Cheap, easy test to spot fentanyl in opioids could stem fatal overdoses. There’s just one problem.

A lab technician demonstrates the use of fentanyl testing strips at the Rhode Island Department of Health Laboratory in Providence, Rhode Island, January 10, 2018.
A lab technician demonstrates the use of fentanyl testing strips at the Rhode Island Department of Health Laboratory in Providence, Rhode Island, January 10, 2018. Bloomberg American Health Initiative

A fast, cheap test to see if street drugs contain fentanyl is gaining favor with researchers and drug outreach workers as a breakthrough in preventing overdoses and slowing the nation’s growing death toll from opioid abuse.

However, practical, safety and legal concerns about the fentanyl test strips, including those raised by the manufacturer itself, have slowed the product’s usage nationally and limited its potential to change the behavior and, possibly, the lives of illicit drug users.

The test strips, made by BTNX, Inc. in Ontario, Canada, were designed to test patient urine samples for fentanyl, a powerful opioid pain killer that’s fueling a national epidemic of fatal overdose deaths. The product hasn’t been approved by the U.S. Food and Drug Administration to test drug samples.

Still, drug outreach workers in California, New York and Massachusetts, now give the $1 test strips to drug abusers to see if their own drug stash is tainted with lethal fentanyl. Users simply put some of their drugs or drug residue in water, insert the plastic test strip and wait several minutes for one or two colored lines to appear, indicating a positive or negative test.

“Seeing is believing,” said Daniel Raymond, policy director for the Harm Reduction Coalition, which runs drug outreach programs in New York and Oakland, Ca. “These test strips actually give this visible tangible sign that there’s something unusual going on that people should pay attention to.”

Raymond and others say the strips accurately detect fentanyl in cocaine, heroin methamphetamine and other drugs, while helping to spark a dialogue with users about taking extra precautions.

The problem is, Iqbal Sunderani, CEO of BTNX, said the company can’t vouch for the product’s reliability or safety as a warning system for drug users because of legal liability concerns about its unapproved usage.

“Because it’s used off-label, we cannot recommend that,” Sunderani said.

The product’s low cost, accuracy and ease of use, however, continues to drive interest among advocates eager to trim the nation’s overdose death rate that claimed 64,000 lives in 2016 — 20,000 of which were due to fentanyl, according to researchers at Johns Hopkins University.

Insite, a supervised drug injection facility in Vancouver, Canada first began using the strips to test actual street drugs for fentanyl in 2016. They found that users whose drugs tested positive were more likely to take smaller doses and were less likely to overdose.

That launched a new “off-label” demand for the strips among “harm-reduction” programs that aim to help drug abusers who can’t or won’t stop using. In California, for example, 23 of the state’s 42 needle exchange programs have ordered or distributed the strips, according to the state public health department.

Jess Tilley, co-founder of the New England Drug Users Union, said she hands out over 500 test strips each month in western Massachusetts.

Parents, siblings and spouses want them for addicted loved ones. College students get them for troubled roommates. But usually it’s the drug users themselves who seek Tilley out.

“The common misconception is that drug users don’t care about their health or their lives,” Tilley said. “That couldn’t be further from the truth. People do not want to die.”

A synthetic opioid pain killer, fentanyl is used for acute, chronic pain from advanced cancer and is up to 100 times more powerful than morphine and 40 to 50 times more powerful than heroin. Ingesting doses as small as 0.25 milligrams can be lethal.

In recent years, law enforcement officials have seen a steady increase in fatal overdoses, mainly involving fentanyl that’s produced in illegal laboratories.

Of 5,152 people who died from opioid overdoses in ten states during the second half of 2016, 56.3 percent tested positive for fentanyl, according to the CDC. And fentanyl was a cause of death in 97 percent of those 2,903 fatal overdoses.

In an e-mail statement, the California Department of Public Health said the state’s rising fentanyl death toll “validated” their decision to let needle exchange programs distribute the tests — even if they are being used for a non-FDA approved purpose that even the manufacturer is wary of.

