A comparative study on fourth generation ELISA and rapid assay for diagnosing HIV infection in the high risk group


  • Sukanya Mathupal Department of Skin and STD, Sree Balaji Medical College Hospital, Chennai, Tamil Nadu, India
  • Sathya Narayanan Rajendran Department of Skin and STD, Saveetha Medical College Hospital, Chennai, Tamil Nadu, India




p24 antigen, Fourth generation ELISA, High risk group


Background: Enzyme linked immunosorbent assay (ELISA) is a widely employed method for detecting HIV. Following its successful detection of HIV, the fourth generation ELISA was approved by FDA. The advantage of the FDA approved fourth generation ELISA is it detects p24 antigen, HIV 1&2 antibodies simultaneously and that too 5-7 days prior to conventional tests so that it detects HIV seroconversion earlier reducing its further spread.

Methods: The study was conducted in a tertiary level medical centre after obtaining ethical approval. 200 patients from high risk group and their contacts were selected after a thorough physical examination and tests were done using fourth generation ELISA and rapid assay and these results were compared.

Results: As per our observations, the percentage of patients tested positive by fourth generation ELISA out of 200 subjects was 37% and negative was 63%. The detection rate of HIV positivity by rapid assay in high risk group was 11% and negative was 89%. The detection rate was also higher with fourth generation ELISA when various other parameters were compared.

Conclusions: In this study, the percentage of HIV positivity detected by fourth generation ELISA was higher than that detected by rapid assay showing that fourth generation ELISA is a more sensitive test than rapid assay as well as a better diagnostic modality to opt for when coming to early detection in HIV. 

Author Biographies

Sukanya Mathupal, Department of Skin and STD, Sree Balaji Medical College Hospital, Chennai, Tamil Nadu, India

Assistant Professor, Department of Dermatology

Sathya Narayanan Rajendran, Department of Skin and STD, Saveetha Medical College Hospital, Chennai, Tamil Nadu, India

Department of Skin & STD, Assistant Professor of Dermatology



Weber B, Fall EH, Berger A, Doerr HW. Reduction of diagnostic window by new fourth-generation human immunodeficiency virus screening assays. J Clin Microbiol. 1998;36(8):2235-9.

Bhattacharya P, Kaur R. Implementing fourth generation human immunodeficiency virus enzyme-linked immunosorbent assay, one step forward in blood safety. Asian J Transfus Sci. 2013;7(2):107–108.

Zulfiqar HF, Javed A, Sumbal et al. HIV diagnosis and treatment through advanced technologies. Front Public Health. 2017;5:32.

Gottlieb MS. Discovering AIDS. Epidemiology. 1988; 9:365–367.

Marco L. Schito, M. Patricia D'Souza, S. Michele Owen, Michael P. Busch. Challenges for rapid molecular HIV diagnostics. The Journal of Infectious Diseases. 2010;201(1):1-6.

Bhanu Mehra, Sonali Bhattar, Preena Bhalla, and Deepti Rawat. Rapid tests versus ELISA for screening of HIV infection, our experience from a voluntary counselling and testing facility of a tertiary care centre in North India. ISRN AIDS. 2014;296840:5.

Setia MS, Lindan C, Jerajani H R, Kumta S, Ekstrand M, Mathur M, Gogate A, Kavi A R, Anand V, Klausner JD. Men who have sex with men and transgenders in Mumbai, an emerging risk group for STIs and HIV. Indian J Dermatol Venereol Leprol 2006;72:425-31.

A. S. Olufemi, O. M. Simidele & J. A.Kayode : Pattern Of Presentation Among Hiv/Aids Patients In Makurdi, Nigeria . The Internet Journal of Epidemiology. 2009;6(2)






Original Research Articles