       Document 0114
 DOCN  M9640114
 TI    Diagnosis of pediatric human immunodeficiency virus infection by means
       of a commercially available polymerase chain reaction gene amplification
       [see comments]
 DT    9604
 AU    Nelson RP Jr; Price LJ; Halsey AB; Graven SN; Resnick L; Day NK; Lockey
       RF; Good RA; Department of Pediatrics, University of South Florida
       College of; Medicine, St Petersburg, USA.
 SO    Arch Pediatr Adolesc Med. 1996 Jan;150(1):40-5. Unique Identifier :
       AIDSLINE MED/96133237
 CM    Comment in: Arch Pediatr Adolesc Med 1996 Jan;150(1):39
 AB    OBJECTIVE: To assess the sensitivity and specificity of polymerase chain
       reaction (PCR) in infants and children at risk for human
       immunodeficiency virus (HIV) infection. DESIGN: A prospective, blinded
       study of 286 HIV-seropositive infants and children. Infection was
       diagnosed by antibody detection after 18 months of age, two positive
       direct tests (p24 antigen and HIV culture), or the presence of an
       illness that defines the acquired immunodeficiency syndrome. SETTING:
       University of South Florida and All Children's Hospital, St Petersburg,
       inpatient and outpatient centers. PARTICIPANTS: Two hundred eighty-six
       infants and children seropositive for HIV who were examined between July
       1988 and September 1992. MAIN OUTCOME MEASURES: Sensitivity,
       specificity, and predictive values of a commercially available PCR test.
       RESULTS: Five hundred sixty-seven PCR tests were performed on samples
       from 286 seropositive subjects followed up for a minimum of 16 months.
       Of the subjects, 105 were confirmed to be infected and 181 uninfected.
       Overall, 96 of 105 initial PCRs in infected subjects were positive
       (sensitivity, 91.4%; positive predictive value, 99%). If samples
       obtained during the first week of life are excluded, 95 to 100 samples
       were positive (sensitivity, 95%). Of 181 initial PCR tests from
       seropositive subjects who seroreverted, 180 were negative (specificity,
       99.4%,; negative predictive value, 95.2%). The predictive value of a
       positive test was 90.9% and that of a negative test was 93.1% in the
       first month of life. All 145 initial samples obtained between 5 weeks
       and 12 months of age correctly predicted infection status (positive
       predictive value, 100%). CONCLUSIONS: Gene amplification by means of a
       commercially available PCR is useful in the diagnosis of HIV infection
       for infants born to seropositive mothers. Between day 7 through 1 year
       of age, HIV infection is accurately diagnosed by the PCR assay.
 DE    Age Factors  Child, Preschool  *Disease Transmission, Vertical  Human
       HIV Core Protein p24/BLOOD  HIV Infections/*BLOOD/DIAGNOSIS/TRANSMISSION
       Infant  Infant, Newborn  Neonatal Screening/METHODS  Polymerase Chain
       Reaction/*STANDARDS  Prospective Studies  Reagent Kits,
       Diagnostic/*STANDARDS  Sensitivity and Specificity  Single-Blind Method
       CLINICAL TRIAL  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

