Roche Molecular Diagnostics' microbiology-related PCR-based testing products include an FDA-approved in vitro diagnostic test for the rapid and reliable detection of M. tuberculosis in untreated patients who have AFB (Acid Fast bacilli) positive smear results within hours as opposed to weeks with conventional culture methods. Roche also offers detection kits for two of the most common non-tuberculosis bacteria, M. avium and M. intracellulare (MAC).

In addition, Roche is developing a portfolio of assays for screening and diagnosis of Healthcare Associated Infections. The first assay to be introduced in this field is the LightCycler® SeptiFast Test MGRADE, which provides species identification within 6 hours of pathogens causing blood stream infections*.

Please note: Not all products are available in all countries.

Diagnostic Assays

• Bacterial and fungal detection
  LightCycler® SeptiFast Test MGRADE *
• Detection and identification of mecA DNA in human K-EDTA-blood
  LightCycler® SeptiFast MecA Test MGRADE *
• Mycobacterium tuberculosis detection
  COBAS® TaqMan® MTB Test *
  COBAS® AMPLICOR MTB Test *****
• Mycobacterium avium detection
  COBAS® AMPLICOR M.avium Test **
• Mycobacterium intracellulare detection
  COBAS® AMPLICOR M.intracellulare Test **

Kits for Research

Kits are available for the following parameters:

• mec A detection (MRSA)
  LightCycler® Research Use Only MRSA Detection Kit ***
• vanA/B detection (VRE)
  LightCycler® Research Use Only VRE Detection Kit ***
• Staphylococcus aureus and coagulase-negative Staphylococcus spp. (CoNS)
  LightCycler® Staphylococcus Research Use Only Kit MGRADE ***
• S.E.T.S II Kit ****
• S.T.A.R. Buffer ****

Instruments

• Automated amplification and detection
  COBAS® AMPLICOR Analyzer
• Realtime PCR
  LightCycler® 2.0 Instrument
  COBAS® TaqMan® 48 Analyzer
• MagNA Pure LC Instrument ****
• MagNA Lyser Instrument ****

* Not available in the United States
** Available only in Japan
*** For Research Use Only. Not for use in diagnostic procedures. Not available in the United States.
**** For General Laboratory Use. For in vitro use only
***** Not available in the United States; Available in Japan