Unlike molecular tests currently available that target a single pathogen or a limited pathogen group, the assay is designed to enable the concurrent detection of herpes simplex virus type 1 and type 2 (HSV-1^[1], HSV-2^[2]), varicella-zoster virus (VZV^[3]), and monkeypox virus (MPXV^[4]) in a single test. The Allplex™ HSV-1&2/VZV/MPXV Assay is the first multiplex PCR test designed to simultaneously and differentially detect viral pathogens of ulcerative skin lesions in the U.S. market.

These pathogens frequently present with similar clinical symptoms, vesicular or pustular lesions, that are difficult to distinguish by appearance alone. When clinicians test for only one pathogen at a time, cases caused by the untested viruses can be missed entirely. This product addresses the unmet need in the market for simultaneous evaluation of multiple clinically overlapping pathogens in a single assay.

In a poster presented at the 2024 Clinical Virology Symposium^[5], scientists evaluated samples that had previously tested negative using single-pathogen methods and found that a multiplex PCR assay identified HSV, VZV, or MPXV clade I/II in 54 out of 966 of those samples, pointing to a meaningful population of cases that single-target testing can leave undiagnosed.