Title
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
Date Issued
01 September 2020
Access level
open access
Resource Type
journal article
Author(s)
Shah M.
Paradis S.
Betz J.
Beylis N.
Bharadwaj R.
Joloba M.
Mave V.
Nakiyingi L.
Nicol M.P.
Pradhan N.
King B.
Armstrong D.
Knecht D.
Maus C.E.
Cooper C.K.
Dorman S.E.
Manabe Y.C.
Publisher(s)
Oxford University Press
Abstract
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.
Start page
1161
End page
1167
Volume
71
Issue
5
Language
English
OCDE Knowledge area
Sistema respiratorio
Enfermedades infecciosas
Subjects
Scopus EID
2-s2.0-85089811965
PubMed ID
Source
Clinical Infectious Diseases
ISSN of the container
10584838
Sponsor(s)
The authors thank Salma Kodsi from Becton, Dickinson and Company, Becton, Dickinson and Company (BD) Life Sciences-Diagnostic Systems, for her insights. The authors also thank Valentin Parvu, Indrias Berhane, Qing Liang, and Christina Chiao of Becton, Dickinson and Company, BD Life Sciences-Diagnostic Systems, for statistical support. The individuals acknowledged here have no additional funding or additional compensation to disclose. This work was supported by Becton, Dickinson and Company.
Sources of information:
Directorio de Producción Científica
Scopus