Resources for Providers and Laboratories pertaining to Extragenital STD Testing.
NCSD is collaborating with the National Network of STD Clinical Prevention Training Centers (NNPTC) and the Association of Public Health Laboratories (APHL) to produce resources for clinics and laboratories to ensure that extragenital testing is available across the country. We are also proud of the ongoing work of the Gay Men’s Health Equity Workgroup, a partnership between NASTAD and NCSD, to develop additional tools for Health Departments around extragenital screening best practices.
Extragenital testing for gonorrhea and chlamydia in men who have sex with men (MSM) is a high priority issue for curbing STD rates in the US. It is important for health departments, medical providers, and laboratories to understand the scope of these issues.
The CDC recommends the following screening for MSM, regardless of condom use, using Nucleic Acid Amplification Tests (NAATs) as the preferred test:
Many clinical settings do not yet have capacity to do extragenital tests. For assistance with building clinical capacity to conduct extragenital tests, please contact the STD Clinical Consultation Network. You can submit a request for assistance from the NNPTC to increase your capacity for extragenital testing in your clinical setting.
To support providers in ensuring the maximum billing potential, the STD Technical Assistance Center developed an excellent coding guide for the use of NAATs with extragenital specimens.
As an additional resource, NCSD and NNPTC developed summary treatment guidelines that can be printed as a poster and put in medical offices for quick reference.
NAAT is the recommended test method for both Chlamydia trachomatis and Neisseria gonorrhoeae in men and women. 6 The optimal specimen type to detect chlamydia or gonorrhea infection in men is a first-catch urine which is equivalent to a urethral swab. NAAT is also the recommended test method for rectal and oropharyngeal specimens. While there are several FDA-cleared NAATs for use on urine and urethral swabs, rectal and oropharyngeal samples are not approved specimen types for these tests. Therefore, in order to test these specimen types, laboratories must perform a validation study to modify the test that is compliant with their regulations.
Many laboratories, including large commercial labs* such as LabCorp, Quest Diagnostics and the Center for Disease Detection, as well as many state and local public health laboratories have gone through the process to validate their FDA-cleared NAAT for use on rectal and/or oropharyngeal specimens.7 Those laboratories still interested in bringing on testing or those asked to start testing rectal and oropharyngeal samples using NAAT can do the following:
*Mention of specific commercial laboratories is for information only and does not imply endorsement.
May 23, 2019 – The FDA cleared tests from Hologic and Cepheid to diagnose chlamydia and gonorrhea in the throat and rectum