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Roche's cobas Epstein-Barr Virus Test Receives the US FDA's Authorization for Transplant Patients

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Roche's cobas Epstein-Barr Virus Test Receives the US FDA's Authorization for Transplant Patients

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  • The US FDA has granted de novo class II for cobas EBV test- providing HCPs a tool for monitoring transplant patients at risk for complications from infections or reactivations of EBV
  • The cobas EBV test is a PCR viral load test that runs on the fully automated and widely available cobas 6800/8800 systems and has been calibrated to WHO’s international standard
  • The test has received the FDA’s BDD and has robust coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL-1E+08 IU/mL in EDTA plasma

­ Ref: Roche | Image: Roche 

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