Performance evaluation of four type-specific commercial assays for detection of herpes simplex virus type 1 antibodies in a Middle East and North Africa population

Rana S. Aldisi, Malaz S. Elsidiq, Soha Dargham, Afifah S. Sahara, Enas S. Al-Absi, Mariam Y. Nofal, Layla I. Mohammed, Laith Aburaddad, Gheyath K. Nasrallah

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: The number of diagnostic assays for the detection of herpes simplex virus type 1 (HSV-1) antibodies has increased over the years. However, their performance characteristics could vary among global populations. Objective: To investigate performance of two commercial ELISA kits, HerpeSelect® 1 ELISA and Euroimmun Anti-HSV-1 (gC1) ELISA (IgG); and two commercial immunoblot (IB)/Western blot (WB) assays, HerpeSelect® 1 and 2 Immunoblot IgG, and Euroimmun Anti-HSV-1/HSV-2 gG2 Euroline-WB (IgG/IgM); in detecting HSV-1 antibodies in a Middle East and North Africa (MENA) population. Study design: Blood specimens were collected from blood donors in Doha, Qatar, June 2013–2016. Twenty specimens were randomly selected from 10 MENA nationalities (Egypt, Iran, Jordan, Lebanon, Pakistan, Palestine, Qatar, Sudan, Syria, and Yemen; total = 200), and tested for HSV-1 antibodies. Results: Across all six comparisons between assays, positive percent agreement ranged between 95.7% (95% CI: 91.4–98.3%) and 100.0% (95% CI: 97.8–100.0%). Negative percent agreement ranged between 86.2% (95% CI: 68.3-96.1%) and 96.2% (95% CI: 80.4–99.9%). Overall percent agreement ranged between 95.7% (95% CI: 91.7–97.8%) and 99.4% (95% CI: 96.7–99.9%). Cohen's kappa statistic ranged between 0.84 (95% CI: 0.73–0.95) and 0.98 (95% CI: 0.93–1.00). Compared against IB/WB, HerpeSelect® and Euroimmun had sensitivities and specificities >96% and >86%, respectively. Positive and negative predictive values were >97% and >83%, respectively. Conclusion: The assays showed excellent concordance with one another, and with a high kappa statistic. The ELISA kits demonstrated robust diagnostic performance compared to the IB/WB assays. These findings support the assays’ utility in clinical diagnosis and research in MENA populations.

Original languageEnglish
Pages (from-to)1-7
Number of pages7
JournalJournal of Clinical Virology
Volume103
DOIs
Publication statusPublished - 1 Jun 2018

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Northern Africa
Eastern Africa
Middle East
Human Herpesvirus 1
Western Blotting
Qatar
Enzyme-Linked Immunosorbent Assay
Antibodies
Population
Immunoglobulin G
Syria
Yemen
Lebanon
Jordan
Sudan
Human Herpesvirus 2
Egypt
Pakistan
Iran
Blood Donors

Keywords

  • Cohen's kappa statistic
  • Concordance measures
  • HSV-1
  • Sensitivity
  • Serology
  • Specificity

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases

Cite this

Performance evaluation of four type-specific commercial assays for detection of herpes simplex virus type 1 antibodies in a Middle East and North Africa population. / Aldisi, Rana S.; Elsidiq, Malaz S.; Dargham, Soha; Sahara, Afifah S.; Al-Absi, Enas S.; Nofal, Mariam Y.; Mohammed, Layla I.; Aburaddad, Laith; Nasrallah, Gheyath K.

In: Journal of Clinical Virology, Vol. 103, 01.06.2018, p. 1-7.

Research output: Contribution to journalArticle

Aldisi, Rana S. ; Elsidiq, Malaz S. ; Dargham, Soha ; Sahara, Afifah S. ; Al-Absi, Enas S. ; Nofal, Mariam Y. ; Mohammed, Layla I. ; Aburaddad, Laith ; Nasrallah, Gheyath K. / Performance evaluation of four type-specific commercial assays for detection of herpes simplex virus type 1 antibodies in a Middle East and North Africa population. In: Journal of Clinical Virology. 2018 ; Vol. 103. pp. 1-7.
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abstract = "Background: The number of diagnostic assays for the detection of herpes simplex virus type 1 (HSV-1) antibodies has increased over the years. However, their performance characteristics could vary among global populations. Objective: To investigate performance of two commercial ELISA kits, HerpeSelect{\circledR} 1 ELISA and Euroimmun Anti-HSV-1 (gC1) ELISA (IgG); and two commercial 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); in detecting HSV-1 antibodies in a Middle East and North Africa (MENA) population. Study design: Blood specimens were collected from blood donors in Doha, Qatar, June 2013–2016. Twenty specimens were randomly selected from 10 MENA nationalities (Egypt, Iran, Jordan, Lebanon, Pakistan, Palestine, Qatar, Sudan, Syria, and Yemen; total = 200), and tested for HSV-1 antibodies. Results: Across all six comparisons between assays, positive percent agreement ranged between 95.7{\%} (95{\%} CI: 91.4–98.3{\%}) and 100.0{\%} (95{\%} CI: 97.8–100.0{\%}). Negative percent agreement ranged between 86.2{\%} (95{\%} CI: 68.3-96.1{\%}) and 96.2{\%} (95{\%} CI: 80.4–99.9{\%}). Overall percent agreement ranged between 95.7{\%} (95{\%} CI: 91.7–97.8{\%}) and 99.4{\%} (95{\%} CI: 96.7–99.9{\%}). Cohen's kappa statistic ranged between 0.84 (95{\%} CI: 0.73–0.95) and 0.98 (95{\%} CI: 0.93–1.00). Compared against IB/WB, HerpeSelect{\circledR} and Euroimmun had sensitivities and specificities >96{\%} and >86{\%}, respectively. Positive and negative predictive values were >97{\%} and >83{\%}, respectively. Conclusion: The assays showed excellent concordance with one another, and with a high kappa statistic. The ELISA kits demonstrated robust diagnostic performance compared to the IB/WB assays. These findings support the assays’ utility in clinical diagnosis and research in MENA populations.",
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AU - Sahara, Afifah S.

