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                In Vitro Diagnostics

In Vitro Diagnostics

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          The CDC & FDA Antibiotic Resistance Isolate BankIn Vitro Diagnostics The CDC & FDA Antibiotic Resistance Isolate Bank
  
  	
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    PrintThe Antibiotic Resistance Isolate Bank (AR Isolate Bank) is a collaboration between the Centers for Disease Control and Prevention (CDC) & the U.S. Food and Drug Administration (FDA) to create a repository of resistant bacterial and yeast isolates of national medical concern that have been phenotypically and genotypically characterized. Panels containing these well-characterized isolates are available free of charge to requesting institutions as a resource to support the development of drugs (for example, antibacterial and antifungal agents) and in vitro diagnostic tests.
 
The AR Isolate Bank is routinely updated with 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, private and reference laboratories). The CDC has shipped thousands of isolate panels from the AR Isolate Bank.
 
Available panels and ordering instructions can be found on the AR Isolate Bank on CDC.gov.

AR Isolate Bank on CDC.gov

Use of the AR Isolate Bank

Isolates from the AR Isolate Bank can be used in development of various diagnostic tests and may be used in studies to support the FDA premarket notification application of such tests, though 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.
 
The isolates in the AR Isolate Bank are derived from various specimen sources that are associated with previously known or newly emerging resistance mechanisms. The isolates have been recovered from samples from health care-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.

Background

Antimicrobial resistance is a major public health concern. The National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) was developed in early 2015, following issuance of Executive Order 13676 in September 2014. The National Action Plan outlined various goals to slow the emergence of resistant bacteria, prevent the spread of resistant infections, strengthen national surveillance efforts to combat resistance, advance the development and use of rapid and innovative diagnostic tests, and accelerate the development of new antimicrobial agents, vaccines, and other therapeutics.

To achieve these goals, the AR Isolate Bank was created in July 2015 as a collaboration between the FDA and the CDC. The AR Isolate Bank has been a valuable resource to diagnostic and drug companies by providing access to phenotypically and genotypically characterized resistant bacterial and yeast isolates of national medical concern to support the development of drugs (for example, antibacterial and antifungal agents) and in vitro diagnostics tests.
 
The AR Isolate Bank also serves as a valuable resource to government agencies, academic institutions, clinical laboratories, commercial laboratories, and public health institutions.

                                                                                  Content current as of:
      09/09/2021
              
              
Regulated Product(s)
		 Medical DevicesIn Vitro Diagnostics

          
                        Companion Diagnostics
          Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
          Direct-to-Consumer Tests
          Nucleic Acid Based Tests


                        Blood Glucose Monitoring Devices
          Drugs of Abuse Tests
          Home Use Tests
          Laboratory Developed Tests
          Precision Medicine
          Tests Used In Clinical Care
          Warfarin INR Test Meters
 
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