cobas® HSV 1 and 2 Test

The confidence of dual-target detection

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

The cobas^® HSV 1 and 2 test for use on the cobas^® 4800 System utilizes a dual-target approach to ensure accurate identification of HSV-1 and HSV-2 from genital lesions.

Reliable identification with optimized sensitivity and specificity

Compared to a CE- and FDA-cleared nucleic acid amplification test (NAAT), cobas^® HSV 1 and 2 delivers high sensitivity and specificity in the direct detection of HSV-1 and HSV-2 DNA in clinical specimens.*

Kontakta oss

The cobas^® HSV 1 and 2 uniquely delivers dual-target detection that amplifies two separate regions on each of the HSV-1 and HSV-2 genomes. Since drug-resistant mutations can occur at certain sites, this approach provides confidence in the detection of existing and emerging strains of HSV.

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 CE- and FDA-cleared nucleic acid amplification test. Just load your primary sample vials and you’re ready to go.

Source: Argent Global Systems Workflow Study, 2014

Flexible, mixed-batch testing

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

CE-IVD

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.

US-IVD

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.

References

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

Registration status

CE-IVD; US-IVD