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Industry terminology you need to know.
Tampering or manipulation of a urine specimen with the intention of altering the test results. The use of adulterants can cause false negative results in drug tests by either interfering with the screening test and/or destroying the drugs present in the urine. Specimen substitution can also fall into this category, where as a patient will use a “clean” specimen in place of their own if they fear negative results.
A substance whose chemical constituents are being identified and measured.
A blood protein produced in response to and counteracting a specific antigen. Antibodies combine chemically with substances that the body recognizes as alien, such as bacteria, viruses, and foreign substances in the blood.
A toxin or other foreign substance that induces an immune response in the body, especially the production of antibodies.
An investigative (analytic) procedure in laboratory medicine, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity (the analyte). The analyte can be a drug, a biochemical substance, or a cell in an organism or organic sample.
The amount of alcohol in the bloodstream; expressed as a percentage. Simplified, most states consider a driver impaired with a BAL of 0.08% - this is 8/100th of a percent of their blood is comprised of alcohol. On average, the possibility of death occurs with concentrations of 0.40%–0.50% - just under ½ percent concentrations.
Any of a group of closely related compounds that include cannabinol and the active constituents of cannabis. THC and CBD are two of the most commonly known Cannabinoids.
The target drug or metabolite used to establish the cut-off value for that specific assay. A standard, reference material, or substance used to standardize or calibrate an instrument or laboratory procedure.
Chain of Custody (CCF)
In legal contexts, refers to the chronological documentation or paper trail that records the sequence of custody, control, transfer, analysis, and disposition of physical or electronic evidence. Chain of Custody Forms (CCF) are used to track the entire process of implementing a drug test.
Regular and repeated use of a drug over an extended period of time.
Urine spiked with known quantities of drugs or metabolites. Used to confirm the functionality of the test. On an instant drug test, this is the line that should appear in the control section of the test regardless of whether it is a positive or negative result. If no control line appears the test is invalid.
Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. See our CLIA-Waived section for more details.
Current Procedural Terminology, or CPT is an expansive, important code set published and maintained by the American Medical Association (AMA). CPT codes are used to describe tests, surgeries, evaluations, and any other medical procedure performed by a healthcare provider on a patient. CPT codes are an integral part of the billing process. CPT codes tell the insurance payer what procedures the healthcare provider would like to be reimbursed for and are also used to track important health data and measure performance and efficiency.
Beginning January 1, 2017, there are new presumptive (screen) toxicology CPT codes that will replace the existing AMA CPT and CMS HCPCS codes for presumptive drug testing. All AMA and CMS definitive drug testing codes remain unchanged at this time.
The following AMA CPT codes for presumptive drug testing are deleted:
In addition, the following AMA CPT codes for specimen validity testing are deleted:
CMS will also recognize the new AMA codes and delete the following G codes:
Presumptive drug testing
CPT code: 80305
Drug test(s), presumptive, any number of drug classes, qualitative; any number of devices or procedures, (e.g., immunoassay) capable of being read by direct optical observation only (e.g., dipstick, cups, cards, cartridges) includes sample validation when performed, per date of service (maps to 80300 or G0477).
CPT code: 80306
Drug test(s), presumptive, any number of drug classes, qualitative; any number of devices or procedures, (e.g., immunoassay) read by instrumented assisted direct optical observation (e.g., dipstick, cups, cards, cartridges) includes sample validation when performed, per date of service (maps to 80300 or G0478).
CPT code: 80307
Drug test(s), presumptive, any number of drug classes, qualitative; any number of devices or procedures, by instrument chemistry and analyzers (e.g., utilizing immunoassay [EIA, ELISA, EMIT, FPIA, IA, KIMS, RIA]), chromatography (e.g., GC, HPLC), and mass spectrometry either with or without chromatography, (DAT, DESI, GC-MS, GC-MS/MS, LC-MS, LC-MS/MS, LDTD, MALDI, TOF) includes sample validation when performed, per date of service (maps to 80301, 80302, 80303, 80304 and G0479). Most of our presumptive drug tests at Quest Diagnostics will fit the CPT code 80307.
When a positive result occurs but is caused by a substance other than what substances the test is known or expected to test for.
The minimum concentration of drugs or metabolites in urine to trigger a positive result measured in nanograms over mililiter (ng/mL).
