Evaluation of the Light-Cycler® SeptiFast Test in Newborns With Suspicion of Nosocomial Sepsis.

Background: Nosocomial sepsis (NS) in newborns (NBs) is associated with high mortality rates and low microbial recovery rates. To overcome the latter problem, new techniques in molecular biology are being used.

Objectives: To evaluate the diagnostic efficacy of SeptiFast test for the diagnosis of nosocomial sepsis in the newborn.

Materials And Methods: 86 blood specimens of NBs with suspected NS (NOSEP-1 Test > 8 points) were analyzed using Light Cycler SeptiFast (LC-SF) a real-time multiplex PCR instrument. The results were analyzed with the Roche SeptiFast Identification Software. Another blood sample was collected to carry out a blood culture (BC).

Results: Sensitivity (Sn) and specificity (Sp) of 0.69 and 0.65 respectively, compared with blood culture (BC) were obtained for LC-SF. Kappa index concordance between LC-SF and BC was 0.21. Thirteen (15.11%) samples were BC positive and 34 (31.39%) were positive with LC-SF tests.

Conclusions: Compared with BC, LC-SF allows the detection of a greater number of pathogenic species in a small blood sample (1 mL) with a shorter response time.