Pediatric, Adolescent, and Maternal AIDS Branch, CRMC, NICHD, National Institutes of Health, DHHS, Bethesda, MD 20892-7510, USA.
Pediatr Infect Dis J. 2009 Jul;28(7):614-8. doi: 10.1097/INF.0b013e31819ac33b.
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).
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.
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).
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.
本研究旨在评估在美国和波多黎各参与国际母婴艾滋病临床试验组方案 1025（P1025）的 HIV-1 感染妇女所生婴儿的 HIV-1 感染诊断检测的时间安排、使用的诊断检测类型以及相关成本。
P1025 是一项针对 HIV-1 感染妇女及其婴儿的前瞻性队列研究，在美属波多黎各的临床机构开展。该研究于 2002 年开始招募，目前仍在进行中。对婴儿的随访至少持续至分娩/出生后 6 个月。本分析的研究人群包括所有已知 HIV-1 感染状态的活产婴儿，截至 2006 年 12 月 31 日，出生于纳入研究妇女。
共有 988 名婴儿有 5147 次 HIV-1 诊断检测结果报告。每名婴儿接受 HIV-1 诊断检测的中位数为 5 次（第 10 百分位数，第 90 百分位数：3 次，7 次），报告的检测次数最多的婴儿为 13 次。首次、第二次、第三次和第四次 HIV-1 诊断检测的中位年龄分别为 0.1 周、2.3 周、7.0 周和 17.6 周。核酸扩增检测（NAATs）占所有诊断检测的 86.9%（HIV-1 DNA PCR 检测：n=4082[79.3%]；其他 NAATs：n=389[7.6%]）。每名婴儿 HIV-1 诊断检测的中位费用为 1168 美元（第 10 百分位数，第 90 百分位数：762 美元，1642 美元）。
美国和波多黎各临床机构报告的 HIV-1 暴露婴儿的大多数检测为 NAATs，但每名婴儿接受的 HIV-1 诊断检测数量以及每名婴儿 HIV-1 诊断检测相关成本差异很大。
