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Published on: September 6, 2019
Performance of HIV Rapid Tests Among Breastfeeding, Malawian Infants
Emily R Smith1, Anna D Sheahan, Robert S Heyderman
1From the *Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina; †MLW Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi; ‡Division of Infectious Diseases, Department of Medicine, §Department of Health Policy and Management, Gillings Schools of Global Public Health, ¶Department of Biostatistics, Gillings School of Global Public Health, and ‖Department of Microbiology and Immunology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina; **Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital, Blantyre, Malawi; and ††Epidemiology and Social Medicine, University of Antwerp, Antwerp, Belgium.
Insights
Rapid HIV tests show limited value in young infants, with specificity improving significantly after 6 months of age. Updated guidelines are needed to optimize HIV diagnosis in breast-fed infants.
Area of Science:
- Pediatrics
- Infectious Diseases
- Public Health
Background:
- Early infant diagnosis of HIV (EID) is crucial for timely antiretroviral therapy initiation.
- Point-of-care rapid HIV tests are vital in resource-limited settings for EID.
- Breast-fed HIV-exposed infants require accurate and affordable diagnostic tools.
Purpose of the Study:
- To evaluate the performance of two common HIV rapid tests (Determine and Unigold) in young, breast-fed HIV-exposed infants.
- To assess the utility of these rapid tests for diagnosing incident HIV infections during the breastfeeding period.
- To inform the development of updated testing guidelines based on infant age and test type.
Main Methods:
- Prospective data collection on HIV rapid test performance in Malawi and the University of North Carolina.
- Comparison of Determine and Unigold rapid tests against HIV DNA/RNA PCR as the gold standard.
- Calculation of sensitivity, specificity, and predictive values at 3-month intervals from 3 to 18 months of age.
Main Results:
- Both Determine and Unigold showed minimal clinical value at 3 months of age due to low specificity.
- Unigold demonstrated improved specificity from 6 months (83.7%) and 9 months (97.7%), becoming a viable screening tool.
- Both tests performed well in identifying HIV-free children from 12 months, but missed some incident HIV infections.
Conclusions:
- Current rapid HIV tests have age-dependent utility for EID in breast-fed infants.
- Updated guidelines incorporating test type and infant age are urgently needed for optimal care.
- Improved diagnostic strategies are essential for the 1.5 million HIV-exposed infants born annually.
Introduction:
Timely, accurate and affordable testing algorithms at point-of-care are critical for early infant HIV diagnosis and initiation of antiretroviral therapy in the postpartum period. We aimed to assess the utility of HIV rapid tests for young, breast-fed HIV-exposed infants in resource limited, high HIV burden settings.
Materials And Methods:
We collected data on the performance of 2 commonly used rapid tests (Determine and Unigold) in Malawi between 2008 and 2012 or at the University of North Carolina between 2014 and 2015. For each 3-month interval between ages 3 and 18 months, we calculated the sensitivity, specificity, positive and negative predictive values of each test compared with the HIV DNA/RNA PCR gold standard. We also assessed the utility of each rapid test to diagnose incident HIV infection during the breastfeeding period.
Results:
Among 121 HIV-exposed infants who were negative at age 6 weeks, 21 (17.2%) became infected by 18 months. At 3 months of age, both rapid tests had minimal clinical value with specificity values of 7.0% [95% confidence interval (CI): 2.3-15.7] for Determine and 19.4% (95% CI: 11.1-30.5) for Unigold. Starting at age 6 and 9 months, the Unigold test could be used as a screening tool in the follow-up of HIV-exposed infants with specificity values of 83.7% (95% CI: 74.4-89.9) and 97.7% (95% CI: 94.6-99.7), respectively. Starting at age 12 months, the type of test became less important as both tests performed well in identifying HIV-free children, although both tests failed to detect some incident HIV infections.
Conclusions:
Updated guidelines for the use of rapid tests in young HIV-exposed children that explicitly take type of test and infant age into account are urgently needed to ensure optimal care for the 1.5 million HIV-exposed infants born annually.
