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rapid test for bloodstream infections (PhenoTest BC Kit)
Indications:
- suspected sepsis
Procedure:
- uses proprietary instrument (Pheno System) for analysis
Clinical significance:
- identify 14 different species of bacteria or 2 species of yeast from blood in ~90 minutes
- can provide antibiotic sensitivity on 18 selected antibiotics for a subset of the identified organisms in 6-7 hours
- identifies presence of 2 indicators of antibiotic resistance
Complications:
- false positives
- correct identification of pathogen in >95% of cases
Mechanism of action:
- identifies genetic material in blood homologous to DNA known to be unique to specific bacteria or yeast
General
clinical microbiology test
References
- FDA News Release. February 23, 2017
FDA allows marketing of test to identify organisms that cause
bloodstream infections and provide antibiotic sensitivity results.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm543150.htm