By Nicholas Borgert

 A number of factors are influencing the future of domestic drugs of abuse testing (DAT). While clinical DAT continues to be stable with some growth, workplace testing—a major component of nonclinical drug testing—has taken a dip.

Statistics indicate that today’s workplace remains a hotbed of drug abuse. A recent government study found nearly 75% of drug abusers are employed. Other findings: One in six workers has a drug problem. Drug-related problems cost employers an extra $7,000 to $10,000 per employee each year.

Absenteeism for drug-abusing workers is way up—1,600%—and their productivity drops off about 33%. Substantial percentages of these drug abusers admit to peddling drugs at work and stealing from their employers.

Despite all that, vendors of workplace drug-testing products say companies are ordering fewer drug tests. They blame the decrease on the economy. As companies seek ways to cut costs, the drug testing of job applicants and existing workers has emerged as a convenient target.

Dealing with adulterants
Challenges to test validity are another concern. A new industry has emerged in the last decade. Web sites abound with information on adulterants and ways to beat a drug test. “Deny that you have used any illegal substances and insist that there must be something wrong with their test,” urges one Web site. Urine tests, the site claims, are especially unreliable.

“Cincinnati-based Spectrum Labs has been in the cleansing/detoxification business for 10 years,” says Kevin Pressler, its national marketing manager. Today, Spectrum employs a staff of 12, including two chemists. Its products are sold at more than 1,000 stores in the U.S., and the company offers a 200% money-back guarantee on all products.

Up to 95% of drug testing is urine-based. So Spectrum developed UrineLuck®—a detoxifying agent that can be secretly poured into a urine sample. Pressler says the product removes all the toxins from the urine.

“All our products are to be used the same day a drug test is given. Nothing is going to clean out a person’s system permanently,” Pressler says. “Until employers start doing away with the tests, we’ll be around. If a company really cared about safety at work, it would perform an impairment test for every employee, every morning. But they don’t do that.”

“Adulterants are probably the biggest challenge to the validity of non-STAT drug tests,” says Susan Watanabe, PhD, senior product manager for Olympus Diagnostic Systems Group. In an effort to improve the reliability of test results, labs often run three to five additional tests to check on the presence of interfering substances, she says.

Because the Olympus AU platform uses an open reagent system, labs can implement their own specialized reagents for adulterants while depending on automated checks on the instruments for onboard reagent management.

 Most drug testing is urine based, but one Web site claims that urine tests are especially unreliable.

According to James Linehan, Roche DAT product manager, most reference labs are well equipped to perform adulterant testing for determining whether a specimen has been compromised. Among the most common preventive steps are the detection of low creatinine levels in urine samples and a specific gravity test dealing with density of materials in the sample, he says.

Kelli Ryzewski, marketing director for drug testing at Dade Behring, says the DAT providers have all the necessary scientific expertise to respond to adulterant products. “The challenge is to stay current with the newest developments,” she says. “At one point, oxidizing agents were all the rage. Dade Behring now has a screen to pick up oxidizing agents. And we’re working on a screen for Ecstasy as well as other designer drugs.”

Here is a look at what various companies are doing in the area of drugs of abuse testing.

Dade Behring
At Dade Behring, drugs of abuse testing and therapeutic drug monitoring are included under the company’s Syva EMIT® products and Dimension® platform.

Ryzewski says that while Dade Behring continues to supply its point-of-care customers for drugs of abuse testing, the market has become oversaturated and Dade has refocused on other market segments.

“At one point, we had 28 competitors in POC drug testing,” she says. “Now we’re centering our efforts mostly on meeting the needs of high-volume toxicology labs and reference labs.”

While the amount of workplace testing has dropped in recent months, Dade Behring’s business in the rest of the nonclinical market has been growing tremendously.

“A large part of our business comes from nonclinical testing. Criminal justice has been particularly strong for us; methadone maintenance has been effective, too,” she says. “We’re seeing double-digit growth in that business.”

This spring, Dade Behring introduced the V-Twin™, an upgraded version of the company’s Viva platform. The V-Twin offers the benefits of two Viva systems put together. Features include built-in redundancies, bar coding, and twice the throughput of the first-generation Viva. “While the new system is best suited for nonclinical applications, a lot of hospitals are looking at it too,” she says.

Biosite
Now in its second decade, Biosite’s flagship Triage® Drugs of Abuse (DOA) Panel continues to be used by a sizable part of the rapid-testing market. A frequent choice for hospital laboratories and emergency departments, the panel is also used for such nonclinical applications as workplace screening, occupational health, and criminal justice. Triage DOA Panels detect up to nine illicit and prescription drugs in 15 minutes based on urine samples.

