cobas® Babesia

Roche's first whole blood PCR test for donor screening

cobas Babesia test

Detect four species of Babesia known to cause disease in humans

The cobas® Babesia test is able to detect four common species of Babesia and uses Roche’s new whole blood collection tube, which simplifies Babesia sample preparation by consolidating steps within the tube itself to provide an efficient solution for testing laboratories. 

The test is a real-time PCR test for the direct detection of Babesia (B. microti, B. duncani, B. divergens, B. venatorum) DNA and RNA in whole blood samples.

Features and Benefits

  • Real-time detection of Babesia
  • Covers four species in a single test (B. microti, B. duncani, B. divergens, B. venatorum)

 

Streamline your workflow and ensure reliable results with automated testing

 

  • Ready-to-use reagents - no thawing, pouring or mixing required
  • Stabilized real-time PCR reagents do not require calibration
  • Full-process internal control helps ensure result integrity
  • True external positive controls with cobas® Babesia Control Kit that have no direct effect on result calculation
  • Can be run simultaneously with other assays on the cobas® 6800/8800 Systems

Intended use

Intended use for cobas® Babesia test

The cobas® Babesia test for use on the cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Whole blood samples from all donors may be screened as individual samples.

This test is not intended for use as an aid in diagnosis of Babesia infection.

This test is not intended for use on samples of cord blood.

This test is not intended for use on cadaveric blood specimens.

Intended use for Roche Whole Blood Collection Tube

The Roche Whole Blood Collection Tube is a direct draw whole blood collection tube. It is intended for the collection, transport, storage and lysis of whole blood and subsequent stabilization of DNA and RNA for use with the cobas® Babesia nucleic acid test for use on the cobas® 6800/8800 Systems (cobas® Babesia). It is used in settings where a venous blood sample is collected by a trained healthcare worker.

Registration status

US-IVD

 

Disclaimer: please consult your local Roche representative for information on the cobas® Babesia test in your country.

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