Diagnosis of neonatal sepsis by broad range 16S real-time PCR

• Context: The standard diagnostic test (blood culture) for suspected neonatal sepsis has limitations in sensitivity, specificity and 16 S polymerase chain reaction has been suggested as a new diagnostic tool for neonatal sepsis.Objective:To develop and evaluate a new real-time polymerase chain reaction (PCR) method for detection of bacterial DNA in blood samples collected from infants with suspected neonatal sepsis. Primary outcome was the sensitivity, specificity, and positive and negative predictive value of the 16 S real-time PCR assay as compared with blood culture.Design: Prospective study of diagnostic test.Setting: Two Swedish Level III neonatal intensive care units.Patients: 317 infants < 3 months of age subjected to blood culture as decided by the attending neonatologist.Main outcome measures: Sensitivity and specificity of the studied PCR method was the main outcome, with simultaneously collected blood culture acting as the gold standard. Detailed case studies was performed in all cases with conflicting results, to verify if PCR could detect pathogens in culture negative sepsis.Results: The material comprised 368 samples from 317 infants. When compared with blood culture, the assay yielded a sensitivity of 79%, a specificity of 90%, a positive predictive value of 59%, and a negative predictive value of 96%. PCR detected 29/35 (83%) of the Coagulase negative staphylococci samples and 15/21 (71%) of the remaining cultures. In five samples, PCR (but not blood culture) could detect a pathogen that was present in blood culture more than 24 hours earlier.Conclusions: This study presents an evaluation of a new real-time PCR technique that can detect culture-positive sepsis, and suggests that PCR has the potential to detect bacteria in culture-negative samples even if collected after the initiation of intravenous antibiotics.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Pediatrik (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Pediatrics (hsv//eng)

Nyckelord

MEDICINE

MEDICIN

Pediatrik

Pediatrics

Medicine

Medicin

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vet (ämneskategori)

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