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Abstract
Introduction : Rapid testing and detection of acute HIV infection are two important arms in the prevention of HIV infection. Virologic testing for HIV remains the mainstay for early diagnosis of the infection. Nucleic acid-based testing for HIV however, requires expensive laboratory infrastructure and well-trained personnel, thereby making it not easily accessible in Low- Middle- Income Countries (LMIC). HIV DNA polymerase chain reaction is currently used by few laboratories in many LMIC to detect HIV in children born of HIV-positive mothers before 18 months. Challenges relating to timely result notification can be reduced if the Early Infant Diagnosis (EID) Programme is decentralized and with easy access to laboratory facilities using other tests with high performance characteristics. Methods: We evaluated the performance of five assays to identify HIV antibodies, p24 antigen, proviral DNA or viral RNA in 109 infants born to HIV-positive mothers in Yaounde, Cameroon. Results: The test performance (using plasma) of the HIV p24 antigen ELISA by Perkin Elmer, Roche Amplicor HIV-1 DNA PCR and the Abbott Realtime HIV-1 assay was 100% identifying 12 positive cases. A positive and significant correlation between the HIV-1 RNA viral load and HIV p24 antigen level was found (p<0.05). Conclusion: Therefore, HIV p24 antigen detection by ELISA can be used for early diagnosis of HIV and thus recommended for a decentralized EID Programme in LMIC.
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References
- Jean Bosco Elat, National AIDS Control Committee Report, 2011. Ministry of Public Health.
- Fiscus SA, Wiener J, Abrams EJ, Bulterys M, Cachafeiro A, Respess RA. Ultrasensitive p24 antigen assay for diagnosis of perinatal human immunodeficiency virus type 1 infection. J Clin Microbiol. 2007 Jul;45(7):2274-7. Epub 2007 May 2.
- Respess RA, Cachafeiro A, Withum D, Fiscus SA, Newman D, Branson B, et al. Evaluation of an ultrasensitive p24 antigen assay as a potential alternative to human immunodeficiency virus type 1 RNA viral load assay in resource-limited settings. J Clin Microbiol. 2005 Jan;43(1):506-8.
- Tehe A, Maurice C, Hanson DL, Borget MY, Abiola N, Maran M, et al. Quantification of HIV-1 p24 by a highly improved ELISA: an alternative to HIV-1 RNA based treatment monitoring in patients from Abidjan, Côte d'Ivoire. J Clin Virol. 2006 Nov;37(3):199-205. Epub 2006 Sep 14.
- Sherman GG, Stevens G and Stevens WS. Affordable diagnosis of humman immunodeficiency virus infection in infants by p24 antigen detection. Pediatr Infect Dis J. 2004; 23: 173-6.
- Spector SA, Kennedy C, McCutchan JA, Bozzette SA, Straube RG, Connor JD, et al . The antiviral effect of zidovudine and ribavirin in clinical trials and the use of p24 antigen levels as a virologic marker. J Infect Dis. 1989. 159(5):822-8.
- http://www.roche.com
- The Abbott RealTime HIV-1 assay
- http://www.abbottmolecular.com/products/infectious-diseases/realtime-pcr/hiv-1-assay.html
- http://www.productosweens.com/eng/immuno1.swf
- http://www.perkinelmer.com/Catalog/Family/ID/AllianceR%20HIV1%20P24%20ELISA%20Kit.
- Jörg Schüpbach. 2003. Viral RNA and p24 Antigen as Markers of HIV Disease and Antiretroviral Treatment Success. International Archives of Allergy and Immunology; 132:196 – 209.
- (FDA Consumer Report, http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm216409.htm. Accessed in October 2011).
- Judith N. Torimiro, Roberta Rodrigo, Desire Takou, Nanfack A, Pizzi D, Ngong I, et al. HIV Type 1 Intersubtype Recombinants Predominate in the AIDS Epidemic in Cameroon. New Microbiologica 2009. 32:325 – 332.
- Fiebig EW, Wright DJ, Rawald BD, Garrette PE, Schumachere RT, Peddadaf L, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS. 2003. 17:1871–1879.
- Nkenfou CN, Lobé EE, Ouwe-Missi-Oukem-Boyer O, Sosso MS, Dambaya B, Gwom LC, et al. Implementation of HIV Early Infant Diagnosis and HIV Type 1 RNA Viral Load Determination on Dried Blood Spots in Cameroon: Challenges and Propositions. 2012. AIDS Res Hum Retroviruses. 28(2):176-81. doi: 10.1089/AID.2010.0371.
