Sexually Transmitted Infections

sexually-transmitted-disease

 

The economic and emotional burden of STIs underscores the need for effective screening

Sexually transmitted infections (STIs) constitute a major burden on global health, as this group of infections ranks among the top five disease categories for which adults seek healthcare. More than 1 million people acquire an STI every day.1

The astounding incidence of these infections places the healthcare system under severe economic strain. In the US, the lifetime cost of treating eight of the most common STIs contracted in just one year is $15.6 billion. Furthermore, the total direct medical cost in the US associated with chlamydia, gonorrhea, and herpes simplex virus-2 (HSV-2) infections alone is estimated to be a staggering $1.2 billion annually.

However, the substantial monetary costs on healthcare overall cannot be overshadowed by the severe health consequences. 

sti

 

STI Systems

 

cobas® 4800 

Engineered for Peace of Mind

Fully automated sample preparation with real-time polymerase chain reaction (PCR) technology for amplification and detection.

Best combination of technologies available:

cobas x 480 Instrument

  • Fully automated sample preparation from primary vials
  • Ready-to-use, load-and-go reagents
  • No thawing or mixing required
  • Less than 20-minute set-up for full run of 94 samples
cobas 4800

cobas z 480 Analyzer

  • Real-time PCR with digital data capture provides accurate qualitative results with no gray zone
  • Eliminates the need for equivocal sample retesting
  • Advanced results algorithm eliminates the need for manual curve analysis

Features and Benefits

Easy-to-learn and easy-to-use software

  • Intuitive user interface
  • Requires only a few hours training at all levels of laboratory personnel
  • Seamlessly integrates both system components

Streamlines Workflow

  • Fully automated sample preparation
  • High quality nucleic acid extraction technology
  • Robust engineering reduces maintenance and downtime
  • Bidirectional connectivity with an LIS for automated results reporting reduces labor and potential for error

Promotes Lab Efficiency

  • Processes up to 384 samples a day
  • Efficient for labs with lower throughput requirements
  • Load primary collection tubes and liquid cytology vials directly on the system
  • Minimal input volumes allow multiple tests from the same patient specimen

 

cobas p 480 

Automated sample handling increases efficiency while reducing repetitive tasks.

The cobas p 480 instrument reduces hands-on time and offers a fast, reliable way to manage sample caps while eliminating repetitive motions that can cause injury.

  • General-purpose, stand-alone instrument for automated sample handling
  • Up to 94 specimens per run processed in less than 30 minutes

Automated uncapping of mixed samples

  • cobas® PCR Media tubes
  • SurePath™ containers
  • PreservCyt® containers

Automated recapping

  • cobas® PCR Media tubes
  • SurePath™ containers

Standardized sample handling

  • Automated barcode check and alignment
  • Automated mixing produces consistent homogeneity
  • Precision movement reduces the risk of cross-contamination
  • Minimizes the potential for human error

Increases laboratory efficiency

  • Simple, user-friendly operation
  • Processes multiple sample types simultaneously
  • Offers the flexibility to support a variety of throughput requirements
  • High-throughput operation allows a single instrument to support more than one analytic system
  • No LIS or data connection required

Replacement caps ensure a quality seal

  • Protect recapped samples for transport, storage or other testing needs
  • Better seal integrity compared to parafilm or cellophane over pierced or open samples
  • Packaged for easy loading and automated recapping

 

Assays

Paving the way for improved CT/NG testing

In 1993, Roche introduced its first-ever, FDA-cleared polymerase chain reaction (PCR) test — a molecular test for CT. Three years later, Roche introduced a CT/NG test with internal controls. 

With every generation, Roche has continued to improve CT/NG testing through advances in automation and accuracy. Today, the latest generation cobas® 4800 CT/NG Test makes it easier to deliver faster, more reliable and more accurate answers.

