As the United States aims to increase early diagnosis and treatment of people with HIV, a greater focus has been placed on determining the accuracy of HIV tests in real-world settings—not only to minimize the number of false positive or negative test results, but to better identify people during theearly (acute) stages of infectionwhen the risk of transmission is especially high.
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In order to do this, researchers from the University of California, San Francisco (UCSF) conducted a review of over 21,000 HIV tests performed between the years 2003 and 2008 in some of the city’s high-prevalence populations.
Of four types of tests used during this period—from first-generation antibody tests to rapid oral tests—761 people were diagnosed with HIV (3.6% prevalence), of which 58 were identified during acute infection.
As accuracy is related to sensitivity (the percentage of tests that were positive in a person with the condition) and specificity (the percentage of tests that were negative in a person without the condition), the take-home message is that there is room for improvement in HIV testing to capture more acute infection.
What the Findings Tell Us
From the point of view of specificity, the figures confirmed that the incidence of false positives remains extremely low, even with the earlier generation tests.
By contrast, the rate of false negatives varied considerably, with the saliva-based OraQuick Advance rapid test performing the worst.
The figure only worsened when retesting blood from the acute stage infections. Of the 58 samples tested, the third-generation rapid tests achieved a sensitivity of only 5.2% to 34.5%, meaning that the majority of such infections would be missed using these rapid, antibody-based tests.
Even the fourth-generationDetermine rapid antigen/antibody test was able to identify only half of the acute infections, despite having an estimated sensitivity of 96.6% and specificity of 100%. According to the UCSF researchers, the Determine test worked best during acute infection when the patient’sviral loadwas over 500,000.
The lab-based ARCHITECT combination antigen/antibody test performed best. It had an estimated sensitivity of 99.4% and a specificity of 99.5%, and the tests identified 83% of acute infections.
Making an Informed Choice
In terms of testing selection and performance, the following conclusions can be reasonably drawn:
With that being said, high levels of sensitivity are only part of the reason why certain tests are preferred over others.
For example, a significant number of people fail to return for their results after testing. The ability to return a result within 20- to 30 minutes makes rapid testing the ideal choice for most people (and increases the likelihood that they’ll be linked to care).
3 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Pilcher CD, Louie B, Facente S, et al.Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco.PLoS ONE. 2013;8(12):e80629. doi:10.1371/journal.pone.0080629Zhu, W., Zeng, N. and Wang, N. (2010)Sensitivity, Specificity, Accuracy, Associated Confidence Interval and ROC Analysis with Practical SAS Implementations. NESUG Proceedings: Health Care and Life Sciences, Baltimore, Maryland.Chavez P, Wesolowski L, Patel P, Delaney K, Owen SM.Evaluation of the performance of the Abbott Architect HIV ag/ab combo assay.Journal of Clinical Virology. 2011;52:S51-S55. doi:10.1016/j.jcv.2011.09.010Additional ReadingU.S. Food and Drug Administration (FDA). First Rapid Home-Use HIV Kit Approved for Self-Testing.FDA Consumer Health Information.Silver Spring, Maryland; 2012.
3 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Pilcher CD, Louie B, Facente S, et al.Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco.PLoS ONE. 2013;8(12):e80629. doi:10.1371/journal.pone.0080629Zhu, W., Zeng, N. and Wang, N. (2010)Sensitivity, Specificity, Accuracy, Associated Confidence Interval and ROC Analysis with Practical SAS Implementations. NESUG Proceedings: Health Care and Life Sciences, Baltimore, Maryland.Chavez P, Wesolowski L, Patel P, Delaney K, Owen SM.Evaluation of the performance of the Abbott Architect HIV ag/ab combo assay.Journal of Clinical Virology. 2011;52:S51-S55. doi:10.1016/j.jcv.2011.09.010Additional ReadingU.S. Food and Drug Administration (FDA). First Rapid Home-Use HIV Kit Approved for Self-Testing.FDA Consumer Health Information.Silver Spring, Maryland; 2012.
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
Pilcher CD, Louie B, Facente S, et al.Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco.PLoS ONE. 2013;8(12):e80629. doi:10.1371/journal.pone.0080629Zhu, W., Zeng, N. and Wang, N. (2010)Sensitivity, Specificity, Accuracy, Associated Confidence Interval and ROC Analysis with Practical SAS Implementations. NESUG Proceedings: Health Care and Life Sciences, Baltimore, Maryland.Chavez P, Wesolowski L, Patel P, Delaney K, Owen SM.Evaluation of the performance of the Abbott Architect HIV ag/ab combo assay.Journal of Clinical Virology. 2011;52:S51-S55. doi:10.1016/j.jcv.2011.09.010
Pilcher CD, Louie B, Facente S, et al.Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco.PLoS ONE. 2013;8(12):e80629. doi:10.1371/journal.pone.0080629
Zhu, W., Zeng, N. and Wang, N. (2010)Sensitivity, Specificity, Accuracy, Associated Confidence Interval and ROC Analysis with Practical SAS Implementations. NESUG Proceedings: Health Care and Life Sciences, Baltimore, Maryland.
Chavez P, Wesolowski L, Patel P, Delaney K, Owen SM.Evaluation of the performance of the Abbott Architect HIV ag/ab combo assay.Journal of Clinical Virology. 2011;52:S51-S55. doi:10.1016/j.jcv.2011.09.010
U.S. Food and Drug Administration (FDA). First Rapid Home-Use HIV Kit Approved for Self-Testing.FDA Consumer Health Information.Silver Spring, Maryland; 2012.
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