Customize your JAMA Network experience by selecting one or more topics from the list below.
Janssen RS, Satten GA, Stramer SL, et al. New Testing Strategy to Detect Early HIV-1 Infection for Use in Incidence Estimates and for Clinical and Prevention Purposes. JAMA. 1998;280(1):42–48. doi:10.1001/jama.280.1.42
From the Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Ga (Drs Janssen and Satten); the National Reference Laboratory for Infectious Diseases, American Red Cross, Rockville, Md (Dr Stramer); the Blood Centers of the Pacific, Irwin Center, San Francisco, Calif (Drs Rawal and Busch); the Viral Epidemiology Branch, National Cancer Institute, Rockville, Md (Dr O'Brien); Boston Biomedica, Inc, West Bridgewater, Mass (Ms Weiblen); the Department of Laboratory Medicine (Dr Busch), the AIDS Program (Drs Hecht and Kahn), and the Center for AIDS Prevention Studies (Dr Chesney), University of California, San Francisco; the Medical Research Centre, Port-of-Spain, Trinidad (Dr Jack); and the Institute of Human Virology, University of Maryland School of Medicine, Baltimore (Dr Cleghorn).
Context.— Differentiating individuals with early human immunodeficiency virus
1 (HIV-1) infection from those infected for longer periods is difficult but
important for estimating HIV incidence and for purposes of clinical care and
Objective.— To develop and validate a serologic testing algorithm in which HIV-1–positive
persons with reactive test results on a sensitive HIV-1 enzyme immunoassay
(EIA) but nonreactive results on a less sensitive (LS) EIA are identified
as having early infection.
Design.— Diagnostic test and testing strategy development, validation, and application.
Specimens were tested with both a sensitive HIV-1 EIA (3A11 assay) and a less
sensitive modification of the same EIA (3A11-LS assay).
Settings and Participants.— For assay development: 104 persons seroconverting to HIV-1 comprising
38 plasma donors, 18 patients of a sexually transmitted disease clinic in
Trinidad, and 48 participants in the San Francisco Men's Health Study (SFMHS);
268 men without the acquired immunodeficiency syndrome (AIDS) in the SFMHS
who had been infected for at least 2.5 years; and 207 persons with clinical
AIDS; for testing strategy validation: 488 men in the SFMHS from 1985 through
1990 and 1275449 repeat blood donors at 3 American Red Cross blood centers
from 1993 through 1995; and for HIV-1 incidence estimates: 2 717 910 first-time
blood donors. We retrospectively identified persons eligible for a study of
Main Outcome Measure.— Ability to identify early HIV infection.
Results.— Estimated mean time to being 3A11 reactive/3A11-LS nonreactive was 129
days (95% confidence interval [CI], 109-149 days). Our testing strategy accurately
diagnosed 95% of persons with early infection; however, 0.4% (1/268) of men
with established infection and 2% (5/207) of persons with late-stage AIDS
were misdiagnosed as having early HIV-1 infection. Average yearly incidence
estimates in SFMHS subjects were 1.5% per year vs observed average incidence
of 1.4 per 100 person-years. Incidence in repeat blood donors using the sensitive/less
sensitive assay testing strategy was 2.95 per 100000 per year (95% CI, 1.14-6.53/100000)
vs observed incidence of 2.60 per 100000 person-years (95% CI, 1.49-4.21/100000).
Overall incidence in first-time blood donors was 7.18 per 100000 per year
(95% CI, 4.51-11.20/100000) and did not change statistically significantly
between 1993 and 1996. Use of the sensitive/less sensitive testing strategy
alone would have identified all 17 persons with antibodies to HIV-1 eligible
for a study of early HIV-1 infection and would have increased enrollment.
Conclusions.— The sensitive/less sensitive testing strategy provides accurate diagnosis
of early HIV-1 infection, provides accurate estimates of HIV-1 incidence,
can facilitate clinical studies of early HIV-1 infection, and provides information
on HIV-1 infection duration for care planning.
Create a personal account or sign in to: