College of American Pathologists
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  Analyte Specific Reagents
  Q & A


Page last updated: October 4, 2003

Q: Does the analyte specific reagent (ASR) disclaimer requirement apply to the use of all in-house developed tests?

A: No. As long as the laboratory is not using a product purchased from a manufacturer that is labeled as an ASR and all activities in support of production of the active ingredients of the in-house test occur within the four walls of the lab, the ASR disclaimer statement is not required on the resulting test report.

Q: Are laboratories required to issue disclaimers on test reports when a test is being used by a laboratory for a non-FDA approved use?

A: No. The ASR disclaimer statement is intended to cover "home brews" built from ASRs. It is not intended to be used to cover "off-label" uses of FDA cleared or approved products (e.g., use of an FDA cleared or approved product for a use other than that designated on the label).

Q: Is the disclaimer language required on test reports if a laboratory modifies an ASR assay?

A: Yes. The disclaimer statement is required in all instances when an ASR is used by a laboratory.

Q: Is a disclaimer statement necessary when using an assay purchased from a manufacturer labeled as an immunohistochemistry (IHC) reagent?

A: No. Assays purchased from manufacturers under the IHC label do not require a disclaimer statement when used by laboratories. The disclaimer statement only applies to ASRs.

Q: Is a disclaimer statement required when ASRs are used in non-clinical laboratory settings for purposes other than providing diagnostic information to patients and practitioners (e.g., forensic, academic, research settings)?

A: No. The ASR rule does not apply to reagents sold to and used in non-clinical settings.

Q: Is a disclaimer statement necessary when an ASR assay that is FDA approved or cleared as part of a test kit is used independently by a laboratory?

A: Yes. A disclaimer statement must be appended to the test report when an ASR is used independently of the FDA approved or cleared test kit.

Q: Where can I obtain additional information on the FDA ASR and IHC final rules?

A: Additional information is available in information packet DGP 110, Analyte Specific Reagents, and in information packet DGP 117, Immunohistochemistry (IHC) Reagents. Order information packets


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