By Louise Lazear

While the United States war on drugs takes a back seat to the military campaign in Afghanistan, the number of U.S. drug abusers continues to grow. In fact, an estimated 14 million Americans use illicit drugs, according to the 2000 National Household Survey on Drug Abuse. Of the estimated 11.8 million adult drug users, 77 percent were employed in either full- or part-time work.

In light of heightened security precautions since the events of September 11 and a flood of candidates for a diminishing numbers of jobs, employers are more enthusiastic than ever about embracing drug screening tools that provide accurate, non-alterable results. Urine testing has long been the gold standard specimen for drug testing, but hair and oral fluid may offer advantages in convenience and cost. Draft federal guidelines for specimen validation, proposed alternative specimen matrices and point-of-collection testing (POCT) regulation and a move by the FDA to regulate onsite screening devices point to a challenging year ahead for specimen donors and specimen evaluators.

Workplace safety
Drug testing was initially implemented to increase workplace safety among federal and federally-regulated employees such as airplane pilots and the drivers of large 18-wheeler trucks. The National Institute of Drug Abuse developed guidelines to ensure uniformity among participants, and then passed on responsibility to the Substance Abuse and Mental Health Services Administration (SAMHSA) of the Department of Health and Human Services (HHS). SAMHSA is responsible for standardization of federally regulated workplace drug testing programs. Although workplace drug testing in the private sector is not regulated by CLIA 88 or HHS, government standards significantly influence the market. In the United States, upwards of 45 million tests are performed annually, generating revenues of $800 million to $1 billion, and $1.5 billion worldwide. Despite all that testing, less than five percent of tests performed produce positive results.

Specimen adulteration
With many jobs today requiring at least a pre-employment drug test, there’s plenty of motivation and methods for beating the system. Urine adulteration, as any reader of High Times can tell you, is almost as popular as urine screening. In response to the estimated $40 million drug test adulteration market, HHS has proposed new rules requiring validation of all urine specimens prior to testing. They include determination of creatinine concentrations, pH and a general assessment for oxidizing adulterants. Specific gravity determinations and testing for specific adulterants are required under certain conditions. According to Yale Caplan, Ph.D., director of National Scientific Services and a member of the scientific team developing urine specimen validity standards, most laboratories perform some type of validation testing, but there is no consistency. “Right now, some labs do it automatically on all specimens, and some do it only if the client asks for it…The rule will make it uniform. The problem with all this is the cost.” The proposed regulations, which add at least three additional tests to workplace drug programs, are scheduled to come into effect in the next few months.

Another factor propelling HHS to address this issue, is the greater market acceptance of POCT, according to Ted Shults, chairman of the American Association of Medical Review Officers (AAMRO). “We’ve seen for four or five years now the development of point-of-collection onsite urine tests, which for screening purposes, are beginning to give you almost equivalent efficacy found in a laboratory assay.” Based on input from stakeholders such as federal agencies, service providers and manufacturers, HHS proposed new POCT guidelines that address cut-off concentrations, requirements for collection and chain-of-custody issues. For federally-mandated programs, HHS proposes that POCT devices be cleared by FDA and included in the HHS Conforming Products list.

With all its advances in sensitivity and efficacy, many agree that the remaining challenges for point-of-care testing are specimen collection, integrity and chain of custody issues. Consequently, future technical developments will likely focus on integrated “hands-off” testing methods that minimize human intervention and provide higher accuracy, according to Steve Przybylski, vice president at LifeSign, a manufacturer of POCT devices.

While urine maintains its position as the gold standard, a surge of alternative specimen matrices has prompted HHS to propose additional guidelines. Using urine testing as a benchmark, these draft guidelines address use, assay sensitivities, specimen collection and chain-of-custody issues for oral fluid, hair and sweat patch testing because the distinct properties of each specimen type impact its application. “When you go from urine to hair, or urine to oral fluids, you are really measuring something different. For example, oral fluids give a better measurement of impairment but with a narrow window of exposure. Hair testing doesn’t give you much information on impairment, but provides a much longer window of exposure. The integration of these new technologies with policies and objectives is an important consideration,” said Shults.

Tamper-proof methods
Thus, manufacturers strive to develop accurate, tamper-proof methods that offer ease of collection and lower costs. For example, Avitar Inc. of Canton, Mass., offers both a hair and an oral fluid method for workplace (forensic use only) drug testing programs. While hair testing provides a 90-day history of drug use and is performed under direct observation with little threat of adulteration, market acceptance is a major hurdle. “Urine testing is the gold standard. One of the biggest challenges is getting clients to accept or perceive value in an alternative matrix,” said Matt Andrie, director of marketing at Avitar. However, manufacturers also believe that economics will eventually drive the market. “Using alternative matrices provides significant cost savings, and there will be tremendous economic pressure to accept the technology,“ said R. Sam Niedbala, Ph.D., chief science officer at OraSure Technologies in Bethlehem, Pa. Combining an oral fluid matrix with onsite technology is a major focus at OraSure. “In the U.S., 50 percent of the cost of drug testing is the cost of collecting and shipping the sample. If you can eliminate or reduce this, then you have changed the paradigm.” OraSure’s not-yet-FDA-approved UPlink Rapid Detection System is a POCT device that uses a proprietary technology to assess for drugs of abuse and infectious disease in a variety of biological samples.

Safety and economics are two reasons why FDA is making a move to regulate onsite drugs-of-abuse testing. In a draft guidance document, the federal watchdog agency proposes that screening tests used in the home, workplace, insurance and sports comply with OTC regulations. It also proposes that the cost of confirmatory testing be included in the price of the product. Some manufacturers and industry advocates balk at this, estimating that the OTC process alone would add $50,000 to $200,000 to the cost of a product. Others laud the FDA oversight as a guarantee that positive screens receive confirmatory testing automatically — a safeguard that anyone supplying a sample should have available. This issue is well worth watching, as advocates for each camp prepare their arguments. It all may come down to this — how would you feel if the sample in question came from the hair on your head?

Louise Lazear is a freelance writer in Charlotte, NC.