Urine-Based HIV-1 Testing System
DESCRIPTION
The urine-based HIV-1 test system (e.g., CalypteŽ HIV-1 Urine EIA) is used to screen individuals for reaction to human immunodeficiency virus type 1 (HIV-1) antibodies. The HIV-1 virus causes the vast majority of AIDS in the United States. The CalypteŽ urine-based HIV-1 standard testing algorithm is to test all initially reactive samples in duplicate to determine if they are repeatedly reactive. All repeatedly reactive samples are then further tested using the urine procedure of the Cambridge Biotech HIV-1 Western blot system. This urine test system includes an enzyme immunoassay (EIA) test for detection of HIV-1 antibodies followed by a Western Blot confirmatory test for those samples shown to be EIA repeatedly reactive. At present, if a urine sample is positive for HIV-1 antibodies the individual must be retested with a more accurate test using a blood sample.
POLICY
Use of the urine-based HIV-1 test system in the diagnosis of human immunodeficiency virus type 1 is considered investigational.
ADDITIONAL INFORMATION
Well-designed, published studies are not available that show the sensitivity and specificity (accuracy) of urine-based HIV-1 testing is as beneficial as established alternatives (e.g., blood testing).
SOURCES
Berrios, D. C., Avins, A. L., Haynes-Sanstad, K., Eversley, R., & Woods, W. J. (1995). Screening for human immunodeficiency virus antibody in urine. Archives of Pathology & Laboratory Medicine, 119 (2), 139-141.
Centers for Disease Control and Prevention. (2001, November). Revised guidelines for HIV counseling, testing, and referral. 50 (RR-19), 1-110. Retrieved November 30, 2005 from http://www.cdc.gov/mmwr/PDF/rr/rr5019.pdf.
Centers for Disease Control and Prevention. (January, 2007). How HIV tests work. Retrieved September 29, 2008 from http://www.cdc.gov/hiv/topics/testing/resources/qa/tests_work.htm.
Meehan, M. P., Sewankambo, N. K., Wawer, M. J., McNairn, D., Quinn, T. C., Lutalo, T., et al. (1999). Sensitivity and specificity of HIV-1 testing of urine compared with serum specimens; Rakai, Uganda. The Rakai Project Team. Sexually Transmitted Diseases, 26 (10), 590-592. Abstract retrieved November 5, 2002 from PubMed database.
Oelemann, W. M., Lowndes, C. M., Verissimo Da Costa, G. C., Morgado, M. G., Castello-Branco, L. R., Grinsztejn, B., et al. (2002). Diagnostic detection of human immunodeficiency virus type 1 antibodies in urine: A Brazilian study. Journal of Clinical Microbiology, 40 (3), 881-885. Abstract retrieved November 5, 2002 from PubMed database.
Tribble, D. R., Rodier, G. R., Saad, M. D., Binson, G., Marrot, F., Salah, S., et al. (1997). Comparative field evaluation of HIV rapid diagnostic assays using serum, urine, and oral mucosal transudate specimens. Clinical and Diagnostic Virology, 7 (3), 127-132. Abstract retrieved November 5, 2002 from PubMed database.
Urnovitz, H. B., Sturge, J. C., & Gottfried, T. D. (1997). Increased sensitivity of HIV-1 antibody detection. Nature Medicine, 3 (11), 1258.
U. S. Food and Drug Administration. (1996, August). FDA Talk Paper (T96-55). Retrieved November 5, 2002 from http://www.fda.gov/bbs/topics/ANSWERS/ANS00753.html.
U. S. Food and Drug Administration. (2001, June). Summary of Safety and Effectiveness. Retrieved November 5, 2002 from http://www.fda.gov/cber/pmasumm/P010009S.pdf.
ORIGINAL EFFECTIVE DATE: 5/1/2000
MOST RECENT REVIEW DATE: 8/11/2011
ID_BT
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