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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