title: Human immunodeficiency virus diagnostic testing of infants at clinical sites in North America: 2002-2006.
abstract: 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.
authors.affiliation: Pediatric, Adolescent, and Maternal AIDS Branch, CRMC, NICHD, National Institutes of Health, DHHS, Bethesda, MD 20892-7510, USA. jennifer_read@nih.gov
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Read
authors.forename: Susan
authors.initials: S
authors.lastname: Brogly
authors.forename: Michael
authors.initials: M
authors.lastname: Basar
authors.forename: Gwendolyn
authors.initials: G
authors.lastname: Scott
mesh_terms: D019411:Clinical Laboratory Techniques / Q000191:economics* / Q000379:methods*; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000175:diagnosis*; D011446:Prospective Studies; D011647:Puerto Rico; D014481:United States