Analytical Framework for Examining the Value of Antibacterial Products. 5 Rapid Point-of-Care (POC) Diagnostics

04/15/2014

There is a need for specific and inexpensive rapid point of care (POC) diagnostic tests that can be used for clinical management of infectious diseases.  Diagnostics are important as they allow tailoring treatment with antibacterial drugs, reducing unnecessary antibacterial drug use and thereby delaying the development of antibacterial resistance.  However, the tools need to be readily available at point-of-care and cost-effective, such as the rapid strep test.  Additionally, the tools that work best are technologies that can be used across the entire patient population.  Given the potential complexity of some of these tests, there also needs to an educational component so healthcare practitioners know how to use the tests and be able to interpret the test results.

At present, it takes about 3 days (and sometimes a week) to identify organisms.  If such tests could be done more expeditiously, physicians can institute a narrower antibacterial drug therapy relieving the pressure in terms of selecting resistant organisms (by using antibacterial drugs that are ineffective against the organism, one starts selecting out mutants that are more resistant and become more resistant over time).

The different types of rapid POC diagnostic tools for bacterial diseases currently available in the market may be imperfect; they may be costly, not particularly fast, or otherwise limited in scope.  Some of these diagnostics include:

  • PNA FISH test – The test is done on a positive blood culture and reportedly returns results in 24-36 hours.  Additionally, laboratories reportedly have found it difficult to incorporate this test into their workflow.
  • BioFire Diagnostics FilmArray® System – This molecular assay can identify 17 viruses and 4 bacteria within an hour, but currently costs around $300 (although price will likely go down in the future).
  • Procalcitonin (PCT) – This is a test used in some hospitals to diagnose sepsis or to rule it out.  However, because the test does not reveal whether the infection is multi-drug resistant, it is not widely adopted.

One of the challenges that relate to the use of rapid POC diagnostics is the existence of a range of organisms residing on the body without causing infections, which makes it difficult to pinpoint which bacteria are actually causing the infection.  By adjusting the cut-off result in molecular assays to distinguish colonized from organisms actually causing the signs and symptoms of infection, this issue has been partially mitigated.  However, this factor may impact the acceptance of rapid POC diagnostics by healthcare providers.

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