Clinical application

What would you do if you had the opportunity to deliver a revolutionary microbiology platform to the world? Would you first look at identifying environmental sources of bacterial contamination? Would you use the technology to help protect the nation's food supply? Would your first choice be protecting the health of production and companion animals? Would you use it to identify infections and screen high-risk patients in healthcare settings?

Although there are many potential applications for this technology, the area of greatest need now is in accelerating antibiotic susceptibility results to physicians as they treat patients with infections. With antibiotic resistance increasing and without new antibiotics to replace those that are decreasingly effective, doctors face huge challenges in selecting and optimizing appropriate antibiotics for their patients. Bacteriophage Amplification Technology (BAT^™) can accelerate bacterial identification and antibiotic susceptibility test (ID/AST) results to shorten the time to results by at least 24 to 48 hours. In critical blood stream infections, this time clearly translates to reduced hospital length of stay and better patient outcomes.

As the figure below illustrates, MicroPhage's proprietary bacteriophage amplification technology is well suited for many clinical applications where identification of bacteria and antibiotic susceptibility testing is of interest. Bacteriophage developed to be specific to a target species are supplied in our kit along with a proprietary growth medium. The clinical sample (blood, a body site swab, urine, or fecal material) is combined with the proprietary reagents, mixed, and allowed to incubate. During this incubation period (dependent on target species and sample type), bacteriophage "find" and amplify in viable target bacteria, producing an exponential increase in bacteriophage protein. The increase of this protein can easily be detected on a rapid immunoassay strip much like a home pregnancy test. The presence of a test line corresponds to the presence of the viable target bacterium through positive bacteriophage amplification.

Two tests are performed on the same detector. The first test lane includes no antibiotic, and therefore, tests only for the presence of the target bacteria (ID test). The second test lane combines antibiotic with the clinical sample and the amplification broth. If the antibiotic kills the target bacteria, or the bacteria are not present, the phage will not replicate (RS test).

If the ID test lane is positive:

A negative result on the RS test lane indicates the bacteria are Sensitive to the antibiotic.
A positive result on the RS test lane indicates the bacteria are Resistant to the antibiotic.

Do not read the RS test lane if the ID test lane is negative.

Preparation:

The clinical sample is combined with:

A proprietary amplification broth
Proprietary bacteriophage that target the bacteria in question
The antibiotic in question (antibiotic is present in the RS lane, only).

Incubation:

If the target bacteria is present, and not killed by antibiotic in the test, the bacteriophage will multiply exponentially more quickly than the target bacteria, themselves.

Detection:

The incubated sample is dispensed into a Lateral Flow Immunoassay that detects proteins that are phage specific.