Rana S Aldisi1, Malaz S Elsidiq2, Soha R Dargham3, Afifah S Sahara2, Enas S Al-Absi4, Mariam Y Nofal2, Layla I Mohammed4, Laith J Abu-Raddad5, Gheyath K Nasrallah6. 1. Department of Biomedical Science, College of Health Sciences, Qatar University, Doha, Qatar; BioMedical Research Center, Qatar University, Doha, Qatar. 2. Department of Biomedical Science, College of Health Sciences, Qatar University, Doha, Qatar. 3. Infectious Disease Epidemiology Group, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation - Education City, Doha, Qatar. 4. BioMedical Research Center, Qatar University, Doha, Qatar. 5. Infectious Disease Epidemiology Group, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation - Education City, Doha, Qatar; Department of Healthcare Policy and Research, Weill Cornell Medicine, Cornell University, New York, USA. 6. Department of Biomedical Science, College of Health Sciences, Qatar University, Doha, Qatar; BioMedical Research Center, Qatar University, Doha, Qatar. Electronic address: gheyath.nasrallah@qu.edu.qa.
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.
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.
Authors: Gheyath K Nasrallah; Soha R Dargham; Farah Shurrab; Duaa W Al-Sadeq; Hadeel Al-Jighefee; Hiam Chemaitelly; Zaina Al Kanaani; Abdullatif Al Khal; Einas Al Kuwari; Peter Coyle; Andrew Jeremijenko; Anvar Hassan Kaleeckal; Ali Nizar Latif; Riyazuddin Mohammad Shaik; Hanan F Abdul Rahim; Hadi M Yassine; Mohamed G Al Kuwari; Hamda Qotba; Hamad Eid Al Romaihi; Patrick Tang; Roberto Bertollini; Mohamed H Al-Thani; Asmaa A Althani; Laith J Abu-Raddad Journal: Sci Rep Date: 2021-06-04 Impact factor: 4.379
Authors: Ibrahim M Sayed; Mohamed A El-Mokhtar; Mahmoud Abdel Rahman Mahmoud; Amal A Elkhawaga; Shereen Gaber; Nermien H Seddek; Lobna Abdel-Wahid; Ahmed M Ashmawy; Enas Ahmed Reda Alkareemy Journal: Infect Drug Resist Date: 2021-01-12 Impact factor: 4.003