinger CM, Linas B.

J Hepatol. 2019 Jul;71(1):62-70. doi: 10.1016/j.jhep.2019.02.011. Epub 2019 Feb 21.


The impact of Xpert MTB/RIF-do we have a final answer?

Schumacher SG, Denkinger CM.

Lancet Glob Health. 2019 Feb;7(2):e161-e162. doi: 10.1016/S2214-109X(18)30493-5. No abstract available.


Toward the Development of a Circulating Free DNA-Based In Vitro Diagnostic Test for Infectious Diseases: a Review of Evidence for Tuberculosis.

Fernández-Carballo BL, Broger T, Wyss R, Banaei N, Denkinger CM.

J Clin Microbiol. 2019 Mar 28;57(4). pii: e01234-18. doi: 10.1128/JCM.01234-18. Print 2019 Apr. Review.


Can we predict tuberculosis cure? What tools are available?

Goletti D, Lindestam Arlehamn CS, Scriba TJ, Anthony R, Cirillo DM, Alonzi T, Denkinger CM, Cobelens F.

Eur Respir J. 2018 Nov 8;52(5). pii: 1801089. doi: 10.1183/13993003.01089-2018. Print 2018 Nov. Review.


A Novel Sensitive Immunoassay Targeting the 5-Methylthio-d-Xylofuranose-Lipoarabinomannan Epitope Meets the WHO's Performance Target for Tuberculosis Diagnosis.

Sigal GB, Pinter A, Lowary TL, Kawasaki M, Li A, Mathew A, Tsionsky M, Zheng RB, Plisova T, Shen K, Katsuragi K, Choudhary A, Honnen WJ, Nahid P, Denkinger CM, Broger T.

J Clin Microbiol. 2018 Nov 27;56(12). pii: e01338-18. doi: 10.1128/JCM.01338-18. Print 2018 Dec.


Upfront Xpert MTB/RIF testing on various specimen types for presumptive infant TB cases for early and appropriate treatment initiation.

Raizada N, Khaparde SD, Rao R, Kalra A, Sarin S, Salhotra VS, Swaminathan S, Khanna A, Chopra KK, Hanif M, Singh V, Umadevi KR, Nair SA, Huddart S, Tripathi R, Surya Prakash CH, Saha BK, Denkinger CM, Boehme C.

PLoS One. 2018 Aug 30;13(8):e0202085. doi: 10.1371/journal.pone.0202085. eCollection 2018.


Xpert® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance.

Kohli M, Schiller I, Dendukuri N, Dheda K, Denkinger CM, Schumacher SG, Steingart KR.

Cochrane Database Syst Rev. 2018 Aug 27;8:CD012768. doi: 10.1002/14651858.CD012768.pub2. Review.


An evaluation framework for new tests that predict progression from tuberculosis infection to clinical disease.

Kik SV, Schumacher S, Cirillo DM, Churchyard G, Boehme C, Goletti D, Rangaka MX, Denkinger CM, Lienhardt C, Gilpin C, Matteelli A, Cobelens F.

Eur Respir J. 2018 Oct 25;52(4). pii: 1800946. doi: 10.1183/13993003.00946-2018. Print 2018 Oct.


Diagnostic Test for Incipient Tuberculosis: A Step Forward, Many More to Go.

Schumacher SG, Denkinger CM.

Am J Respir Crit Care Med. 2018 May 1;197(9):1106-1107. doi: 10.1164/rccm.201803-0469ED. No abstract available.


"Before Xpert I only had my expertise": A qualitative study on the utilization and effects of Xpert technology among pediatricians in 4 Indian cities.

McDowell A, Raizada N, Khaparde SD, Rao R, Sarin S, Kalra A, Salhotra VS, Nair SA, Boehme C, Denkinger CM.

PLoS One. 2018 Mar 16;13(3):e0193656. doi: 10.1371/journal.pone.0193656. eCollection 2018.


Accelerating access to quality TB care for pediatric TB cases through better diagnostic strategy in four major cities of India.

Raizada N, Khaparde SD, Salhotra VS, Rao R, Kalra A, Swaminathan S, Khanna A, Chopra KK, Hanif M, Singh V, Umadevi KR, Nair SA, Huddart S, Prakash CHS, Mall S, Singh P, Saha BK, Denkinger CM, Boehme C, Sarin S.

PLoS One. 2018 Feb 28;13(2):e0193194. doi: 10.1371/journal.pone.0193194. eCollection 2018.


Accuracy of Xpert Mtb/Rif Ultra for the Diagnosis of Pulmonary Tuberculosis in Children.

Nicol MP, Workman L, Prins M, Bateman L, Ghebrekristos Y, Mbhele S, Denkinger CM, Zar HJ.

Pediatr Infect Dis J. 2018 Oct;37(10):e261-e263. doi: 10.1097/INF.0000000000001960.


