Analyte specific reagents (ASRs) are defined as antibodies (both polyclonal and monoclonal), specific receptor proteins, ligands, nucleic acid sequences and similar reagents that bind or react with specific substances in a specimen.1 They are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.1 According to FDA, ASRs are the “building blocks” of Laboratory Developed Tests (LDTs).2
BD Biosciences ASRs are manufactured:
- Under an ISO 13485:2016 certified quality management system in accordance with 21 CFR Part 820
- in an ISO 13485:2016 certified and MDSAP participating facility.
The BD portfolio of ASRs provides laboratories with a wide choice of “building blocks” to select from, and BD’s commitment to quality manufacturing helps ensure consistency of the products.
BD’s commitment to quality includes, but is not limited to:
- Ensuring batch-to-batch consistency
- Documented procedures and employee training
- Equipment maintenance and monitoring records
- Materials traceability
- Lot-specific certificates of analysis
- Quality Assurance review of released products
Who uses BD ASRs?
- ASRs are used by laboratories certified under the Clinical Laboratory Improvement Amendments of 1088 (CLIA) and that meet the regulatory requirements under CLIA to perform high complexity testing and clinical laboratories regulated under VHA Directive 1106.
- Manufacturers of tests that are cleared or approved by the FDA use ASRs.
- Organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research and other nonclinical laboratories. 21 CFR 809.30 (b).
Where can I get more information about BD ASRs?
- ASR manufacturers can only provide limited information about an ASR because they are intended to be building blocks for tests. They are intended to be used to develop a test for which the developer must establish instructions for use and performance claims under 21 CFR 809.10(e)(1)(x), 809.30(d)(4).
- For information on instructions for proper storage and handling as well as composition, concentration, binding affinity, cross reactivities, and interactions, please see the product Technical Data Sheet (TDS).
- Because manufacturers cannot make a claim about the analytical or clinical performance of ASRs, it is up to the laboratories to determine the application or design of a panel.
View our complete offering of BD Biosciences ASRs .
References
1. Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions | FDA
2. Laboratory Developed Tests | FDA