Sepsis/Meningitis

EuSep Screen® Plus

REF

9345

Description

Real time PCR test for the detection of bacterial DNA belonging to the 8 invasive strains of Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, with differential identification of Haemophilus influenzae type b (Hib)

Packaging

8 test

Certification

“Sepsis is a rare complication of an infection, the consequences of which can be very serious and potentially fatal. It consists of an excessive inflammatory response of the organism to a generalized infection that damages tissues and organs, compromising their functioning” – Istituto Superiore di Healthcare (ISS) – 2019
Molecular diagnostic tools enable the pathogens identification in a short time and therefore they can limit the use of broad-spectrum antibiotics, which may be un-effective. EuSep Screen® Plus is able to detect non-viable pathogen as a consequence of antibiotics administration before the sample’s collection.

Summary Documents Related products Information Request

Summary

Technology

Real Time PCR technology

Target

Haemophilus influenzae
Streptococcus pneumoniae
Neisseria meningitidis

Genetic region

gene ctrA (Neisseria meningitidis strain A, B, C, W135, H, Z, 29E, NT)
gene lytA (Streptococcus pneumoniae, all the serotypes)
gene fuck (Haemophilus influenzae capsulated a-f strains and not capsulated strains)
gene bcs3 (Haemophilus influenzae type b capsulated)

Mastermix number

Internal control

Exogenous

Fluorophores

Limit of Detection (LoD)

2 copies/µl (10 copies/reaction)

Analytical specificity

A wide range of pathogens was used to test the assay. No cross-reactivity was found.

Diagnostic sensitivity

100 %

Diagnostic specificity

100 %

Specimen

Whole blood
CSF
Pleuric fluid
Synovial fluid
Other sterile human biological material

Validated thermalcyclers

Applied Biosystems™ 7300 e 7500, 7500 Fast e 7500 Fast Dx
Step One e Step One Plus Real-time PCR Instrument system (Thermo Fisher Scientific)
CFX96 Touch, CFX Connect, CFX Opus 96 Real-time PCR detection system (Bio-Rad)
Eppendorf RealPlex
Qiagen Rotor-Gene 3000/6000

Software

Easy-NAT