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Arch Pediatr Adolesc Med. 2009 Jan;163(1):6-11. doi: 10.1001/archpediatrics.2008.513.

Diagnosis of neonatal sepsis using universal primer polymerase chain reaction before and after starting antibiotic drug therapy.

Author information

  • 1Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India. sourabhdutta@yahoo.co.in

Abstract

OBJECTIVE:

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.

DESIGN:

Prospective study of diagnostic tests.

SETTING:

Level III neonatal intensive care unit. Patients 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.

INTERVENTIONS:

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.

RESULTS:

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.

CONCLUSION:

Universal primer PCR can accurately diagnose neonatal sepsis before but not after antibiotic drugs are given.

PMID:
19124696
[PubMed - indexed for MEDLINE]
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