Evaluation of Sensitivity and Specificity of Third and Fourth Generation ELISA in detecting Hepatitis B Virus among Blood Donors

Authors

  • Shreya P Desai  Student, Delhi Public School, Surat, Gujarat, India and Study carried Out at Surat Raktadan Kendra & Research Centre, Surat, Gujarat, India

DOI:

https://doi.org/10.32628/IJSRST52310571

Keywords:

Hepatitis B, HBsAg, 3rd generation ELISA, 4th Generation ELISA.

Abstract

Aim

To compare the 4th generation ELISA with 3rd generation ELISA for early detection of HBV infection among voluntary blood donors and for specificity.

Material and methods

779 samples of voluntary blood donors were tested for HBsAg by 3rd generation ELISA and 4th generation ELISA.

The results were compared and discrepant samples were further tested by NAT (RT-PCR) and HBe antigen and HBc antibody by CMIA.

Results

279 were found HBsAg reactive and 500 samples were found non-reactive by third generation ELISA.

Out of these 279 we found 3 samples to be non-reactive by fourth generation ELISA.

Discrepant samples were then tested for NAT which  also gave comparative results with fourth generation ELISA. Two samples were further tested for marker study. Marker study also showed that these two samples were negative for HBV infection.

Conclusions

  • The results of 4th generation ELISA, NAT and HBV markers were found comparable in our prospective study
  • We had 3 false positives with III generation
  • Thus 4th generation kit for HBsAg is more specific than 3rd generation ELISA and comparable with better method like NAT.
  • In India where NAT testing is costly and not mandatory, 4th generation ELISA can be preferred as it is will decrease false positive and rejection of donors

References

  1. Zhang Introduction to the global framework, towards 100% Voluntary Blood Donation WHO 2010
  2. Standards for Blood Banks and Blood Transfusion services- National AIDS Control Organization (NACO), Health and Family Welfare, Government of India.
  3. https://talk.ictvonline.org/ictv-reports/ictv_9th_report/reverse-transcribing-dna-and-rna-viruses-2011/w/rt_viruses/155/hepadnaviridae
  4. https://academic.oup.com/labmed/article/42/8/488/2657686
  5. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
  6. Naidu NK, Bharucha ZS, Sonawane V, Ahmed I. Nucleic acid testing: Is it the only answer for safe Blood in India. Asian J Transfusion Sci. 2016;10(1):79–83. doi:10.4103/0973-6247.175423
  7. Meril Diagnostics, MERILISA HBsAg ELISA kit literature.
  8. Biorad Diagnostics, Monolisa™ HBs Ag ULTRA kit literature.
  9. Roth WK, Busch MP, Schuller A, Ismay S, Cheng A, Seed CR, et al. International survey on NAT testing of blood donations: Expanding implementation and yield from 1999 to 2009. Vox Sang. 2012;102:82– 90.[PubMed] [Google Scholar]
  10. Altona Diagnostics, AltoStar® HBV PCR Kit 1.5 , kit literature.

International Journal of Scientific Research in Science and Technology

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Published

2023-10-30

Issue

Volume 10, Issue 5, September-October-2023

Section

Research Articles

License

Copyright (c) IJSRST

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

How to Cite

[1]
Shreya P Desai "Evaluation of Sensitivity and Specificity of Third and Fourth Generation ELISA in detecting Hepatitis B Virus among Blood Donors " International Journal of Scientific Research in Science and Technology(IJSRST), Online ISSN : 2395-602X, Print ISSN : 2395-6011,Volume 10, Issue 5, pp.512-516, September-October-2023. Available at doi : https://doi.org/10.32628/IJSRST52310571