Table 2.

Methodological characteristics of included studies, summarizing study aims, conclusions, and demographic data.

Study ID	Patient demographic data	Aims/rationale	Conclusions
Al‐Shobaili et al [24]	58% male; mean age 37 (SD 13.6) years	To evaluate a point-of-care test (HerpeSelect Express Rapid Test) for more rapid turnaround of results in a nonlaboratory setting.	The HerpeSelect Express Rapid Test has adequate sensitivity and specificity for confirming HSVa-2 infection in patients with genitourinary disease. The test is good at diagnosing high-risk individuals.
Barrado et al [28]	52.2% male; mean age 56.9 (SD 19.7) years	Assess if conjunctival swab samples were equivalent to corneal scrapings to diagnose herpetic keratitis.	Conjunctival swabs may serve as supplemental method for the diagnosis of typical HKb despite limited sensitivity when the collection of corneal scrapings would not be feasible. PCRc must be considered the gold standard for diagnosis of typical HK.
Burton et al [30]	92% male; 67% African American; 33% white; 97% heterosexual	To assess type-specific tests for HSV-2 in patients with chronic hepatitis C infection	In veterans with chronic hepatitis C infection, HerpeSelect 1 HSV-2 index values between 1.1 and 2.89 should be confirmed with an alternate test for HSV-2 infection. Only effective within certain range.
Gitman et al [31]	26.4% male; 148 adult; 23 pediatric	Compare the performance, time to result, and cost of the Simplexa HSV 1 & 2 Direct PCR with those of conventional	Simplexa HSV 1 & 2 Direct PCR is expensive but required the least training, had the lowest hands-on time and fastest assay time (75 min vs 3 hours by LDTd HSV PCR), detected most positives, considered an internal control, and provided the HSV type.
Granato et al [32]	—e	To evaluate the performance of Amplivue HSV-1 + 2 assay compared with ELVIS HSV IDD3 in detecting HSV-1-2 from clinical specimens.	The results of this study show that the AmpliVue HSV-1/2 assay was more sensitive than ELVIS culture for detecting HSV-1 and HSV-2 in a wide variety of cutaneous and mucocutaneous specimens
Hobbs et al [33]	198 adult male and female; 18 samples used for Kalon assay; 178 samples used for the Focus assay	To evaluate and validate the use of Focus and Kalon ELISAsf in detecting HSV-2 antibodies from dried blood sample as part of an HIV prevention trial.	The use of dried blood spots can reduce time and provide an effective way to test for HSV-2 in resource-limited settings. The study found that the use of dried blood spots with the Kalon assay did not perform well and that the use of dried blood spots with the Focus assay resulted in comparable sensitivity and specificity to the use of serum sample.
Lang et al [34]	—	Compare HSV-Q and real-time HSV PCR in terms of accuracy and cost. Device approved for anogenital infections; this study investigates its use on lesions from other anatomical locations.	The HSV-Qx assay was found to be highly sensitive and accurate. Gray zone may be required for specimens with values falling between 50 and 800 maximum relative fluorescence units. HSV-Qx has a lower cost per specimen ($22) compared with that of HSV-LC ($34). Samples lying near the positivity cut off should be retested.
Lee at al [35]	—	To evaluate the analytical and clinical performance of the Luminex ARIES assay in detecting HSV-1 and HSV-2 compared with an approved assay for the HSV testing for the diagnosis of meningitis/encephalitis.	The analytical performance results of the assay showed that the assay had lower sensitivity than the comparator. On the other hand, the clinical performance results of the assay showed that it had comparable performance to the routinely used assay. Compared with 2 other routinely used assays, the ARIES assay required the shortest amount of hands-on and assay time and was the least labor-intensive. The study concluded that Luminex ARIES assay can be used for successful detection of HSV-1 and HSV-2 for skin and genital infections, meningitis, and encephalitis.
Liermann et al [36]	Healthy children aged between 5 months and 3 years, healthy voluntary blood donors aged 18 to 65 years, or hospitalized patients aged between 14 and 70 years	Evaluate the HSV type-common and type-specific IgGg and IgMh enzyme-linked immunosorbent assays for the diagnosis of acute and latent HSV infections.	HSV type-common IgM ELISAs can be useful to confirm acute newly acquired HSV infections; the use of single-type IgM ELISAs on the basis of whole-virus antigen is dispensable.
