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Human immunodeficiency virus diagnostic testing of infants at clinical sites in North America: 2002-2006
Jennifer S Read1, Susan Brogly, Michael Basar
1Pediatric, Adolescent, and Maternal AIDS Branch, CRMC, NICHD, National Institutes of Health, DHHS, Bethesda, MD 20892-7510, USA. jennifer_read@nih.gov
Insights
Diagnosis of HIV-1 infection in infants born to infected mothers involves multiple tests, primarily nucleic acid amplification tests (NAATs). Costs and testing frequency varied significantly across infants, highlighting the need for standardized diagnostic approaches.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Diagnostics
- Public Health
Background:
- Infants born to HIV-1-infected mothers require timely and accurate diagnosis.
- The International Maternal Pediatric Adolescent AIDS Clinical Trials Group Protocol 1025 (P1025) aimed to evaluate diagnostic practices for these infants.
Purpose of the Study:
- To assess the timing of diagnostic testing for HIV-1 infection in infants.
- To identify the types of diagnostic assays utilized.
- To determine the associated costs of diagnosis for HIV-1-exposed infants.
Main Methods:
- Prospective cohort study (P1025) involving HIV-1-infected women and their infants in the US and Puerto Rico.
- Analysis included live-born infants with known HIV-1 status through December 31, 2006.
- Data collected on diagnostic assay types, timing, and costs.
Main Results:
- Nearly 1000 infants generated over 5000 HIV-1 diagnostic test results.
- Nucleic acid amplification tests (NAATs), including HIV-1 DNA PCR, comprised 86.9% of all assays.
- Median testing cost per infant was $1168, with significant variability.
Conclusions:
- NAATs were the predominant diagnostic assays for HIV-1-exposed infants in this cohort.
- The number of diagnostic assays and associated costs per infant showed considerable variation.
- Findings underscore potential areas for optimizing HIV-1 diagnostic strategies in infants.
Background:
Our objectives were to assess the timing of testing, the types of diagnostic assays used, and the costs associated with the diagnosis of HIV-1 infection among infants born to HIV-1-infected women enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group Protocol 1025 (P1025).
Methods:
P1025 is a prospective cohort study of HIV-1-infected women and their infants at clinical sites in the United States and Puerto Rico. Enrollment began in 2002 and is ongoing. Follow-up of infants continued for at least 6 months after delivery/birth. The study population for this analysis comprised all live born infants of known HIV-1 infection status, born by December 31, 2006 to enrolled women.
Results:
Nine hundred eighty-eight infants had 5147 HIV-1 diagnostic test results reported. The median number of HIV-1 diagnostic assays performed per infant was 5 (10th, 90th percentiles: 3, 7), and the greatest number of tests reported per infant was 13. The median ages at the time of the first, second, third, and fourth HIV-1 diagnostic assay were 0.1, 2.3, 7.0, and 17.6 weeks, respectively. Nucleic acid amplification tests (NAATs) represented 86.9% of all diagnostic assays (HIV-1 DNA PCR assays: n = 4082 [79.3%]; other NAATs: n = 389 [7.6%]). The median cost per infant for HIV-1 diagnostic testing was $1168 (10th, 90th percentiles: $762, $1642).
Conclusions:
Most assays reported for HIV-1-exposed infants at clinical sites in the United States and Puerto Rico were NAATs, but the number of HIV-1 diagnostic assays performed per infant, and the cost associated with HIV-1 diagnostic testing per infant, varied greatly.
