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Proposals to Make Good Tests Better

J. Sanford Schwartz, MD; Peter E. Dans, MD; Bruce P. Kinosian, MD

JAMA. 1988;259(17):2574-2579.

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.

(JAMA 1988;259:2574-2579)

Author Affiliations
From the Section of General Medicine, Department of Medicine (Dr Schwartz) and the Leonard Davis Institute of Health Economics (Drs Schwartz and Kinosian), University of Pennsylvania, Philadelphia; the Office of Medical Practice Evaluation and Department of Medicine of The Johns Hopkins Medical Institutions, Baltimore (Dr Dans); and the Division of General Medicine Department of Medicine, University of Maryland, Baltimore (Dr Kinosian).

Footnotes
Reprint requests to Section of General Medicine, Silverstein 3, Hospital of the University of Pennsylvania, 3400 Spruce St, Philadelphia, PA 19104 (Dr Schwartz).

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