The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have teamed up to create a repository of resistant bacterial and yeast isolates of national medical concern that have been phenotypically and genotypically characterized.
Called the Antibiotic Resistance Isolate Bank (AR Isolate Bank), it contains isolate panels that are available free of charge as a resource for developing drugs and diagnostic testing panels.
The AR Isolate Bank has new resistant isolates and their corresponding resistance markers. The isolates are preassembled into panels and then, upon request, isolates and/or panels are shipped to diagnostic and pharmaceutical companies, academia, as well as clinical and public health laboratories. For example, academic medical centers or private and reference laboratories may use the panels and isolates in the development of lab developed tests (LDTs).
As of February 2021, the bank had 29 panels and 952 isolates.
Available panels and ordering instructions can be found on the AR Isolate Bank on CDC.gov and can be used in development of diagnostic tests and in studies; however, the FDA will also accept premarket submissions that use well-characterized isolates from other sources. The isolates in the AR Isolate Bank may be helpful in challenging tests for the detection of infectious diseases and their associated resistance mechanisms, as well as antimicrobial susceptibility testing devices, to ensure the tests can efficiently detect a variety of resistant microorganisms and/or molecular markers of resistance.
Derived from various specimen sources and emerging resistance mechanisms, the isolates in the AR Isolate Bank, the isolates are from samples from healthcare-associated and community-associated infections, foodborne illnesses, and sexually transmitted infections, such as gonorrhea. Each isolate is verified for purity and identified using matrix-assisted laser desorption-ionization time of flight mass spectrometry (MALDI-TOF MS) and 16S rRNA gene sequencing (as needed). Antimicrobial susceptibility testing (AST) is performed using the reference broth microdilution method in accordance with Clinical and Laboratory Standards Institute (CLSI) standards. In addition, whole genome sequencing is performed on isolates to identify resistance markers and to better understand the genotypic basis of resistance.
