Updated laboratory requirement for all laboratory-developed tests
January 20, 2017
The most recent College of American Pathologist (CAP) checklist¹ contains an updated requirement (COM.40630) for all laboratory-developed tests (LDTs). We must provide the following statement on our laboratory reports:
The following tests were developed and their analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the FDA. These assays have been validated pursuant to the CLIA regulations and are used for risk assessment purposes.
- Urine Hemoglobin Screen
- Urine Leukocyte Screen
- Urine pH
- Beta Blockers (BAB)
- Diuretic Agents (DIU)
- Urine Protein
- Microalbumin
- Urine ethanol (qualitative)
- Serum Cotinine
- Dried Blood Cocaine
- Dried Blood Cotinine
This language will be added to laboratory profiles effective 1/27/17
