cobas® TV/MG

Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems

IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> TV/MG
Proven efficiency giving you the freedom to do more

Sexually transmitted infection rates are increasing.1 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.

Also validated for use with male urine and clinician-collected and clinician-instructed self-collected meatal swab** specimens.

* TV only
** MG only

 

Simplicity and flexibility to meet varying throughput and workflow requirements

  • 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

Trichomonas Vaginalis
Intended Use

cobas®  TV/MG on the cobas®  5800/6800/8800 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.

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

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    Technical Documents

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