Test customers demand more tests, more results, faster than ever

July 19, 2011
| Reprints
Driven by growing demand, firms like Avee Laboratories invest heavily in new facilities and technology

Today, more than ever, demand for drug testing continues to grow due to many factors: the proliferation of drugs subject for abuse, the creativity (or desperation) of abusers, the impact of abuse in the workplace and society, the rising costs associated with drug abuse treatment, and the growing desire of employers and lawmakers to deter or prevent abuse.

Nationwide, the rise in drug testing demand has been matched by the growth in funds made available to pay for it. Here's why: Drug testing is now recognized as a tool for implementing the National Drug Control Strategy. Drug addiction is now recognized as a national epidemic. And, addiction treatment is now covered due to the implementation of insurance parity. So, both public and private insurers have made drug testing a covered service.

The state of Florida provides two regional examples of the factors that drive drug testing's growth. First, it's been on the front lines of a battle against prescription drug abuse, trying to curtail the damage wrought by regional “pill mills” that flooded the market with cheap opioid pain medications. Second, it's the largest state yet to require that adults who apply for Temporary Assistance for Needy Families undergo (and pass) drug testing to qualify for benefits. (Read more on that story here.)

Not surprisingly, in 2008, Florida became the home of one of the newest and fastest-growing drug-testing facilities—Avee Laboratories (Clearwater). On a recent visit to Avee's headquarters, which is already in the midst of relocating to a larger nearby facility, I saw firsthand how the drug testing industry is scaling up to make secure, precise, and individualized drug testing available with the kind of repeatability and precision one might see in a highly advanced manufacturing organization.

At present, Avee processes some 25,000 samples per month, with hundreds arriving from around the nation not only to its Clearwater location, but to a newly opened lab in Massachusetts. Brian Slattery, an Avee vice president, explains that about one-third of the samples are from individuals involved in inpatient or outpatient addiction treatment, while the rest are from individuals being monitored for their ongoing use of controlled substances for management of chronic pain. So, third-party payments are the rule.

Given the demographics of these individuals, Slattery says Avee “expects to see a lot of positives” from initial screening tests and, like many competing labs in the region, performs a lot of confirmation testing. Confimation testing involves the use of a more sensitive test method to validate instant or screening test results. Instead of a simple “yes/no” result, confirmation returns a quantified value for the substance in question. He explains that the design and technology adopted in Avee's Clearwater lab was shaped by customer demand for fast, detailed confirmation test reports.

While Avee depends on its back-room technology for precise results, the credibility and reliability of its test process are maintained by CLIA-regulated, COLA-accredited processes that govern requirements for lab inspections; sample custody, handling, and storage; quality assurance; equipment calibration, and other factors. The chain of custody for each sample begins at receiving, where sample identifying data and content are verified and each labeled, coded sample is divided into two portions.

One portion, a parent sample, proceeds to the test lab. The other, a control sample, is transported to direct to storage. Once it enters the lab, the parent sample is placed in an automated sampling system, which automatically extracts, codes, and prepares smaller “child” samples. The child samples are assembled into batches of 80 and loaded into automated test equipment.

Because Avee's lab is less than two years old, it has standardized on the latest liquid chromatography (LC) equipment. And, while the results of liquid chromatography offer no advantage over gas chromatography in terms of test accuracy, the liquid chromatography process eliminates the need to gasify samples and, therefore, produces precise results from liquid samples far more quickly. According to Slattery, a comprehensive confirmation panel can be provided for a sample in just 14 minutes. Processing an entire batch of 80 samples occupies each of the many automated LC testing rigs for hours, so test batches are typically run on an overnight basis.

While customers may select from a wide range of testing options, Avee's process dictates consistency. According to Slattery, all samples that enter the lab undergo a wide range of tests, with computerized results extracted and reported to the customer for only the range of screening or confirmation results that the customer has requested. At the conclusion of the lab testing process, all remaining parent/child sample materials are taken to storage, where they are saved along with the control sample for a specified period to complete the sample's required chain of custody.

Instant screen results prompt provider-patient exchange

While no instant drug screening method can rival the precision and accuracy of a lab-based confirmation test, instant screening tests continue to play an important role in the relationships between providers and patients, explains Brian Slattery, a vice president at Avee Laboratories (Clearwater, Fla.).

“The benefit of the instant screen is that both patients and providers can see a positive result. It's a situation that could promote some questions if an unexpected substance is found,” he says. And, while the implications of an unexpected positive are obvious for a patient in addiction treatment (a breach of sobriety), the implications for a pain management patient could be even more serious.

Slattery adds that identifying an unexpected metabolite-or discovering that an expected metabolite is absent-provides vital information to a provider. Such a result “indicates to the provider that there could be an unknown substance of abuse, a diversion or lack of compliance involving a controlled substance, or presence of a substance that could cause a negative interaction.” The results also “might signal that the treatment relationship has changed and provide reason for a prescriber to put a refill on hold, pending further information.”

Confirmation testing is just that-a far more sensitive testing method used to validate any “instant” screening (yes/no) with a quantified value for the substance in question.

Avee processes about 25,000 samples per month. Because virtually all of its equipment has been purchased within the last 18 months or so, it is equipped exclusively with liquid chromatography-which can provide a comprehensive confirmation panel for a sample in just 14 minutes. Due to sample processing volume, however, each 80-sample test runs overnight.

Avee's tests target a broad range of substances, because, says marketing manager Jody Lewis, “addicted individuals might take just about any substance to get high.”

Topics