Biomedical Engineering Reference
In-Depth Information
Systems, Inc. (SDS, Vancouver Washington). These two companies commercialized devices for
saliva collection in the early 1990s, and these devices continue to be in widespread use for specific
applications today. In addition, the products developed by these companies led to a much broader
interest in saliva as a diagnostic fluid, and since then a plethora of new tools have become available
that has greatly expanded the applications and opportunities for salivary diagnostics. This chapter
attempts to cover the potential uses of saliva that have been explored so far and provides an indica-
tion of what can be expected in the future as the role of salivary diagnostics grows in an exponen-
tial fashion.
22.2.1
Saliva diagnostic assays in the market to date
22.2.1.1
HIV
Currently the OraSure
s
HIV-1 Oral Fluid Collection Device is available in conjunction with a
newly FDA-approved HIV 1/2 ELISA kit from Avioq Diagnostics for laboratory HIV testing.
A second oral-based test from Bio-Rad (the GS HIV 1/2 plus O ELISA) is also available for HIV
diagnosis using saliva. In each case, results are confirmed by a definitive laboratory-based oral fluid
(Western blot) test also manufactured by OraSure. Current markets for the OraSure HIV-1 test
device include public health screening, surveillance, and a very large market in insurance risk
assessment. In 2000, OraSure Technologies also launched the very first rapid diagnostic test for
HIV diagnosis using oral fluid specimens. The OraQuick
s
HIV 1/2 device is an immunochromato-
graphic test that delivers results in 20 min or less at the point of care. OraQuick
s
HIV 1/2 collects
saliva around the gum line under the lip area, using a paddle-shaped device, which incorporates a
proprietary test strip in the handle of the device (
99.5% sensitivity). This test may soon receive
FDA approval for over-the-counter use (reference: Washington Post, May 14, 2012).
.
22.2.1.2
Drugs of abuse
OraSure Technologies is also a major player in the drugs of abuse area. The Intercept
s
Collection Device is used to collect saliva, which is immediately reflexed to a laboratory and
tested for a range of drug entities using ELISA tests originally developed by the company.
Currently, the predominant tests are the NIDA-5 series of drugs (cannabinoids (THC), opiates,
amphetamines, cocaine, and phencyclidine (PCP)); however, there are now also applications for a
number of drugs tested for by a variety of companies. One of the other most successful companies
is Immunalysis, who provides a range of microplate ELISA assays that are optimized for oral
fluid samples. Examples of other drugs of abuse in the market are tests for buprenorphine, metha-
done, and benzodiazepines, among others. In some cases it is parent drug that is detected, whereas
in others it is a metabolite of the parent compound that is quantified. The current major applica-
tions include the workplace testing environment (including the Federal workplace), drug courts,
methadone clinics, and military applications.
Newer devices are now entering the market, and these include the VersiSAL
Saliva Collection
Device (Oasis Diagnostics,
www.4saliva.com
, Vancouver, WA), which has been validated for use in
the forensics area with ELISA test kits from Neogen Corporation (
www.neogen.com
,
Lansing,MI)
and its subsidiary company, International Diagnostic Systems (IDS, St. Joseph, MI) and the Greiner
s
