FDA Clears Assay for Herpes Simplex and Varicella-Zoster Viruses

The US Food and Drug Administration (FDA) has given 510(k) clearance for a new molecular assay for herpes simplex virus (HSV) types 1 & 2 and varicella-zoster virus (VZV), developed to run on the Solana platform.

Quidel Corporation (San Diego, CA, USA) received the FDA clearance for its Solana HSV-1+2/VZV Assay for qualitative detection and differentiation of HSV-1, HSV-2, and VZV DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active HSV-1, HSV-2, and/or VZV infection.

Herpetic lesions can be a result of the primary infection or from a reactivation of the latent virus, causing recurrent episodes. HSV-1 and HSV-2 are genetically and antigenically distinct. HSV-2 is the most common cause of genital infections, due to venereal transmission, often from an infected partner who does not have visible sores and who may not know that he or she is infected. HSV-1 is commonly associated with other disease locations, although both serotypes have been shown to cause disease in various locations of the body.

VZV is a DNA virus of the family Herpesviridae. Primary infection results in chickenpox (varicella), which rarely results in complications (e.g. encephalitis or pneumonia). Latency occurs with VZV remaining dormant in the nervous system of the infected person. In approximately 10-20% of cases, VZV reactivates later in life, producing shingles.

With Solana HSV-1+2/VZV Assay, specimens submitted in a broad range of transport media can be tested. In addition to being compatible with many commonly used transport media, the easy-to-use assay requires no upfront extraction of DNA, and generates three accurate results within an hour.

Solana can process up to 12 patient samples per run, and provides timesaving workflow advantages in moderately complex settings. Results are reported on the screen, stored in the instrument, can be saved to a USB drive, printed, and/or sent to the LIS. Supervisors can set access rights for higher security. Solana can also come with Virena, Quidel’s wireless data management and surveillance system.

"Quidel has long been a leader in developing innovative Respiratory and Women's Health assays. Our latest product introduction, the Solana HSV-1+2/VZV assay, broadens our molecular diagnostic offerings for Women's Health assays in the moderately complex setting," said Douglas Bryant, president and CEO of Quidel, "We believe that the Solana platform will provide the laboratorian with a fast and accurate method to diagnose many Women's Health conditions."

HSV-1+2/VZV is Quidel's fifth molecular diagnostic test to receive FDA 510(k) clearance in the Solana format, the other four being: Strep Complete, Influenza A+B, Trichomonas, and Group A Strep.

With the Solana franchise, Quidel has broadened its molecular strategy to include instrumented systems, and grown the number of its available FDA-cleared platforms. Quidel's other FDA-cleared molecular solutions include the AmpliVue non-instrumented system for lower-volume moderately complex labs, and Lyra reagents for higher throughput, highly complex laboratories that are compatible with existing PCR infrastructure.

Solana HSV-1+2/VZV Assay is not intended for use in prenatal screening, nor for use with cerebrospinal fluid or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS).

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