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.
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.*
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.
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.
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.
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:
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.
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.
References
CE-IVD; US-IVD
