JMIR Publications

ABSTRACT

Background:

Herpes simplex viruses (HSV) 1 and 2 are common infections affecting the global population. HSV 1 is the most common type estimated to affect 67% of the global population. HSV can have rare, but severe manifestations such as encephalitis and neonatal herpes necessitating the use of reliable and accurate diagnostic tools for the detection of the viruses. Currently used HSV diagnostic tools require highly specialized skills, availability of a laboratory setting and may lack sensitivity. More recent HSV diagnostic tools are numerous and need to be identified and compared in a systematic way to be able to make the best decision about which diagnostic tool to use. Diagnosis of HSV is essential for prompt treatment with antivirals. To select the best test for a patient, knowledge of the performance and limitations of each test are critical.

Objective:

This systematic review summarizes recent study articles evaluating HSV-1 and HSV-2 diagnostic tools.

Methods:

Following the PRISMA guidelines, selection criteria, data extraction and data analysis were determined prior to commencement of the study. Studies assessing the specificity/sensitivity of an HSV 1 or HSV 2 diagnostic tool published between 2012 and 2018 were included. Quality assessment of included studies was performed using the quality assessment of diagnostic accuracy studies (QUADAS-2) tool.

Results:

Searches of the PubMed database yielded 264 studies. Eleven studies included eleven molecular assays, and eight studies included 19 different serological assays for the detection of either HSV 1, HSV 2 or both types of the virus. A greater proportion of tools based on molecular assays are being developed by commercial entities. Studies that tested molecular assays mostly focused on cutaneous and mucosal HSV infections (n=13); two studies focused on ocular disease, while a single one on central nervous system manifestations. The Simplexa HSV-1/2 Direct is currently the only FDA approved device for use on cerebrospinal fluid. No tools focused on prenatal screening. We also present performance metrics of tests for benchmarking of future technology. Most of the included studies had a high risk of bias rating in half of the QUADAS-2 tool risk of bias domains.

Conclusions:

The landscape of diagnostic tools for HSV-1 and HSV-2 infections is rapidly moving away from laboratory based and culture methods that have long been considered the gold standard technique. The majority of tools study cutaneous and mucosal HSV infections (n=13); two tests focused on ocular disease, while a single one on CNS manifestations. No diagnostic tools included in our systematic review are currently suitable for use as prenatal tools, however. The incidence of acute infections is rising, and since these infections present the greatest risk to unborn fetuses further work needs to be done to develop diagnostic tools to detect primary infection in expectant mothers to prevent vertical transfer. This will assist in lowering the rate of neonatal herpes, which can be a life threatening condition. We believe this can only be achieved through prenatal screening for primary infection and subsequent medical intervention. Clinical Trial: N/A