For in vitro diagnostic use. Others cobas HSV 1 and 2 Test IVD cobas® HSV 1 and 2 Test RMD-4800-HSV-001 for use on the cobas® 4800 system 06 768 199 190 6 768 199 190 06768199190 6768199190 06768199190 KIT COBAS 4800 HSV 1&2 AMP/DET 80T IVD cobas HSV 1 and 2 Test 00875197005226 Reagents, kits 1 kit 80 tests true 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 differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected, external 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.Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years. en The cobas® HSV 1 and 2Test contains two major processes: (1) automated sample preparation to extract nucleic acids from the anogenitallesion specimens; (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and real-time detection of cleaved fluorescent-labeled HSV-1and HSV-2 specific oligonucleotide detection probes. An Internal Control, containing unrelated randomized DNA sequence, is added to all samples prior to automated sample preparation and is amplified and detected simultaneously with each sample to monitor the entire process.Sample preparationSample preparation for the cobas® HSV 1 and 2 Test is automated with the use of the cobas® x 480 instrument. Viruses in the anogenital lesion samples are lysed with chaotropic agent, proteinase K, and SDS reagents. Released nucleic acids, along with added Internal Control DNA, are bound by magnetic glass particles. They are washed and then eluted into a small volume of buffer. The instrument then takes an aliquot of the eluted material and sets up the PCR reaction with an activated Master Mix.PCR amplification and TaqMan® detectionThe PCR cycling steps and detection of target signal occurs in the cobas® z 480 analyzer. The Master Mix reagent contains primer pairs and probes for five targets: the DNA polymerase region B and Thymidine Kinase region C of HSV-1 gene; the Glycoprotein B 3’ end region and Thymidine Kinase region C of HSV-2 gene, and Internal Control. The dual target design for HSV-1 and HSV-2 enhances the assay robustness. If the targets nucleic acid sequences are present, amplification with the corresponding primers will occur by a thermostable DNA polymerase, generating PCR products (amplicon). These products are detected by specific TaqMan probes containing a fluorescent dye and a quencher. Normally, the quencher suppresses the fluorescence of the dye. However, if the PCR product is present, the probe hybridizes to the product and gets cleaved by the 5’ to 3’ nuclease activity of the polymerase. This reaction allows the fluorescence to be emitted from the dye, and the signal is recorded in real time during each PCR cycle by the cobas® z 480 analyzer. The signal is interpreted by the cobas® 4800 System Software and reported as final results.Selective amplificationSelective amplification of target nucleic acid from the specimen is achieved in the cobas® HSV 1 and 2 Test by the use of AmpErase (uracil-N-glycosylase) enzyme and deoxyuridine triphosphate (dUTP). The AmpErase enzyme recognizes and catalyzes the destruction of DNA strands containing deoxyuridine10, but not DNA containing deoxythymidine. Deoxyuridine is not present in naturally occurring DNA, but is always present in amplicon due to the use of deoxyuridine triphosphate in place of thymidine triphosphate as one of the dNTPs in the Master Mix reagent; therefore, only amplicon contain deoxyuridine. Deoxyuridine renders contaminating amplicon susceptible to destruction by AmpErase enzyme prior to amplification of the target DNA. AmpErase enzyme, which is included in the Master Mix reagent, catalyzes the cleavage of deoxyuridine-containing DNA at the deoxyuridine residues by opening the deoxyribose chain at the C1-position. When heated in the first thermal cycling step at the alkaline pH of Master Mix, the amplicon DNA chain breaks at the position of the deoxyuridine, thereby rendering the DNA non-amplifiable. AmpErase enzyme is inactive at temperatures above 55ºC, i.e., throughout the thermal cycling steps, and therefore does not destroy target amplicon. The cobas® HSV 1 and 2 Test has been demonstrated to inactivate at least 1000 copies of deoxyuridine-containing HSV 1 and 2 amplicon per PCR.10. Longo MC, Berninger MS, Hartley JL. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions. Gene. 1990;93(1):125-128. en

cobas® CT/NG v2.0 Test
cobas® HSV 1 and 2 Test

For use on the cobas® 4800 System

IVD

cobas® CT/NG v2.0 Test

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.

Features and benefits

Easy to learn, easy to use

The dual-target approach of cobas® CT/NG for both the genomic and cryptic plasmid DNA of C. trachomatis enables the detection of all major serovars of CT and nvCT strains for a highly sensitive test.
The use of two sets of primers targeting the highly conserved direct repeat region (DR9) and a conserved sequence variant amplify and detect both wild type and variant versions of N. gonorrhoeae.

Reliable results

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

Quality control in every step

An internal control utilizing an identical randomized internal target sequence is added to each sample and 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 minimizes the risk of false positive results by degrading previously amplified targets allowing sample preparation and detection in the same lab.

cobas® HSV 1 and 2 Test

The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated FDA-cleared test for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected external 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.

