Performance of four diagnostic assays for detecting herpes simplex virus type 2 antibodies in the Middle East and North Africa

Gheyath K. Nasrallah, Soha Dargham, Afifah S. Sahara, Malaz S. Elsidiq, Laith Aburaddad

Research output: Contribution to journalArticle

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).

Original languageEnglish
Pages (from-to)33-38
Number of pages6
JournalJournal of Clinical Virology
Volume111
DOIs
Publication statusPublished - 1 Feb 2019

Fingerprint

Northern Africa
Eastern Africa
Human Herpesvirus 2
Middle East
Antibodies
Qatar
Enzyme-Linked Immunosorbent Assay
Western Blotting
Immunoglobulin G
Syria
Yemen
Population
Lebanon
Sensitivity and Specificity
Jordan
Sudan
Egypt
Pakistan
Human Herpesvirus 1
Virus Diseases

Keywords

  • Cohen's kappa statistic
  • Concordance measures
  • HSV-2
  • Middle East and North Africa
  • Sensitivity
  • Serology
  • Specificity

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

Cite this

Performance of four diagnostic assays for detecting herpes simplex virus type 2 antibodies in the Middle East and North Africa. / Nasrallah, Gheyath K.; Dargham, Soha; Sahara, Afifah S.; Elsidiq, Malaz S.; Aburaddad, Laith.

In: Journal of Clinical Virology, Vol. 111, 01.02.2019, p. 33-38.

Research output: Contribution to journalArticle

@article{763154247b5f44298c76a7a30cecb4a6,
title = "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{\circledR} 2 ELISA IgG and Euroimmun Anti-HSV-2 (gG2) ELISA (IgG), and two immunoblot (IB)/Western blot (WB) assays: HerpeSelect{\circledR} 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).",
keywords = "Cohen's kappa statistic, Concordance measures, HSV-2, Middle East and North Africa, Sensitivity, Serology, Specificity",
author = "Nasrallah, {Gheyath K.} and Soha Dargham and Sahara, {Afifah S.} and Elsidiq, {Malaz S.} and Laith Aburaddad",
year = "2019",
month = "2",
day = "1",
doi = "10.1016/j.jcv.2019.01.001",
language = "English",
volume = "111",
pages = "33--38",
journal = "Journal of Clinical Virology",
issn = "1386-6532",
publisher = "Elsevier",

}

TY - JOUR

T1 - Performance of four diagnostic assays for detecting herpes simplex virus type 2 antibodies in the Middle East and North Africa

AU - Nasrallah, Gheyath K.

AU - Dargham, Soha

AU - Sahara, Afifah S.

AU - Elsidiq, Malaz S.

AU - Aburaddad, Laith

PY - 2019/2/1

Y1 - 2019/2/1

N2 - 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).

AB - 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).

KW - Cohen's kappa statistic

KW - Concordance measures

KW - HSV-2

KW - Middle East and North Africa

KW - Sensitivity

KW - Serology

KW - Specificity

UR - http://www.scopus.com/inward/record.url?scp=85059666532&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85059666532&partnerID=8YFLogxK

U2 - 10.1016/j.jcv.2019.01.001

DO - 10.1016/j.jcv.2019.01.001

M3 - Article

VL - 111

SP - 33

EP - 38

JO - Journal of Clinical Virology

JF - Journal of Clinical Virology

SN - 1386-6532

ER -