Revising expectations from rapid HIV tests in the emergency department

Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
Annals of internal medicine (Impact Factor: 17.81). 09/2008; 149(3):153-60.
Source: PubMed


Expanded HIV screening efforts in the United States have increased the use of rapid HIV tests in emergency departments. The reported sensitivity and specificity of rapid HIV tests exceed 99%.
To assess whether a reactive rapid oral HIV test result correctly identifies adults with HIV infection in the emergency department.
Diagnostic test performance assessment within the framework of a randomized, clinical trial.
Brigham and Women's Hospital emergency department (Boston, Massachusetts) from 7 February to 1 October 2007.
849 adults with valid rapid oral HIV test results.
Rapid HIV testing with the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test (OraSure Technologies, Bethlehem, Pennsylvania). Patients with reactive rapid test results were offered enzyme-linked immunoassay, Western blot, and plasma HIV-1 RNA testing for confirmation.
Specificity and positive likelihood ratio.
39 patients had reactive results (4.6% [95% CI, 3.2% to 6.0%]). On confirmation, 5 patients were HIV-infected (prevalence, 0.6% [CI, 0.1% to 1.1%]) and 26 were non-HIV-infected (8 patients declined confirmation). The estimated rapid test specificity was 96.9% (CI, 95.7% to 98.1%). Sensitivity analyses of the true HIV status of unconfirmed cases and test sensitivity resulted in a positive likelihood ratio of 8 to 32. Western blot alone as a confirmation test provided conclusive HIV status in only 50.0% (CI, 30.8% to 69.2%) of patients at first follow-up. The addition of HIV-1 RNA testing to the confirmation protocol improved this rate to 96.2% (CI, 88.8% to 100.0%).
Test sensitivity cannot be assessed because nonreactive OraQuick test results were not confirmed.
Although patients with a reactive oral OraQuick HIV screening test in the emergency department had an 8- to 32-fold increased odds of HIV infection compared with the pretest odds, the specificity of the test was lower than anticipated.

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    • "We decided to change to only a fingerstick blood technology for clinical implementation. This modification was made to streamline the testing algorithm, minimize cost and minimize the likelihood of having a false positive rapid test result (Walensky, Arbelaez et al. 2008). One LRADAC study participant had a false positive test result during the implementation of CTN0032, and this contributed to the agency's decision to change testing methods. "
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    • "This study was conducted within the Universal Screening for HIV-infection in the Emergency Room (USHER) trial, funded by the National Institutes of Health; details of the USHER trial have been published elsewhere [16–18]. The parent study was conducted in the ED of Brigham and Women’s Hospital, a tertiary academic medical center in Boston, Massachusetts. "
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    • "Although the convenience of rapid testing is an important advantage, continued evaluation of the accuracy of rapid testing is necessary. In our trial, we had only one positive result, which was a true positive; thus, the false-positive rate was 0. However, a trial of testing in emergency department with rigorous quality control found a false-positive rate of approximately 3.1%.46 Patients should be counseled that positive rapid tests require confirmation. "
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