Table 3.

Molecular assays for the detection of herpes simplex virus, summarizing the different molecular assays studied within the 10 included studies. Information includes regulatory status, collection/storage/transport method, and performance.

Test	Study ID	Manufacturer	FDAa status	EMAb status	Sample type	Collection method
Real-time singleplex PCRc	Barrado et al [28]	University Hospital Madrid, Spain (academic)	No	No	Corneal scrapings and conjunctival swabs	Corneal scrapings by a platinum Kimura spatula using as viral transport medium UTM (Universal transport medium, Copan Diagnostic, Inc). Conjunctival swabs were obtained by polyester swabs.
Simplexa HSV 1 & 2 Direct	Gitman et al [31]	Focus Diagnostics, Cypress, CA	Yes	Unclear	Dermal, ocular, mouth	Swabs were collected from local clinics, doctors’ offices, and inpatient wards in 3 mL of M4 viral transport medium (Remel, Lenexa, KS)
Simplexa HSV 1 & 2 Direct	Binnicker et al [29]	Focus Diagnostics, Cypress, CA	Yes	Unclear	CSFd	Unknown how CSF collected.
AmpliVue HSV-1 & 2 assay	Granato et al [32]	Quidel, San Diego, CA	Yes	Unclear	Cutaneous and mucocutaneous swabs	All specimens were collected on swabs, transported to the laboratory in viral transport medium
Viper HSV-Qx assay	Lang et al [34]	BD Diagnostics, Sparks, MD	Yes (only for anogenital lesions)	Unclear	Anogenital and oral swabs	—e
Luminex ARIES HSV-1 & 2 assay	Lee et al [35]	Luminex Corp, Austen, TX	Yes (only for cutaneous or mucocutaneous lesion samples)	Unclear	Lesion swab samples	Lesion swab samples were collected in clinic and deidentified for the study
BD ProbeTec HSV-Qx (HSVQx) system	Van Der Pol et al [40]	BD Diagnostics, Sparks, MD	Yes (only for anogenital lesions)	—	Anogenital swabs	Sampled using a polyester swab, which was placed directly into universal viral transport medium (Becton, Dickinson [BD], Sparks, MD), and then using a second, foam-tipped swab, which was placed directly into the BDQx liquid wet-swab transport medium (Qx WS).
IDbox HSV-1/2 assay	Miller et al [38]	GenturaDx, Hayward, CA	No	No	Genital swabs	Swabs collected in 3 mL of universal transport medium, transported to labs, aliquoted samples stored in −70°C
HSV OligoGen kit	Parra-Sánchez et al [39]	Operon-Immuno&Molecular Diagnostics, Zaragoza, Spain	No	No	Various swabs; 110 ulcer specimens, 48 urine, 48 endocervical, 43 CSFs, 4 urethral, and 3 pharyngeal swabs	Cobas PCR media urine sample kit or cobas PCR media female swab sample kit (Roche Diagnostics GmbH, Mannheim, Germany); 110 ulcer specimens, 48 urine, 48 endocervical, 43 CSF, 4 urethral, and 3 pharyngeal swabs
HSV DNA (by PCR) and HSV specific sIgA antibody levels (ELIZA)	Shoji et al [27]	School of Medicine, Tokyo, Japan (academic)	No	No	Tears	Using Schirmer strips (Schirmer Tear Production Measuring Strips; Showa- Yakuhinkako, Tokyo, Japan)
IsoGlow HSV typing assay	Tong et al [42]	BioHelix Corp, Beverly, MA	No	Unclear	Swabs	Clinical swabs suspended in vial transport medium were collected from the Cleveland Clinic (Cleveland, OH). The samples were shipped on ice for overnight delivery and were aliquoted on receipt. Some were placed at −80°C for long-term storage, and some were placed at −20°C for short-term storage or near-term testing.

^aFDA: Food and Drug Administration.

^bEMA: European Medicines Agency.

^cPCR: polymerase chain reaction.

^dCSF: cerebrospinal fluid.

^eNot applicable.