Biomedical Engineering Reference
In-Depth Information
Table 22.3
Manufacturers of Salivary Hormone (ELISA) Test Kits
Company
Country
Web Site
DRG
United States
www.drg-international.com
IBL Hamburg
Germany
www.ibl-international.com
Hoelzel Diagnostika
Germany
www.hoelzel-biotech.com
Diametra
Italy
www.diametra.com
Alpco
United States
www.alpco.com
IBL America
United States
www.ibl-america.com
ELISA test kit from OraSure, the Immunalysis Quantisal
Device and ELISA test kit, the Oasis
Diagnostics
s
VersiSAL
s
Device and Neogen/IDS ELISA microplate kits, as well as the Neogen
UltraSal-2
t
t
Collection Device and associated ELISA kit from Neogen.
22.2.1.5
Applications of saliva in molecular diagnostics
22.2.1.5.1
DNA
DNA Genotek (Ottawa, Canada,
www.dnagenoetk.com
) was the first company to commercialize a
broad-based tool for the collection of saliva with subsequent application in genotyping, microar-
rays, and sequencing. Collection of (whole) mouth saliva into DNA Genotek's OraGene
device
takes 10 min after which pure DNA is isolated from the stabilized sample and used in one of the
above-mentioned downstream applications. Until recently, this device was used specifically for
research applications; however, the device was recently cleared by the US FDA for clinical use in
conjunction with the GenMark Diagnostics eSensor Assay for Warfarin sensitivity. The OraGene
device has also found application in the high-profile “direct to consumer” area where companies
such as 23 and Me, Navigenics, Complete Genomics, Knome, and Pathway Genomics offer “per-
sonal genome” testing to members of the public. Newer tools in this area include the DNA isola-
tion and stabilization kits from Isohelix (
www.isohelix.com
) and Norgen Biotek Ontario Canada
(
www.norgenbiotek.com
)
and the DNASAL
s
t
Salivary DNA Collection Device from Oasis
Diagnostics
(Vancouver, United States,
www.4saliva.com
)
.
OralDNA Labs (
www.oraldna.com
), a subsidiary of Quest Diagnostics, offers a testing service
in the United States for two tests in its Clinical Laboratory Implementation Act (CLIA)-approved
testing facility in Brentwood, Tennessee. My PerioPath
s
is promoted as a “Salivary DNA Test
that determines the risk of periodontal infections” and is based upon the detection of a series of
bacterial pathogens in saliva. OraRisk HPV
s
is a “Salivary DNA Test that determines who is at
increased risk for HPV-related oral cancers” and identifies various HPV subtypes as low,
medium, or high risk as an indicator of overall risk for HPV-related oral carcinoma. Each patient
gargles a solution, which harvests DNA, that is subsequently transferredbyafunneldeviceintoa
transportation tube that is sent to the laboratory for downstream testing.
s
