ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020
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.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 2 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- Xpert MTB/XDR for detection of pulmonary tuberculosis and resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin.The Cochrane database of systematic reviews · 2022Pooled it
- Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis.The Cochrane database of systematic reviews · 2021Pooled it
- Increased sensitivity of the updated FluoroType MTBDR V2 with addition of ISJournal of clinical microbiology · 2026Article
- A cartridge-based assay for improved detection of multidrug-resistantJournal of clinical microbiology · 2026Article
- Rates and risk factors of monoresistance against isoniazid and multidrug-resistant tuberculosis in Almaty, Kazakhstan.BMC infectious diseases · 2026Article
- Diagnostic performance of the FluoroType MTBDR assay for rifampicin and isoniazid resistance in routine laboratory setting.African journal of primary health care & family medicine · 2026Article
- Diagnostic accuracy of the BD MAX MDR-TB assay on sputum and tongue swabs forMicrobiology spectrum · 2026Article
- Undetected rifampicin-resistant tuberculosis associated with rpoB I491F and V170F mutations in Botswana: Diagnostic implications.Journal of global antimicrobial resistance · 2026Article
- Evaluation of the Novel RITA MTBC Assay for Tuberculosis Detection: A Pilot Comparison with GeneXpert and BD MAX™.Pathogens (Basel, Switzerland) · 2025Article
- Off-label evaluation of the BD MAX MDR-TB assay for rapid diagnosis of rifampicin and isoniazid resistance ofJournal of clinical microbiology · 2025Article
- Tuberculosis Today: Microbial Insights, Epidemiological Trends, and the Role of Molecular Diagnostics.Pathogens (Basel, Switzerland) · 2025Review
- Comparative Analysis of 2 Diagnostic Devices for Detection ofOpen forum infectious diseases · 2025Article
- The Usefulness of the BD MAX MDR-TB Molecular Test in the Rapid Diagnosis of Multidrug-Resistant Tuberculosis.Pathogens (Basel, Switzerland) · 2025Article
- Evaluation of the cobas MTB and MTB-RIF/INH assay in clinical samples for the detection ofJournal of clinical microbiology · 2025Article
- Utility of Rapid Molecular Assays for Detecting Multidrug-ResistantDiagnostics (Basel, Switzerland) · 2025Article
- Development of a Multiplex Real-Time PCR for Diagnosis of Tuberculosis and Multidrug Resistance.Current microbiology · 2025Article
- Prevalence and molecular characterization of drug-resistantFrontiers in cellular and infection microbiology · 2025Article
- A duplex one-step recombinase aided PCR assay for the rapid and sensitive detection of the isoniazid resistance genes katG and inhA inFrontiers in microbiology · 2025Article
- Diagnostic Accuracy of BD MAX MDR-TB Assay Performed on Bronchoscopy Specimens in Patients with Suspected Pulmonary Tuberculosis.Tuberculosis and respiratory diseases · 2025Article
- Near-infrared imaging for visualizing the synergistic relationship between autophagy and NFS1 protein during multidrug resistance using an ICT-TICT integrated platform.Chemical science · 2024Article
Corrections and comments
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Authors and funding
19 authors at 10 institutions in 6 countries.
Funding
Abstract
backgroundTuberculosis (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.
methodsOutpatient 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).
results1053 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.
conclusionsThe 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.
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