What is an Analyte Specific Reagent (ASR)?
ASR stands for Analyte Specific Reagent. ASRs are regulated by the U.S. Food and Drug Administration (FDA). The FDA created this regulatory status to ensure availability of individual reagents meeting specific quality requirements for clinical laboratories to use in developing Laboratory Developed Tests (LDTs). Many flow cytometry in vitro diagnostic tests fall into this category. This status is not recognized in countries outside of the United States.
At a glance:
- ASRs are designed to meet FDA requirements for LDT components in clinical laboratories.
- The laboratory does the validation and performance evaluation of the LDT using the ASRs.
- Beckman Coulter ensures consistent and high-quality conjugated antibodies, manufactured under current Good Manufacturing Practices (cGMP) conditions. Note that manufacturers are subject to audit by the FDA to ensure strict guidelines for manufacturing processes are followed.