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    cobas® HSV 1 and 2 Test

    Bring more to your STI menu

Medical value is delivered with PCR testing for Herpes Simplex Virus

Molecular testing by polymerase chain reaction (PCR) technology is regarded as the most sensitive method of direct detection for HSV-1 and HSV-2.1

The introduction of the cobas® HSV 1 and 2 Test* is an example of how robust molecular testing strategies have evolved to include amplification of multiple sites of the viral genome, a so-called “dual target” approach, to ensure accurate identification of HSV despite evolving mutations. The cobas® HSV 1 and 2 Test** has been designed to reliably identify the presence of HSV-1 and HSV-2 from genital lesions. 

*Not available in the US

**Direct comparison of anogenital swab specimens to CE-and FDA-cleared NAAT HSV-1/2 Test includes discrepant resolution with sequencing (n=370 for HSV-1 and n=369 for HSV-2).


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

Test Overview

cobas hsv test sensitivity and specificity

Performance of the cobas® HSV 1 and 2 Test compared to a CE- and FDA-cleared nucleic acid amplification test (NAAT)

Amplify your reliability

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 for optimal patient treatment and management decisions.

The cobas® HSV 1 and 2 Test: 

  • Amplifies two separate regions on each of the HSV-1 and HSV-2 genomes, resulting in robust, dual-target detection
  • Optimizes sensitivity and specificity
  • Improved confidence in results as new HSV strains emerge
  • Adds to the expanded test menu on the cobas®  4800 System, which also includes CT/NG testing 

Test Performance

Optimized sensitivity and specificity

The cobas® HSV 1 and 2 Test is highly sensitive and specific as demonstrated in a clinical correlation with CE- and FDA-cleared NAAT HSV-1/2 Test evaluating 370 anogenital lesion swabs for HSV-1 and 369 for HSV-2, following discrepant analysis with sequencing.

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HSV-1
Sensitivity 100%
Specificity 99%
Positive Predictive Value 97%
Negative Predictive Value 100%
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HSV-2
Sensitivity 100%
Specificity 98%
Positive Predictive Value 97%
Negative Predictive Value 100%

Dual-target Detection

Reliably identifies the presence of HSV-1 and HSV-2

The cobas® HSV 1 and 2 Test uniquely delivers dual-target detection that amplifies two separate regions on each of the HSV-1 and HSV-2 genomes, delivering result confidence, as drug-resistant mutations can occur at certain sites.

Reduce hands-on time with a flexible, automated workflow 

Sample Preparation

Delivers time-saving flexibility 

The cobas® HSV 1 and 2 Test 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 the cobas® HSV 1 and 2 Test 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

Hands-on Time

Requires less hands-on time than competitors 

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

Mixed Batch Testing

The cobas® 4800 System offers flexibility with parallel sample processing capabilities. cobas® HSV 1 and 2 Test samples can be run with different tests and sample types in one run.

Run mixed batch assays of: 

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

 

In addition to parallel sample processing, the cobas® 4800 System offers an expanding test menu.

 

  Learn about the system ›

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cobas® HSV 1 and 2 Assay Performance and Specifications
Sample Type Anogenital lesion swab specimens
Sample Processing Primary vial loading with MSwab System directly on the cobas® 4800 System 
Sample Versatility  Molecular or culture capability
Contamination Control AmpErase
Target Region HSV-1: Thymidine Kinase, DNA polymerase 
HSV-2: Glycoprotein B, Thymidine Kinase
Limit of Detection (LOD) 0.479 HSV-1 TCID50 Units/mL 
0.112 HSV-2 TCID50 Units/mL 
Analytical Specificity No cross reactivity (evaluated 6 herpes family viruses and 31 organisms 
associated with anogenital specimens)
Clinical Sensitivity* HSV-1: 100% 
HSV-2: 100%
Clinical Specificity* HSV-1: 99.7% 
HSV-2: 97.8%
Workflow Mixed batch capability, optimized sample loading

*Direct comparison of anogenital swab specimens to CE- and FDA-cleared NAAT HSV-1/2 Test includes discrepant resolution with sequencing (n=370 for HSV-1 and n=369 for HSV-2). 

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.

  • Acronyms:

References:

1. Patel et al. 2011 European guidelines for the management of genital herpes. Int J STD and AIDS 22: 1-10 3.