A standardised method for interpreting the association between mutations and phenotypic drug resistance in Mycobacterium tuberculosis.

Miotto P, Tessema B, Tagliani E, Chindelevitch L, Starks AM, Emerson C, Hanna D, Kim PS, Liwski R, Zignol M, Gilpin C, Niemann S, Denkinger CM, Fleming J, Warren RM, Crook D, Posey J, Gagneux S, Hoffner S, Rodrigues C, Comas I, Engelthaler DM, Murray M, Alland D, Rigouts L, Lange C, Dheda K, Hasan R, Ranganathan UDK, McNerney R, Ezewudo M, Cirillo DM, Schito M, Köser CU, Rodwell TC.

Eur Respir J. 2017 Dec 28;50(6). pii: 1701354. doi: 10.1183/13993003.01354-2017. Print 2017 Dec.


Estimated clinical impact of the Xpert MTB/RIF Ultra cartridge for diagnosis of pulmonary tuberculosis: A modeling study.

Kendall EA, Schumacher SG, Denkinger CM, Dowdy DW.

PLoS Med. 2017 Dec 14;14(12):e1002472. doi: 10.1371/journal.pmed.1002472. eCollection 2017 Dec.


Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study.

Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, Hall SL, Chakravorty S, Cirillo DM, Tukvadze N, Bablishvili N, Stevens W, Scott L, Rodrigues C, Kazi MI, Joloba M, Nakiyingi L, Nicol MP, Ghebrekristos Y, Anyango I, Murithi W, Dietze R, Lyrio Peres R, Skrahina A, Auchynka V, Chopra KK, Hanif M, Liu X, Yuan X, Boehme CC, Ellner JJ, Denkinger CM; study team.

Lancet Infect Dis. 2018 Jan;18(1):76-84. doi: 10.1016/S1473-3099(17)30691-6. Epub 2017 Nov 30. Erratum in: Lancet Infect Dis. 2018 Feb 21;:.


Diagnostic accuracy of serological diagnosis of hepatitis C and B using dried blood spot samples (DBS): two systematic reviews and meta-analyses.

Lange B, Cohn J, Roberts T, Camp J, Chauffour J, Gummadi N, Ishizaki A, Nagarathnam A, Tuaillon E, van de Perre P, Pichler C, Easterbrook P, Denkinger CM.

BMC Infect Dis. 2017 Nov 1;17(Suppl 1):700. doi: 10.1186/s12879-017-2777-y. Review.


Diagnostic accuracy of detection and quantification of HBV-DNA and HCV-RNA using dried blood spot (DBS) samples - a systematic review and meta-analysis.

Lange B, Roberts T, Cohn J, Greenman J, Camp J, Ishizaki A, Messac L, Tuaillon E, van de Perre P, Pichler C, Denkinger CM, Easterbrook P.

BMC Infect Dis. 2017 Nov 1;17(Suppl 1):693. doi: 10.1186/s12879-017-2776-z. Review.


Detection of Mycobacterium tuberculosis pncA Mutations by the Nipro Genoscholar PZA-TB II Assay Compared to Conventional Sequencing.

Willby MJ, Wijkander M, Havumaki J, Johnson K, Werngren J, Hoffner S, Denkinger CM, Posey JE.

Antimicrob Agents Chemother. 2017 Dec 21;62(1). pii: e01871-17. doi: 10.1128/AAC.01871-17. Print 2018 Jan.


Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous meningitis in HIV-infected adults: a prospective cohort study.

Bahr NC, Nuwagira E, Evans EE, Cresswell FV, Bystrom PV, Byamukama A, Bridge SC, Bangdiwala AS, Meya DB, Denkinger CM, Muzoora C, Boulware DR; ASTRO-CM Trial Team.

Lancet Infect Dis. 2018 Jan;18(1):68-75. doi: 10.1016/S1473-3099(17)30474-7. Epub 2017 Sep 14.


Implementation of Xpert MTB/RIF in 22 high tuberculosis burden countries: are we making progress?

Cazabon D, Suresh A, Oghor C, Qin ZZ, Kik SV, Denkinger CM, Pai M.

Eur Respir J. 2017 Aug 31;50(2). pii: 1700918. doi: 10.1183/13993003.00918-2017. Print 2017 Aug. No abstract available.


The New Xpert MTB/RIF Ultra: Improving Detection of Mycobacterium tuberculosis and Resistance to Rifampin in an Assay Suitable for Point-of-Care Testing.

Chakravorty S, Simmons AM, Rowneki M, Parmar H, Cao Y, Ryan J, Banada PP, Deshpande S, Shenai S, Gall A, Glass J, Krieswirth B, Schumacher SG, Nabeta P, Tukvadze N, Rodrigues C, Skrahina A, Tagliani E, Cirillo DM, Davidow A, Denkinger CM, Persing D, Kwiatkowski R, Jones M, Alland D.

