Clinical Update

BioDetect: Identifying Non-Urine Substances

Healthcare providers rely on medication adherence test results to assist in measuring compliance and evaluating recent substance use. Providers must remain aware of specimen substitution attempts to avoid misuse and diversion going unidentified. Aegis’s expanded validity measure called BioDetect™ assists with identification of substituted and synthetic urine specimens. Through the identification of unique markers expected in human urine, healthcare providers have greater insight into an individual’s medication adherence.

Synthetic Urine1, 2-4

Synthetic urine, also known as “fake urine,” is one mechanism of substitution and is typically manufactured to include creatinine, specific gravity, physiological pH levels, or other specimen validity parameters in the samples.Synthetic urine products have a similar color, density, and temperature making them a common method to substitute urine tests. Common ingredients in synthetic urine may include uric acid, sodium and potassium chloride, urea, phosphorus sodium, purified or distilled water, and creatinine. Many of the products come with instructions, heating pad, and temperature indicators and are available in powder and liquid formulations. These products are alarmingly accessible and sold in smoke shops, on reputable sites like Amazon, or directly from the manufacturer’s website. A 2020 market search submitted ten synthetic urine samples for testing at five forensic drug testing laboratories to be analyzed for similarities and differing factors compared to authentic urine.2 These samples proved difficult to detect as synthetic using standard assays including LC/MS/MS.

BioDetect™ Testing at Aegis

Individuals may substitute a specimen to mask the use of non-prescribed substances or may spike a prescribed drug into the substituted specimen to appear compliant with prescribed medications. This can create difficulty for providers, who are utilizing routine specimen validity testing, to adequately identify aberrant behaviors. Aegis’s BioDetect™ test includes unique markers expected to be present in routinely analyzed human urine. Thus, when an authentic urine specimen is provided, it is expected the components of the BioDetect™ test will be present. BioDetect™ testing is included on all urine samples to improve a provider’s ability to identify samples that are not consistent with routinely analyzed human urine. The noncompliance to prescription medications in addition to an unexpected BioDetect™ result on an Aegis urine sample is always alarming. The chart below demonstrates the frequency of the top 10 prescribed medications by class in samples with unexpected BioDetect™ results at Aegis. The data includes a total of 1,969,559 urine samples collected from January 2022 to October 2023, with 8960 (0.45%) samples reporting with unexpected BioDetect™ results.


The following illustration categorizes the same data set by the percent of urine specimens with Unexpected BioDetect™ results by state. States with overall low sample volume were excluded.

Individuals in various treatment settings may rely on urine substitution as one of several different methods of adulteration to “pass” a urine drug test. Use of non-urine substances, such as sample substitution with synthetic urine to mask aberrant behaviors, may complicate interpretation of results. When the latter occurs, medication non-adherence and substance use may go unnoticed, and an individual receiving treatment may be at risk for negative outcomes.5 BioDetect™ provides information to identify aberrant behaviors to both guide risk stratification and determine causes of non-adherence.6


Pain Management

The results below represent an Aegis urine sample in a pain management setting that reflects noncompliance with prescribed medications. The sample has concomitant unexpected BioDetect™ results demonstrating inconsistency with routinely analyzed human urine informing the provider the drug results cannot be applied to objectively assess medication adherence. The unexpected BioDetect™ results provide direction to identify diversion or substance use and to determine causes of non-adherence.6 The opioid epidemic is particularly impactful on those requiring chronic opioid therapy to manage debilitating pain, where medication non-adherence and substance use may go unnoticed, and individuals receiving treatment may be at risk for negative outcomes.5 Data accumulated by the U.S. Department of Health and Human Services (HHS) from 2020 showed 1.6 million individuals had an opioid use disorder, over 10 million individuals misused prescription opioids, and over 70,000 individuals died from drug overdose. HHS reported approximately 75% of all drug overdose deaths in 2020 involved an opioid.Though progress has been made over the past few years to curtail the epidemic, there still remains an unfortunate uptick in overdoses and hospitalizations secondary to opioid use.8 Growing availability of novel psychoactive substances (NPS), including designer opioids, has further complicated this issue, as use of substances of varying concentrations and strengths can significantly increase the risk for overdose when taken in combination with prescription drugs. As providers navigate this landscape, identification of sample substitution or synthetic urine is of particular importance to guide their treatment decisions.