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Multicenter Study
. 2020 Aug 22;71(5):1161-1167.
doi: 10.1093/cid/ciz932.

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

Maunank Shah  1 , Sonia Paradis  2 , Joshua Betz  1   3 , Natalie Beylis  4   5 , Renu Bharadwaj  6 , Tatiana Caceres  7 , Eduardo Gotuzzo  7 , Moses Joloba  8 , Vidya Mave  1   6 , Lydia Nakiyingi  8 , Mark P Nicol  4   9 , Neeta Pradhan  6 , Bonnie King  1 , Derek Armstrong  1 , Deborah Knecht  2 , Courtney E Maus  2 , Charles K Cooper  2 , Susan E Dorman  10 , Yukari C Manabe  1   8
Affiliations
Multicenter Study

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

Maunank Shah et al. Clin Infect Dis. .

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.

Keywords: HIV; Mycobacterium infections; diagnosis; multidrug; resistance; tuberculosis.

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Figures

Figure 1.
Figure 1.
Study population and study flow diagram. Abbreviations: INC, incomplete; IND, indeterminate; INV/EC, invalid/external control; MAX, BD MAX assay; MGIT, BACTEC MGIT 960 system; MTB, Mycobacterium tuberculosis; MTBc, M. tuberculosis complex; NEG, negative; POS, positive; TB, tuberculosis; TBcID, BD MGIT TBc Identification Test; UNR, unresolved.
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