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Table 6 Commercially available serological assays for HSV diagnosis approved by the Food and Drug Administration (US) (FDA, 2013)

From: Diagnosis of genital herpes simplex virus infection in the clinical laboratory

    

HSV-1

HSV-2

Assay

Manufacturer

Format

Collection method

Sensitivity

Specificity

Sensitivity

Specificity

Biokit HSV-2 Rapid Test

Biokit

Point of care

Heparinized capillary whole blood, serum

NA

NA

93%-96%

95%-98%

HerpeSelect HSV-1 and HSV-2 Immunoblot

Focus Diagnostics

Western blot with recombinant proteins

Serum

99.3%

95.1%

97.3%

93.7%

HerpeSelect HSV-1 ELISA, HerpeSelect HSV-2 ELISA

Focus Diagnostics

ELISA

Serum

91.2%-96%

92. 3%-95.2%

96.1% -100%

97.0%-96.1%

CaptiaHsv 1 IgG Type Specific Elisa Kit&CaptiaHsv 2 IgG Type Specific Elisa Kit

Trinity Biotech

ELISA

Serum

87.9%-87.7%

100%-98.2%

96.7%-100%

90.3%-91.5%

Liaison HSV-1 & Liaison HSV-2 Type SpecificIgGAssay

Diasorin

ELISA

Serum

96.9%-98.7%

91.3%-96.8%

98.1%-94.8%

98.0%-97.3%

Zeus ELISA HSV GG-2 IgG Test System & Zeus ELISA HSV GG-1 IgG Test System

Zeus Scientific

ELISA

Serum

96.8%

97.1%

98.8%

100%

BioPlex HSV-1 & HSV-2 IgG panel

Biorad

Luminex

Serum, lithium heparini plasma, EDTA plasma

100%-100%

98. 3%-97.4%

99.4%-100%

100%-100%

Elecsys HSV-1 IgG and HSV-2 IgG assays

Roche Diagnostics

Chemiluminescence

Serum, lithium heparin plasma, EDTA plasma

94.2%-91.0%

90. 3%-95.7%

93.6%-97.8%

98.7%-98.7%

  1. NA: Not Applicable.