Wide Variability in the Sensitivity and Specificity of Rotavirus Immunoassay Diagnostic Kits in Practice

  • Rouba Shaker Department of Pediatrics and Adolescent Medicine, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
  • Ebla Abdalrahman Department of Pediatrics and Adolescent Medicine, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
  • Zainab Ali Department of Pediatrics and Adolescent Medicine, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
  • Lina Reslan Center for Infectious Diseases Research, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
  • Houda Harastani Center for Infectious Diseases Research, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
  • Amjad Haidar Center for Infectious Diseases Research, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
  • Soha Ghanem Department of Pediatrics and Adolescent Medicine, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
  • Farah Hajar Department of Pediatrics and Adolescent Medicine, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
  • Adlette Inati Department of Pediatrics, Nini Hospital, Tripoli, Lebanon
  • Mariam Rajab Department of Pediatrics, Makassed General Hospital, Beirut, Lebanon
  • Ghassan Baassiri Department of Pediatrics, Hammoud Hospital University Medical center, Saida, Lebanon
  • Bassam Ghanem Department of Pediatrics, Nabatieh Governmental Hospital, Nabatieh, Lebanon
  • Hassan Fakhoury Department of Pediatrics, Rafik Hariri University Hospital, Beirut, Lebanon
  • George Araj Center for Infectious Diseases Research, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
  • Ghassan M Matar Center for Infectious Diseases Research, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
  • Ghassan Dbaibo Department of Pediatrics and Adolescent Medicine, American University of Beirut, Faculty of Medicine, Beirut, Lebanon
Keywords: Rotavirus gastroenteritis, rapid kits, sensitivity, specificity

Abstract

Introduction: Most hospitals rely on rapid antigen-detection kits for the diagnosis of rotavirus infection. Several small studies reviewed the sensitivity and specificity of some of these kits. These studies showed discrepancy in results obtained for sensitivity and specificity that varied according to the type of kit used, area of study, and type of test used as standard for diagnosis of rotavirus infection. The objective of the study is to determine the sensitivity and specificity of five commonly used rotavirus immunoassay kits in comparison to RT-PCR as standard.

Methodology: Stool samples (N = 1,414) collected from children under 5 years of age hospitalized with gastroenteritis were tested for rotavirus by immunoassay kits and RT-PCR in a prospective hospital-based surveillance study conducted at 7 centers in Lebanon. Concordance and discrepancy between the two methods was used to calculate sensitivity and specificity, using RT-PCR as the “gold standard”.

Results: The sensitivity and specificity were respectively 95.08% and 86.62% for the SD Bioline® (Standard Diagnostics, Inc, South Korea) kit calculated on 645 samples, 65.86% and 45.90% for the VIROTECT® (Trinity Biotech, Ireland) kit calculated on 327 samples, 83.9% and 64.2% for the Rota-Strip (C-1001) (Coris Bioconcept, Belgium) calculated on 95 samples, 52.3% and 10.9% for the Acon® (Acon Laboratories, Inc, California, USA) kit calculated on 122 samples, 68.1% and 20% for the VIKIA® Rota-Adéno (Biomerieux, France) kit calculated on 32 samples.

Conclusion: A wide discrepancy was detected between the calculated and advertised sensitivity and specificity for most of the kits.

Published
2021-11-30
How to Cite
1.
Shaker R, Abdalrahman E, Ali Z, Reslan L, HarastaniH, HaidarA, GhanemS, Hajar F, Inati A, RajabM, Baassiri G, Ghanem B, Fakhoury H, Araj G, Matar GM, Dbaibo G (2021) Wide Variability in the Sensitivity and Specificity of Rotavirus Immunoassay Diagnostic Kits in Practice. J Infect Dev Ctries 15:1701-1707. doi: 10.3855/jidc.11922
Section
Original Articles