Skip Navigation LinksSkip Navigation Links
Centers for Disease Control and Prevention
Safer Healthier People
Blue White
Blue White
bottom curve
CDC Home Search Health Topics A-Z spacer spacer
Blue curve MMWR spacer

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.

Disclaimer   All MMWR HTML versions of articles are electronic conversions from ASCII text into HTML. This conversion may have resulted in character translation or format errors in the HTML version. Users should not rely on this HTML document, but are referred to the electronic PDF version and/or the original MMWR paper copy for the official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.

**Questions or messages regarding errors in formatting should be addressed to

Page converted: 09/19/98


Safer, Healthier People

Morbidity and Mortality Weekly Report
Centers for Disease Control and Prevention
1600 Clifton Rd, MailStop E-90, Atlanta, GA 30333, U.S.A


Department of Health
and Human Services

This page last reviewed 5/2/01