Researchers announce new drug screening method

Dec 08 2017

Researchers announce new drug screening method

Canadian researchers have developed a new drug screening technique that could enable the rapid and accurate identification of fentanyl, along with many other illicit drugs which have been difficult to detect by urinalysis.

The method developed at McMaster University in Hamilton, Ont., would also expedite results by enabling technicians to run many more tests simultaneously, eliminating the two-stage process currently used in testing, with improved accuracy.

The new method, reported in the current edition of the journal Analytical Chemistry, would address one of the primary causes of the opioid epidemic by better enabling public health and law enforcement agencies to monitor the constant flow of new, synthetic drugs entering the illegal market.

Current drug testing methods rely on immunoassays. An immunoassay is a biochemical test that measures the presence or concentration of a macromolecule or a small molecule in a solution through the use of an antibody or an antigen. Scientists say immunoassays are ineffective in testing many new, synthetic drugs, including synthetic opioids, tranquilizers, stimulants and anti-anxiety drugs.

As a result, conventional testing methods produce a high number of false positives and false negatives, which requires additional tests to confirm findings.

“Drug testing is always behind the times since screening relies on antibody reagents that target only known drugs and they are prone to error, which contributes to higher health care costs and delays to clinical decision making,” says Phillip Britz-McKibbin, a professor in the Department of Chemistry and Chemical Biology at McMaster and lead author of the study.

“Current technologies are not specific, accurate nor comprehensive enough, which impairs a physician’s ability to properly care for patients, such as monitoring for drug compliance, potential substitution or polydrug usage,” he says. Only accurate urine tests can show whether or not the patient is following a doctor’s prescription or taking other harmful substances that can hamper treatment efficacy and patient safety, Britz-McKibbin adds.

Researchers plan to further validate the new method by comparing it to conventional screening tests for a wide range of drugs of abuse on a group of hospital inpatients.

Earlier this year, the U.S. Food and Drug Administration FDA granted 510(k) clearance to the Sefria fentanyl urine enzyme immunoassay – the first immunoassay of its kind to receive clearance. The FDA action makes it available for use by certified reference laboratories, hospitals, physician offices and other healthcare settings that perform testing. Previously, fentanyl immunoassay tests were only available for forensic testing.

The Sefria technology was developed and is being marketed by Pomona, Calif.-based Immunalysis Corp., a division of Alere Inc. (NYSE: ALR).

The availability of an FDA-cleared fentanyl immunoassay enables more reference and hospital laboratories to conduct precise qualitative screening, which is a key strategy in stemming the alarming increase in misuse and abuse of fentanyl,” says Kathy Miller, vice president of sales and marketing at Immunalysis Corp. 

According to the Centers for Disease Control and Prevention, death rates from synthetic opioids such as fentanyl increased by 72.2 percent from 2014 to 2015, partly due to their low cost and high potency, which can be up to 50 times greater than heroin and 100 times greater than morphine.

Fentanyl-related drug overdoses are often caused by unintentional ingestion when it is combined with street market heroin or cocaine, according to scientists, making it much more dangerous.