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Update: Serologic Testing for Antibody to Human Immunodeficiency Virus

NCJ Number
108812
Journal
Morbidity and Mortality Weekly Report Volume: 36 Issue: 52 Dated: (January 8, 1988) Pages: 833-840
Editor(s)
M B Gregg, G A Ingraham
Date Published
1988
Length
8 pages
Annotation
Given the medical and social significance of a positive human immunodeficiency virus (HIV) antibody test, it is imperative that test results be accurate and that test interpretations be correct.
Abstract
For these reasons, the U.S. Public Health Service emphasizes that an individual be considered to have serologic evidence of HIV infection only after an enzyme immunoassay (EIA) screening test is repeatedly reactive and another tests such as the Western Blot (WB) or immunofluorescence assay has been performed to validate results. Repeating initially reactive EIA tests increases diagnostic specificity by decreasing the possibility of technical laboratory error. High-specificity, supplemental tests should be conducted by a laboratory with high performance standards. While it is claimed that WB false negatives are low, in clinical trials, 10 to 15 percent of tests produced an indeterminate result. Despite the existence of a licensed WB test, many laboratories use unlicensed WB tests or fail to meet acceptable performance standards. In addition, laboratories often use their own criteria for interpreting test results. Results of proficiency testing studies indicate that the predictive value of both positive and negative test results for HIV antibody are extremely high for laboratories with good quality control and high performance standards using licensed and well-standardized tests. 5 tables and 6 references.