Availability of an assay for detecting Mycobacterium tuberculosis, including rifampin-resistant strains, and considerations for its use - United States, 2013

Abstract

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. 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. Providers and laboratories need to ensure that specimens are available for other recommended mycobacteriological testing. The Xpert MTB/RIF assay aids in the prompt diagnosis of TB and RMP-resistant disease. RMP resistance most often coexists with isoniazid (INH) resistance; TB that is resistant to both drugs is multidrug-resistant (MDR)† TB. Because the prevalence of RMP resistance is low in the United States (about 1.8% of TB cases), a positive result indicating a mutation in the rpoB gene of MTBC should be confirmed by rapid DNA sequencing for prompt reassessment of the treatment regimen and followed by growth-based drug susceptibility testing (DST). CDC offers these services free of charge.§