Multicenter Evaluation of Meridian Bioscience HSV 1&2 Molecular Assay for Detection of Herpes Simplex Virus 1 and 2 from Clinical Cutaneous and Mucocutaneous Specimens

Abstract

Herpes simplex virus 1 (HSV-1) and 2 (HSV-2) are doublestranded DNA viruses of the Herpesviridae family and are a common cause of cutaneous and mucocutaneous oral and genital lesions (1, 2). Historically, HSV-1 has been associated with oral lesions while HSV-2 has more often been associated with genital lesions, although recently this epidemiology has been changing. Additionally, HSV can cause invasive disease, including sepsis and fulminate encephalitis in neonates that are infected by exposure to herpetic lesions present at the time of birthing (3). Infection with HSV-1 is common, with seroprevalence reaching 50% to 70% in developed countries and Ͼ80% in developing countries (4-6). The seroprevalence of HSV-2 varies from 5% to 40% (7,8). While there is no cure for HSV infections, specific antiviral therapy exists to alleviate symptoms, shorten the duration of recurring outbreaks, and to treat life-threatening manifestations (9). Therefore, accurate laboratory diagnosis of these infections is important.The diagnosis of HSV based solely on clinical exam is difficult. Typical HSV lesions can mimic those of other sexually transmitted infectious agents (e.g., Treponema pallidum and Haemophilus ducreyi), staphylococcal folliculitis, herpes zoster, and skin abrasion due to physical injury (10). Therefore, it is essential to confirm all possible herpetic infections with laboratory diagnostics. Classically, laboratory diagnosis of superficial HSV infections relied on the collection of vesicular exudate or scrapings from a lesion and inoculation into a susceptible cell line (Hep-2, A549, etc.). Following incubation, cells are observed microscopically for viral-induced cytopathic effects (CPE) over 5 to 14 days (11). Standard cell culture was improved with the development of the enzymelinked virus-inducible system (ELVIS; Diagnostic Hybrids, Athens, OH), which increased sensitivity and reduced turnaround time (TAT) to approximately 24 h (12, 13). Overall, the sensitivity and specificity of ELVIS has been reported to range from 88% to 100% and 98% to 100%, respectively (14, 15). Importantly, the sensitivity of all culture-based diagnostics is dependent upon the presence and load of viable virus in a specimen, which is affected by the age of the lesion and specimen handling (16-18).Molecular assays include laboratory-developed and FDAcleared multiplex assays for simultaneous detection of and differ-

Asian guidelines for genital herpes

“…BD ProbeTec HSV-Qx system (anogenital swabs), Viper HSV-Qx assay (anogenital and oral swabs), AmpliVue HSV-1 & 2 assays, Illumigene HSV 1&2 assay (cutaneous and mucocutaneous swabs), and Luminex ARIES HSV-1 & 2 assays (cutaneous and mucocutaneous swabs) are FDA approved molecular methods for diagnosis of genital herpes [68]. Compared to the viral culture method, these molecular methods have sensitivity and specificity ranging between 94.8-98.9 % and 93.2-97.6 %, respectively, for detecting HSV-1 and HSV-2 [69][70][71].…”

Current and Future Trends in the Laboratory Diagnosis of Sexually Transmitted Infections

“…Another assay exploiting LAMP applied to the concept of "lab-on-a-chip" successfully detected NG, CT, MH, and UU directly from genitourinary secretions [92]. The Illumigene (Meridian Bioscience, Cincinnati, OH, USA) HSV-1,2 multiplex LAMP assay has been thoroughly evaluated in a multicenter study, and detects and differentiates the two viruses with a higher sensitivity compared to other molecular assays and even higher than that of culture [93]. A very rapid detection (less than one hour) has also been successfully achieved simultaneously for CT and NG using a strand invasion-based (SIBA) approach [94].…”

Amplification chemistries in clinical virology

“…However, complicated primer design and the possibility of carry-over contamination still remain a concern for LAMP-based assays [50,56]. A commercial LAMP assay demonstrating > 94% sensitivity and > 95% specificity is available for the detection of HSV 1 & 2 [57]. LAMP-based assays have also been developed for the detection of emerging viral pathogens such as SARS-CoV [58], chikungunya, and dengue virus [59].…”