Table 1.
Summary of included studies. Table summarizes study location, herpes subtype, sample size, study design (retrospective or prospective), and the name of the diagnostic test under study as well as the tools it will be compared with.
| Study ID | Country | Study design | HSVa-1/2 | Sample size | Disease | Test | Test type | Comparison |
| Al‐Shobaili et al [24] | Saudi Arabia | Prospective | HSV-2 | 60: 35 male and 25 female | Genital ulcer disease (genital) | Herpe Select Express Rapid Test (Focus Technologies Inc, Cypress, CA) | Immunochromatographic (serology-based HSV detection assay) | HerpeSelect 2 IgGELISA (Focus Technologies Inc, Cypress, CA); Kalon HSV-2 IgGb ELISAc assay (Kalon Biological Ltd, Guilford, United Kingdom); MAb-EIAd |
| Barrado et al [28] | Spain | Prospective | HSV-1 | 188 | Suspicion of herpetic epithelial keratitis and nonherpetic corneal ulcer (ocular) | Real-time singleplex PCRe | Molecular assays for detection of HSV | Cell Culture- csPCR, csCC, cswPCR, csWCC |
| Burton et al [30] | United States | Retrospective | HSV-2 | 84 | Veterans with hepatitis C and HSV-2 coinfection | Focus HerpeSelect Hsv-2 IgG (Focus Technologies Inc, Cypress, CA) | Serology-based HSV detection assay | Biokit HSV-2 rapid assay (Biokit United States, Lexington, MA) |
| Gitman et al [31] | United States | Prospective | HSV-1, HSV-2 | 171 | Dermal, genital, ocular, mouth | Simplexa HSV 1 & 2 PCR (Focus Diagnostics, Cypress, CA) | Molecular assays for the detection of HSV | Cell culture (Diagnostic Hybrids, Athens, OH); Cytospin-enhanced DFAf; Real-time TaqMan PCR (LDTg HSV PCR) |
| Granato et al [32] | United States | Prospective | HSV-1, HSV-2 | 1351 | Cutaneous and mucocutaneous herpes infection (cutaneous) | AmpliVue HSV-1 & 2 assay (Quidel, San Diego, CA) | Molecular assays for detection of HSV | ELVIS HSV ID and D3 Typing System (Quidel DHI, Athens, OH) |
| Hobbs et al [33] | Kenya | Retrospective | HSV-2 | 198 | Not specified | HerpeSelect 2 (Focus Diagnostics, Cypress, CA); Kelon ELISA (Kalon Biological, Guildford, United Kingdom) | Serology-based HSV detection assay | Same tests but with serum sample |
| Lang et al [34] | Canada | Prospective | HSV-1, HSV-2 | 276 | Anogenital, oral | Viper HSV-Qx assay (BD Molecular Diagnostics) | Molecular assays for detection of HSV | LightCycler 2.0 platform (HSV-LC) (Roche Diagnostics, Basel, Switzerland) |
| Lee et al [35] | Singapore | Retrospective | HSV-1, HSV-2 | 117 | Not specified | Luminex ARIES HSV-1 & 2 assay (Luminex Corp, Austen, TX) | Molecular assays for detection of HSV | Förster resonance energy transfer-based PCR assay and FTD Neuro 9 assay (Fast Track Diagnostics, Junglinster, Luxembourg) |
| Liermann et al [36] | Germany | Retrospective | HSV-1, HSV-2 | 263 | Not specified | Orgentec ELISA Anti-HSV-2 IgM (Mainz, Germany); Orgentec ELISA Anti-HSV-1 IgM (Mainz, Germany); Orgentec ELISA anti-HSV-1/2 IgM (Mainz, Germany); Serion ELISA classic HSV-2 IgM IgM (Würzburg, Germany); Serion ELISA classic HSV-1 IgM (Würzburg, Germany); Serion ELISA classic HSV-1 + 2 IgM IgM (Würzburg, Germany); Orgentec ELISA Anti-HSV-2 IgG (Mainz, Germany); Orgentec ELISA anti-HSV-1 IgG (Mainz, Germany); Serion ELISA classic HSV-2 IgG IgM (Würzburg, Germany); Serion ELISA classic HSV-1 IgG IgM (Würzburg, Germany); Serion ELISA classic HSV-1 + 2 IgG IgM (Würzburg, Germany) | Serology-based HSV detection assay | HerpeSelect 1 ELISA IgG (Focus Diagnostics, Cypress, CA); HerpeSelect 2 ELISA IgG (Focus Diagnostics, Cypress, CA); Immunoblot assay recomLine HSV-1 & 2 IgG (Mikrogen, Neuried, Germany) |
