cobas® ️TV/MG

Proven efficiency giving you the freedom to do more

Sexually transmitted infection rates are increasing. Now, more than ever before, differentiating between STIs is critical to ensure patients receive quick and effective treatment. cobas® TV/MG provides an efficient solution to meet the growing demand for STI testing by combining two key targets into one assay. With demonstrated assay performance across a broad set of specimen types, cobas® TV/MG provides an easy and convenient method for reliable STI testing.

Features and benefits

 

Exceptional assay performance
 
  • Highly sensitive test using a multi-copy exclusive target for TV and dual-target design for MG
  • Exceptional performance demonstrated in urogenital samples
  • Validated for IVD use for TV testing both male and female patients
 
Broader information for improved patient care decisions

 

  • cobas® TV/MG has been validated for use with female urogenital specimens, including urine, clinician-collected and clinician-instructed self-collected vaginal swab and endocervical swab specimens all collected in cobas® PCR media – and cervical specimens* collected in PreservCyt® Solution.
  • Validated for use with male urine and meatal swab** specimens.

* TV only
** MG only

 
Simplicity and flexibility to meet varying throughput and workflow requirements

 

  • Highest throughput molecular test for TV/MG on the market1
  • Onboard capacity of up to 4,608 TV/MG tests with onboard reagent stability of 90 days
  • Continuous loading of samples with no pre-sorting required for mixed test requests
  • Simultaneous processing of multiple tests from the same patient sample
  • Full automation and process control of all STI tests onto a single platform including LDTs­­

Trichomonas Vaginalis   

Trichomonas-Vaginalis

Mycoplasma Genitalium

Mycoplasma Genitalium

Intended use

 

cobas® TV/MG on the cobas® 6800/8800 Systems is an automated, qualitative in vitro nucleic acid diagnostic test that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.). cobas® TV/MG also detects TV DNA in cervical specimens collected in PreservCyt solution and MG DNA in self-collected meatal swab specimens (collected in a clinical setting) and clinician-collected meatal swab specimens. This test is intended as an aid in the diagnosis of TV and MG infections in individuals suspected to have TV or MG infection.

A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher sensitivity compared to endocervical swabs and urine. For males, urine is the preferred specimen type due to higher sensitivity compared to meatal swabs. If vaginal swab or male urine is not used and MG testing is negative, further testing with the preferred specimen type may be indicated if M. genitalium infection is strongly suspected.

Registration status

US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

References

1. Aptima HIV and HCV Package Inserts, Hologic Panther Manual, Abbott RealTime package inserts, CAP Today 2018 automation guide.  Actual workflow may vary by specific lab demands. Roche data on file.

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