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Diagnosis of Tuberculosis by Nucleic Acid Amplification Methods Applied to Clinical Specimens

CDC and the Food and Drug Administration (FDA) have received inquiries from health-care providers about rapid assays for detecting Mycobacterium tuberculosis in clinical specimens. These assays, currently being offered by several commercial diagnostic laboratories, are based on DNA or RNA amplification procedures, such as the polymerase chain reaction. The false-positive rate, false-negative rate, reproducibility, and predictive value of these tests are not fully understood. In addition, none of the tests have been reviewed or approved by FDA, and their usefulness in patient management and public health practices has not been established. For the diagnostic evaluation of persons suspected of having tuberculosis, the Public Health Service advises clinicians to continue to rely on established techniques: medical history, physical examination, chest roentgenogram, tuberculin skin test, acid-fast stains of clinical specimens, standard or radiometric procedures for cultures and antimicrobial susceptibility testing, and nucleic acid probes for species identification of M. tuberculosis isolates.

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