Diagnosis of pediatric human immunodeficiency virus infection by means of a commercially available polymerase chain reaction gene amplification
R. P. Nelson Jr, L. J. Price, A. B. Halsey, S. N. Graven, L. Resnick, N. K. Day, R. F. Lockey and R. A. Good
Department of Pediatrics, University of South Florida College of Medicine, St Petersburg, USA.
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.
