Verification of performance specifications for a US Food and Drug Administration-approved molecular microbiology test: Clostridium difficile cytotoxin B using the Becton, Dickinson and Company GeneOhm Cdiff assay.
BACKGROUND
US Food and Drug Administration (FDA)-approved diagnostic tests based on molecular genetic technologies are becoming available for an increasing number of microbial pathogens. Advances in technology and lower costs have moved molecular diagnostic tests formerly performed for research purposes only into much wider use in clinical microbiology laboratories.


OBJECTIVE
To provide an example of laboratory studies performed to verify the performance of an FDA-approved assay for the detection of Clostridium difficile cytotoxin B compared with the manufacturer's performance standards.


METHODS
We describe the process and protocols used by a laboratory for verification of an FDA-approved assay, assess data from the verification studies, and implement the assay after verification.


RESULTS
Performance data from the verification studies conducted by the laboratory were consistent with the manufacturer's performance standards and the assay was implemented into the laboratory's test menu.


CONCLUSIONS
Verification studies are required for FDA-approved diagnostic assays prior to use in patient care. Laboratories should develop a standardized approach to verification studies that can be adapted and applied to different types of assays. We describe the verification of an FDA-approved real-time polymerase chain reaction assay for the detection of a toxin gene in a bacterial pathogen.
Department of Pathology, University of Utah School of Medicine, Salt Lake City, 84108, USA. robert.schlaberg@path.utah.edu
Robert
R
Schlaberg
Michael J
MJ
Mitchell
Edward W
EW
Taggart
Rosemary C
RC
She
D001426:Bacterial Proteins / Q000032:analysis / Q000235:genetics*; D001427:Bacterial Toxins / Q000032:analysis / Q000235:genetics*; D016360:Clostridioides difficile / Q000235:genetics*; D004761:Enterocolitis, Pseudomembranous / Q000175:diagnosis*; D005243:Feces / Q000737:chemistry; D006801:Humans; D008828:Microbiological Techniques / Q000295:instrumentation* / Q000379:methods*; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D060888:Real-Time Polymerase Chain Reaction; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
D001426:Bacterial Proteins; D001427:Bacterial Toxins; C031815:toxB protein, Clostridium difficile