FDA has granted premarket clearance to the Simplexa VZV swab direct assay from DiaSorin Molecular, Cypress, Calif. The CLIA moderate-complexity assay is designed for use on the company’s Liaison MDx instrument to detect varicella-zoster virus (VZV) DNA from cutaneous and mucocutaneous swab specimens.

DiaSorin Molecular attained the CE mark for the assay last September. The assay complements the company’s Simplexa VZV direct kit, which is intended for use with cerebrospinal fluid samples.

Michelle Tabb, DiaSorin Molecular

Michelle Tabb, DiaSorin Molecular

VZV infection causes two clinically distinct forms of disease: a primary infection (chickenpox), and a secondary infection (shingles). Although vaccines have been around since the 1990s, it is estimated that 90% of the population will acquire the virus by the age of 15. VZV infections can affect different areas of the body—including the eyes, genitals, nasal cavities, and skin—and can cause severe long-term disability or disfigurement depending on the affected site and treatment.

It is not always possible to visually distinguish VZV lesions from herpes simplex virus (HSV) lesions because the clinical presentation can be similar. This makes it critical for labs to identify VZV infection for proper patient treatment and management.

DiaSorin LMDX DAD Image - VZV Swab FDA“With this release, we now offer a comprehensive menu of VZV and HSV tests from cerebrospinal fluid, mucocutaneous swab specimens, and cutaneous swab specimens,” says Michelle Tabb, PhD, chief scientific officer at DiaSorin Molecular. “Customers can also run these tests at the same time using the same disc. We are dedicated to providing products that streamline testing workflows and improve patient management.”

For more information, visit DiaSorin Molecular.

Featured image: Shingles on human skin. Image © Parkinsonsniper, courtesy Dreamstime (ID 30563680).