Human immunodeficiency virus diagnostic testing of infants at clinical sites in North America: 2002-2006

Pediatr Infect Dis J. 2009 Jul;28(7):614-8. doi: 10.1097/INF.0b013e31819ac33b.


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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Clinical Laboratory Techniques / economics*
  • Clinical Laboratory Techniques / methods*
  • Cohort Studies
  • Female
  • HIV Infections / diagnosis*
  • HIV-1 / isolation & purification*
  • Humans
  • Infant
  • Infant, Newborn
  • Infectious Disease Transmission, Vertical*
  • Male
  • Pregnancy
  • Pregnancy Complications, Infectious / diagnosis*
  • Prospective Studies
  • Puerto Rico
  • United States