FDA Allows Marketing of Automated Antibiotic Sensitivity Test for Bacteremia
The blood culture kit can simultaneously detect and identify 14 different species of bacteria and two species of yeast that cause bloodstream infection.
The Food and Drug Administration (FDA) has approved the PhenoTest BC Kit (Accelerate), the first test to identify pathogenic bacteria commonly associated with bacteremia and provide antibiotic sensitivity results.
The PhenoTest BC Kit can identify bacteria or yeast from a positive blood culture in about 1.5 hours, producing results up to 40 hours faster than conventional methods.
For certain organisms, the test can provide information that helps guide treatment decisions in approximately 6.5 hours after the organisms have been detected.
The blood culture kit can simultaneously detect and identify 14 different species of bacteria and two species of yeast that cause bactermia, while also providing antibiotic sensitivity information on 18 selected antibiotics for a subset of the identified organisms as appropriate. The test can also identify the presence of two indicators of antibiotic resistance.
Approval was based on a clinical study that included more than 39,000 tests conducted on 1,850 samples across 13 trial sites. The study showed overall sensitivity of 97.4% and specificity of 99.3% for identification. Results for testing whether the bacteria were sensitive to antibiotics were also accurate when compared to traditional tests.
Risks associated with use of the PhenoTest BC Kit include false positive findings; results should always be interpreted alongside additional laboratory test results.
The PhenoTest BC Kit is performed on the Accelerate Pheno System.
FDA allows marketing of test to identify organisms that cause bloodstream infections and provide antibiotic sensitivity results [news release]. Silver Spring, MD: US Food and Drug Administration Press Office; February 23,2017. Accessed February 27, 2017.