For more information, visit: https://www.rochemicrobiologytests.com/

TESTS for use on the cobas® 4800 System

  • cobas® CT/NG
  • cobas® HPV 
  • cobas® HSV 1 and 2

 

cobas® 4800 CT/NG Test

The Simple Path to Accuracy 

CT and NG multiplex assay with flexible order capability

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. No cross reactivity with commensal Neisseria or other bacterial species has been observed with the NG assay.

cobas-4800-ct-ng

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: Canada-IVD

The cobas® 4800 CT/NG Test is an in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in patient specimens. The Test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swab specimens, clinician-collected vaginal swab specimens, clinician-instructed self-collected vaginal swab specimens, and male and female urine in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens in PreservCyt® Solution (Hologic, Inc.). This test is intended to be used as a diagnostic as well as a screening tool in both symptomatic and asymptomatic populations.

For more information, visit: https://www.rochemicrobiologytests.com/sexually-transmitted-infections/chlamydia-gonorrhea-testing.html

 

cobas® 4800 HPV

Delivering Confidence with Every Result on cobas® 4800 Systems

The cobas® 4800 HPV test – for cervical cancer screening and patient risk stratification

The cobas® 4800 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.

cobas-4800-hpv
hr-hpv

The tests simultaneously provide pooled results on high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18, at clinically relevant infection levels. Cervical cell specimens can be collected in PreservCyt® Solution, cobas® PCR Cell Collection Media and SurePath™ Preservative Fluid.

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® 4800 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® 4800 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

cobas® 4800 HPV product summary

Description Summary
Sample type PreservCyt® Solution, SurePath™ Preservative Fluid, cobas® PCR Cell Collection media
Minimum amount of sample required (µl) 1,000
Sample processing value (µl) 400
Internal cellular control ß-globin
Simultaneous 16/18 genotyping Yes; HPV 16, HPV 18 and 12 hrHPV
Genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68
Test duration <3.5 hours for first HPV result

Summary of Intended Use

cobas® HPV for use on the cobas® 4800 System

Canada-IVD

The cobas® 4800 Human Papillomavirus (HPV) Test is a qualitative in vitro test for the detection of human papillomavirus 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 (types) HPV16 and HPV18 while concurrently detecting the rest of the 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 cobas® PCR Cell Collection Media (Roche Molecular Systems, Inc.), PreservCyt® Solution (Cytyc Corp.) and SurePath™ Preservative Fluid (BD Diagnostics-TriPath). 

Indications for use of the cobas® 4800 HPV Test are: 

(a) The cobas® 4800 HPV Test is indicated for use in screening patients 21 years and older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology results to determine the need for referral to colposcopy. 

(b) The cobas® 4800 HPV Test is indicated for use in screening patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. 

(c) The cobas® 4800 HPV Test is indicated for use in patients 30 years and older adjunctively with cervical cytology to assess the presence or absence of high risk HPV types. 

(d) The cobas® 4800 HPV Test is indicated for use in patients 30 years and older adjunctively with cervical cytology to assess the presence or absence of HPV genotypes 16 and 18. 

(e) The cobas® 4800 HPV Test is indicated for use as a first-line primary screening test in patients 25 years and older to identify women at increased risk for the development of cervical cancer or presence of high-grade disease. 

(f) The cobas® 4800 HPV Test is indicated for use as a first-line primary screening test in patients 25 years and older to assess the presence or absence of HPV genotypes 16 and 18. 

The results from the cobas® 4800 HPV Test, 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 the cobas® HPV Test are not intended to prevent women from proceeding to colposcopy.

References

  1. cobas® 4800 HPV Test [package insert, CAN-IVD]. Branchburg, NJ: Roche Molecular Systems, Inc.
  2. Heideman DA, Hesselink AT, Berkhof J, et al. Clinical validation of the cobas® 4800 HPV Test for cervical screening purposes. J Clin Microbiol. 2011;49(11):3983-3985. doi: 10.1128/JCM.05552-11.
  3. Meijer CJ, Berkhof J, Castle PE, et al. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer. 2009;124(3):516-20. doi: 10.1002/ijc.24010.

