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Abstract

Background: In April2009, a novel influenza A(H1N1) virus emerged in North America andMexico. In the face of a pandemic influenza, serology provides important public health data and is a valuable research tool. The labor intensiveness of the hemagglutination inhibition (HI) test is a major hindrance to its use on a large scale in routine. Recently, a commercial enzyme-linked immunosorbent assay (ELISA) (pandemic A(H1N1) IgG and IgA Genzyme Virotech®) has been developed. In addition, the need for surveillance led us to develop complement fixation test (CF) with2009 A(H1N1) viral lysate. The following study was conducted to assess the antibody detection accuracy of this two tests in comparison with the HI test as “gold standard”.

Patients and methods: Serum samples tested in this study were collected from 2 groups of subjects. The first group comprised 75 unvaccinated patients; the second group comprised 69 subjects receiving immunosuppressive therapy and vaccinated three weeks ago against2009 A(H1N1). All were tested by the three techniques.

Results and conclusion: Sero-prevalence was significantly higher in vaccinated than unvaccinated subjects (p = 0,032). In vaccinated group, the ELISA IgA gave a sensitivity of 61% and a specificity of 78%, ELISA IgG gave the same value for specificity but 75% for sensitivity; the CF titre cut-off (80) gave a sensitivity of 15% and a specificity of 87%. The CF titer cut-off value that provided the highest sensitivity (71%) and specificity (78%) was 10. In unvaccinated patients, the ELISA IgG gave a sensitivity of 57% and 87% for specificity; the CF titre cut-off (80) gave a sensitivity of 70% and a specificity of 100%.; strong positive correlation (r²=0.67, p<0.0001) was noted between CF and IH titers. CF results had good concordance with HI for general population screening. ELISA may be superior to CF for the detection of2009 A(H1N1) antibodies among vaccinated patients. 

Keywords

ELISA complement fixation hemagglutination inhibition pandemic A(H1N1) influenza

Article Details

How to Cite
Tagajdid, R., Casalegno, J. S., Lina, B., Mrani, S., & Mekki, Y. (2014). Evaluation of Routine Serological Diagnostic Methods for the 2009 Pandemic Influenza A (H1N1) Virus. HEALTH SCIENCES AND DISEASE, 15(1). https://doi.org/10.5281/hsd.v15i1.335

References

  1. Centers for Disease Control and Prevention (CDC). Swine influenza A (H1N1) infection in two children-southern California, March-April 2009. Morbidity and Mortality Weekly Report. 2009;58: 400–402.
  2. Fraser C, et al. Pandemic potential of a strain of influenza A (H1N1) : early findings. Science. 2009; 324:1557–1561.
  3. Papenburg J, Baz M, Hamelin E and al. Evaluation of Serological Diagnostic Methods for the 2009 Pandemic Influenza A (H1N1) Virus. Clinical And Vaccine Immunology. 2011;18(3):520–522.
  4. Wasenko JM. et al. Enhanced diagnosis of pandemic (H1N1) 2009 influenza infection using molecular and serological testing in intensive care unit patients with suspected influenza. Clinical Infectious Diseases. 2010;51:70–72.
  5. Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. New England Journal of Medicine. 2009; 360: 2605–2615.
  6. Writing Committee of the WHO Consultation on Clinical Aspects of Pandemic Influenza. Clinical aspects of pandemic 2009 influenza A (H1N1) virus infection. New England Journal of Medicine. 2010;362:1708–1719.
  7. World Health Organization. 2002. WHO manual on animal influenza diagnosis and surveillance. Available: http://www.who.int.gate2.inist.fr/csr/resources/publications/influenza/en/whocdscsrncs20025rev.pdf. Accessed 22 Feb 2010.
  8. Eichelberger M, Golding H, Hess M, and al. FDA/NIH/WHO public workshop on immune correlates of protection against influenza A viruses in support of pandemic vaccine development, Bethesda, Maryland, US, December 10–11, 2007. Vaccine. 2008;26:4299.
  9. Talbot PJ. ELISA. p. 149 – 153. In Payement P, Trude M, ed. Manuel de techniques virologiques, 1989, 3ème édition. La Presse de l’Université de Quebec.
  10. National standard method : Complement fixation tests. www.evaluations-standards.org.uk. Available 11.12.09.
  11. Constantine N, Lana D. Immunoassays for the diagnosis of infectious diseases. p. 218-233. In: Murray PR, ed. Manual of Clinical Microbiology. 2003, 8th ed. Washington, DC: ASM Press.
  12. Edward WT. Harry R. Thomas B and Christine ML. Comparison of Complement Fixation With Two Enzyme-Linked Immunosorbent Assays for the Detection of Antibodies to Respiratory Viral Antigens. American Journal of Clinical Pathology. 2006;125:460-466.
  13. Influenza Report 2006: www.InfluenzaReport.com (Pathogenesis and Immunology) Accessed online 30 March 2006.
  14. Mackay HJ, McGee J, Villa D and al. Evaluation of pandemic H1N1 (2009) influenza vaccine in adults with solid tumor and hematological malignancies on active systemic treatment. Journal of Clinical Virology. 2011;50(3):212-6.
  15. Prince HE and Leber AL. Comparison of Complement Fixation and Hemagglutination Inhibition Assays for Detecting Antibody Responses following Influenza Virus Vaccination. Clinical Diagnosis Laboratory Immunology. 2003;10(3): 481–482.
  16. Papenburg J. Baz M. Hamelin ME and al. Evaluation of Serological Diagnostic Methods for the 2009 Pandemic Influenza A (H1N1) Virus. Clinical and Vaccine Immunology. 2011;18(3):520-522.
  17. Ziegler T, Katz JM., Cox NJ, and Regnery HL. Influenza viruses. p. 673-678. In Rose NR, De Macario EC, Folds JD, Lane HC, and Nakamura RM. Manual of clinical laboratory immunology, 1997, 5th ed. American Society for Microbiology, Washington, DC.
  18. Delangue J, Salez N, Ninove L and al. Serological study of the 2009 pandemic due to influenza A H1N1 in the metropolitan French population. Clinical Microbiology and Infection. 2012;18(2):177-83.
  19. Veguilla V, Hancock K, Jarad Schiffer J. Sensitivity and Specificity of Serologic Assays for Detection of Human Infection with 2009 Pandemic H1N1 Virus in U.S. Populations. Journal of Clinical Microbiology. 2011;49(6):2210-2215.