Multicenter Study of the Accuracy of the BD MAX Multidrug-resistant Tuberculosis Assay for Detection of Mycobacterium tuberculosis Complex and Mutations Associated With Resistance to Rifampin and Isoniazid.
HIV
Mycobacterium infections
diagnosis
multidrug
resistance
tuberculosis
Journal
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213
Informations de publication
Date de publication:
22 08 2020
22 08 2020
Historique:
received:
27
06
2019
accepted:
08
10
2019
pubmed:
29
9
2019
medline:
28
4
2021
entrez:
28
9
2019
Statut:
ppublish
Résumé
Tuberculosis (TB) control is hindered by absence of rapid tests to identify Mycobacterium tuberculosis (MTB) and detect isoniazid (INH) and rifampin (RIF) resistance. We evaluated the accuracy of the BD MAX multidrug-resistant (MDR)-TB assay (BD MAX) in South Africa, Uganda, India, and Peru. Outpatient adults with signs/symptoms of pulmonary TB were prospectively enrolled. Sputum smear microscopy and BD MAX were performed on a single raw sputum, which was then processed for culture and phenotypic drug susceptibility testing (DST), BD MAX, and Xpert MTB/RIF (Xpert). 1053 participants with presumptive TB were enrolled (47% female; 32% with human immunodeficiency virus). In patients with confirmed TB, BD MAX sensitivity was 93% (262/282 [95% CI, 89-95%]); specificity was 97% (593/610 [96-98%]) among participants with negative cultures on raw sputa. BD MAX sensitivity was 100% (175/175 [98-100%]) for smear-positive samples (fluorescence microscopy), and 81% (87/107 [73-88%]) in smear-negative samples. Among participants with both BD MAX and Xpert, sensitivity was 91% (249/274 [87-94%]) for BD MAX and 90% (246/274 [86-93%]) for Xpert on processed sputa. Sensitivity and specificity for RIF resistance compared with phenotypic DST were 90% (9/10 [60-98%]) and 95% (211/222 [91-97%]), respectively. Sensitivity and specificity for detection of INH resistance were 82% (22/27 [63-92%]) and 100% (205/205 [98-100%]), respectively. The BD MAX MDR-TB assay had high sensitivity and specificity for detection of MTB and RIF and INH drug resistance and may be an important tool for rapid detection of TB and MDR-TB globally.
Sections du résumé
BACKGROUND
Tuberculosis (TB) control is hindered by absence of rapid tests to identify Mycobacterium tuberculosis (MTB) and detect isoniazid (INH) and rifampin (RIF) resistance. We evaluated the accuracy of the BD MAX multidrug-resistant (MDR)-TB assay (BD MAX) in South Africa, Uganda, India, and Peru.
METHODS
Outpatient adults with signs/symptoms of pulmonary TB were prospectively enrolled. Sputum smear microscopy and BD MAX were performed on a single raw sputum, which was then processed for culture and phenotypic drug susceptibility testing (DST), BD MAX, and Xpert MTB/RIF (Xpert).
RESULTS
1053 participants with presumptive TB were enrolled (47% female; 32% with human immunodeficiency virus). In patients with confirmed TB, BD MAX sensitivity was 93% (262/282 [95% CI, 89-95%]); specificity was 97% (593/610 [96-98%]) among participants with negative cultures on raw sputa. BD MAX sensitivity was 100% (175/175 [98-100%]) for smear-positive samples (fluorescence microscopy), and 81% (87/107 [73-88%]) in smear-negative samples. Among participants with both BD MAX and Xpert, sensitivity was 91% (249/274 [87-94%]) for BD MAX and 90% (246/274 [86-93%]) for Xpert on processed sputa. Sensitivity and specificity for RIF resistance compared with phenotypic DST were 90% (9/10 [60-98%]) and 95% (211/222 [91-97%]), respectively. Sensitivity and specificity for detection of INH resistance were 82% (22/27 [63-92%]) and 100% (205/205 [98-100%]), respectively.
CONCLUSIONS
The BD MAX MDR-TB assay had high sensitivity and specificity for detection of MTB and RIF and INH drug resistance and may be an important tool for rapid detection of TB and MDR-TB globally.
Identifiants
pubmed: 31560049
pii: 5574845
doi: 10.1093/cid/ciz932
pmc: PMC7442848
doi:
Substances chimiques
Isoniazid
V83O1VOZ8L
Rifampin
VJT6J7R4TR
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1161-1167Subventions
Organisme : FIC NIH HHS
ID : D43 TW009771
Pays : United States
Informations de copyright
© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.
Références
Expert Rev Respir Med. 2008 Oct;2(5):583-8
pubmed: 20477293
Lancet Infect Dis. 2017 Feb;17(2):223-234
pubmed: 27865891
J Infect Dis. 2015 Apr 1;211 Suppl 2:S21-8
pubmed: 25765103
J Clin Microbiol. 2011 Mar;49(3):802-7
pubmed: 21191055
Health Technol Assess. 2015 May;19(34):1-188, vii-viii
pubmed: 25952553
J Clin Microbiol. 2010 Jan;48(1):229-37
pubmed: 19864480
Int J Tuberc Lung Dis. 2017 Feb 1;21(2):129-139
pubmed: 28234075
Int J Tuberc Lung Dis. 2011 Jul;15(7):990-2
pubmed: 21682979
Cochrane Database Syst Rev. 2014 Jan 21;(1):CD009593
pubmed: 24448973
Int J Tuberc Lung Dis. 2017 Jun 1;21(6):670-676
pubmed: 28482962
N Engl J Med. 2010 Sep 9;363(11):1005-15
pubmed: 20825313
J Antimicrob Chemother. 2013 Dec;68(12):2915-20
pubmed: 23838950
PLoS One. 2019 Jan 24;14(1):e0211355
pubmed: 30677101
J Clin Microbiol. 2012 Jan;50(1):81-5
pubmed: 22075601
Open Forum Infect Dis. 2016 Aug 24;3(3):ofw150
pubmed: 27704008
Int J Tuberc Lung Dis. 2012 Feb;16(2):216-20
pubmed: 22137551
J Clin Microbiol. 2013 Aug;51(8):2633-40
pubmed: 23761144
Int J Tuberc Lung Dis. 2003 Dec;7(12):1163-71
pubmed: 14677891
J Clin Microbiol. 2007 Aug;45(8):2635-40
pubmed: 17537937