Liu et al [37]	64% male; mean age 35.9 (SD 4.52) years for males; mean age 30.7 (SD 4.65) years for females	Need for a convenient, high-quality, rapid, and inexpensive domestic serodiagnostic kit that differentiates between HSV-1 and HSV-2.	The study indicates that gG321–580H has a high diagnostic potential for HSV-2 virus serodiagnosis in humans.
Loughman et al [25]	30% male; median age of 40.5 (range: 15-85)	To validate the HSV-2 biochip assay as a point-of-care test to be able to use it in resource-limited settings.	Membrane-touch biochip requires some improvements such as expanded calibration before it can be used as a rapid diagnosis tool. The tool was validated and performs comparable to other standard diagnostic methods. The study concluded that the assay could work potentially as a rapid, point-of-care test for HSV-2.
Binnicker et al [29]	—	Investigates a more rapid, cheaper method of detecting HSV in CSFi fluid that only uses a small amount of fluid. This makes it suitable for use in neonates.	The Simplexa HSV-1/2 assays demonstrated a combined sensitivity and specificity of 96.2% and 97.9%, respectively. Assay does not require nucleic acid extraction. Results are available in 60 min. The Simplexa assay requires only 50 mL of CSF.
Miller et al [38]	—	New system designed to maximize sensitivity. This study assesses whether this is achieved and is fully automated.	Assay shows acceptable clinical performance characteristics and demonstrates promise for further development of this fully automated platform for detection of pathogen nucleic acid in clinical laboratories
Parra-Sánchez et al [39]	42.2% male; median age 30.5 (Q1-Q3 24.0-39.0) years	Evaluate a new assay, the HSV OligoGen Kit for the detection of HSV in several types of clinical samples	Detection of HSV-1 and HSV-2 in clinical samples by HOKj was not significantly different from detection by LCHK assay (P ≥.8, t test). Statistical data obtained in this study confirm the usefulness and reliable results of this new assay from a variety of specimens.
Patel et al [26]	51% male; median age (IQR) of 32.0 (27-39); HIV-positive: 50%	Evaluate an onsite HSV tool in a population of HIV infected and noninfected patients and to evaluate the precision of the Kalon HSV-2 IgG ELISA.	In populations with optimal diagnostic accuracy, Kalon is a reliable stand-alone method for on-site HSV-2 IgG antibody detection. Kalon can be utilized in resource-limited settings, enhancing the feasibility to monitor the epidemic and assess intervention efforts.
Van Der Pol et al [40]	34% male; median age: 25 years (range: 17-71)	Results of a multicenter study evaluating the performance of a recently FDAk-approved, commercially available, type-specific nucleic acid amplification test that allows type-specific HSV discrimination.	Assay performs as well as the other assays on a fully automated system that provides results within a few hours rather than many days. No differences in test performance based on gender, clinic type, location of the lesion, or type of lesion were observed.
Shevlin and Morrow [41]	35% male (estimate); Pediatric sera (age <18 years) were not included	Evaluation of a point-of-care and inexpensive device to detect anti-HSV anybody in serum or blood.	UHR is a reliable, low-cost alternative to other point-of-care HSV-2 diagnostic tests. Showed both sensitivity and specificity in a small group of adults.
Shoji et al [27]	51% male	Assesses whether the combined utilization of IgAantibody (HSV-sIgA) levels in tears and real-time PCR can improve diagnostic ability.	The combination of laboratory detection of HSV DNA by real-time PCR and of HSV-sIgA by ELISA using tear samples enables higher reliability in diagnosing the subgroups of HSKl.
Tong et al [42]	—	Substantial market need for a low-cost, point-of-care HSV typing assay. Such a device is assessed within this study.	Both formats of the IsoGlow HSV typing assay had sensitivities comparable to that of the FDA-cleared IsoAmp HSV test and specificity for the 2 types of HSV comparable with that of ELVIS HSV turnaround time of around 1 hour.

^aHSV: herpes simplex virus.

^bHK: Herpes Keratitis.

^cPCR: polymerase chain reaction.

^dLDT: laboratory developed test.

^eNot applicable.

^fELISA: enzyme-linked immunosorbent assay.

^gIgG: immunoglobulin G.

^hIgM: immunoglobulin M.

ⁱCSF: cerebrospinal fluid.

^jHOK: HSV OligoGen kit.

^kFDA: Food and Drug Administration.

^lHSK: Herpes Simplex Keratitis.