Recently, CDC and APHL convened a taskforce to develop recommendations for new diagnostic testing guidelines for the identification of Chlamydia trachomatis, Neisseria gonorrhea and Treponema palladium. In their recommendations the taskforce suggests the use of several tests in ways that are not currently cleared or approved by FDA.
Although it is clearly preferable that only FDA cleared or approved tests be used in diagnostic laboratory testing, there are instances where FDA cleared or approved tests do not exist, yet there is a critical public health need for a particular type of testing. In response to this need, the APHL/ CDC STD Steering Committee has developed a checklist that laboratories may use as a guide to navigate the process of verifying and documenting the performance characteristics of tests that are not FDA-cleared or approved, or for verifying and documenting off-label testing (using an FDA cleared or approved test in a manner not covered in the product insert).
The checklist is intended to be used as a general guideline for the verification of all tests that are not FDA-cleared or approved, however, some of the information may be more specifically geared to molecular testing for infectious disease agents. Also included below are several specific examples of how these checklists may be used to design verification study protocols specifically for the verification of NAAT on rectal and/ or pharyngeal specimens.
This checklist has been reviewed by laboratory professionals at the Centers for Medicare and Medicaid (CMS). However, users should note that the local CLIA inspector approves the final verification of performance characteristics. It may be beneficial to clear your verification study design with your local CLIA inspector prior to the initiation of verification testing. To veiw the checklists and example protocols, please click on the links below.
General Checklist for the Establishment of Performance Specifications of Off-Label Tests
Example Verification Protocol: Use of NAAT to Identify Chlamydia and Gonorrhea in Rectal Specimens
Example Verification Protocol: Use of NAAT to Identify Chlamydia and Gonorrhea in Pharyngeal Specimens