Background Identification of genital herpes can have important implications for clinical management of HIV infected patients, immunosuppressed individuals, pregnant women, and individuals with HSV seronegative partners. This study was performed to establish preliminary performance characteristics for the newly developed cobas^® HSV-1/2 Test by evaluating analytical sensitivity and specificity, specimen stability, and clinical performance compared with the BD ProbeTec™ HSV-1/2 Test.

Methods Analytical sensitivity was determined using viral culture spiked into a contrived background matrix at predetermined concentrations. Nine levels of viral target were evaluated using the prototype cobas^® HSV-1/2 Test. These viral culture panels were also used to assess analytical sensitivity compared to the BD ProbeTec™ HSV-1/2 Test. Preliminary exclusivity of the cobas^® HSV-1/2 Test was evaluated with other herpes family viruses (n = 7) and a collection of microorganisms that might be found in lesion swab specimens (n = 31). We also evaluated clinical lesion swab specimens (collected in UVT media for the BD Test and MSwab Media for the cobas^® Test). Transport and storage stability of anogenital lesion swab samples collected in MSwab media was assessed by testing specimens stored at RT, 2–8C and –20C.

Results The cobas^® HSV-1/2 test displayed excellent analytical sensitivity of 150 vp/mL (HSV 1) and 100 vp/mL (HSV-2). When compared to the BD ProbeTec™ HSV-1/2 Test, superior sensitivity was observed for both HSV-1 and HSV-2 with the cobas^® HSV-1/2 Test. Exclusivity studies showed no cross reactivity. The cobas^® HSV-1/2 Test showed excellent performance with lesion swab specimens, observing a sensitivity and specificity of 100% and 100% for HSV-1 and 100% and 94% for HSV-2, respectively. Preliminary specimen stability studies for routine laboratory workflow indicate favourable performance.

Conclusion The cobas^® HSV-1/2 test, run on the fully automated cobas^® 4800 system, exhibited excellent preliminary performance characteristics, suitable for identifying low concentration HSV-1 and HSV-2 from anogenital lesions.