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FDA OKs Rapid Test for Bloodstream Infections

The US Food and Drug Administration (FDA) today gave market clearance today to PhenoTest BC Kit (Accelerate Diagnostics), which rapidly identifies pathogens that cause bloodstream infections as well as antibiotics that might work against them.

With a quicker turnaround in test results, clinicians can treat bloodstream infections much sooner, critical in staving off sometimes fatal complications such as septic shock, the agency said in a news release.

Traditional tests to identify sources of bloodstream infection and discern their susceptibility to antibiotics may take 24 to 48 hours to deliver results. In contrast, the PhenoTest BC Kit, performed on the manufacturer’s Pheno system, can identify 14 different species of bacteria or two species of yeast from a positive blood culture in about 90 minutes. In another 6 to 7 hours, it delivers results on antibiotic susceptibility. The test also picks up on two indicators of antibiotic resistance.

The FDA greenlighted the PhenoTest BC Kit based on the manufacturer’s primary clinical study of 1850 positive blood cultures. The test correctly identified bacteria or yeast in the cultures 95% of the time, and proved accurate in assessing antibiotic susceptibility when compared to traditional tests.

The PhenoTest BC Kit comes with the risk of false positives, so results should always be interpreted in light of additional lab tests, according to the agency.

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