Availability of an assay for detecting Mycobacterium tuberculosis, including rifampin-resistant strains, and considerations for its use - United States, 2013
Published Date:October 18, 2013
Corporate Authors:National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (U.S.). Division of Tuberculosis Elimination.
Keywords:Drug Resistance, Bacterial/genetics
Mycobacterium Tuberculosis/drug Effects
Mycobacterium Tuberculosis/isolation & Purification
Nucleic Acid Amplification Techniques
Practice Guidelines As Topic
Tuberculosis, Pulmonary/drug Therapy
Tuberculosis, Pulmonary/prevention & Control
Series:MMWR. Morbidity and mortality weekly report ; v. 62, no. no. 41, p. 821-7
Description:In August 2013, the Food and Drug Administration (FDA) permitted marketing of the Xpert MTB/RIF assay (Cepheid, Sunnyvale, California) to detect DNA of the Mycobacterium tuberculosis complex (MTBC) and genetic mutations associated with resistance to rifampin (RMP) in unprocessed sputum and concentrated sputum sediments (1). Along with clinical, radiographic, and other laboratory findings, results of the assay aid in the diagnosis of pulmonary tuberculosis (TB). The assay is a nucleic acid amplification-based (NAA)* test using a disposable cartridge in conjunction with the GeneXpert Instrument System. Sensitivity and specificity of the Xpert MTB/RIF assay for detection of MTBC appear to be comparable with other FDA-approved NAA assays for this use, although direct comparison studies have not been performed. Sensitivity of detection of RMP resistance was 95% and specificity 99% in a multicenter study using archived and prospective specimens from subjects aged ≥18 years suspected of having TB who had 0–3 days of antituberculous treatment. CDC continues to recommend following published U.S. guidelines for TB diagnosis and infection control practice, including the use and interpretation of NAA test results.
Supporting Files:No Additional Files
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