Biomedical Engineering Reference
In-Depth Information
Bio-One Saliva Collection System ( www.grienerbioone.com , Vienna, Austria]. Neogen also has its
own large method of collecting saliva known as UltraSal-2
, which has been validated to oral fluid
specimens for multiple Neogen drug assays for the forensic market place. As well as traditional labo-
ratory ELISA procedures, there are other technologies for drug screening that have moved to oral
fluid testing. One such technology for rapid, high throughput testing is homogeneous immunoassay
performed on large instrument platforms. Examples of companies providing such technologies
includes Thermo Scientific ( www.thermoscientific.com ) , who provide multiplex testing for the
NIDA-5 drugs using the Oral-Eze Saliva Collection Device from Quest Diagnostics ( www.questdiag-
nostics.com ) and its own CEDIA reagents optimized for oral specimens. The Thermo Scientific
reagents are optimized for a series of automated analyzers. A similar technology is available from
Roche Diagnostics ( www.roche-diagnostics.us ) , through collaboration with OraSure Technologies. In
this instance, collection of specimens using the OraSure Intercept
t
Collection Device is followed
by homogeneous immunoassay using Roche's KIMS (Kinetic Interaction of Micro-particles in
Solution) technology. Four drug assays are now FDA cleared and on sale in the United States for
multiple automated systems.
It is beyond the scope of this chapter to list all of the many available rapid oral drug screens,
but some of the manual point-of-care tests that are available are shown in Table 22.2 for reference
purposes.
There is a need and a market for roadside testing for drugs of abuse; however, currently avail-
able tools (mostly qualitative lateral flow-based systems) require additional improvements in order
to provide value in law-enforcement decision making and these are as follows:
s
1. Improvement in the sensitivity for key drugs, for instance, marijuana (tetrahydrocannabinol,
THC), where a cutoff close to the SAMHSA (Substance Abuse Mental Health Services
Administration) cutoff of 4 ng/mL is needed
2. Linkage to a hand-held reading device to eliminate any subjectivity in reading test results
Table 22.2 List of Representative Rapid Oral Drugs of Abuse Tests/Manufacturers
Manufacturer
Web Site
Product Name
American Biomedica Corporation
www.abmc.com
OralStat
JAJ Scientific
www.jajinternational.com
QikTech
Innovacon (Alere)
www.innovaconinc.com
OrALert
Mavand
www.mavand.com
RapidSTAT
Envitec
www.envitec.com
SmartClip
Sun Biomedical
www.sunbiomed.com
OraLine
Branan Medical
www.brananmedical.com
Oratect XP
Ulti-med
www.ultimed.org
SalivaScreen
Varian
www.varian.com
OraLab 6
Securetec
www.securetec.net
DrugWipe 6
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