| Liu et al [37] | China | Prospective | HSV-2 | 318 | Not specified | gG321580His ELISA test | Serology-based HSV detection assay | HerpeSelect 2 ELISA IgG (Focus Diagnostics, Cypress, CA) |
| Loughman et al [25] | France | Retrospective | HSV-2 | 60: 42 female and 18 male | Not specified | HSV-2 biochip test using reagents from the HerpeSelect® 2 IgG kit (Focus Diagnostics, CA; product EL0920G) | Serology-based HSV-2 immunoassay with biochip | LIAISON HSV-2 type specific IgG chemiluminescent immunoassay test (DiaSorin, MN) |
| Binnicker et al [29] | United States | Prospective | HSV-1, HSV-2 | 100 | Central nervous system infection due to herpes simplex virus (CNS) | Simplexa HSV 1 & 2 Direct (Focus Diagnostics, Cypress, CA) | Molecular assays for detection of HSV | Roche HSV-1/2 ASR (Roche Diagnostics, Indianapolis) |
| Miller et al [38] | United States | Prospective | HSV-1, HSV-2 | 179 | Genital herpes | IDbox HSV-1/2 assay (GenturaDx) | Molecular assays for detection of HSV | Culture; MultiCode HSV PCR |
| Parra-Sánchez et al [39] | Spain | Prospective | HSV-1, HSV-2 | 283 | Various mucosal and cutaneous lesions, CSF, urinary | HSV OligoGen kit (Operon-Immuno&Molecular Diagnostics, Zaragoza, Spain) | Molecular assays for detection of HSV | Roche LightCycler HSVóQual Kit assay (Roche Diagnostics, Basel, Switzerland) |
| Patel et al [26] | South Africa and Zambia | Retrospective | HSV-2 | 3408 | HSV-2/HIV-1 coinfected individuals and HIV-uninfected heterosexual partners | Kalon HerpeSimplex virus type 2 IgG ELISA (Kalon Biological Ltd, Surrey, United Kingdom) | Serology-based HSV detection assay | Washington HSV western blot |
| Van Der Pol et al [40] | United States | Prospective | HSV-1, HSV-2 | 508 | Anogenital infections (anogenital) | BD ProbeTec HSV-Qx (HSVQx) system (BD Diagnostics, Sparks, MD) | Molecular assays for detection of HSV | Elvis culture system (San Diego); Laboratory-developed PCR assay |
| Shevlin and Morrow [41] | United States | Retrospective | HSV-2 | 100 | Not specified | Uni-Gold HSV-2 rapid (Trinity Biotech, Ireland) | Serology-based HSV detection assay | Washington HSV western blot |
| Shoji et al [27] | Japan | Prospective | Viral subtype could not be ascertained | 59 + 23 healthy volunteers | Herpes simplex keratitis (ocular) | HSV DNA (by PCR) and HSV specific sIgA antibody levels (ELIZA) in tears | Serology-based HSV detection assay and molecular assays for detection of HSV | —h Control patients? |
| Tong et al [42] | United States | Prospective | HSV-1, HSV-2 | 176 | Genital and oral lesions (oral and genital) | IsoGlow HSV typing assay (BioHelix Corp, Beverly, MA) | Molecular assays for detection of HSV | IsoAmp HSV (BioHelix Corp, Beverly, MA); ELVIS Shell Vial Assay (Diagnostic Hybrids, Athens, OH) |
aHSV: herpes simplex virus.
bIgG: immunoglobulin G.
cELISA: enzyme-linked immunosorbent assay.
dMAb-EIA: monoclonal antibody enzyme immunoassay.
ePCR: polymerase chain reaction.
fDFA: direct fluorescent antibody.
gLDT: laboratory developed test.
hNot applicable.