Nucleic acid amplification tests for tuberculosis.

Traditional methods for laboratory diagnosis of tuberculosis (TB) may require weeks, and delay can impede treatment and control efforts. Nucleic acid amplification (NAA) tests, such as polymerase chain reaction (PCR) and other methods for amplifying DNA and RNA, may facilitate rapid detection of microorganisms. An NAA test for Mycobacterium tuberculosis complex (Amplified Mycobacterium Tuberculosis Direct Test of MTD [Gen-Probe, San Diego, California]) was recently approved by the Food and Drug Administration (FDA) for use on processed clinical specimens, and others are under development. Although NAA tests have been offered by individual laboratories, approval of commercial kits may result in increased use for clinical practice and TB control. This report summarizes potential uses of NAA tests for TB diagnosis and provides interim guidelines for the use of such tests.