Conclusion and References
Technological evolution in clinical laboratory diagnostics has advanced considerably by allowing for the direct molecular detection of a pathogen in a clinical specimen rather than relying on isolation and cultivation. This approach has decreased the time required to identify a pathogen because the laboratory is no longer limited by the growth kinetics of the organism. Therefore, patients can be evaluated and if infected can be treated promptly, thereby diminishing progression to disease and disrupting transmission. As with all changes in laboratory technology, a synthesis of scientific evidence is required for an informed decision regarding the implementation of a new or improved test platform. Previous CDC recommendations to use NAATs for the detection of chlamydia and gonorrhea as the standard laboratory test remain. These updated CDC recommendations now specify that vaginal swabs are the preferred specimen for screening women and include the use of rectal and oropharyngeal specimens among populations at risk for extragenital tract infections. FDA clearance is important for widespread use of a test, and it is important that clearance be obtained for NAAT use with rectal and oropharyngeal specimens, and with vaginal swabs collected in other than clinic settings.
Future revisions to these recommendations will be influenced by the development and marketing of new laboratory tests, or indications of existing tests, for chlamydia and gonorrhea.Improvements in molecular tests that continue to decrease detection time and decrease the test complexity might facilitate the use of NAATs in non-traditional laboratory settings such as physician offices, health fairs, school clinics, or other outreach venues. Shifting chlamydia and gonorrhea diagnostics from laboratories might require new recommendations on test application or reporting positive cases of reportable diseases. Periodic updates to these recommendations will be available on the CDC Division of STD Prevention website (http://www.cdc.gov/std).
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