“There is no legal barrier to using the test strips in the manner currently being employed by (the needle exchange programs),” the department’s e-mail said.

But in Baltimore, Health Commissioner a Leana Wen opposes handing out the test strips even though intravenous drug use and opioid overdoses are rampant in the city. Wen said the chance of false positive and false negative readings outweigh the potential benefits of the tests.

"The last thing I want for people to do is to test a supply of drugs, see that it’s negative for fentanyl and assume that it's safe,” Wen said. “That’s a major concern because, first it may be inaccurate. And second, there are other fentanyl derivatives that may not be picked up with this test.”

And even if a batch of drugs doesn’t contain fentanyl, “it doesn’t mean that the supply of drugs is safe,” Wen said. “Pure heroin and cocaine can cause overdoses just like fentanyl. We don’t want people to use this, assuming that depending on the result, it’s safe (for them) to use.”

A survey of San Francisco drug abusers who used the tests found the strips sometimes provide faint lines that can make the test results hard to determine. It also noted the strips don’t provide information about the level of fentanyl that may be in drugs.

“The strip tests aren’t a magic bullet, but I think they give us another tool to start to get ahead of this threat around fentanyl-involved overdoses,” Raymond said.

BTNX’ Sunderani said the company will leave it to drug experts to decide how the strips can best be utilized. But as his product’s off-label reputation grows, more people contact him directly to discuss the opioid problem, he said.

“Sometimes we get calls from parents who just lost their children,” Sunderani said. “It’s heartbreaking to see how big this problem is."

BTNX has sold the strips for about six years, mainly as a diagnostic test for medical professionals, Sunderani said.

Last year, sales for drug outreach purposes accounted for only three to five percent of the product’s sales, Sunderani said. But demand from that sector is growing. After selling only 75,000 strips for drug outreach in 2016, sales jumped to 200,400 strips through November 2017, he said.

“This year it could be double that,” Sunderani said, based on the “gut feel of the inquiries we’re getting.”

Sunderani doesn’t expect to raise the price of the tests as demand heats up.

“We’re happy with bringing the price point to a dollar per test and that’s what we’re sticking to,” he said. “We could take advantage of (the demand) but I would think that’s the wrong thing to do, considering there’s such an epidemic.”

In addition to fentanyl, the strips also detect 10 of the drug’s derivatives, including carfentanil, which is used as a tranquilizer in large animals like elephants. It’s 10,000 times more powerful than morphine and 100 times more powerful than fentanyl, according to the Drug Enforcement Administration.

The DEA has issued public warnings about the dangers of both, fentanyl and carfentanil.

The study by researchers at Johns Hopkins University found the test strips detected the lowest concentrations of fentanyl and were more accurate in reporting the presence or absence of the drug than two other detection methods, both of which are vastly more expensive and use light and radiation to determine the structure and properties of drug samples.

The research, which included surveys of 335 drug users in Baltimore, Boston and Providence, R.I., also found that 70 percent of participants would modify their behavior if they knew their drugs contained fentanyl. The changes include either not using the tainted drugs, using them more slowly or consuming them with someone nearby in case of overdose, said Susan Sherman, a professor at Hopkins’ Bloomberg School of Public Health and a co-author of the study.

Tilley said many of her contacts whose drugs tested positive for fentanyl won’t consume or shoot up unless someone is present with the overdose-reversal drug, naloxone.

“If this test strip is helping somebody realize that they cannot be alone when they use, to me that’s a win,” Tilley said. “It overrides the chance that there might be a false negative.”

If more evidenced based research shows the test to be safe and effective, Wen said they could play a role in stemming the overdose epidemic. Until then, she said everyone should assume the worst. She urged users to keep naloxone handy and never use drugs alone.

“If you’re using drugs, you should assume fentanyl is in the drug supply,” Wen said. “Don’t bother testing. You should just assume it’s there.”