Anogenital lesion swab specimens for cobas® HSV 1 and 2 testing are collected with the MSwab Collection, Transport and Preservation Kit.

Primary specimens are loaded directly on the cobas® 4800 System for testing; no manual pipetting required.
Specimens collected with the MSwab kit are suitable for bacterial culture of gram positive aerobic and facultative anaerobic organisms, virus culture of HSV 1 and HSV 2, and nucleic acids detection of bacteria and viruses.
Mixed run capabilities: cobas® HSV 1 and 2 testing can be performed with the cobas® Cdiff and cobas® MRSA/SA tests on the cobas® 4800 system.

Would you like to know more about the cobas® CT/NG v2.0 Test and cobas® HSV 1 and 2 Tests?

Please submit your information in the following form to be contacted by a Roche representative with more details.

The confidence of dual-target detection

Only tests with AmpErase enzyme and the internal control to minimize false positives and negative results

cobas® CT/NG v2.0 Test

The cobas® CT/NG v2.0 Test uses multiple detection channels on the cobas® z 480 Analyzer for the detection of CT, NG, with the Internal Control in one reaction.

Dual Probe Design

The CT primers and probes are designed to detect targets in both cryptic plasmid and MOMP genomic DNA. The design of the CT primers and probes enables the detection of all major serovars of CT and the Swedish CT Mutant (nvCT), strains that may harbor deletions in the cryptic plasmid, and strains that do not carry the cryptic plasmid.

The NG target region has 2 highly conserved sequence variations that enable the detection of a combination of both target variations with no-cross reactivity with commensal Neisseria or other bacterial species.

CT: Clinical Performance Compared with Patient Infected Status by Gender and Sample Type, and Symptom Status

NG: Clinical Performance Compared with Patient Infected Status by Gender, Sample Type, and Symptom Status

HSV 1 and 2 comparison with composite reference method (culture and Sanger sequencing)

View Full Table

Reliable identification with optimized sensitivity and specificity

HSV-1		HSV-2
Sensitivity	92.9%	Sensitivity	97%
Specificity	98.8%	Specificity	94.6%
Positive Predictive Value	95.1%	Positive Predictive Value	92.6%
Negative Predictive Value	98.2%	Negative Predictive Value	97.9%

Proven efficiency, giving you the freedom to do more

With STI rates on the rise, cobas® CT/NG 2.0 and HSV 1 and 2 tests provide a solution for the growing demand. The cobas® 4800 System brings flexible sample loading to your fingertips. Handling multiple types of primary and secondary vials in the same run, laboratories can reduce manual effort, improve efficiency and reduce the risk of error, to more efficiently manage daily workflow.

Time-saving automation

The cobas® HSV 1 and 2 saves time with first-of-its-kind primary vial loading. Using the MSwab™ system, specimens collected on a FLOQSwab™are transferred directly into the primary vial for testing. The MSwab system is optimized for molecular and culture applications.

Perform cobas® HSV 1 and 2 on as few as 6 or as many as 94 specimens, using the fastest, most advanced real-time PCR amplification and detection available today. Labs can run 4 to 5 small runs or 2 high-volume runs for up to 194 results/day.

De-cap and load directly from primary vials

Reduced hands-on time

The cobas® HSV 1 and 2 on the cobas® 4800 System requires 77% less hands-on time than a competitive FDA-cleared nucleic acid amplification test. Just load your primary sample vials and you’re ready to go.

Flexible testing with mixed-run capabilities

The parallel sample processing capabilities of the cobas® 4800 System allows cobas® HSV 1 and 2 samples to be run with different tests and sample types in a single run.

Run mixed batch assays of:

Anogenital lesions (cobas® HSV 1 and 2 Test)
Nasal (cobas® MRSA/SA Test)
Stool (cobas® Cdiff Test)

Streamline your sexually transmitted infection portfolio with the expanded test menu of the cobas® 4800 System—test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) on the same system with the same Roche quality results.

Intended use

cobas® CT/NG v2.0 Test

The cobas® CT/NG v2.0 Test is an automated, in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media, 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.

cobas® HSV 1 and 2 Test

The cobas® 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 differentiation of Herpes Simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected, external 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.

The cobas® CT/NG for use on the cobas® 5800/6800/8800 Systems

cobas® CT/NG 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 Chlamydia trachomatis (CT) and/or Neisseriagonorrhoeae (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens (collectedin a clinical setting), and 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.

Registration status

IVD

References

cobas® CT/NG v2 Test package insert, 07127553001-10EN, Rev. 11
cobas® HSV 1 and 2 Test package insert, 06979378001-0lEN, Rev. 2.0

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