One of the key concepts within drug testing is the application of a cut-off level. This is the point which segregates a test result as being either positive or negative.
For drug screening tests, a cut-off is chosen that will optimise drug detection but minimise the number of false positive results. It is important to note that a negative sample doesn’t mean that it is drug free; it might contain a drug at a concentration that is lower than the defined cut-off.
If a drug test is reported as screen positive or presumptive positive, this merely shows a response, which is usually because a drug is present. It cannot show how much drug was taken or be correlated to any degree of impairment. As this is a screening tool, all presumptive positives require a confirmation test.
Anyone designated in DOT regulations as a safety-sensitive employee is subject to DOT drug & alcohol testing. What follows is an overview of what jobs are defined as safety-sensitive functions subject to testing.
Flight crews, flight attendants, flight instructors, air traffic controllers at facilities not operated by the FAA or under contract to the U.S. military, aircraft dispatchers, aircraft maintenance or preventative maintenance personnel, ground security coordinators and aviation screeners. Direct or contract employees of 14 CFR Part 121 or 135 certificate holders, Section 91.147 operators and air traffic control facilities not operated by the FAA or under contract to the US Military. See FAA regulations at 14 CFR Part 120.
Commercial Motor Carriers FMCSA
Commercial Drivers License (CDL) holders who operate Commercial Motor Vehicles, 26,001 lbs. gvwr. or greater, or operate a vehicle that carries 16 passengers or more including the driver, or required to display a DOT placard in the transportation of hazardous material.1 1 In some instances, states allow waivers from this qualification, such as operators of fire trucks and some farm equipment. Check with your state department of motor vehicles for more information. See FMCSA regulation at 49 CFR Part 382.
An agency of the U.S. Department of Homeland Security. Crew members operating a commercial vessel. See USCG regulations at 46 CFR Parts 4 & 16.
Operations, maintenance and emergency response. See PHMSA regulations at 49 CFR Part 199.
Hours of Service Act personnel, engine & train, signal service or train dispatchers. See FRA regulations at 49 CFR Part 219.
Vehicle operators, controllers, mechanics and armed security. See FTA regulations at 49 CFR Part 655.
Links to these regulations can be found on-line at www.dot.gov/odapc.
Remember: The tasks you actually perform qualify you as a safety-sensitive employee, not your job title. Also, some employees, like managers and supervisors, may be qualified for these jobs but not currently performing them. Do they have to be tested as well? In most cases, yes…if that employee may be asked at a moment’s notice or in an emergency to perform a safety sensitive job. Be sure to check industry specific regulations for further clarification.
Is a metabolite of ethanol which is formed in the body by glucuronidation following exposure to ethanol, usually from drinking alcoholic beverages.
When a test reads a negative result and should not be.
When a test read a positive result and should not be.
Fentanyl is an Opioid used as a pain reliever available in many forms including, injection, transdermal patch, and sublingual lozenge. It is an extremely potent narcotic analgesic 100 times more potent than Morphine with rapid on set effects and a short lasting duration of effects. Fentanyl has gained popularity as a recreational drug and can be produced illegally at low costs, often being mixed with, or mimicking drugs like Oxycodone and Heroin, creating lethal doses. Fentanyl is currently a Scheduled II controlled substance in the United States.
Forensic Use Only
Tests that can be used by Criminal Justice and Law Enforcement.
A substance formed in or necessary for metabolism or metabolic processes allowing the body to break down what has been ingested. Certain drug metabolites can simply be waste, while others are what actually causes the desired effects among drug users. In some cases a drug’s metabolite can be detected in a person’s system longer than the parent drug, in which, testing for a drug metabolite such as EtG would be a better option for determaining alcohol use.
A Medical Review Officer (MRO) is a person who is a licensed physician and who is responsible for receiving and reviewing laboratory results generated by an employer’s drug testing program and evaluating medical explanations for certain drug test results.
A term used in pharmacology that represents substances derived from the natural plant opium. Three major psychoactive opiates are Morphine, Codeine, and Thebaine which are all naturally occurring alkaloids found in the opium poppy. Opiates have been used for centuries as pain relievers and are now known for their high potential for abuse, due to their euphoric effects and addictive properties both mental and physical. Habitual users often suffer from extreme withdrawal symptoms after cessation.
