Cepheid, a US-based molecular diagnostics company, has received approval from the US Food and Drug Administration (FDA) to market its updated Xpert MRSA/SA Blood Culture (BC) test.
Running on the fully-integrated, self-contained and automated platform, GeneXpert System, the Xpert MRSA/SA BC test processes blood culture specimens to identify whether a patient’s blood is infected with either Methicillin-resistant Staphylococcus aureus (MRSA) or Staphylococcus aureus.
Conventional culture methods take anywhere between 24 and 48 hours, but the Xpert MRSA/SA BC test takes less than one hour.
This will help physicians, microbiologists and pharmacists manage sepsis effectively and quickly. It is estimated that sepsis is one of the top ten leading causes of death in the US.
Cepheid chairman and CEO John Bishop said the updated Xpert MRSA/SA BC test along with the GeneXpert System offers the ability to obtain specific accurate results.
Cepheid vice president for scientific affairs Dr Fred Tenover noted that having the capability to differentiate MRSA, S. aureus and CoNS rapidly in blood culture specimens is a major responsibility of the clinical laboratory.
"The clear advantage of the three target detection algorithm in the Xpert MRSA/SA BC test is the direct identification of both MRSA and S. aureus in approximately one hour," Tenover added.
According to the recent CDC data, S. aureus (including MRSA) is the most common cause of central line-related bloodstream infections and, along with coagulase-negative staphylococci (CoNS), comprises nearly 24% of all central line infections.
The GeneXpert System combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions to provide an integrated and automated nucleic acid analysis.
Designed to purify, concentrate, detect and identify targeted nucleic acid sequences, it offers results directly from unprocessed samples.