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To compare the Western Blot (WB) patterns of paired urine and serum samples from subjects who tested repeatedly reactive in an investigational urine HIV-1 antibody EIA test and negative on a licensed serum HIV-1 antibody EIA test. METHODS: 7,607 paired urine and serum specimens were obtained from subjects at low and high risk for infection with HIV-1 from the U.S. and Haiti and tested by multiple centers. A portion of these specimens were linked as to donor identity. Neat urine specimens were tested in an investigational EIA employing an HIV-1 recombinant envelope protein, with confirmation of repeatedly reactive specimens using a modification of a licensed WB procedure. Serum specimens were tested by licensed EIA, with confirmation of repeatedly reactive specimens using a licensed WB procedure. RESULTS: Of 1,804 subjects participating in the linked study, 7 were urine EIA repeatedly reactive, urine WB confirmed positive and were serum EIA negative. On WB, 3 ofthe 7 serum samples demonstrated a positive p24 band. One of these 3 samples came from a 41 yr old female atrisk for HIV infection, one from a35 year old female with SLE andone from one a 16 yr old male with acute glomerular nephritis. Of the remaining 4 samples, two were from female sexual partners of HIV-1 positive persons, one from a male with non-gonococcal urethritis and one from a female with Hodgkin's Disease. Of the 5,803 unlinked subjects, two samples were found to be urine EIA and WB positive and serum EIA and WB negative. CONCLUSION: The WB confirmed presence of urine HIV-1 envelope antibody is highly suggestive of an HIV-1 infection. Four out of seven WB reactive urine samples were from EIA seronegative subjects at high risk for HIV-1 infection. The presence of HIV-1 envelopeantibody in urine but not in blood suggests that, in some subjects, the immune response to HIV-1 may be compartmentalized, as in this example, to the urogenital tract. |
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