CLIA-WAIVED TESTS
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality
CDC’s responsibilities for the national CLIA program include:
- Providing analysis, research, and technical assistance
- Developing technical standards and laboratory practice guidelines, including standards and guidelines for cytology
- Conducting laboratory quality improvement studies
- Monitoring proficiency testing practices
- Developing and distributing professional information and educational resources
- Managing the Clinical Laboratory Improvement Advisory Committee (CLIAC)
CLIA-WAIVED TESTING OPTIONS
CUSTOMIZE A URINE CUP OR DIP TEST WITH ANY OF THESE DRUGS TO MAKE SURE YOU ARE STAYING COMPLIANT
| DRUG | CUT-OFF | WOD | Certification |
| Amphetamines (AMP) | 500, 1000ng/mL | 2 hr. - 4 Days | FDA CLIA-Waived |
| Bariturates (BAR) | 300ng/mL | 2 hr. - 7 Days | FDA CLIA-Waived |
| Benzodiazepines (BZO) | 300ng/mL | 2 hr. - 7 Days | FDA CLIA-Waived |
| Buprenorphine (BUP) | 10ng/mL | 1 - 3 Days | FDA CLIA-Waived |
| Cocaine (COC) | 150, 300ng/mL | 1 hr. - 4 Days | FDA CLIA-Waived |
| Ecstacy (MDMA) | 500 ng/mL | 2 hr. - 4 Days | FDA CLIA-Waived |
| Marijuana (THC) | 50ng/mL | 2 hr. - 40 Days | FDA CLIA-Waived |
| Methadone (MTD) | 300ng/mL | 1 hr. - 3 Days | FDA CLIA-Waived |
| Methadone Metabolite (EDDP) | 100ng/mL | 1 hr. - 3 Days | FDA CLIA-Waived |
| Methamphetamines (mAMP) | 500, 1000ng/mL | 2 hr. - 4 Days | FDA CLIA-Waived |
| Morphine (MOP) | 300ng/mL | 2 hr. - 4 Days | FDA CLIA-Waived |
| Opiates (OPI) | 2000ng/mL | 2 hr. - 4 Days | FDA CLIA-Waived |
| Oxycodone (OXY) | 100ng/mL | 2 hr. - 4 Days | FDA CLIA-Waived |
| Phencyclidine (PCP) | 25ng/mL | 4 hrs. - 14 Days | FDA CLIA-Waived |
| Propoxyphene (PPX) | 300ng/mL | 1 hr. - 3 Days | FDA CLIA-Waived |
| Tricyclic Antidepressants (TCA) | 1000ng/mL | 2-10 Days | FDA CLIA-Waived |
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