 

LINEAR ARRAY® HPV Genotyping Test (CE-IVD)

Ability to detect HPV DNA and individual types 

Persistent HPV infection with specific high-risk HPV types is an indicator of high grade lesions (HSIL).1 HPV genotyping assays may be used in cytology negative, HR-HPV-positive women over 30 in the same manner as HPV triage testing is currently utilized in women with ASC-US or BMD cytology.2

LINEAR ARRAY® HPV Genotyping Test is a qualitative test that detects 37 high- and low-risk human papillomavirus genotypes, including those considered a significant risk factor for HSIL progression to cervical cancer.

genotyping-test

Features and Benefits

Features

  • Ability to detect HPV DNA and individual types
  • Capable of detecting HPV genotypes present in a multiple infection, which can occur in up to 35% of patient samples3
  • Ability to detect HPV DNA and individual types may be attributed to the use of:4 
    • Standardized, quality-controlled reagents
    • Primer concentrations that minimize competition due to coamplification
  • HPV genotypes include: 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68, 69, 70, 71, 72, 73 (MM9), 81, 82 (MM4), 83 (MM7), 84 (MM8), IS39, and CP6108 (high-risk in bold)

Benefits

  • Helps identify women at risk and optimize treatment strategies
  • Helps further stratify women with normal cytology who are HPV positive into different risk categories5
  • Identifying infection with HPV Type 16 and Type 18 among these women justifies immediate colposcopy6
  • Women with other HR-HPV infections at lower risk can be managed less aggressively6
  • Provides physicians with actionable information to treat the highest risk patients immediately7

Intended Use

This test is a qualitative in vitro test for the detection of human papilloma virus in clinical specimens. The test utilizes amplification of target DNA by the polymerase chain reaction (PCR) and nucleic acid hybridization and detects thirty seven anogenital HPV DNA genotypes [6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68, 69, 70, 71, 72, 73 (MM9), 81, 82 (MM4), 83 (MM7), 84 (MM8), IS39 and CP6108] in cervical cells collected in PreservCyt® Solution.

Available in Canada

References

  1. Kjaer SK, Type specific persistence of high risk human papillomavirus (HPV) as indicator of high grade cervical squamous intraepithelial lesions in young women: population based prospective follow up study. BMJ. 2002;325(7364):572.
  2. Wright TC, et al. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. AM J Obstet Gynecol. 2006;197(4):346-355.
  3. van Hamont D, et al. Evaluation of the SPF10-INNO LiPA human papillomavirus (HPV) genotyping test and the Roche linear array HPV genotyping test. J Clin Microbiol. 2006;44(9):3122-3129.
  4. Coutlée F, et al. Enhanced detection and typing of human papillomavirus (HPV) DNA in anogenital samples with PGMY primers and the Linear array HPV genotyping test. J Clin Microbiol. 2006;44(6):1998-2006.
  5. Meijer CJ, Snijders PJ, Castle PE. Clinical utility of HPV genotyping. Gynecol Oncol. 2006;103:12-17.
  6. Khan MJ, Castle PE, Lorincz AT, et al. Elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005;97:1072-1079.
  7. Wright TC Jr, Massad LS, Dunton CJ, et al. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. Am J Obstet Gynecol. 2007;197:346-355.

 

cobas® HSV 1 and 2 Test

Bring More to Your STI Menu 

Highly sensitive and specific test designed to reliably detect the presence of HSV-1 and HSV-2 DNA in clinical specimens.

The cobas® HSV 1 and 2 Test provides the confidence of dual-target detection and Roche-quality results.

Due to differing outcomes regarding disease severity, sequelae and recurrence rates, it is essential to differentiate whether a patient has HSV-1 or HSV-2. The cobas® HSV 1 and 2 Test offers a highly sensitive and specific test for the direct detection of HSV-1 and HSV-2 DNA in clinical specimens, delivering reliable results. The cobas® HSV 1 and 2 Test has been designed to reliably identify the presence of HSV-1 and -2 from genital lesions.

cobas-4800

Features and Benefits

Performance

  • Robust, dual-target detection amplifies two separate regions on each of the HSV-1 and HSV-2 genomes
  • Optimizes sensitivity and specificity

Workflow

  • Save time with first-of-its-kind primary sample vial loading
  • Run MRSA/SA and HSV-1 and -2 samples at the same time, on the same system

Flexibility

  • One instrument for CT/NG, HSV, HPV, MRSA/SA, and oncology testing
  • Confident patient tracking—from primary vial to final result.

Intended Use

The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and typing of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.

For more information, visit: https://www.rochemicrobiologytests.com/sexually-transmitted-infections/herpes-simplex-virus-testing.html