AU - Al-Absi, Enas S.

AU - Nofal, Mariam Y.

AU - Mohammed, Layla I.

AU - Aburaddad, Laith

AU - Nasrallah, Gheyath K.

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N2 - Background: The number of diagnostic assays for the detection of herpes simplex virus type 1 (HSV-1) antibodies has increased over the years. However, their performance characteristics could vary among global populations. Objective: To investigate performance of two commercial ELISA kits, HerpeSelect® 1 ELISA and Euroimmun Anti-HSV-1 (gC1) ELISA (IgG); and two commercial immunoblot (IB)/Western blot (WB) assays, HerpeSelect® 1 and 2 Immunoblot IgG, and Euroimmun Anti-HSV-1/HSV-2 gG2 Euroline-WB (IgG/IgM); in detecting HSV-1 antibodies in a Middle East and North Africa (MENA) population. Study design: Blood specimens were collected from blood donors in Doha, Qatar, June 2013–2016. Twenty specimens were randomly selected from 10 MENA nationalities (Egypt, Iran, Jordan, Lebanon, Pakistan, Palestine, Qatar, Sudan, Syria, and Yemen; total = 200), and tested for HSV-1 antibodies. Results: Across all six comparisons between assays, positive percent agreement ranged between 95.7% (95% CI: 91.4–98.3%) and 100.0% (95% CI: 97.8–100.0%). Negative percent agreement ranged between 86.2% (95% CI: 68.3-96.1%) and 96.2% (95% CI: 80.4–99.9%). Overall percent agreement ranged between 95.7% (95% CI: 91.7–97.8%) and 99.4% (95% CI: 96.7–99.9%). Cohen's kappa statistic ranged between 0.84 (95% CI: 0.73–0.95) and 0.98 (95% CI: 0.93–1.00). Compared against IB/WB, HerpeSelect® and Euroimmun had sensitivities and specificities >96% and >86%, respectively. Positive and negative predictive values were >97% and >83%, respectively. Conclusion: The assays showed excellent concordance with one another, and with a high kappa statistic. The ELISA kits demonstrated robust diagnostic performance compared to the IB/WB assays. These findings support the assays’ utility in clinical diagnosis and research in MENA populations.

AB - Background: The number of diagnostic assays for the detection of herpes simplex virus type 1 (HSV-1) antibodies has increased over the years. However, their performance characteristics could vary among global populations. Objective: To investigate performance of two commercial ELISA kits, HerpeSelect® 1 ELISA and Euroimmun Anti-HSV-1 (gC1) ELISA (IgG); and two commercial immunoblot (IB)/Western blot (WB) assays, HerpeSelect® 1 and 2 Immunoblot IgG, and Euroimmun Anti-HSV-1/HSV-2 gG2 Euroline-WB (IgG/IgM); in detecting HSV-1 antibodies in a Middle East and North Africa (MENA) population. Study design: Blood specimens were collected from blood donors in Doha, Qatar, June 2013–2016. Twenty specimens were randomly selected from 10 MENA nationalities (Egypt, Iran, Jordan, Lebanon, Pakistan, Palestine, Qatar, Sudan, Syria, and Yemen; total = 200), and tested for HSV-1 antibodies. Results: Across all six comparisons between assays, positive percent agreement ranged between 95.7% (95% CI: 91.4–98.3%) and 100.0% (95% CI: 97.8–100.0%). Negative percent agreement ranged between 86.2% (95% CI: 68.3-96.1%) and 96.2% (95% CI: 80.4–99.9%). Overall percent agreement ranged between 95.7% (95% CI: 91.7–97.8%) and 99.4% (95% CI: 96.7–99.9%). Cohen's kappa statistic ranged between 0.84 (95% CI: 0.73–0.95) and 0.98 (95% CI: 0.93–1.00). Compared against IB/WB, HerpeSelect® and Euroimmun had sensitivities and specificities >96% and >86%, respectively. Positive and negative predictive values were >97% and >83%, respectively. Conclusion: The assays showed excellent concordance with one another, and with a high kappa statistic. The ELISA kits demonstrated robust diagnostic performance compared to the IB/WB assays. These findings support the assays’ utility in clinical diagnosis and research in MENA populations.

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