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We have developed a standardized platform that enables more sensitive and
less expensive testing for a variety of biomolecules, including bacteria,
viruses, toxins, bioterrorist agents such as anthrax spores, and prions. The
assay combines two proven methods, reporter bacteriophage technology, and
Enzyme linked Immunosorbent Assay (ELISA) into one integrated method. The
integrated technology, known as the Bacteriophage Linked Immunosorbent Assay
(BALISA) harnesses the signal amplification produced by bacteriophage
amplification, and enzymatic cleavage of a substrate to produce a very
sensitive assay, capable of rapid detection of the target biomolecule. See
the US patent application
UA20070054292A1, patent issued under 7,276,332.
All immunoassays, regardless of their format or usage, require a reliable
and sensitive detection system. t\The most sensitive immunoassays are
radioimmunoassays. However, the ELISA is the most widely used. ELISA assays
rely on enzyme catalyzed detection, and typically employ colorimetric
substrates that result in color formation. The enhanced sensitivity enabled
by the BALISA will greatly improve the quality of immunologically based
tests. The sensitive detection afforded by the BALISA offers other
advantages over existing technologies. If one chooses to trade off
sensitivity for a shorter assay time period, use of ultra-sensitive
detection technology enables faster measurement of analytes. Finally,
ultra-sensitive detection technology enables one to further dilute difficult
samples such as meat. This improved sensitivity is especially critical in
the detection of biomolecules which may be present in low concentrations,
such as prions or microorganisms that have a very slow generation time, such
as Mycobacterium tuberculosis. The BALISA consists of a reporter
bacteriophage that has been genetically modified to carry the lacZ reporter
gene, which encodes for β-galactosidase. The availability of the different
classes of substrates (colorimetric, fluorescent, or luminescent)for β-galactosidase
allows the BALISA to become extremely versatile. For example, if the BALISA
was used in a field setting where it would be difficult to employ the use of
instrumentation, the colorimetric substrate could be employed, enabling
visual detection of the test result. If the reporter assay was conducted in
a laboratory, where the use of instrumentation is more practical, the
fluorescent or luminescent substrates could be utilized, allowing for more
sensitive detection of the biomolecule in question. The reporter
bacteriophage is further modified, such that any biomolecule binding moiety,
such as an antibody or aptamer, is specifically attached to the capsid of
the bacteriophage. The reporter bacteriophage remains infectious, because
the ligand is specifically attached to the capsid (head of the bacteriophage),
allowing the tail fibers to remain free. The technology has been developed
using bacteriophage T4, but any bacteriophage could be utilized in the
BALISA.
Like an ELISA, a BALISA is an antibody sandwich capture assay in which one
antibody is immobilized and serves to capture a ligand while a second
antibody, which binds to a different epitope on the ligand, is used for
quantitation. In ELISA, the second antibody is labeled with biotin so that a
streptavidin/enzyme conjugate can be used to produce the signal. In BALISA,
however, the second antibody is attached to the capsid of the reporter
bacteriophage (to produce a bacteriophage linked antibody (BLA)). Therefore,
when the secondary antibody binds to the target ligand, the reporter
bacteriophage is also bound to the ligand via its capsid. After several wash
steps to remove any unbound BLA, a helper bacteria (E. coli JM109 or similar
lacZ- strain), and a β-galactosidase substrate is added. The reporter
bacteriophage will infect the helper bacteria and produce copies of itself,
and at the same time, produce multiple copies of β-galactosidase, which is
detected by cleavage of the substrate. The BALISA is outlined in Figure 1
below.

The advantages of this system over other systems are numerous. The major
advantage is sensitivity. Since the detection aspect of the assay is based
on bacteriophage replication and enzymatic cleavage of a substrate, the
assay has two built in signal amplification steps. It is clear that many
bacteriophages can bind to a single target ligand. Therefore, the
sensitivity of this assay should be vastly superior to other methods because
as few as 10-100 bacteriophages would be able to produce a detectable
signal. In practical terms, this means that the system should be able to
directly detect 10-100 particles of the target ligand, and the actual
detection number is expected to be lower than that, since more than one
bacteriophage will bind to a single ligand. In addition, the method
described here, in which multiple assays can be produced from a single
bacteriophage is advantageous, and cost effective, because the assays can be
produced based on a standardized platform. Also, the choice of different
substrates imparts a versatility on the BALISA not observed with other
tests. The use of colorimetric substrates would allow for the test to be
performed in the field without instrumentation. While the colorimetric
substrates are the least sensitive, the bacteriophage amplification and
enzymatic cleavage steps will still allow for sensitive detection of the
target ligand. The luminescent substrates allow for extremely sensitive
detection of the target ligand. We are currently developing the BALSIA so
that it can be read using handheld luminometers, thereby allowing for very
sensitive detection of the target ligand in the field. Handheld luminometers
are already widely used in the pharmaceutical and food industries for
hygiene monitoring.
If your company would like to learn more about this technology and how your
company may apply it in commercial or industrial situations or even sponsor
a research project to help reduce it to practice, please contact the
director of the University of Wyoming Research Products Center,
Davona Douglass.
Research Products Center
Dept. 3672
1000 E. University Ave.
Laramie, WY 82071
(307)766-2520
Fax: (307) 766-2530
e-mail: WyomingInvents@uwyo.edu