MBio. 2017 Aug 29;8(4). pii: e00812-17. doi: 10.1128/mBio.00812-17.


Computer-aided reading of tuberculosis chest radiography: moving the research agenda forward to inform policy.

Ahmad Khan F, Pande T, Tessema B, Song R, Benedetti A, Pai M, Lönnroth K, Denkinger CM.

Eur Respir J. 2017 Jul 13;50(1). pii: 1700953. doi: 10.1183/13993003.00953-2017. Print 2017 Jul. No abstract available.


Long-lasting tuberculous pleurisy.

Petruccioli E, Scriba TJ, Petrone L, Hatherill M, Cirillo DM, Joosten SA, Codecasa LR, Ottenhoff TH, Denkinger CM, Goletti D.

Eur Respir J. 2017 May 25;49(5). pii: 1700356. doi: 10.1183/13993003.00356-2017. Print 2017 May. No abstract available.


Diagnostic accuracy of the Xpert® MTB/RIF cycle threshold level to predict smear positivity: a meta-analysis.

Lange B, Khan P, Kalmambetova G, Al-Darraji HA, Alland D, Antonenka U, Brown T, Balcells ME, Blakemore R, Denkinger CM, Dheda K, Hoffmann H, Kadyrov A, Lemaitre N, Miller MB, Nikolayevskyy V, Ntinginya EN, Ozkutuk N, Palacios JJ, Popowitch EB, Porcel JM, Teo J, Theron G, Kranzer K.

Int J Tuberc Lung Dis. 2017 May 1;21(5):493-502. doi: 10.5588/ijtld.16.0702. Review.


Diagnostic Performance of Tuberculosis-Specific IgG Antibody Profiles in Patients with Presumptive Tuberculosis from Two Continents.

Broger T, Basu Roy R, Filomena A, Greef CH, Rimmele S, Havumaki J, Danks D, Schneiderhan-Marra N, Gray CM, Singh M, Rosenkrands I, Andersen P, Husar GM, Joos TO, Gennaro ML, Lochhead MJ, Denkinger CM, Perkins MD.

Clin Infect Dis. 2017 Apr 1;64(7):947-955. doi: 10.1093/cid/cix023.


Comparative accuracy of the REBA MTB MDR and Hain MTBDRplus line probe assays for the detection of multidrug-resistant tuberculosis: A multicenter, non-inferiority study.

Havumaki J, Hillemann D, Ismail N, Omar SV, Georghiou SB, Schumacher SG, Boehme C, Denkinger CM.

PLoS One. 2017 Mar 24;12(3):e0173804. doi: 10.1371/journal.pone.0173804. eCollection 2017.


Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis.

Nabeta P, Havumaki J, Ha DT, Caceres T, Hang PT, Collantes J, Thi Ngoc Lan N, Gotuzzo E, Denkinger CM.

PLoS One. 2017 Mar 2;12(3):e0173092. doi: 10.1371/journal.pone.0173092. eCollection 2017.


Clinical Application of Interferon-γ Release Assays for the Prevention of Tuberculosis in Countries with Low Incidence.

Lange C, Mandalakas AM, Kalsdorf B, Denkinger CM, Sester M.

Pathog Immun. 2016;1(2):308-329. doi: 10.20411/pai.v1i2.173. Epub 2016 Jan 4.


A tuberculosis biomarker database: the key to novel TB diagnostics.

Yerlikaya S, Broger T, MacLean E, Pai M, Denkinger CM.

Int J Infect Dis. 2017 Mar;56:253-257. doi: 10.1016/j.ijid.2017.01.025. Epub 2017 Jan 31. Review.


FIND Tuberculosis Strain Bank: a Resource for Researchers and Developers Working on Tests To Detect Mycobacterium tuberculosis and Related Drug Resistance.

Tessema B, Nabeta P, Valli E, Albertini A, Collantes J, Lan NH, Romancenco E, Tukavdze N, Denkinger CM, Dolinger DL.

J Clin Microbiol. 2017 Apr;55(4):1066-1073. doi: 10.1128/JCM.01662-16. Epub 2017 Jan 18.


Accuracy of line probe assays for the diagnosis of pulmonary and multidrug-resistant tuberculosis: a systematic review and meta-analysis.

Nathavitharana RR, Cudahy PG, Schumacher SG, Steingart KR, Pai M, Denkinger CM.

Eur Respir J. 2017 Jan 18;49(1). pii: 1601075. doi: 10.1183/13993003.01075-2016. Print 2017 Jan. Review.


Correlates of tuberculosis risk: predictive biomarkers for progression to active tuberculosis.

Petruccioli E, Scriba TJ, Petrone L, Hatherill M, Cirillo DM, Joosten SA, Ottenhoff TH, Denkinger CM, Goletti D.

Eur Respir J. 2016 Dec;48(6):1751-1763. doi: 10.1183/13993003.01012-2016. Epub 2016 Nov 11. Review.

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