Here at Confirm BioSciences, we understand that drug testing information and terminology can often be confusing and difficult to understand. We’ve created a resource with the most common terminology to help give a better understanding of our products and services.
The Clinical Laboratory Improvement and Amendments of 1988 is the regulatory agency that oversees all of the facilities in the United States that conduct laboratory testing on humans for diagnosis and health assessment purposes, including the treatment and prevention of diseases.
CLIA waived drug tests are test systems that have been approved for a waiver based on CLIA’s criteria and are cleared by the FDA for home use, as listed in the CLIA regulations.
Drug metabolism refers specifically to the chemical alteration that a drug undergoes while being processed by the body. When a drug enters the body, it gets altered and this alteration results in substances called drug metabolites. Most drugs that enter the body are metabolized by the liver.
Drug Test Cut-Off Level
A drug test cut-off level is the level at which anything under that cut-off is considered a negative drug test result and anything above the level is considered a positive drug test result. This cut-off level is determined at a point intended to optimize the detection of drug use while minimizing the possibility of a false positive result.
Gas Chromatography Mass Spectrometry (GC/MS)
Gas chromatography mass spectrometry are two very powerful, very sensitive instruments that are used to detect and study trace amounts of chemicals. GC/MS can measure the amount of every single chemical present in a given sample by simply comparing the chemical to a pre-measured standard. This type of testing is used as confirmatory testing on positive drug test specimens.
Medical Review Officer
A Medical Review Officer is a licensed physician with a Doctor of Medicine or Doctor of Osteopathy degree. There are a number of requirements for a doctor to be eligible to act as an MRO, based on the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs. These requirements include:
- Expert knowledge and training in the toxicology and pharmacology of illicit drugs and substances.
- Professional training in:
- HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs
- Procedures in collecting federal agency specimens
- Chain of custody including reporting and record keeping protocols for all specimen types
- Proper procedures for the review, interpretation and reporting of results
- Passing of the examination conducted by an HHS-approved agency
The Substance Abuse and Mental Health Services Administration is the federal agency under the Department of Health and Human Services whose mission it is to decrease mental illness and substance abuse across the nation.
SAMHSA guidelines indicate that businesses or companies that employ individuals working in safety sensitive jobs should have a drug screening system in place. The declare the program must test for five specified drug categories including:
In some instances, other drug panels may be requested, however they are not required as part of SAMHSA regulations.
Still have more questions regarding drug testing terminology, processes and procedures? Please visit our FAQ page, here.