Rapid Serologic Testing with Immune-Complex-Dissociated HIV p24 Antigen for Early Detection of HIV Infection in Neonates
Steven A. Miles, Erin Balden, Larry Magpantay, LeAnn Wei, Alison Leiblein, David Hofheinz, Gary Toedter, E. Richard Stiehm, Yvonne Bryson, for The Southern California Pediatric AIDS Consortium
Background Serologic detection of human immunodeficiency virus(HIV) infection in neonates is complicated by the presence ofimmune complexes, consisting of passively transferred maternalantibodies and HIV antigens. A new, rapid assay has been designedto disrupt these immune complexes in order to permit the detectionof a specific HIV antigen. We evaluated the efficacy of thisassay in detecting HIV infection in neonates.
Methods We measured p24 antigen in blood samples from both infectedand uninfected children of HIV-infected mothers. The sampleswere treated with glycine hydrochloride to dissociate the immunecomplexes, followed by neutralization with TRIS-hydrochloricacid. A commercial HIV p24 antigen assay was then used, withan optical density greater than 0.120 at a wavelength of 450nm defined as indicating a positive result.
Results Of eight cord-blood samples from neonates with provedHIV infection, five were positive for immune-complex-dissociatedp24 antigen. For two other neonates the first postnatal sample,obtained on days 12 and 18, was positive. There was no follow-upsample for the eighth neonate. Of 22 uninfected neonates, 20were negative on the cord-blood assay. Two neonates had positivecord-blood samples, but the first postnatal sample was negative.Thus, the tests with early postnatal samples identified theHIV-infection status correctly for all 29 children who couldbe evaluated. In a separate group of 78 children (median age,188 weeks), the specificity of the test was 100 percent andthe sensitivity 81 percent.
Conclusions The immune-complex-dissociated HIV p24 antigen assayis a rapid, simple serologic test that may be of value in diagnosingHIV infection in neonates born to HIV-infected women.
Source Information
From the Center for AIDS Research and Education (S.A.M., L.M., A.L.) and the Department of Pediatrics (E.B., L.A.W., E.R.S., Y.B.), the University of California, Los Angeles, and the Coulter Corporation, Hialeah, Fla. (D.H., G.T.).
Address reprint requests to Dr. Miles at the UCLA CARE Center, Rm. BH-412C, CHS, Los Angeles, CA 90024-1793.
Early Detection of HIV in Neonates
Fauvel M., Henrard D., Delage G., Lapointe N., Fiscus S. A., Vernazza P., Lim W., Miles S. A., Bryson Y.
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N Engl J Med 1993;
329:60-62, Jul 1, 1993.
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