Creating a Molecular Atmosphere: Phase 3

Abstract

The use of laboratory-developed tests (LDT) was unfamiliar to me before I started to create this molecular atmosphere within our microbiology department at the System Laboratory of OSF Saint Francis Medical Center. My experience with diagnostic testing had usually included using a kit containing a product insert with step-by-step instructions on how to perform the test in question. However, the herpes simplex virus (HSV) assay and Bordetella pertussis/parapertussis (hereafter, Bordetella) test performed via real-time PCR needed to be developed, validated, and verified; protocols needed to be written based on the steps that we found to be successful. LDTs, also known as home-brew tests, are developed in-house and used for research or diagnostic purposes. LDTs are not frequently encountered in certified clinical laboratories; they are more commonly found in research-based facilities. This type of assay has not been approved by the United States Food and Drug Administration (FDA), so no commercial kits are available. Laboratories that create home-brew assays can make the reagents themselves or buy reagents from outside vendors and develop their own protocol for testing. The validation … [↵][1]* To whom correspondence should be addressed. E-mail: stephanie.e.wallace{at}osfhealthcare.org [1]: #xref-corresp-1-1