Performance of Four Diagnostic Assays for Detecting Herpes Simplex Virus Type 2 Antibodies in the Middle East and North Africa

Abstract

Background Assessments of commercial assays in detecting herpes simplex virus type 2 (HSV-2) antibodies have shown variable sensitivity and specificity, and variation in performance by global population. Objective To evaluate performance of four assays in detecting HSV-2 antibodies in a composite Middle Eastern and North African (MENA) population. The assays are two ELISA kits: HerpeSelect® 2 ELISA IgG and Euroimmun Anti-HSV-2 (gG2) ELISA (IgG), and two immunoblot (IB)/Western blot (WB) assays: HerpeSelect® 1 and 2 Immunoblot IgG and Euroimmun Anti-HSV-1/HSV-2 gG2 Euroline-WB (IgG/IgM). Study design Blood specimens were drawn from blood donors between 2013–2016 in Doha, Qatar. Twenty specimens from ten nationalities (Egypt, Iran, Jordan, Lebanon, Pakistan, Palestine, Qatar, Sudan, Syria, and Yemen; total = 200) were randomly selected and tested for HSV-2 antibodies. Results In the six possible assay comparisons, Cohen’s kappa statistics indicated fair to good agreement, ranging between 0.57 (95% CI 0.28-0.86) and 0.69 (95% CI 0.44-0.95). Meanwhile, positive percent agreement ranged between 50.0 (95% CI 18.7–81.3%) and 63.6% (95% CI 30.8–89.1%); negative percent agreement ranged between 97.8% (95% CI 94.4–99.4%) and 99.5% (95% CI 97.0–100.0%); and overall percent agreement ranged between 95.8% (95% CI 91.9–97.9%) and 97.5% (95% CI 94.2–98.9%). The two ELISA kits demonstrated comparable sensitivities and specificities ≥50% and >98%, respectively, with respect to the IB/WB assays. Conclusion The study provided, for the first time, primary data on performance of these assays in diagnosing HSV-2 infection in MENA populations. Findings support comparable performance and utility of these assays, and demonstrate challenges in establishing seropositivity (versus seronegativity).