Table 1. Comparison of Commericial Gonorrhea Tests*

*The majority of commercial NAATs [Nucleic Acid Amplification Tests] have been cleared** by the Food and Drug Administration (FDA) to detect C. trachomatis and N. gonorrhoeae in endocervical swabs from women, urethral swabs from men, and urine from both men and women. In addition, other specimens (e.g., those from the vagina and eye) have been used with satisfactory performance, although these applications have not been cleared by FDA. Testing of rectal and oropharyngeal specimens with NAATs has had limited evaluation and is not recommended.²⁰

**The term cleared is used by the Food and Drug Administration (FDA) to describe the process they use to review applications to market the class of diagnostic tests that includes C. trachomatis and N. gonorrhoeae tests discussed in these guidelines. The term approved is used by FDA to describe a more rigorous process they use to review applications to market classes of diagnostic tests that involve, for example, higher levels of risk if the test result is erroneous than is the case for C. trachomatis or N. gonorrhoeae.²⁰

Note: NA = Not Available.

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