Human Immunodeficiency Virus Test Evaluation, Performance, and Use

Abstract

Human immunodeficiency virus (HIV) tests are essential for detecting asymptomatic infection and are helpful in confirming the diagnoses of acquired immunodeficiency syndrome-related complex and acquired immunodeficiency syndrome. Nonetheless, many aspects of their use remain controversial, partly because of concerns about test accuracy. This article reviews the scientific basis for the evaluation, performance, and use of the most commonly employed HIV assays. Current test performance could be improved by better standardization of test procedures and institution of mandatory proficiency testing and licensure of clinical laboratories that perform HIV testing. Test utility could be enhanced by sequencing tests more appropriately and by interpreting test results in conjunction with the clinical purpose for which the test is being used and the characteristics of the population under study. Finally, HIV tests should be evaluated in a manner that minimizes spectrum and referral bias and inadequate reference standard confirmation, problems that have affected the evaluation of current tests.

Diagnostic validity of the chemiluminescent method compared to polymerase chain reaction for hepatitis B virus detection in the routine clinical diagnostic laboratory

“…[24] Weakly positive results are also more likely to be falsely positive with other infectious disease assays, including anti-HIVand anti-HBc. [252627]…”

Indirect immunofluorescence test performance and questionnaire results from the Centers for Disease Control Model Performance Evaluation Program for human immunodeficiency virus type 1 testing

“…Sensitivity and specificity were calculated by a method similar to that of Galen and Gambino (8), but to avoid the possible confusion of the sensitivities calculated in these evaluations with the same estimates derived from testing clinical specimens, we used the terms analytic sensitivity and analytic specificity (5). Because the specimens were selected to maximize the ability to discriminate between good and poor tests, the distribution of reactivities did not approximate that of clinical specimens, nor did it contain the likely confounding variables that would be required to estimate clinical parameters (17). Analytic sensitivity was defined as the percentage of positive reports on samples designated positive on the basis of the reference laboratories' results, and analytic specificity was defined as the percentage of negative reports on samples designated negative on the basis of reference laboratories' results.…”

“…The occurrence of false-positive results necessitates the confirmation of repeatedly EIA-positive specimens by other, more specific methods. Both WB and IIF are used as supplemental tests to confirm positive screening results, and both have advantages and disadvantages (4,9,12,13,(15)(16)(17). Although the MPEP evaluated performance with all of these tests, this paper will report only the results of evaluations of IIF test performance obtained during 1988.…”

Current status of clinical laboratory tests for the human immunodeficiency virus

“…Many routine tests are performed on populations at low risk for AIDS; thus, an increasingly high percentage of false test results can be expected (16,(70)(71)(72).…”