Opioids, unlike opiates, are synthetic and semi-synthetic substances, but similar to opiates, in that they bind to the opioid receptors of the brain and produce similar euphoric effects. Opioids include drugs such as, but not limited to, Oxycodone or OxyContin, Heroin, and Fentanyl. Like opiates, they share a high risk for abuse and can be lethal when not taken properly.
This describes medications that can be purchased at ordinary retail stores without a prescription from a medical practitioner.
A compound from which derivatives can be obtained from. When calibrating a drug test, the manufacturer will find the substance most readily and reliably available in the specimen. In some cases this will be the parent compound, or component of the actual substance being tested for and in other cases this can be a metabolite, which is what the body creates in response to metabolizing the parent compound.
Medical diagnostic testing designed to be performed at where the patient is located, or “point of care”.
A qualitative test tells you if a particular substance (analyte) is present in the specimen. If you were testing for alcohol a qualitative test will only determine the presence of alcohol and not the actual alcohol level.
A quantitative test tells you the amount or level of a particular substance (analyte) that is present in a specimen. If you were testing for alcohol a quantitative test can determine the acutal level of alcohol in a specimen.
A strip of paper impregnated with a reagent to a given substance, used in testing for that substance in a body fluid or other secretion.
The Substance Abuse and Mental Health Services Administration (SAMHSA) is the agency within the U.S. Department of Health and Human Services that leads public health efforts to advance the behavioral health of the nation. SAMHSA’s mission is to reduce the impact of substance abuse and mental illness on America’s communities.
An initial test that has not been confirmed by a laboratory, such as a point-of-care instant test device or a desk top analyzer.
A semi-quantitative test will produce a result “range” not as specific as quantitative tests but more specific than qualitative tests. They are are realtively insensitive and subject to less false positive results.
Instant test strips are manufactured with a 24-month shelf-life and tests should not be used (and the results absolutely not be relied upon) after their expiration. The expiration of a multi-panel test is based on the oldest strip on the test. In addition, a new lot number is assigned any time in the manufacturing process when one (or more) “lots” of a specific strip are changed. This is to keep accurate tracking of the manufacturing parameters of that particular item. Should any issues arise down the road, the manufacturer has a certain amount of tests from that lot (called “retains”) that they keep for doing their own quality control investigations.
The exceptions to the 24-month shelf life are the urine alcohol and saliva alcohol tests; these are only 12-month from manufacture to expiration.
The narrowness of the range of substances with which an antibody or other agent acts or is effective or the extent to which a diagnostic test is specific for a particular condition, trait, etc.
Third Party Administrator
Organization that processes insurance claims or certain aspects of employee benefit plans and administrative duties for a separate entity.
Analysis of urine by physical, chemical, and microscopical means to test for the presence of disease, drugs, etc.
Window of Detection
The window of detection is the time that a drug can be detected in a biological sample above a specified cut-off for the test being performed. There is a period of time immediately before and after this detection window when the drug will be present in the sample but at a level below the cut-off.
Tests are designed to be drug or drug group specific and the cut-off level has been determined to optimise detection without giving false positives.
Drugs are detected in oral fluid either from direct deposition in the mouth or by transfer from the blood stream following ingestion and absorption. Any drugs present in the bloodstream are metabolised in the liver before being excreted in the urine. This process results in drugs appearing in the urine later than oral fluid. The drugs are detectable for a significantly longer time in urine than in oral fluid.
Figure 1: A visual representation of a cut-off level and window of detection.
The actual time a drug will remain detectable in a sample will depend on some or all of the following:
- The amount of drug taken
- How frequently the drug is taken
- The nature of the drug itself
- An individual’s metabolism and general health
- The amount of fluids taken since taking the drug
- The amount of exercise taken since taking the drug
- Genetic variations that affect a response to drugs
For example if a person smoked a single spliff the cannabis could remain detectable in urine for no more than 2–3 days and may even be as short as one day depending on the strength of cannabis. However if their cannabis use is habitual and heavy it is stored in the fatty tissues, resulting in a much wider detection window (sometimes up to 30 days).
The shortest window of detection is found with oral fluid.
Drugs can be detected in urine for longer, and in consequence the window of detection for some drugs can be affected by whether their effects are short or long acting.
Hair provides a historic record of drug use, and detection windows are based entirely on hair length. It takes about 14 days for the drugs to appear in the hair shaft, and moving away from the scalp, every 1cm of hair length approximates to a one month window of detection.
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