Current status of clinical laboratory tests for the human immunodeficiency virus

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Abstract
The predictive values of positive and negative test results for human immunodeficiency virus (HIV) antibody are extremely high in laboratories that have good quality control and high performance standards and use licensed FDA‐approved enzyme immunoassay (EIA) and Western blot standardized tests. With a carefully designed protocol, the false‐positive rate of combined EIA and Western blot has been reported to be as low as 1 in 105. When results of HIV confirmatory antibody tests are indeterminate, other tests such as culture and nucleotide probe methods for HIV DNA or RNA may help resolve false‐reactive screening EIA tests. Improvements are constantly in progress for HIV laboratory tests with the use of recombinant DNA‐derived antigens and synthetic polypeptides. With the use of new‐generation synthetic polypeptide antigens, specific assays to identify HIV‐1 and HIV‐2 have been developed. Recently, assays for the HIV regulatory gene products have been studied for their predictive potential. Antibodies to nef protein, a regulator of HIV‐1 replication, may be an early indicator of HIV infection.