According to Felice Szeto-Wong, Biosite marketing communications and product support specialist, the Triage Tox Drug Screen is the latest addition to the Triage DOA line. It is a one-step DOA screen that runs on the Triage MeterPlus platform.

“The Triage TOX Drug Screen provides an objective result reported by the MeterPlus rather than a subjective result that requires interpretation,” says Szeto-Wong. “That’s critical for quick diagnosis by emergency department physicians. Connectivity is another advantage, as it easily integrates into laboratory information systems.”

Szeto-Wong adds that many low-priced drugs of abuse tests for nonclinical use are trying to make their way into the hospital market. “But I don’t think their technology and results thresholds are appropriate for hospital laboratories,” she says. “Biosite has tested the specificity of each of the nine drug classes detected in the Triage DOA Panels against more than 900 compounds and respective metabolites.

“A lower price should not be the key reason to switch drugs of abuse testing. Instead, rapid response, high quality, and accurate results should be the main reasons to consider a drugs of abuse test, or any test that is used for clinical decisions,” she says. “Biosite is driven by the development of novel markers for acute diseases.” While its ExpressTest for workplace drug testing is still available, Biosite is concentrating on the clinical segment. Biosite teams up with Fisher Healthcare for Triage® DOA marketing in the U.S. It partners with German giant E. Merck Group for Triage DOA marketing in Europeand Central and South America.

Roche Diagnostics
Over the past year, Roche has refocused its drugs of abuse testing business, says James Linehan, Roche DAT product manager. Now, the company is concentrating on the DAT reference lab and hospital marketplace.

As a result, Roche sold its nonclinical products line business, including job screening and criminal justice, to Varian, a California-based company heavily involved in toxicology testing. It was not an insignificant exchange: Roche nonclinical DAT sales totaled nearly $30 million last year; Roche controlled more than 50% of that market segment in 2002. “We took a long look at nonclinical testing and decided that focusing on clinical DAT testing best fits our corporate goals,” Linehan says.

He estimates the DAT market testing for reference labs and hospitals at about $180 million, with Roche controlling about 10% of that. Roche Abuscreen OnLine reagents are marketed for use on automated analyzers, while its OnTrak TesTCard 9 Panel is a rapid screen (five minutes or fewer) for nine drugs suited to point-of-care use.

According to Linehan, DAT is almost evenly divided between POC and automated platforms. “Half the hospitals—about 2,800—use point-of-care drug screens instead of analyzers, mostly because of costs. It’s not cost-effective to put seven or eight reagents onto an analyzer and then use the analyzer for only a limited amount of tests,” he says.

A key Roche advantage, says Linehan, is that both its POC and automated tests share virtually the same antibodies and reagents. This simplifies purchasing, staff training, and procedural issues. Linehan says his data suggests more companies, responding to a poor economy, are conducting fewer pre-employment drug tests to reduce costs.

Olympus America Inc.
Susan Watanabe of Olympus Diagnostic Systems Group says that as hospitals become increasingly sophisticated in assessing the true cost of patient management, there is a movement to shift POC tests back into the lab and invest in specimen transport and information systems.

Once a specimen is received in the lab, the Olympus family of chemistry-immuno systems (AU400e, AU640e, AU2700, and AU5400) can process a seven-test DAT panel in less than 9 minutes. Results can be sent to an LIS where data is formatted and accessible immediately.

“Increasing demand for non-STAT testing for insurance, drug courts, and employment also favors DAT done in a central lab,” Watanabe says. The central labs’ capability to test for adulterants in parallel is a big advantage. Speed, automated repeats for positive specimens, QC tracking, and data management are all available from Olympus systems.

Watanabe says Olympus continues to increase placements of its systems in hospitals and labs as primary chemistry systems. The systems offer bar-coded reagents for drugs of abuse testing, as well as general and specialty chemistries and therapeutic drug monitoring. More than 1,000 Olympus AU systems are in labs in the U.S., with more than 4,000 placed worldwide.

“Olympus has seen a more than 10% annual growth in AU system sales over the last five years in the U.S.,” says Watanabe. A key to sales growth is the company’s success with dedicated DAT instruments in partnership with Dade Behring, she says. Breadth of systems is another key. “As labs build their businesses, the standardized Olympus AU line offers scalability,” she says. The benefits come in the areas of training costs, LIS interfacing, and inventory.

Nicholas Borgert is a contributing writer for Clinical Lab Products.