- Brauer M, De Villiers JC, Mayaphi SH. Evaluation of the Determine™ fourth generation HIV rapid assay. J Virol Methods. 2013 Apr;189(1):180-3. doi: 10.1016/j.jviromet.2013.01.017. Epub 2013 Feb 4.
- Chrisotpher D. Pilcher, Katerina A. Christopoulos, Mathew Golden. Public Health Rationale for rapid Nucleic Acid or p24 Antigen Tests for HIV. JID, 2010. :201(Suppl 1), S7 - S15.
References
Jean Bosco Elat, National AIDS Control Committee Report, 2011. Ministry of Public Health.
Fiscus SA, Wiener J, Abrams EJ, Bulterys M, Cachafeiro A, Respess RA. Ultrasensitive p24 antigen assay for diagnosis of perinatal human immunodeficiency virus type 1 infection. J Clin Microbiol. 2007 Jul;45(7):2274-7. Epub 2007 May 2.
Respess RA, Cachafeiro A, Withum D, Fiscus SA, Newman D, Branson B, et al. Evaluation of an ultrasensitive p24 antigen assay as a potential alternative to human immunodeficiency virus type 1 RNA viral load assay in resource-limited settings. J Clin Microbiol. 2005 Jan;43(1):506-8.
Tehe A, Maurice C, Hanson DL, Borget MY, Abiola N, Maran M, et al. Quantification of HIV-1 p24 by a highly improved ELISA: an alternative to HIV-1 RNA based treatment monitoring in patients from Abidjan, Côte d'Ivoire. J Clin Virol. 2006 Nov;37(3):199-205. Epub 2006 Sep 14.
Sherman GG, Stevens G and Stevens WS. Affordable diagnosis of humman immunodeficiency virus infection in infants by p24 antigen detection. Pediatr Infect Dis J. 2004; 23: 173-6.
Spector SA, Kennedy C, McCutchan JA, Bozzette SA, Straube RG, Connor JD, et al . The antiviral effect of zidovudine and ribavirin in clinical trials and the use of p24 antigen levels as a virologic marker. J Infect Dis. 1989. 159(5):822-8.
The Abbott RealTime HIV-1 assay
http://www.abbottmolecular.com/products/infectious-diseases/realtime-pcr/hiv-1-assay.html
http://www.productosweens.com/eng/immuno1.swf
http://www.perkinelmer.com/Catalog/Family/ID/AllianceR%20HIV1%20P24%20ELISA%20Kit.
Jörg Schüpbach. 2003. Viral RNA and p24 Antigen as Markers of HIV Disease and Antiretroviral Treatment Success. International Archives of Allergy and Immunology; 132:196 – 209.
(FDA Consumer Report, http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm216409.htm. Accessed in October 2011).
Judith N. Torimiro, Roberta Rodrigo, Desire Takou, Nanfack A, Pizzi D, Ngong I, et al. HIV Type 1 Intersubtype Recombinants Predominate in the AIDS Epidemic in Cameroon. New Microbiologica 2009. 32:325 – 332.
Fiebig EW, Wright DJ, Rawald BD, Garrette PE, Schumachere RT, Peddadaf L, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS. 2003. 17:1871–1879.
Nkenfou CN, Lobé EE, Ouwe-Missi-Oukem-Boyer O, Sosso MS, Dambaya B, Gwom LC, et al. Implementation of HIV Early Infant Diagnosis and HIV Type 1 RNA Viral Load Determination on Dried Blood Spots in Cameroon: Challenges and Propositions. 2012. AIDS Res Hum Retroviruses. 28(2):176-81. doi: 10.1089/AID.2010.0371.
Brauer M, De Villiers JC, Mayaphi SH. Evaluation of the Determine™ fourth generation HIV rapid assay. J Virol Methods. 2013 Apr;189(1):180-3. doi: 10.1016/j.jviromet.2013.01.017. Epub 2013 Feb 4.
Chrisotpher D. Pilcher, Katerina A. Christopoulos, Mathew Golden. Public Health Rationale for rapid Nucleic Acid or p24 Antigen Tests for HIV. JID, 2010. :201(Suppl 1), S7 - S15.