Modifications of FDA-cleared/approved tests.
- Resource Type
- Letter to the Editor
- Authors
- Rychert, Jenna; Genzen, Jonathan R
- Source
- American Journal of Clinical Pathology. Nov2023, Vol. 160 Issue 5, p542-542. 1p.
- Subject
- *TEST validity
*PATHOLOGICAL laboratories
*PATIENT care
- Language
- ISSN
- 0002-9173
The authors of this article respond to additional information provided by Dr. El-Khoury regarding the use of test modifications with FDA-cleared/approved assays. They acknowledge that there are numerous reasons why test modifications or supplemental validation studies may be necessary, such as optimizing interference thresholds or reestablishing reference intervals. The responsibility for ensuring the analytical validity of test modifications in the United States is described within the Clinical Laboratory Improvement Amendments (CLIA) standards. The authors argue for retaining the flexibility for test modifications under CLIA oversight, as overregulation could hinder patient care. [Extracted from the article]