Biomedical Engineering Reference
In-Depth Information
3.
Provision of a hard copy of test results for evidentiary purposes
4.
Faster acquisition of test results
5.
Provision of a secondary (“B”) sample for confirmation and anticorruption practices
Several companies have tried to solve the above problems and have met with limited commercial
success. The most notable companies are Cozart Biosciences (United Kingdom,
www.concateno.
com
,
now Alere, Inc.), Securetec (Germany,
www.securetec.net
)
, and Mavand (Germany,
www.
mavand.com
)
. While these companies have met with partial commercial success, additional improve-
ments will allow these manufacturers to meet the requirements of an EU organization known as
ROSITA (ROadSIde Testing Assessment) for use at the roadside (
www.ROSITA.org
)
. ROSITA is an
independent body that evaluates all drug testing devices with potential application in law enforce-
ment. ROSITA was set up to address the $164 billion annual cost in the European Union of “drivers
who are under the influence of drugs.” While all devices come under the scope of ROSITA, the
strong preference is for oral-based tests that are user friendly and will be adopted by all police forces
in the world.
22.2.1.3
Steroid hormones for general wellness
Saliva is an ideal medium for hormone assessment, and this has resulted in quite an “explosion”
in the number of laboratories testing for specific hormones. Driven by naturopaths, herbalists,
and nontraditional practicing physicians, a large and thriving market has developed where multi-
ple laboratories provide “saliva collection kits” direct to consumers. Responding to advertise-
ments in magazines focused on general health, nutrition, and fitness, customers are sent a kit in
the regular mail that allows them to collect their own saliva (usually into a saliva cup) and send
thesamplebacktoacentralizedlaboratory where the results are evaluated for cortisol, testoster-
one, progesterone, estradiol, dehydroepiandrosterone (DHEA), and others and the results reported
back to the individual as “normal” or “abnormal” together with recommendations on any follow-
up actions. Perhaps this would include joining a fitness program or consulting a doctor because
the level of a particular hormone is outside of the accepted “normal range,” but since no diagno-
sisisgiven(justtipsandrecommendations related to general health status), these tests fall out-
side of the realm of “diagnostic tests.” Among hormones tested clinically, cortisol is by far the
largest due to the correlation of cortisol levels to stress and the growing hypothesis that stress is
implicated in many chronic diseases, such as cardiovascular diseases, infectious diseases, and
others.
Salimetrics Corporation (United States,
www.salimetrics.com
) has an FDA-cleared salivary cor-
tisol (ELISA) assay kit and also sells a complete range of salivary hormone assays optimized to
saliva specimens (
Table 22.3
).
22.2.1.4
Cotinine
Cotinine, the active metabolite of nicotine, is evaluated in smoking cessation programs and is used
as a key indicator of risk in life insurance testing. Urine and salivary cotinine can be evaluated
using a series of ELISA test kits. Available systems include the OraSure Collection device and
