title: Signal-boosted qualitative ultrasensitive p24 antigen assay for diagnosis of subtype C HIV-1 infection in infants under the age of 2 years.
abstract: The gold standard for diagnosis of HIV-1 infection in infants under the age of 2 years is DNA or reverse transcriptase polymerase chain reaction. However, these tests are expensive and therefore not available in resource-limited countries. With the increasing availability of antiretroviral drugs for prevention of mother-to-child transmission of HIV and treatment of AIDS in resource-poor countries, there is an urgent need to develop cheaper, alternative, and cost-effective laboratory methods for early diagnosis of infant HIV-1 infection that will be useful in identifying infected infants who may benefit from early cotrimoxazole prophylaxis or commencement of antiretroviral therapy. We evaluated an alternative method, the enzyme-linked immunosorbent assay-based qualitative ultrasensitive p24 antigen assay for diagnosis of subtype C HIV-1 infection in infants under the age of 2 years using DNA polymerase chain reaction as the reference method. The assay showed a sensitivity of 96.7% (95% CI: 93.0-100) for detection of HIV-1 infection among infants 0-18 months of age with a specificity of 96.1% (95% CI: 91.7-100). These evaluated parameters were not statistically different between infants aged 0-6 and 7-18 months. The ultrasensitive p24 antigen assay is a useful diagnostic test for detection of HIV-1 infection among infants aged 0-18 months.
authors: Department of Immunology, Division of Infectious Diseases, College of Health Sciences, University of Zimbabwe, Harare. LZIJENAH@HEALTHNET.ZW
authors: Lynn S
authors: LS
authors: Zijenah
authors: Ocean
authors: O
authors: Tobaiwa
authors: Simbarashe
authors: S
authors: Rusakaniko
authors: Kusum J
authors: KJ
authors: Nathoo
authors: Margaret
authors: M
authors: Nhembe
authors: Petronella
authors: P
authors: Matibe
authors: David A
authors: DA
authors: Katzenstein
mesh_terms: D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D016655:HIV Core Protein p24 / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology*; D015497:HIV-1 / Q000145:classification*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D012680:Sensitivity and Specificity; D015030:Zimbabwe
chemical_list: D016655:HIV Core Protein p24