Related Experiment Video
Updated: May 21, 2026
Development of a Quantitative Recombinase Polymerase Amplification Assay with an Internal Positive Control
Published on: March 30, 2015
False-negative post-18-month confirmatory HIV tests in HIV DNA PCR-positive children: a retrospective analysis
Anthony J Garcia-Prats1, Heather R Draper, Jill E Sanders
1Baylor College of Medicine International Pediatric AIDS Initiative at Texas Children's Hospital (BIPAI), Texas Children's Hospital, Houston, TX 77030, USA. to.tonygp@gmail.com
Insights
False-negative HIV tests in children on antiretroviral therapy (ART) are common. Early ART initiation is linked to these inaccurate results, potentially leading to misdiagnosis and care discontinuation for HIV-infected children.
Area of Science:
- Pediatric Infectious Diseases
- HIV/AIDS Clinical Management
- Public Health Virology
Background:
- WHO guidelines recommend confirmatory HIV testing after 18 months for children diagnosed under 18 months.
- This strategy relies on antibody testing, which can be affected by factors like antiretroviral therapy (ART).
Observation:
- A retrospective review of 109 children diagnosed with HIV before 18 months at a Lesotho clinic was conducted.
- Post-18-month confirmatory HIV rapid tests and DNA PCR results were analyzed.
Findings:
- A significant proportion of children (20.2% rapid tests negative, 24.8% discordant) showed non-positive results after 18 months, with most on ART.
- Early ART initiation (before 9 months) was associated with non-positive rapid tests.
- Conflicting results between HIV DNA PCR and antibody tests were observed in children on ART.
Implications:
- False-negative HIV antibody tests and DNA PCRs in children on ART are a concern.
- These inaccuracies may lead to the inappropriate discontinuation of ART and discharge of HIV-infected children from care.
- The findings highlight the need to re-evaluate HIV diagnostic strategies in children receiving early ART.
Objective:
The WHO guidelines for children less than 18 months old diagnosed with HIV based on presumptive clinical diagnosis or one virologic test recommend confirmatory HIV antibody testing after 18 months of age. This study describes post-18-month HIV test results following this WHO-recommended confirmatory testing strategy.
Design:
Case series and retrospective review of routine program data.
Methods:
Children enrolled at the Baylor Children's Clinical Center of Excellence, a pediatric and family HIV clinic in Maseru, Lesotho from December 2005 through January 2009 with a positive HIV DNA PCR at less than 18 months of age and HIV rapid test results after 18 months of age were included. Post-18-month confirmatory HIV test results are described. Factors associated with non-positive confirmatory rapid tests were determined using binary logistic regression.
Results:
Of the 109 children meeting inclusion criteria, 22 (20.2%) had negative and 27 (24.8%) discordant confirmatory rapid tests. Forty-six of these 49 were on antiretroviral therapy (ART). Among these 49, 11 of 24 post-18-month HIV DNA PCRs were negative, whereas nine of 10 post-18-month HIV ELISAs were positive; 29 were definitively and 17 probably HIV-infected, two were uninfected, and one had undetermined status. Only age less than 9 months at ART initiation (odds ratio 4.25, P = 0.002) was associated with non-positive rapid tests.
Conclusion:
False-negative post-18-month confirmatory rapid tests and HIV DNA PCRs in children on ART are common, associated with early ART initiation, and may lead to inappropriate ART discontinuation and discharge from care of truly HIV-infected children.
