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New rule boosts POC drugs-of-abuse testing
Manufacturers
of drugs-of-abuse tests for use at the point of care (POC) are
preparing for a shake-up in the U.S. workplace testing market.
Test services in this $450 million market are dominated by 66
laboratories certified by the Substance Abuse and Mental Health
Services Administration (SAMHSA). The largest of these laboratories
are LabCorp (Research Triangle Park, NC), Quest Diagnostics
Inc. (Teterboro, NJ), and LabOne Inc. (Lenexa, KS).
The Department of Health and Human Services (HHS) and SAMHSA are in the process of revising the rules for workplace testing so as to establish procedures and conditions for on-site testing. The changes come in response to lobbying efforts by representatives of workplace testing programs and manufacturers of drugs-of-abuse tests that use samples other than blood (particularly those that use saliva).
HHS has been circulating a draft of its Mandatory Guidelines for Federal Workplace Drug Testing Programs since June 2000. The draft documents have been discussed at several meetings held in collaboration with manufacturers and representatives of workplace testing programs. Work on the final rule is under way, and it is expected to be published in the Federal Register within two years.
In 1999, some 30 million drugs-of-abuse tests were run in the workplace. Approximately 10 million of these tests were mandated by the workplace testing acts for employees in the transportation and other industries regulated by the Federal Transit Administration and the Department of Transportation (DOT). The remainder were conducted for workers in other industries. While those fields are permitted to establish their own testing procedures, they generally follow the lead of HHS.
"We are currently revising our existing procedures for drug testing, and while this does not apply to on-site testing in particular, it is appropriate for vendors to get ready for a change," says Mary Bernstein, director of the Office of Drug and Alcohol Policy and Compliance at DOT.
Formal workplace drugs-of-abuse testing began in 1988. At that time, the authorizing legislation required that all employee drug tests be processed by a federally certified laboratory. Despite the claims of POC test manufacturers, it was generally accepted that the tests available at that time did not meet the accuracy requirements of a stand-alone workplace drug-testing program.
Since 1988, that situation has changed. The availability of accurate and user-friendly drugs-of-abuse tests for use at the point of care has increased significantly. Further, employers have expressed frustration with long turnaround times for test results, giving rise to the need for more-rapid testing such as that potentially offered by POC devices.
The new HHS rule is not expected to open the door to just any POC device. Operators of such FDA-approved devices will be expected to comply with a number of on-site procedures, as well as test- and data-management criteria currently being established by SAMHSA. The rule is still far from final, but the following requirements appear to have gained general acceptance for use in regulating what HHS terms "point-of-collection" testing. (Summaries of the discussions held so far can be found at http://www.health.org/workplace.html)
- Both instrumented and noninstrumented FDA-approved tests will be evaluated by HHS and will be published in an approved-products list.
- Although there has been a discussion of electronic data storage for test results, the creation of requirements for electronic data interchange does not appear to be a priority at this stage in the rule-making process.
- Only two types of specimens will be permitted for POC testing–oral fluid and urine.
- Point-of-collection operators will have to be certified by a manufacturer or some other organization, each of which will itself have to be authorized by HHS.
- The donor will not be permitted to observe the point-of-collection test or to have access to the testing device. In the case of an integrated collection and test device, therefore, a separate sample collection container will have to be used, with an aliquot transferred to the testing device.
- Each test site will be required to perform daily quality assurance and quality control tests.
- Positive tests will require confirmation from a certified laboratory.
FDA-approved drugs-of-abuse tests for use at the point of care are already being marketed by more than 25 companies, but none of the tests has yet been authorized for on-site testing by SAMHSA or DOT (see sidebar). Companies that expect to perform on-site testing will need to have significant infrastructure in order to establish the required operator-training programs and to put in place continued surveillance and education systems. It is not expected that all such on-site testing programs will pass muster with HHS and SAMHSA. Further, it can be expected that devices with an instrumented readout will prevail in such testing sites, simply because such tests are not subject to interpretation by operators.
Major companies already involved in this market–Bio-Rad Laboratories (Hercules, CA), Biosite Diagnostics (San Diego), Dade Behring Inc. (Deerfield, IL), Roche Diagnostics (Indianapolis), and Toxi-Lab Inc. (Irvine, CA)–may have a clear advantage.
Among those developing the HHS rule, there has been considerable discussion about the lack of privacy and risk of sample alteration or sample inadmissibility associated with using urine samples. On the other hand, saliva can be collected on-site and on-demand without compromising the donor's privacy, making it nearly impossible to contaminate test results. For this reason, companies such as AnSys Diagnostics (Lake Forest, CA), Avitar Inc. (Canton, MA), Epitope/SDS (Beaverton, OR), and Lifepoint Inc. (Ontario, CA)–all of which have developed saliva-based drugs-of-abuse tests–may turn out to have a strong advantage when the final rule is established.–Shara Rosen
The InstaCheck point-of-care drugs-of-abuse test by Forefront Diagnostics Inc. (Laguna Hills, CA) is available in single-drug, multidrug, and multitest-panel formats.
