Frequently Asked Questions

What is ASR?

Analyte Specific Reagents (ASR) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.

To Whom Can Manufacturers Sell ASRs?

In the USA, ASR's may only be sold to:

1. In vitro diagnostic manufacturers.
2. Clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as qualified to perform high complexity testing under 42 CFR part 493 or clinical laboratories regulated under VHA Directive 1106 (available from Department of Veterans Affairs, Veterans Health Administration, Washington, DC 20420).
3. 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.

Can the Manufacturer Include Instructions With an ASR?

ASR products are intended for laboratory developed tests (LDTs) and IVD manufacturers. ASR manufacturers should not provide instructions for developing or performing an assay with an ASR, nor make claims to physicians or laboratories regarding analytical or clinical performance for ASRs.

The laboratory that develops an in-house test using the ASR shall inform the ordering person of the test result by appending to the test report the statement: "This test was developed and its performance characteristics determined by (Laboratory Name). It has not been cleared or approved by the U.S. Food and Drug Administration."