Sexually Transmitted Infections Assays

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. 

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^® CT/NG Test makes it easier to deliver faster, more reliable and more accurate answers.

For more information, visit: https://diagnostics.roche.com/us/en/products/product-category/microbiology.html 

TESTS for use on the cobas^® 6800, 8800 Systems

• cobas^® CT/NG and TV/MG
• cobas^® HPV (also on cobas^® 4800 system)  

cobas® 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 Chlamydiastrains 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.

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^® 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® TV/MG

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
use

• 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

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 andfemale 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
 

References

1. Kissinger P. Trichomonas vaginalis: a review of epidemiologic, clinical and treatment issues. BMC Infect Dis. 2015;15:307.

2. Sutton M, Sternberg M, Koumans EH, et al. The Prevalence of Trichomonas vaginalis Infection among Reproductive-Age Women in the United States, 2001–2004. Clin Infect Dis. 2007; 45 (10): 1319-1326 doi:10.1086/522532.

3. Andrea SB, Chapin KC. Comparison of Aptima Trichomonas vaginalis Transcription-Mediated Amplification Assay and BD Affirm VPIII for Detection of T. vaginalis in Symptomatic Women: Performance Parameters and Epidemiological Implications. J Clin Microbiol. 2011;49(3):866-869. doi:10.1128/JCM.02367-10.

4. Update on Laboratory Diagnosis and Epidemiology of Trichomonas vaginalis: You Can Teach an “Old” Dog “New” Trichs. Munson, Erik et al. Clinical Microbiology Newsletter, Volume 38, Issue 20, 159 - 168.

5. Schwebke JR, D. B. Trichomoniasis. Clin Microbiol Rev. 2004 17(4): 794-803; published 15 October 2004; doi:10.1128/CMR.17.4.794-803.2004.

6. Krieger JN. Trichomoniasis in men: old issues and new data. Sex Transm Dis. 1995;22:83-96.

7. Sviben M, Missoni EM, Mestrovic T, Vojnovic G, Galinovic GM. Epidemiology and laboratory characteristics of Trichomonas vaginalis infection in Croatian men with and without urethritis syndrome: a case-control study. Sex Transm Infect. 2015;91:360-4.

8. Patil MJ, Nagamoti JM, Metgud SC. Diagnosis of Trichomonas Vaginalis from Vaginal Specimens by Wet Mount Microscopy, In Pouch TV Culture System, and PCR. J Glob Infect Dis. 2012;4:22-5.

9. Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol. 2009;200:188.e1-7.

10. Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64:1-137.

11. Tully JG, Taylor-Robinson D, Cole RM, Rose DL. A newly discovered mycoplasma in the human urogenital tract. Lancet. 1981;1:1288-91.

12. Jensen JS. Mycoplasma genitalium infections. Diagnosis, clinical aspects, and pathogenesis. Dan Med Bull. 2006;53:1-27.

13. Daley GM, Russell DB, Tabrizi SN, McBride J. Mycoplasma genitalium: a review. Int J STD AIDS. 2014;25:475-87.

14. Getman D, Jiang A, O’Donnell M, Cohen S. Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in the United States. J Clin Microbiol. 2016;54(9):2278-2283. doi:10.1128/JCM.01053-16.

15. Lillis RA, Nsuami MJ, Myers L, Martin DH. Utility of urine, vaginal, cervical, and rectal specimens for detection of Mycoplasma genitalium in women. J Clin Microbiol. 2011;49:1990-2.

16. Mezzini TM, Waddell RG, Douglas RJ, Sadlon TA. Mycoplasma genitalium: prevalence in men presenting with urethritis to a South Australian public sexual health clinic. Intern Med J. 2013;43:494-500.cobas^® TV/MG 08308535001-02EN Doc. Rev. 2.0 71

17. Longo MC, Berninger MS, Hartley JL. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions. Gene. 1990;93:125-8.

18. Higuchi R, Dollinger G, Walsh PS, Griffith R. Simultaneous amplification and detection of specific DNA sequences. Biotechnology (N Y). 1992;10:413-7.

19. Heid CA, Stevens J, Livak KJ, Williams PM. Real time quantitative PCR. Genome Res. 1996;6:986-94.

20. Center for Disease Control and Prevention. Biosafety in microbiological and biomedical laboratories. 5th edition UDoHaHS, Public Health Service. Centers for Disease Control and Prevention, National Institutes of Health HHS Publication No. (CDC) 21-1112, revised December 2009.

21. Clinical and Laboratory Standards Institute (CLSI). Protection of laboratory workers from occupationally acquired infections. Approved Guideline-Fourth Edition. CLSI Document M29-A4. Wayne PC, 2014.

22. International Air Transport Association. Dangerous Goods Regulations, 57th Edition, 2016.

cobas® HPV

Delivering Confidence with Every Result on cobas^® 4800, 6800 & 8800 Systems

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

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.

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^® 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

cobas^® HPV product summary

Intended use

cobas^® HPV for use on the cobas^® 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.), cobas^® PCR Cell Collection Media (Roche Molecular Solutions, 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.

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.

References

1. Khan MJ, Castle PE, Lorincz AT, et al. The 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(14):1072-1079.
2. Bosch FX, de Sanjosé S. Human papillomavirus and cervical cancer — burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;31:3-13.
3. cobas^® 4800 HPV Test [package insert, CE]. Branchburg, NJ: Roche Molecular Systems, Inc; 2012.
4. Heideman DA, Hesselink AT, Berkhof J, et al. Clinical validation of the ^® 4800 HPV Test for cervical screening purposes. J Clin Microbiol. 2011;49(11):3983-3985. doi: 10.1128/JCM.05552-11.
5. 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.
6. Saville et al. (2018). “Clinical validation of the cobas HPV test on the cobas 6800 system for the purpose of cervical screening” J. Clin. Microbiol. doi:10.1128/JCM.01239-18.
    

cobas® HSV 1 and 2 Test (available on the cobas® 4800 only)

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.

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 vitrodiagnostic 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