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One Size Does Not Fit All: The Public Health Ramifications of Proposed Food and Drug Administration Premarket Review for Extragenital Gonorrhea and Chlamydia Testing.

In October 2014, the US Food and Drug Administration (FDA) announced a proposed new framework to extend their regulatory oversight of laboratory-developed tests (LDTs). An LDT is defined by the FDA as a diagnostic in vitro test developed by a clinical laboratory for use only in that laboratory. However, when a laboratory wishes to take a commercially manufactured device that has been FDA approved for a given diagnostic testing indication but use the device for a different indication (so-called off-label use), they must perform validation studies to demonstrate that the device performs accurately for this use.Manufacturers will pay for performing validation studies when they wish to market the test for a new use indication. However, if a manufacturer does not act and a laboratory performs the validation studies, the FDA considers the device an LDT for this off-label use. When several laboratories individually perform validations and publish their data in peer-reviewed journals, and if such data are in agreement with one another, then this new use can become standard of care. The FDA's appropriate concern is to ensure the quality and performance accuracy of LDTs so their use consistently guides correct clinical management. Nucleic acid amplification tests (NAATs) are FDA approved for detection of both Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) in urogenital sites. Although cultures were originally used to test for these organisms at extragenital sites (i.e., pharynx and rectum), poor culture sensitivity led various laboratories to adopt NAAT assays for such testing. Numerous public health laboratories and clinical sites have shown these assays to be more sensitive than culture for pharyngeal and rectal testing. Ota et al. compared the sensitivity of culture to NAAT assays in detecting extragenital NG and CT. The culture sensitivity was 0% for both the NG and CT pharyngeal sites, 41% for rectal NG, and 21% for rectal CT. In contrast, the NAAT assays had 80% to 100% sensitivity at all sites. Notably, culture detected only 16 cases of extragenital infections, whereas NAATs detected 73 such cases in this study. Similar results were found by Schachter et al., with NG and CT rectal and pharyngeal culture sensitivity ranging from 27% to 44% and NAAT assay sensitivity ranging from 63% to