To study universal primer 16S rRNA gene polymerase chain reaction (PCR) for diagnosis of blood culture–positive neonatal sepsis before and after starting antibiotic drug therapy.
Prospective study of diagnostic tests.
Level III neonatal intensive care unit.
Neonates with a fresh episode of clinically suspected sepsis were enrolled; those with major malformations, life expectancy less than 12 hours, or contaminated blood cultures were excluded.
Before starting antibiotic drug therapy, PCR (0 hour), blood culture, and sepsis screening (complete blood cell counts, micro–erythrocyte sedimentation rate, and C-reactive protein level) were performed. The PCR was repeated 12, 24, and 48 hours after starting antibiotic drug therapy.
Main Outcome Measures
The primary outcomes were the sensitivity and specificity of 0-hour PCR for diagnosing blood culture–positive sepsis, and the secondary outcome was the proportion of 0-hour PCR–positive patients who remained positive after antibiotic drug therapy.
Of 306 patients evaluated, 242 were included (mean [SD] gestation, 32.2 [3.1] weeks; and mean [SD] birth weight, 1529.2 [597.2] g). Blood culture was positive in 52 patients and 0-hour PCR in 57. The sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios of PCR were 96.2%, 96.3%, 87.7%, 98.8%, 26.1, and 0.04, respectively. Two patients were blood culture positive but 0-hour PCR negative, whereas 7 were 0-hour PCR positive but blood culture negative. Of the 0-hour PCR–positive patients, 7 remained positive at 12 hours and none at 24 and 48 hours after starting antibiotic drug therapy. In 0-hour PCR–positive patients, no predictors of positive 12-hour PCR were identified.
Universal primer PCR can accurately diagnose neonatal sepsis before but not after antibiotic drugs are given.