Sexually Transmitted Infections and HPV Assays

A qualitative multiplex assay that simultaneously detects two CT independent DNA targets – one in the cryptic plasmid and the other on the CT genome. This design can detect infections caused by the wild type CT, the Swedish variant (nvCT), and other Chlamydia strains that may harbor deletions in the cryptic plasmid, or those that do not carry the cryptic plasmid.

DR-9, a direct repeat region and target of the NG assay, makes it highly specific to the NG species.

Features and Benefits

Easy to learn, easy to use

• Reduces labour costs and training time

• Intuitive software walks the user through the entire set-up process

• Bidirectional LIS connection protects results integrity and reduces repetitive tasks

Reliable results

•  Automated result algorithm provides clear positive, negative or invalid results

Quality control at every step

• An internal control utilizing an identical randomized internal target sequence is added to each sample and is used throughout the entire process, from sample preparation to amplification and detection

• The internal control minimizes the risk of false negative results due to inhibition

• The AmpErase enzyme degrades previously amplified targets, allowing sample prep and detection in the same lab

Intended Use:

The cobas® CT/NG for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens, clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens, and anorectal swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® Solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.

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

• 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

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 and female urine, clinician instructed self-collected vaginal swab specimens, 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 clinician instructed self-collected meatal swab specimens 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

cobas® BV/CV takes the entire sexual health panel (BV/CV, CT/NG, TV/MG) from one patient sample and runs it on the fully automated cobas x800 platform. This eliminates the need for multiple instruments and reduces hands-on time by allowing you to process all relevant tests from a single patient sample.

The BV/CV assay shall provide a qualitative result based on the detection of the associated targets of Bacterial vaginosis and/or the detection of Candida species

Vaginal specimen collected in cobas PCR media clinician collected and self collected specimens in a clinical setting

With an industry-leading 180-day open kit stability, our ready to load cassettes virtually eliminate reagent waste—empowering users to bring this vital testing to patients with maximum efficiency.

cobas® BV/CV for use 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 bacteria (Gardnerella vaginalis, Lactobacillus spp., and Atopobium vaginae) associated with bacterial vaginosis (BV) and yeast (Candida spp.) associated with candida vaginitis (CV) from clinician-instructed self-collected vaginal swab specimens and clinician- collected vaginal swab specimens, all collected in cobas® PCR Media. The assay amplifies specific DNA targets to detect organisms associated with BV (i.e., G. vaginalis, L. crispatus, L. gasseri, L. jensenii, and A. vaginae) and specific organisms associated with CV (i.e., C. albicans, C. dubliniensis, C. glabrata, C. krusei, C. tropicalis, and C. parapsilosis) but does not differentiate which BV and/or CV organism(s) is present. This test is intended as an aid in the diagnosis of BV and/or CV in symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both.

cobas® HPV Test: Delivering confidence with 3-in-1 HPV test results

The cobas® HPV tests are an automated qualitative in vitro test for the detection of human papillomavirus (HPV) DNA in patient specimens. The tests utilize amplification of target DNA by the polymerase chain reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk HPV (hrHPV) types in a single analysis.

HPV self-sampling

This solution enables a patient to privately collect a vaginal sample for HPV screening following instructions provided by a healthcare worker. The sample is then resuspended after collection in Roche Cell Collection Medium or PreservCyt® Solution. The vaginal sample is clinically validated for analysis with the Roche cobas® 4800 HPV Test on cobas® 4800 or cobas HPV test on a cobas® 5800/6800/8800 system.

Results you can trust by our built-in quality and safety features

• Internal control: The ß-globin internal cellular control helps prevent false negatives. HPV negative specimens with a negative ß-globin result are flagged as invalid, helping to prevent reporting of false negative results

• Use of AmpErase Enzyme: Each reaction contains AmpErase Enzyme, reducing the risk of false positive results from carry-over contamination by differentiating amplification products from target molecules

• No cross reactivity: Demonstrates no cross-reactivity with non-high risk HPV genotypes, ensuring that positive results are clinically meaningful

Peace of Mind Patients Deserve

HPV primary screening with the cobas® HPV test helps identify women at risk for disease, before pre-cancer or cancer develops.

• Assays are validated in clinical performance studies (e.g. cobas® HPV test was validated in the ATHENA Trial)1

• Validated for detection of =CIN2 lesions and not simply presence of HPV1

• Validated to the standards set forth in international guidelines for HPV testing for cervical screening purposes2,3

Intended use

cobas® HPV for use on the cobas®  5800/6800/8800 Systems (cobas® HPV) is an automated qualitative in vitro test for the detection of human papillomavirus (HPV) DNA in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies HPV16 and HPV18 while concurrently detecting the other high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) at clinically relevant infection levels. Specimens are limited to cervical cells collected in Roche Cell Collection Medium (Roche Molecular Systems, Inc.), PreservCyt® Solution (Hologic Corp.) and SurePath™ Preservative Fluid (BD Diagnostics-TriPath).

Indications for use of cobas® HPV are:

A. In women 25 years and older, cobas® HPV is indicated for use in screening patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy. 

B. In women 25 years and older, cobas® HPV is indicated for use in screening patients with ASC-US cervical cytology results to assess the presence or absence of HR HPV genotypes 16 and 18.

C. In women 30 years and older, cobas® HPV is indicated for use adjunctively with cervical cytology to assess the presence or absence of HR HPV types. 

D. In women 30 years and older, cobas® HPV is indicated for use adjunctively with cervical cytology to assess the presence or absence of HPV genotypes 16 and 18.

E. In women 25 years and older, cobas® HPV is indicated for use as a first-line primary screening test to identify women at increased risk for the development of cervical cancer or presence of high-grade disease. 

F. In women 25 years and older, cobas® HPV is indicated for use as a first-line primary screening test to assess the presence or absence of HPV genotypes 16 and 18.

cobas® HPV and cobas® 4800 HPV Test can also be used with healthcare worker–instructed self-collected vaginal specimens collected in Roche Cell Collection Medium or PreservCyt® Solution 

The results from cobas® HPV, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of cobas® HPV are not intended to prevent women from proceeding to colposcopy.